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https://zephyrnet.com/NCT03800407
2019-01-28
https://zephyrnet.com/?p=NCT03800407
NCT03800407https://www.clinicaltrials.gov/study/NCT03800407?tab=tableOluwayemisi Ojewale, MBChB, MPHOluwayemisi.Ojewale@medicine.ufl.edu3522739446Efavirenz (EFV)-based antiretroviral therapy (ART) remains the preferred regimen in human immunodeficiency virus (HIV)-infected children aged 3 years or older on rifampin-containing antituberculosis (anti-TB) therapy. This is because drug interactions between first-line anti-TB therapy with protease inhibitors (PIs) are more severe to adjust for, and interactions with integrase strand transfer inhibitors (INSTIs) are not well studied in that age group. Although, current weight-based EFV dosing recommendation is not optimal in some children, pharmacokinetic-treatment response (PK-PD) data to guide optimal dosing of EFV during concurrent rifampin-containing therapy in children is very limited. The study team propose that EFV concentrations outside the optimal therapeutic range in children will be associated with virologic failure due to lack of efficacy because of low concentrations or increased central nervous system (CNS) toxicities from high concentrations leading to poor medication adherence. The study will determine virological suppression rates in HIV-infected children with and without TB coinfection treated with standard efavirenz-based therapy and examine the factors contributing to poor virologic response.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-03 |
Study First Posted Date | 2019-01-11 |
Last Update Posted Date | 2023-05-16 |
Start Month Year | January 28, 2019 |
Primary Completion Month Year | May 31, 2024 |
Verification Month Year | May 2023 |
Verification Date | 2023-05-31 |
Last Update Posted Date | 2023-05-16 |
Detailed Descriptions
Sequence: | 20619572 |
Description | In a previous study, the study team found that first-line anti-TB therapy had minimal effect on EFV pharmacokinetics (PK) at the population level, but children with TB/HIV coinfection on anti-TB therapy had a trend towards worse virologic outcome compared to those with only HIV infection. Due to the small sample size, the study team were unable to examined the patient factors contributing to the poor virologic response. The study team hypothesized that virologic suppression rates on EFV-based therapy is significantly lower in children with TB/HIV coinfection compared to those with HIV alone. In addition, virologic response will be dependent EFV plasma concentrations, CYP2B6 516 G>T genotype and/or adherence level. This hypothesis is based on the premise that extremes (low and high EFV concentration, respectively) could lead to virologic failure because of lack of efficacy or intolerable side effects leading to poor adherence. The current study will investigate the effect of anti-TB therapy, CYP2B6 genotype and pharmacokinetically determined adherence level on virologic response in children with TB/HIV coinfection treated with EFV-based ART. |
Facilities
Sequence: | 199057015 |
Status | Recruiting |
Name | Kwame Nkrumah University of Science and Technology |
City | Kumasi |
Country | Ghana |
Facility Contacts
Sequence: | 27991441 | Sequence: | 27991442 |
Facility Id | 199057015 | Facility Id | 199057015 |
Contact Type | primary | Contact Type | backup |
Name | Sampson Antwi, MBChB | Name | Anthony Enimil, MBChB |
kantwi@gmail.com | tenimil@live.com | ||
Phone | +233265812061 | Phone | +233208164433 |
Conditions
Sequence: | 51910347 | Sequence: | 51910348 | Sequence: | 51910349 |
Name | Tuberculosis | Name | Human Immunodeficiency Virus | Name | Coinfection |
Downcase Name | tuberculosis | Downcase Name | human immunodeficiency virus | Downcase Name | coinfection |
Id Information
Sequence: | 39954130 | Sequence: | 39954131 | Sequence: | 39954132 |
Id Source | org_study_id | Id Source | secondary_id | Id Source | secondary_id |
Id Value | IRB201801820 TB/HIV – N | Id Value | 2R01HD071779 | Id Value | 5R01HD071779-10 |
Id Type | U.S. NIH Grant/Contract | Id Type | U.S. NIH Grant/Contract | ||
Id Link | https://reporter.nih.gov/quickSearch/2R01HD071779 | Id Link | https://reporter.nih.gov/quickSearch/5R01HD071779-10 |
Countries
Sequence: | 42346744 |
Name | Ghana |
Removed | False |
Design Groups
Sequence: | 55317746 | Sequence: | 55317747 |
Title | EFV-based ART | Title | Concurrent EFV-based ART plus anti-TB therapy |
Description | ART-naïve HIV-infected children aged 3 – 14 years who initiate EFV-based ART | Description | ART-naïve HIV-infected children aged 3 – 14 years with TB coinfection who initiate EFV-based ART while receiving first-line anti-TB therapy |
Interventions
Sequence: | 52224949 |
Intervention Type | Other |
Name | Observational study |
Description | Outcome of EFV-based ART in children with TB/HIV coinfection compared to those with HIV only on EFV-based ART |
Keywords
Sequence: | 79454238 | Sequence: | 79454239 | Sequence: | 79454240 | Sequence: | 79454241 | Sequence: | 79454242 |
Name | Pharmacokinetic | Name | Concurrent antituberculosis therapy | Name | Efavirenz | Name | Virologic response | Name | Children |
Downcase Name | pharmacokinetic | Downcase Name | concurrent antituberculosis therapy | Downcase Name | efavirenz | Downcase Name | virologic response | Downcase Name | children |
Design Outcomes
Sequence: | 176482908 | Sequence: | 176482909 | Sequence: | 176482910 | Sequence: | 176482911 | Sequence: | 176482912 | Sequence: | 176482913 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | TB coinfection status and HIV RNA < 200 copies/mL on EFV-based ART in HIV-infected children. | Measure | Efavirenz plasma mid-dose concentration and HIV RNA suppression < 200 copies/mL. | Measure | Random efavirenz concentration below the limit of detection (poor ART adherence) and HIV RNA suppression rate. | Measure | CYP2B6 516G>T genotype status and random efavirenz concentration below the limit of detection (poor ART adherence). | Measure | CYP2B6 516G>T genotype status and HIV RNA suppression < 200 copies/mL. | Measure | TB coinfection status and risk of virological failure on EFV-based ART. |
Time Frame | At week 24 of HIV therapy. | Time Frame | Up to week 24 of HIV therapy. | Time Frame | Up to week 24 of HIV therapy. | Time Frame | Up to week 24 of HIV therapy. | Time Frame | Up to week 24 of HIV therapy. | Time Frame | Up to week 48 of HIV therapy. |
Description | The proportion of children with TB/HIV coinfection with virological suppression (HIV RNA < 200 copies/mL) on EFV-based ART and anti-TB therapy compared to that in children with only HIV infection on EFV-based therapy. | Description | Relationship between EFV mid-dose concentration and HIV RNA suppression rate in the combined population of HIV-infected children with and without TB coinfection. | Description | Relationship poor ART adherence and EFV-based ART response in the combined population of HIV-infected children with and without TB coinfection. | Description | Relationship between CYP2B6 516G>T genotype status and likelihood of poor EFV-based ART adherence. | Description | Relationship between CYP2B6 516G>T genotype status and likelihood of HIV RNA suppression. | Description | Proportion of children with TB/HIV coinfection compared to those with only HIV infection with virological failure (HIV RNA > 1000 copies/mL) at 12 months of EFV-based ART. |
Browse Conditions
Sequence: | 192438313 | Sequence: | 192438314 | Sequence: | 192438315 | Sequence: | 192438316 | Sequence: | 192438317 | Sequence: | 192438318 | Sequence: | 192438319 | Sequence: | 192438320 | Sequence: | 192438321 | Sequence: | 192438322 | Sequence: | 192438323 | Sequence: | 192438324 | Sequence: | 192438325 | Sequence: | 192438326 | Sequence: | 192438327 | Sequence: | 192438328 | Sequence: | 192438329 | Sequence: | 192438330 | Sequence: | 192438331 | Sequence: | 192438332 | Sequence: | 192438333 | Sequence: | 192438334 | Sequence: | 192438335 |
Mesh Term | Tuberculosis | Mesh Term | Acquired Immunodeficiency Syndrome | Mesh Term | HIV Infections | Mesh Term | Coinfection | Mesh Term | Mycobacterium Infections | Mesh Term | Actinomycetales Infections | Mesh Term | Gram-Positive Bacterial Infections | Mesh Term | Bacterial Infections | Mesh Term | Bacterial Infections and Mycoses | Mesh Term | Infections | Mesh Term | Immunologic Deficiency Syndromes | Mesh Term | Immune System Diseases | Mesh Term | Blood-Borne Infections | Mesh Term | Communicable Diseases | Mesh Term | Sexually Transmitted Diseases, Viral | Mesh Term | Sexually Transmitted Diseases | Mesh Term | Lentivirus Infections | Mesh Term | Retroviridae Infections | Mesh Term | RNA Virus Infections | Mesh Term | Virus Diseases | Mesh Term | Slow Virus Diseases | Mesh Term | Genital Diseases | Mesh Term | Urogenital Diseases |
Downcase Mesh Term | tuberculosis | Downcase Mesh Term | acquired immunodeficiency syndrome | Downcase Mesh Term | hiv infections | Downcase Mesh Term | coinfection | Downcase Mesh Term | mycobacterium infections | Downcase Mesh Term | actinomycetales infections | Downcase Mesh Term | gram-positive bacterial infections | Downcase Mesh Term | bacterial infections | Downcase Mesh Term | bacterial infections and mycoses | Downcase Mesh Term | infections | Downcase Mesh Term | immunologic deficiency syndromes | Downcase Mesh Term | immune system diseases | Downcase Mesh Term | blood-borne infections | Downcase Mesh Term | communicable diseases | Downcase Mesh Term | sexually transmitted diseases, viral | Downcase Mesh Term | sexually transmitted diseases | Downcase Mesh Term | lentivirus infections | Downcase Mesh Term | retroviridae infections | Downcase Mesh Term | rna virus infections | Downcase Mesh Term | virus diseases | Downcase Mesh Term | slow virus diseases | Downcase Mesh Term | genital diseases | Downcase Mesh Term | urogenital diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48073444 | Sequence: | 48073445 |
Agency Class | OTHER | Agency Class | NIH |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | University of Florida | Name | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
Overall Officials
Sequence: | 29131986 |
Role | Principal Investigator |
Name | Awewura Kwara, MD |
Affiliation | University of Florida |
Central Contacts
Sequence: | 11951906 | Sequence: | 11951907 |
Contact Type | primary | Contact Type | backup |
Name | Awewura Kwara, MD | Name | Oluwayemisi Ojewale, MBChB, MPH |
Phone | 3522739501 | Phone | 3522739446 |
awewura.kwara@medicine.ufl.edu | Oluwayemisi.Ojewale@medicine.ufl.edu | ||
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 67816448 | Sequence: | 67816449 |
Design Group Id | 55317747 | Design Group Id | 55317746 |
Intervention Id | 52224949 | Intervention Id | 52224949 |
Eligibilities
Sequence: | 30610335 |
Sampling Method | Non-Probability Sample |
Gender | All |
Minimum Age | 3 Years |
Maximum Age | 14 Years |
Healthy Volunteers | No |
Population | Children aged 3 to 14 years old with HIV infection with or without active TB |
Criteria | Inclusion Criteria:
HIV seropositive children with or without active TB Exclusion Criteria: Unable to obtain informed signed consent parent(s) or legal guardian |
Adult | False |
Child | True |
Older Adult | False |
Calculated Values
Sequence: | 253951421 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 3 |
Maximum Age Num | 14 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 5 |
Designs
Sequence: | 30357579 |
Observational Model | Cohort |
Time Perspective | Prospective |
Responsible Parties
Sequence: | 28729448 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03800394
2019-01-28
https://zephyrnet.com/?p=NCT03800394
NCT03800394https://www.clinicaltrials.gov/study/NCT03800394?tab=tableOluwayemisi Ojewale, MBChB, MPHoawoyemi@ufl.edu3522739446Tenofovir (TFV) disoproxil fumarate (TDF) plus emtricitabine (FTC) or lamivudine (3TC) is the preferred nucleoside backbone of first-line antiretroviral therapy (ART) for adolescents in sub-Saharan Africa. In addition, TDF/FTC is recommended for preexposure prophylaxis (PrEP) for human immunodeficiency virus (HIV) infection in adolescents at substantial risk of acquisition of HIV infection, as well as for hepatitis B virus (HBV) treatment in those with HBV/HIV coinfection. The efficacy TDF and FTC are dependent on intracellular concentrations of the active phosphate anabolites, called TFV diphosphate (TFV-DP) and FTC triphosphate (FTC-TP). However, the intracellular pharmacokinetics of TFV-DP and FTC-TP to examine the adequacy of current dosages in African adolescents has not been previously studied. Thus, examining the pharmacokinetics (PK) of these widely used antiretrovirals in African adolescents is important as ART outcomes remain poor and the recommended dosages of these drugs for children and adolescent were extrapolated from drug approval clinical trials in adult in the United States and Europe.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-03 |
Study First Posted Date | 2019-01-11 |
Last Update Posted Date | 2023-06-15 |
Start Month Year | January 28, 2019 |
Primary Completion Month Year | October 5, 2023 |
Verification Month Year | June 2023 |
Verification Date | 2023-06-30 |
Last Update Posted Date | 2023-06-15 |
Detailed Descriptions
Sequence: | 20672540 |
Description | This study will evaluate the intracellular PK of TFV-DP and FTC-TP in Ghanaian HIV-infected adolescents with and without TB coinfection. As the clinical effects of TDF and FTC are related to the intracellular concentrations of the phosphate anabolites, called TFV-DP and FTC-TP, there is a need to understand the cellular pharmacology of TDF interactions in African HIV-infected adolescents with and without TB, as the study team cannot extrapolate from US patients not on antituberculosis (anti-TB) drugs. This study will enroll HIV-infected adolescents aged 10 to 18 years old with and without TB coinfection who are already established on ART. The study team hypothesize that younger age, adenosine triphosphate (ATP)-binding cassette subfamily C (ABCC) single nucleotide polymorphisms (SNPs) and anti-TB therapy may influence the intracellular TFV-DP and FTC-TP concentrations in adolescents. |
Facilities
Sequence: | 199554958 |
Status | Recruiting |
Name | Kwame Nkrumah University of Science and Technology |
City | Kumasi |
Country | Ghana |
Facility Contacts
Sequence: | 28053624 | Sequence: | 28053625 |
Facility Id | 199554958 | Facility Id | 199554958 |
Contact Type | primary | Contact Type | backup |
Name | Sampson Antwi, MBChB | Name | Anthony Enimil, MBChB |
Kantwi@gmail.com | Tenimil@live.com | ||
Phone | +233265812061 | Phone | +233208164433 |
Facility Investigators
Sequence: | 18299636 | Sequence: | 18299637 |
Facility Id | 199554958 | Facility Id | 199554958 |
Role | Principal Investigator | Role | Sub-Investigator |
Name | Sampson Antwi, MBChB | Name | Anthony Enimil, MBChB |
Conditions
Sequence: | 52043113 | Sequence: | 52043114 | Sequence: | 52043115 |
Name | Human Immunodeficiency Virus (HIV) | Name | Tuberculosis | Name | Coinfection |
Downcase Name | human immunodeficiency virus (hiv) | Downcase Name | tuberculosis | Downcase Name | coinfection |
Id Information
Sequence: | 40057537 | Sequence: | 40057538 |
Id Source | org_study_id | Id Source | secondary_id |
Id Value | IRB201801820 – PKAdol | Id Value | 2R01HD071779 |
Id Type | U.S. NIH Grant/Contract | ||
Id Link | https://reporter.nih.gov/quickSearch/2R01HD071779 |
Countries
Sequence: | 42455772 |
Name | Ghana |
Removed | False |
Design Groups
Sequence: | 55451566 | Sequence: | 55451567 |
Title | HIV only | Title | HIV/TB |
Description | Adolescents aged 10-19 years with HIV infection | Description | Adolescents aged 10-19 years with HIV and TB coinfection |
Interventions
Sequence: | 52354694 |
Intervention Type | Other |
Name | Observational PK study |
Description | Effect of antituberculosis treatment, age and genetic factors on intracellular TFV-DP and FTC-TP concentrations |
Keywords
Sequence: | 79659601 | Sequence: | 79659602 | Sequence: | 79659603 | Sequence: | 79659604 | Sequence: | 79659605 |
Name | Pharmacokinetic | Name | Pharmacogenomic | Name | Tenofovir diphosphate | Name | Emtricitabine triphosphate | Name | Adolescents |
Downcase Name | pharmacokinetic | Downcase Name | pharmacogenomic | Downcase Name | tenofovir diphosphate | Downcase Name | emtricitabine triphosphate | Downcase Name | adolescents |
Design Outcomes
Sequence: | 176935749 | Sequence: | 176935750 | Sequence: | 176935751 | Sequence: | 176935752 | Sequence: | 176935753 | Sequence: | 176935754 | Sequence: | 176935755 | Sequence: | 176935756 | Sequence: | 176935757 | Sequence: | 176935758 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Average concentration (Cav) of intracellular TFV-DP and FTC-TP in Ghanaian HIV-infected adolescents. | Measure | Area under the time-concentration curve 0-24 hours (AUC0-24h) of intracellular TFV-DP and FTC-TP in Ghanaian HIV-infected adolescents. | Measure | Cav of TFV-DP and FTC-TP PK in HIV-infected adolescents with and without TB coinfection. | Measure | AUC0-24h of TFV-DP and FTC-TP PK in HIV-infected adolescents with and without TB coinfection. | Measure | Effect of age on TFV-DP and FTC-TP Cav. | Measure | Effect of age on TFV-DP and FTC-TP AUC0-24h . | Measure | Intracellular TFV-DP and FTC-TP Cav in adolescents compared to that in historical adult controls. | Measure | Intracellular TFV-DP and FTC-TP AUC0-24h in adolescents compared to that in historical adult controls. | Measure | Relationship between Adenosine triphosphate (ATP)-binding cassette subfamily C, member 2 (ABCC2), member 4 (ABCC4) and member 10 (ABCC10) SNPs and TFV-DP and FTC-TP AUC0-24h. | Measure | Prevalence and covariates of intracellular TFV-DP Cav < 95 fmol/106 cells in adolescents. |
Time Frame | After at least 8 weeks of HIV therapy. | Time Frame | After at least 8 weeks of HIV therapy. | Time Frame | After at least 8 weeks of HIV therapy. | Time Frame | After at least 8 weeks of HIV therapy. | Time Frame | After at least 8 weeks of HIV therapy. | Time Frame | After at least 8 weeks of HIV therapy. | Time Frame | After at least 8 weeks of HIV therapy. | Time Frame | After at least 8 weeks of HIV therapy. | Time Frame | After at least 8 weeks of HIV therapy. | Time Frame | After at least 8 weeks of HIV therapy. |
Description | Mean and median Cav of intracellular TFV-DP and FTC-TP in Ghanaian HIV-infected adolescents. | Description | Mean and median AUC0-24h of intracellular TFV-DP and FTC-TP in Ghanaian HIV-infected adolescents. | Description | Geometric mean intracellular TFV-DP and FTC-TP Cav in adolescents with TB/HIV coinfection compared to those only HIV infection. | Description | Geometric mean of intracellular TFV-DP and FTC-TP AUC0-24h in adolescents with TB/HIV coinfection compared to those with only HIV infection. | Description | Geometric mean of intracellular TFV-DP and FTC-TP Cav in adolescents aged 10 – 14 years old compared to that in adolescents aged 15 – 19 years old. | Description | Geometric mean of intracellular TFV-DP and FTC-TP AUC0-24h in adolescents aged 10 – 14 years old compared to that in adolescents aged 15 – 19 years old. | Description | Geometric mean of intracellular TFV-DP and FTC-TP Cav in Ghanaian HIV-infected adolescent compared to published values in adults treated with similar dosage. | Description | Geometric mean of intracellular TFV-DP and FTC-TP AUC0-24h in Ghanaian HIV-infected adolescent compared to published values in adults treated with similar dosage. | Description | Relationship between ABCC2, ABCC4 and ABCC10 SNPs and intracellular TFV-DP and FTC-TP AUC0-24h. | Description | Proportion of Ghanaian adolescents and factors associated with intracellular TFV-DP average concentration < 95 fmol/106 cells. |
Browse Conditions
Sequence: | 192975167 | Sequence: | 192975168 | Sequence: | 192975169 | Sequence: | 192975174 | Sequence: | 192975175 | Sequence: | 192975176 | Sequence: | 192975177 | Sequence: | 192975178 | Sequence: | 192975179 | Sequence: | 192975180 | Sequence: | 192975181 | Sequence: | 192975182 | Sequence: | 192975183 | Sequence: | 192975184 | Sequence: | 192975185 | Sequence: | 192975186 | Sequence: | 192975187 | Sequence: | 192975188 | Sequence: | 192975189 | Sequence: | 192975170 | Sequence: | 192975171 | Sequence: | 192975172 | Sequence: | 192975173 |
Mesh Term | Tuberculosis | Mesh Term | Acquired Immunodeficiency Syndrome | Mesh Term | HIV Infections | Mesh Term | Bacterial Infections | Mesh Term | Bacterial Infections and Mycoses | Mesh Term | Infections | Mesh Term | Immunologic Deficiency Syndromes | Mesh Term | Immune System Diseases | Mesh Term | Blood-Borne Infections | Mesh Term | Communicable Diseases | Mesh Term | Sexually Transmitted Diseases, Viral | Mesh Term | Sexually Transmitted Diseases | Mesh Term | Lentivirus Infections | Mesh Term | Retroviridae Infections | Mesh Term | RNA Virus Infections | Mesh Term | Virus Diseases | Mesh Term | Slow Virus Diseases | Mesh Term | Genital Diseases | Mesh Term | Urogenital Diseases | Mesh Term | Coinfection | Mesh Term | Mycobacterium Infections | Mesh Term | Actinomycetales Infections | Mesh Term | Gram-Positive Bacterial Infections |
Downcase Mesh Term | tuberculosis | Downcase Mesh Term | acquired immunodeficiency syndrome | Downcase Mesh Term | hiv infections | Downcase Mesh Term | bacterial infections | Downcase Mesh Term | bacterial infections and mycoses | Downcase Mesh Term | infections | Downcase Mesh Term | immunologic deficiency syndromes | Downcase Mesh Term | immune system diseases | Downcase Mesh Term | blood-borne infections | Downcase Mesh Term | communicable diseases | Downcase Mesh Term | sexually transmitted diseases, viral | Downcase Mesh Term | sexually transmitted diseases | Downcase Mesh Term | lentivirus infections | Downcase Mesh Term | retroviridae infections | Downcase Mesh Term | rna virus infections | Downcase Mesh Term | virus diseases | Downcase Mesh Term | slow virus diseases | Downcase Mesh Term | genital diseases | Downcase Mesh Term | urogenital diseases | Downcase Mesh Term | coinfection | Downcase Mesh Term | mycobacterium infections | Downcase Mesh Term | actinomycetales infections | Downcase Mesh Term | gram-positive bacterial infections |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48198941 | Sequence: | 48198942 |
Agency Class | OTHER | Agency Class | NIH |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | University of Florida | Name | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
Overall Officials
Sequence: | 29210382 |
Role | Principal Investigator |
Name | Awewura Kwara, MD |
Affiliation | University of Florida |
Central Contacts
Sequence: | 11981812 | Sequence: | 11981813 |
Contact Type | primary | Contact Type | backup |
Name | Awewura Kwara, MD | Name | Oluwayemisi Ojewale, MBChB, MPH |
Phone | 352-273-9501 | Phone | 3522739446 |
awewura.kwara@medicine.ufl.edu | oawoyemi@ufl.edu | ||
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 67977861 | Sequence: | 67977862 |
Design Group Id | 55451566 | Design Group Id | 55451567 |
Intervention Id | 52354694 | Intervention Id | 52354694 |
Eligibilities
Sequence: | 30689779 |
Sampling Method | Non-Probability Sample |
Gender | All |
Minimum Age | 10 Years |
Maximum Age | 19 Years |
Healthy Volunteers | No |
Population | Adolescents aged 10-19 years with HIV with or without TB co-infection. |
Criteria | Inclusion Criteria:
HIV-infected adolescents aged 10 to 19 years old who are stable on antiretroviral regimen containing TDF/FTC (300/200 mg daily) for at least 8 weeks. Exclusion Criteria: Unable to obtain informed signed consent from parent(s) or legal guardian. |
Adult | True |
Child | True |
Older Adult | False |
Calculated Values
Sequence: | 253898317 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 10 |
Maximum Age Num | 19 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 4 |
Number Of Secondary Outcomes To Measure | 6 |
Designs
Sequence: | 30436474 |
Observational Model | Cohort |
Time Perspective | Cross-Sectional |
Responsible Parties
Sequence: | 28802995 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03800381
2019-01-28
https://zephyrnet.com/?p=NCT03800381
NCT03800381https://www.clinicaltrials.gov/study/NCT03800381?tab=tableOluwayemisi Ojewale, MBChB, MPHOluwayemisi.Ojewale@medicine.ufl.edu3522739446Lack of quality-assured pediatric formulations of the first-line antituberculosis (anti-TB) drugs is barrier to optimized tuberculosis (TB) treatment outcome in children. In 2010 and subsequently modified in 2014, the World Health Organization (WHO) recommended increased dosages of the first-line anti-TB drugs for children, but there were no child-friendly fixed-dose combination (FDC) formulations based on the guidelines. A large proportion of children treated with the new guidelines using old formulations did not achieve the desired rifampin peak concentration (Cmax) > 8 mg/L and pyrazinamide Cmax > 35 mg/L. The TB Alliance and the WHO led the development of a new child-appropriate isoniazid/rifampin/pyrazinamide (HRZ) and isoniazid/rifampin (HR) FDC formulation in line with current WHO recommended dosing guidelines. The new formulations dissolve quickly in liquid, have palatable fruit flavors, and are expected to improved daily adherence but no studies have evaluated the pharmacokinetics (PK) of the FDC formulation in children. The study team hypothesize that the new dispersible HRZ FDC tablet, dosed according to current WHO weight-band dosing recommendations will result in better PK parameters for each drug component than that achieved by the old formulation.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-03 |
Study First Posted Date | 2019-01-11 |
Last Update Posted Date | 2022-12-22 |
Start Month Year | January 28, 2019 |
Primary Completion Month Year | August 31, 2023 |
Verification Month Year | December 2022 |
Verification Date | 2022-12-31 |
Last Update Posted Date | 2022-12-22 |
Detailed Descriptions
Sequence: | 20680678 |
Description | This study will evaluate the PK of the new pediatric HRZ FDC tablet in Ghanaian children with TB with and without HIV coinfection. The new HRZ FDC dispersible tablet was designed to be child-friendly and to achieve recommended dosages for each weight-band. The formulation has been rolled out in Africa without PK studies in the target population to verify that the tablets achieves adequate drug concentrations. The current study will evaluate the adequacy of the formulation by examining the PK of the component drugs as well as the effect of HIV coinfection. The direct PK data will be used in a population PK model and stimulations to define optimal weight-band dosages and proportions of the components of the pediatric FDC tablets. |
Facilities
Sequence: | 199609468 |
Status | Recruiting |
Name | Kwame Nkrumah University of Science and Technology |
City | Kumasi |
Country | Ghana |
Facility Contacts
Sequence: | 28059603 | Sequence: | 28059604 |
Facility Id | 199609468 | Facility Id | 199609468 |
Contact Type | primary | Contact Type | backup |
Name | Sampson Antwi, MBChB | Name | Anthony Enimil, MBchB |
antwisampson@yahoo.com | tenimil@live.com | ||
Phone | +233265812061 | Phone | +233208164433 |
Browse Interventions
Sequence: | 95831526 | Sequence: | 95831527 | Sequence: | 95831528 | Sequence: | 95831529 | Sequence: | 95831530 | Sequence: | 95831531 | Sequence: | 95831532 | Sequence: | 95831533 | Sequence: | 95831534 | Sequence: | 95831535 | Sequence: | 95831536 | Sequence: | 95831537 | Sequence: | 95831538 | Sequence: | 95831539 | Sequence: | 95831540 | Sequence: | 95831541 | Sequence: | 95831542 | Sequence: | 95831543 | Sequence: | 95831544 | Sequence: | 95831545 | Sequence: | 95831546 |
Mesh Term | Rifampin | Mesh Term | Isoniazid | Mesh Term | Pyrazinamide | Mesh Term | Antibiotics, Antitubercular | Mesh Term | Antitubercular Agents | Mesh Term | Anti-Bacterial Agents | Mesh Term | Anti-Infective Agents | Mesh Term | Leprostatic Agents | Mesh Term | Nucleic Acid Synthesis Inhibitors | Mesh Term | Enzyme Inhibitors | Mesh Term | Molecular Mechanisms of Pharmacological Action | Mesh Term | Cytochrome P-450 CYP2B6 Inducers | Mesh Term | Cytochrome P-450 Enzyme Inducers | Mesh Term | Cytochrome P-450 CYP2C8 Inducers | Mesh Term | Cytochrome P-450 CYP2C19 Inducers | Mesh Term | Cytochrome P-450 CYP2C9 Inducers | Mesh Term | Cytochrome P-450 CYP3A Inducers | Mesh Term | Fatty Acid Synthesis Inhibitors | Mesh Term | Hypolipidemic Agents | Mesh Term | Antimetabolites | Mesh Term | Lipid Regulating Agents |
Downcase Mesh Term | rifampin | Downcase Mesh Term | isoniazid | Downcase Mesh Term | pyrazinamide | Downcase Mesh Term | antibiotics, antitubercular | Downcase Mesh Term | antitubercular agents | Downcase Mesh Term | anti-bacterial agents | Downcase Mesh Term | anti-infective agents | Downcase Mesh Term | leprostatic agents | Downcase Mesh Term | nucleic acid synthesis inhibitors | Downcase Mesh Term | enzyme inhibitors | Downcase Mesh Term | molecular mechanisms of pharmacological action | Downcase Mesh Term | cytochrome p-450 cyp2b6 inducers | Downcase Mesh Term | cytochrome p-450 enzyme inducers | Downcase Mesh Term | cytochrome p-450 cyp2c8 inducers | Downcase Mesh Term | cytochrome p-450 cyp2c19 inducers | Downcase Mesh Term | cytochrome p-450 cyp2c9 inducers | Downcase Mesh Term | cytochrome p-450 cyp3a inducers | Downcase Mesh Term | fatty acid synthesis inhibitors | Downcase Mesh Term | hypolipidemic agents | Downcase Mesh Term | antimetabolites | Downcase Mesh Term | lipid regulating agents |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52062679 | Sequence: | 52062680 | Sequence: | 52062681 |
Name | Tuberculosis | Name | Human Immunodeficiency Virus | Name | Coinfection |
Downcase Name | tuberculosis | Downcase Name | human immunodeficiency virus | Downcase Name | coinfection |
Id Information
Sequence: | 40072582 | Sequence: | 40072583 |
Id Source | org_study_id | Id Source | secondary_id |
Id Value | IRB201801820 – HRZ PK -N | Id Value | 5R01HD071779-11 |
Id Type | U.S. NIH Grant/Contract | ||
Id Link | https://reporter.nih.gov/quickSearch/5R01HD071779-11 |
Countries
Sequence: | 42470297 |
Name | Ghana |
Removed | False |
Design Groups
Sequence: | 55474109 | Sequence: | 55474110 |
Title | Active TB only | Title | Active TB with HIV Co-infection |
Description | Children with clinical diagnosis or acid-fast bacilli (AFB) smear positive TB disease | Description | Children with clinical diagnosis or AFB smear positive TB disease who test positive for HIV infection |
Interventions
Sequence: | 52375069 |
Intervention Type | Other |
Name | Observational PK study |
Description | The study team will examine the PK and tolerability of the new HRZ 50/75/150 mg dispersible tablet in children with TB with and without HIV coinfection. Intensive PK testing will be performed after at least 4 weeks of treatment in children on first-line anti-TB therapy using the new pediatric HRZ FDC tablet. |
Keywords
Sequence: | 79690399 | Sequence: | 79690400 | Sequence: | 79690401 | Sequence: | 79690403 | Sequence: | 79690404 | Sequence: | 79690402 |
Name | Pharmacokinetic | Name | Pharmacogenomic | Name | Antituberculosis drugs | Name | Tuberculosis | Name | TB/HIV coinfection | Name | Children |
Downcase Name | pharmacokinetic | Downcase Name | pharmacogenomic | Downcase Name | antituberculosis drugs | Downcase Name | tuberculosis | Downcase Name | tb/hiv coinfection | Downcase Name | children |
Design Outcomes
Sequence: | 177004598 | Sequence: | 177004599 | Sequence: | 177004600 | Sequence: | 177004601 | Sequence: | 177004602 | Sequence: | 177004603 | Sequence: | 177004604 | Sequence: | 177004605 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Peak concentration (Cmax) of isoniazid, rifampin and pyrazinamide in the new pediatric HRZ FDC tablet. | Measure | Area under the time-concentration curve from 0-8 hours (AUC0-8h) of isoniazid, rifampin and pyrazinamide in the new pediatric HRZ FDC tablet. | Measure | Cmax of isoniazid, rifampin and pyrazinamide in children with TB with and without HIV coinfection | Measure | AUC0-8h of isoniazid, rifampin and pyrazinamide in children with TB with and without HIV coinfection. | Measure | AUC0-8h of isoniazid, rifampin and pyrazinamide in the new versus old pediatric HRZ FDC tablet. | Measure | Cmax of isoniazid, rifampin and pyrazinamide in the new versus old pediatric HRZ FDC tablet. | Measure | Proportion of children treated with new pediatric HRZ FDC tablet who develop with liver enzymes elevations. | Measure | Identify optimal weight-band dosages of the new HRZ FDC tablet |
Time Frame | After at least 4 weeks of anti-TB therapy | Time Frame | After at least 4 weeks of anti-TB therapy | Time Frame | After at least 4 weeks of anti-TB therapy | Time Frame | After at least 4 weeks of anti-TB therapy | Time Frame | After at least 4 weeks of anti-TB therapy | Time Frame | After at least 4 weeks of anti-TB therapy | Time Frame | After at least 4 weeks of anti-TB therapy | Time Frame | After at least 4 weeks of anti-TB therapy |
Description | Mean and median Cmax of rifampin, isoniazid and pyrazinamide in children with TB treated with the new HRZ FDC tablet. | Description | Mean and median AUC0-8h of rifampin, isoniazid and pyrazinamide in children with TB treated with the new HRZ FDC tablet. | Description | Geometric mean values of Cmax of rifampin, isoniazid and pyrazinamide in children with HIV/TB coinfection compared to those with TB alone. | Description | Geometric mean values of AUC0-8h of rifampin, isoniazid and pyrazinamide in children with HIV/TB coinfection compared to those with TB alone. | Description | Geometric mean values of AUC0-8h of rifampin, isoniazid, and pyrazinamide in children with TB treated with the new FDC tablet compared to those treated with the old formulation in our previous study (historical controls). | Description | Geometric mean values of Cmax of rifampin, isoniazid, and pyrazinamide in children with TB treated with the new FDC tablet compared to those treated with the old formulation in our previous study (historical controls). | Description | Frequency of liver enzymes elevations compared to baseline requiring treatment modification in children with TB with and without HIV coinfection. | Description | Use a population PK model that incorporates demographic, clinical and genetic factors and stimulations to identify the optimal weight-band dosing of the new FDC formulation. |
Browse Conditions
Sequence: | 193053677 | Sequence: | 193053678 | Sequence: | 193053679 | Sequence: | 193053680 | Sequence: | 193053681 | Sequence: | 193053682 | Sequence: | 193053683 | Sequence: | 193053684 | Sequence: | 193053685 | Sequence: | 193053686 | Sequence: | 193053687 | Sequence: | 193053688 | Sequence: | 193053689 | Sequence: | 193053690 | Sequence: | 193053691 | Sequence: | 193053692 | Sequence: | 193053693 | Sequence: | 193053694 | Sequence: | 193053695 | Sequence: | 193053696 | Sequence: | 193053697 | Sequence: | 193053698 | Sequence: | 193053699 |
Mesh Term | Tuberculosis | Mesh Term | Acquired Immunodeficiency Syndrome | Mesh Term | HIV Infections | Mesh Term | Coinfection | Mesh Term | Mycobacterium Infections | Mesh Term | Actinomycetales Infections | Mesh Term | Gram-Positive Bacterial Infections | Mesh Term | Bacterial Infections | Mesh Term | Bacterial Infections and Mycoses | Mesh Term | Infections | Mesh Term | Immunologic Deficiency Syndromes | Mesh Term | Immune System Diseases | Mesh Term | Blood-Borne Infections | Mesh Term | Communicable Diseases | Mesh Term | Sexually Transmitted Diseases, Viral | Mesh Term | Sexually Transmitted Diseases | Mesh Term | Lentivirus Infections | Mesh Term | Retroviridae Infections | Mesh Term | RNA Virus Infections | Mesh Term | Virus Diseases | Mesh Term | Slow Virus Diseases | Mesh Term | Genital Diseases | Mesh Term | Urogenital Diseases |
Downcase Mesh Term | tuberculosis | Downcase Mesh Term | acquired immunodeficiency syndrome | Downcase Mesh Term | hiv infections | Downcase Mesh Term | coinfection | Downcase Mesh Term | mycobacterium infections | Downcase Mesh Term | actinomycetales infections | Downcase Mesh Term | gram-positive bacterial infections | Downcase Mesh Term | bacterial infections | Downcase Mesh Term | bacterial infections and mycoses | Downcase Mesh Term | infections | Downcase Mesh Term | immunologic deficiency syndromes | Downcase Mesh Term | immune system diseases | Downcase Mesh Term | blood-borne infections | Downcase Mesh Term | communicable diseases | Downcase Mesh Term | sexually transmitted diseases, viral | Downcase Mesh Term | sexually transmitted diseases | Downcase Mesh Term | lentivirus infections | Downcase Mesh Term | retroviridae infections | Downcase Mesh Term | rna virus infections | Downcase Mesh Term | virus diseases | Downcase Mesh Term | slow virus diseases | Downcase Mesh Term | genital diseases | Downcase Mesh Term | urogenital diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48218542 | Sequence: | 48218543 |
Agency Class | OTHER | Agency Class | NIH |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | University of Florida | Name | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
Overall Officials
Sequence: | 29221985 |
Role | Principal Investigator |
Name | Awewura Kwara, MD |
Affiliation | University of Florida |
Central Contacts
Sequence: | 11986021 | Sequence: | 11986022 |
Contact Type | primary | Contact Type | backup |
Name | Awewura Kwara, MD | Name | Oluwayemisi Ojewale, MBChB, MPH |
Phone | 3522739501 | Phone | 3522739446 |
awewura.kwara@medicine.ufl.edu | Oluwayemisi.Ojewale@medicine.ufl.edu | ||
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 68004346 | Sequence: | 68004347 |
Design Group Id | 55474109 | Design Group Id | 55474110 |
Intervention Id | 52375069 | Intervention Id | 52375069 |
Eligibilities
Sequence: | 30701978 |
Sampling Method | Non-Probability Sample |
Gender | All |
Minimum Age | 3 Months |
Maximum Age | 14 Years |
Healthy Volunteers | No |
Population | Children aged 3 months to14 years with active TB with or without HIV co-infection |
Criteria | Inclusion Criteria:
Children with active TB with or without HIV coinfection. Active TB diagnosis defined by clinical criteria consistent with active TB and/or a positive AFB smear. Exclusion Criteria: Children with concurrent conditions other than HIV, have acute hepatitis within 30 days of study entry, persistent vomiting, and diarrhea will be excluded from the study. |
Adult | False |
Child | True |
Older Adult | False |
Calculated Values
Sequence: | 253918682 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 3 |
Maximum Age Num | 14 |
Minimum Age Unit | Months |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 4 |
Number Of Secondary Outcomes To Measure | 4 |
Designs
Sequence: | 30448615 |
Observational Model | Cohort |
Time Perspective | Prospective |
Intervention Other Names
Sequence: | 26612909 |
Intervention Id | 52375069 |
Name | New pediatric isoniazid/rifampin/pyrazinamide (HRZ) FDC tablet |
Responsible Parties
Sequence: | 28815095 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03800368
2016-12-21
https://zephyrnet.com/?p=NCT03800368
NCT03800368https://www.clinicaltrials.gov/study/NCT03800368?tab=tableNANANAThe objective of this randomized controlled trial (RCT) is to compare the changes of the sleep-related memory functions in patients with psychosis after they have completed the 12-week high-intensity exercise intervention, the 12-week low-intensity exercise intervention, or the 12-week controlled non-exercise intervention respectively. Fifty-one patients with psychosis, patients who received either the high-intensity exercise or low-intensity exercise as intervention shown a significant improvement to their impaired sleep-related memory function, while those who received non-exercise intervention has no such improvement. Moreover, high-intensity exercise may have a more prominent effect compare to low-intensity exercise.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-03 |
Study First Posted Date | 2019-01-11 |
Last Update Posted Date | 2019-01-11 |
Start Month Year | December 21, 2016 |
Primary Completion Month Year | September 1, 2017 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-11 |
Conditions
Sequence: | 52440219 | Sequence: | 52440220 |
Name | Schizophrenia and Related Disorders | Name | Psychotic Disorders |
Downcase Name | schizophrenia and related disorders | Downcase Name | psychotic disorders |
Id Information
Sequence: | 40350605 |
Id Source | org_study_id |
Id Value | HKU_Psych |
Design Groups
Sequence: | 55891618 | Sequence: | 55891619 | Sequence: | 55891620 |
Group Type | Experimental | Group Type | Experimental | Group Type | Active Comparator |
Title | High-endurance group | Title | Low-endurance group | Title | Psycho-education |
Description | This group of subjects will receive 2-3 sessions of high-intensity cycling exercise training per week, for a total of 12 weeks. The exercise the subjects received will interchange between the aerobic and anaerobic state. | Description | This group of subjects will receive 2-3 sessions of low-intensity cycling exercise training per week, for a total of 12 weeks. The exercise the subjects received will maintain at an aerobic level. | Description | This group of subjects will receive 2-3 sessions of psycho-education class per week, for a total of 12 weeks. The content of the class includes non-exercise related psycho-education content to participants (e.g., food hygiene, psychological well being, food nutrition, etc). |
Interventions
Sequence: | 52749920 | Sequence: | 52749921 |
Intervention Type | Other | Intervention Type | Other |
Name | Exercise | Name | Non-exercise |
Description | Indoor cycling exercise intervention | Description | Psycho-education |
Keywords
Sequence: | 80233147 | Sequence: | 80233148 | Sequence: | 80233149 | Sequence: | 80233150 |
Name | Exercise | Name | Sleep-dependent memory consolidation | Name | Aerobic | Name | Anaerobic |
Downcase Name | exercise | Downcase Name | sleep-dependent memory consolidation | Downcase Name | aerobic | Downcase Name | anaerobic |
Design Outcomes
Sequence: | 178390685 | Sequence: | 178390686 | Sequence: | 178390687 | Sequence: | 178390688 | Sequence: | 178390689 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | The sleep-dependent procedural memory consolidation after 12 weeks of intervention | Measure | The verbal memory consolidation after 12 weeks of intervention | Measure | The attention performance after 12 weeks of intervention | Measure | The sleep quality after 12 weeks of intervention | Measure | The insomnia severity after 12 weeks of intervention |
Time Frame | 12-week Follow-up | Time Frame | 12-week Follow-up | Time Frame | 12-week Follow-up | Time Frame | 12-week Follow-up | Time Frame | 12-week Follow-up |
Description | Tested by comparing the finger-tapping motor sequence task performance between the three groups during the 12-week follow-up assessment. | Description | Tested by comparing the logical memory task performance between the three groups during the 12-week follow-up assessment | Description | Measured by using the cancellation task performance and compare between the three groups during the 12-week follow-up assessment | Description | Measured by using the Pittsburgh Sleep Quality Index (PSQI) and compare the differences between the three groups during the 12-week follow-up assessment | Description | Measured by using the Insomnia Severity Index (ISI) and compare the differences between the three groups during the 12-week follow-up assessment |
Browse Conditions
Sequence: | 194512303 | Sequence: | 194512304 | Sequence: | 194512305 | Sequence: | 194512306 |
Mesh Term | Schizophrenia | Mesh Term | Psychotic Disorders | Mesh Term | Schizophrenia Spectrum and Other Psychotic Disorders | Mesh Term | Mental Disorders |
Downcase Mesh Term | schizophrenia | Downcase Mesh Term | psychotic disorders | Downcase Mesh Term | schizophrenia spectrum and other psychotic disorders | Downcase Mesh Term | mental disorders |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48568425 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | The University of Hong Kong |
Overall Officials
Sequence: | 29425466 |
Role | Principal Investigator |
Name | Lik Hang Lincoln Lo |
Affiliation | The University of Hong Kong |
Design Group Interventions
Sequence: | 68517368 | Sequence: | 68517369 | Sequence: | 68517370 |
Design Group Id | 55891618 | Design Group Id | 55891619 | Design Group Id | 55891620 |
Intervention Id | 52749920 | Intervention Id | 52749920 | Intervention Id | 52749921 |
Eligibilities
Sequence: | 30919508 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 55 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Aged from 18 to 55 Exclusion Criteria: Severe physical illness (Myocardial Infarction, Hypertension, Fracture, Spinal problems in which exercise may be contraindicated), and seizure disorders |
Adult | True |
Child | False |
Older Adult | False |
Calculated Values
Sequence: | 254187921 |
Registered In Calendar Year | 2019 |
Actual Duration | 8 |
Were Results Reported | False |
Has Single Facility | False |
Minimum Age Num | 18 |
Maximum Age Num | 55 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 4 |
Designs
Sequence: | 30665184 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Responsible Parties
Sequence: | 29031876 |
Responsible Party Type | Principal Investigator |
Name | Dr. Lincoln Lik-Hang Lo |
Title | Postdoctoral Fellow |
Affiliation | The University of Hong Kong |
]]>
https://zephyrnet.com/NCT03800355
2018-09-14
https://zephyrnet.com/?p=NCT03800355
NCT03800355https://www.clinicaltrials.gov/study/NCT03800355?tab=tableNANANAAn observational, Other Designs (OD) post-marketing, multicenter study, which will obtain retrospective data from male patients diagnosed with invasive breast cancer between 2000 and 2019 in the medical oncology departments of hospitals that are associated with Spanish Breast Cancer Research Group (GEICAM) (using information obtained from patient medical histories).
<![CDATA[
Studies
Study First Submitted Date | 2018-06-22 |
Study First Posted Date | 2019-01-11 |
Last Update Posted Date | 2023-04-18 |
Start Month Year | September 14, 2018 |
Primary Completion Month Year | October 30, 2023 |
Verification Month Year | April 2023 |
Verification Date | 2023-04-30 |
Last Update Posted Date | 2023-04-18 |
Detailed Descriptions
Sequence: | 20764939 |
Description | One of the objectives of this project is to ensure representativeness of the cases referred to. Accordingly, participating sites agree to enroll in the study male patients who were diagnosed with breast cancer in the period between 2000 and 2019. |
Facilities
Sequence: | 200474328 | Sequence: | 200474310 | Sequence: | 200474311 | Sequence: | 200474312 | Sequence: | 200474313 | Sequence: | 200474314 | Sequence: | 200474315 | Sequence: | 200474316 | Sequence: | 200474317 | Sequence: | 200474318 | Sequence: | 200474319 | Sequence: | 200474320 | Sequence: | 200474321 | Sequence: | 200474322 | Sequence: | 200474323 | Sequence: | 200474324 | Sequence: | 200474325 | Sequence: | 200474326 | Sequence: | 200474327 | Sequence: | 200474329 | Sequence: | 200474330 | Sequence: | 200474331 | Sequence: | 200474332 | Sequence: | 200474333 | Sequence: | 200474334 | Sequence: | 200474335 | Sequence: | 200474336 | Sequence: | 200474337 | Sequence: | 200474338 | Sequence: | 200474339 | Sequence: | 200474340 | Sequence: | 200474341 | Sequence: | 200474342 | Sequence: | 200474343 | Sequence: | 200474344 | Sequence: | 200474345 | Sequence: | 200474346 | Sequence: | 200474347 | Sequence: | 200474348 | Sequence: | 200474349 | Sequence: | 200474350 | Sequence: | 200474351 | Sequence: | 200474352 | Sequence: | 200474353 | Sequence: | 200474354 | Sequence: | 200474355 | Sequence: | 200474356 | Sequence: | 200474357 | Sequence: | 200474358 | Sequence: | 200474359 | Sequence: | 200474360 | Sequence: | 200474361 | Sequence: | 200474362 | Sequence: | 200474363 |
Name | Clínica Universidad de Navarra | Name | Complejo Hospitalario Universitario de Ferrol | Name | Hospital Virgen de los Lirios | Name | Hospital Universitario San Agustín | Name | Hospital General de Granollers | Name | Instituto Catalán de Oncología de L'Hospitalet | Name | Consorci Corporació Sànitari Parc Taulí | Name | Consorci Sanitari de Terrassa | Name | Hospital Universitario Basurto | Name | Consorcio Hospitalario Provincial de Castellón | Name | Hospital General La Mancha Centro | Name | Hospital Universitario Donostia | Name | Onkologikoa | Name | Hospital Universitario de Fuenlabrada | Name | Hospital Universitario de Getafe | Name | Hospital Universitario Severo Ochoa | Name | Hospital Universitario de Móstoles | Name | Hospital Universitario Quirónsalud Madrid | Name | Hospital Clínico Universitario Virgen de la Arrixaca | Name | Hospital Álvaro Cunqueiro | Name | Hospital de Tortosa Verge de la Cinta | Name | Complejo Hospitalario Universitario A Coruña | Name | Hospital del Mar | Name | Hospital Universitari Dexeus-Grupo Quirónsalud-Instituto Oncológico Dr. Rosell | Name | Hospital Universitari Vall D´Hebrón | Name | IDOC Centre Médic | Name | Hospital Virgen de la Luz | Name | Instituto Catalán de Oncología de Girona | Name | Hospital Universitario Virgen de las Nieves | Name | Hospital Juan Ramón Jiménez | Name | Complejo Hospitalario de Jaén | Name | Complejo Hospitalario Universitario Insular-Materno Infantil | Name | Hospital Universitario Lucus Augusti | Name | GenesisCare Madrid Hospital La Milagrosa | Name | Hospital Central de la Defensa Gómez Ulla | Name | Hospital Universitario Infanta Leonor | Name | Hospital Universitario La Paz | Name | Hospital Universitario La Zarzuela | Name | Hospital Universitario Ramón y Cajal | Name | Hospital General Universitario Morales Meseguer | Name | Hospital Regional Universitario | Name | Hospital Universitari Son Espases | Name | Hospital Universitario Nuestra Señora De Candelaria | Name | Hospital de Sant Pau i Santa Tecla | Name | Hospital Universitario de Toledo | Name | Fundación Instituto Valenciano de Oncología | Name | Hospital Arnau de Vilanova | Name | Hospital Clínico Universitario de Valencia | Name | Hospital General Universitario de Valencia | Name | Hospital Universitario La Fe | Name | Hospital Universitario Río Hortega | Name | Hospital Clínico Universitario Lozano Blesa | Name | Hospital Quirón Zaragoza | Name | Hospital Universitario de Araba |
City | Pamplona | City | Ferrol | City | Alcoy | City | Avilés | City | Granollers | City | L'Hospitalet De Llobregat | City | Sabadell | City | Terrassa | City | Bilbao | City | Castellón De La Plana | City | Alcázar De San Juan | City | Donostia-San Sebastián | City | Donostia-San Sebastián | City | Fuenlabrada | City | Getafe | City | Leganés | City | Móstoles | City | Pozuelo De Alarcón | City | El Palmar | City | Vigo | City | Tortosa | City | A Coruña | City | Barcelona | City | Barcelona | City | Barcelona | City | Barcelona | City | Cuenca | City | Girona | City | Granada | City | Huelva | City | Jaén | City | Las Palmas De Gran Canaria | City | Lugo | City | Madrid | City | Madrid | City | Madrid | City | Madrid | City | Madrid | City | Madrid | City | Murcia | City | Málaga | City | Palma De Mallorca | City | Santa Cruz De Tenerife | City | Tarragona | City | Toledo | City | Valencia | City | Valencia | City | Valencia | City | Valencia | City | Valencia | City | Valladolid | City | Zaragoza | City | Zaragoza | City | Vitoria-Gasteiz |
State | Navarra | State | A Coruña | State | Alicante | State | Asturias | State | Barcelona | State | Barcelona | State | Barcelona | State | Barcelona | State | Bizcaia | State | Castellón | State | Ciudad Real | State | Guipúzcoa | State | Guipúzcoa | State | Madrid | State | Madrid | State | Madrid | State | Madrid | State | Madrid | State | Murcia | State | Pontevedra | State | Tarragona | State | Álava | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Zip | 45007 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain |
Conditions
Sequence: | 52282526 |
Name | Breast Cancer, Male |
Downcase Name | breast cancer, male |
Id Information
Sequence: | 40239022 |
Id Source | org_study_id |
Id Value | GEICAM/2016-04 |
Countries
Sequence: | 42657226 |
Name | Spain |
Removed | False |
Design Groups
Sequence: | 55717473 |
Title | Male breast cancer |
Description | The study target population is all cases of male breast cancer (MBC), diagnosed with invasive breast cancer between the years 2000 and 2019, and treated in the Medical Oncology Departments of participating sites. |
Keywords
Sequence: | 80025980 | Sequence: | 80025981 | Sequence: | 80025982 |
Name | Breast Cancer in males | Name | Observational | Name | Gene Sequencing |
Downcase Name | breast cancer in males | Downcase Name | observational | Downcase Name | gene sequencing |
Design Outcomes
Sequence: | 177788856 | Sequence: | 177788857 | Sequence: | 177788858 | Sequence: | 177788859 | Sequence: | 177788860 | Sequence: | 177788861 | Sequence: | 177788862 | Sequence: | 177788863 | Sequence: | 177788864 | Sequence: | 177788865 | Sequence: | 177788866 | Sequence: | 177788867 | Sequence: | 177788868 | Sequence: | 177788869 | Sequence: | 177788870 | Sequence: | 177788871 | Sequence: | 177788872 | Sequence: | 177788873 | Sequence: | 177788874 | Sequence: | 177788875 | Sequence: | 177788876 | Sequence: | 177788877 | Sequence: | 177788878 | Sequence: | 177788879 | Sequence: | 177788880 | Sequence: | 177788881 | Sequence: | 177788882 | Sequence: | 177788883 | Sequence: | 177788884 | Sequence: | 177788885 | Sequence: | 177788886 | Sequence: | 177788887 | Sequence: | 177788888 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | General condition: Age | Measure | General condition: performance status at diagnosis | Measure | General condition and history: substance abuse | Measure | Diagnosis of other primary tumors | Measure | Body mass index (BMI) | Measure | Primary comorbidities | Measure | Mutational status of BReast CAncer gene (BRCA) or other genes of genetic predisposition | Measure | Family history of cancer | Measure | Anatomopathological characteristics of the tumor: date of diagnosis | Measure | Anatomopathological characteristics of the tumor: histology | Measure | Anatomopathological characteristics of the tumor: clinical and/or pathological stage | Measure | Anatomopathological characteristics of the tumor: hormone-receptor expression | Measure | Anatomopathological characteristics of the tumor: Human Epidermal Growth Factor Receptor 2 (HER-2) expression | Measure | Anatomopathological characteristics of the tumor: histologic grade | Measure | Anatomopathological characteristics of the tumor: Ki-67 | Measure | Anatomopathological characteristics of the tumor: lymphovascular invasion | Measure | Treatment data: date of surgery | Measure | Treatment data: type of surgery | Measure | Treatment data: type of chemotherapy | Measure | Treatment data: adjuvant radiotherapy | Measure | Treatment data: adjuvant hormonotherapy | Measure | Treatment data: other type of anti-cancer treatment | Measure | Follow-up data: relapse type | Measure | Follow-up data: site of metastatic disease | Measure | Follow-up data: occurrence of other primary tumors | Measure | Follow-up data: current condition | Measure | Biological and molecular characteristics analyzed in primary tumors: tumor subtypes | Measure | Biological and molecular characteristics analyzed in primary tumors: risk groups | Measure | Date and cause of death | Measure | Disease-free survival (DFS). | Measure | Distant metastasis-free survival (DMFS). | Measure | Progression-free survival (PFS). | Measure | Overall survival (OS). |
Time Frame | From date of patient breast cancer diagnosis until 2019. | Time Frame | From date of patient breast cancer diagnosis until 2019. | Time Frame | From date of patient breast cancer diagnosis until 2019. | Time Frame | From date of patient breast cancer diagnosis until 2019. | Time Frame | From date of patient breast cancer diagnosis until 2019. | Time Frame | From date of patient breast cancer diagnosis until 2019. | Time Frame | From date of patient breast cancer diagnosis until 2019. | Time Frame | From date of patient breast cancer diagnosis until 2019. | Time Frame | From date of patient breast cancer diagnosis until 2019. | Time Frame | From date of patient breast cancer diagnosis until 2019. | Time Frame | From date of patient breast cancer diagnosis until 2019. | Time Frame | From date of patient breast cancer diagnosis until 2019. | Time Frame | From date of patient breast cancer diagnosis until 2019. | Time Frame | From date of patient breast cancer diagnosis until 2019. | Time Frame | From date of patient breast cancer diagnosis until 2019. | Time Frame | From date of patient breast cancer diagnosis until 2017. | Time Frame | From date of patient breast cancer diagnosis until 2019. | Time Frame | From date of patient breast cancer diagnosis until 2019. | Time Frame | From date of patient breast cancer diagnosis until 2019. | Time Frame | From date of patient breast cancer diagnosis until 2019. | Time Frame | From date of patient breast cancer diagnosis until 2019. | Time Frame | From date of patient breast cancer diagnosis until 2019. | Time Frame | From date of patient breast cancer diagnosis until 2019. | Time Frame | From date of patient breast cancer diagnosis until 2019. | Time Frame | From date of patient breast cancer diagnosis until 2019. | Time Frame | From date of patient breast cancer diagnosis until 2019. | Time Frame | From date of patient breast cancer diagnosis until 2019. | Time Frame | From date of patient breast cancer diagnosis until 2019. | Time Frame | From date of patient breast cancer diagnosis until 2019. | Time Frame | From date of patient breast cancer diagnosis until 2019. | Time Frame | From date of patient breast cancer diagnosis until 2019. | Time Frame | From date of patient breast cancer diagnosis until 2019. | Time Frame | From date of patient breast cancer diagnosis until 2019. |
Description | General condition age will be recorded. | Description | Performance status by Eastern Cooperative Oncology Group (ECOG) Scale | Description | Number of Participants With Substance abuse of tobacco and alcohol will be recorded. | Description | Diagnosis of other primary tumors synchronous or metachronous, will be recorded. | Description | BMI is a value derived from the mass (weight) and height. The BMI is defined as the body mass divided by the square of the body height, and is universally expressed in units of kg/m2, resulting from mass in kilograms and height in metres. | Description | Primary comorbidities will be recorded. | Description | Mutational status of BRCA or other genes of genetic predisposition will be recorded. | Description | Family history of cancer will be recorded. | Description | Date of diagnosis will be collected. | Description | The histology of the tumor will be collected | Description | Tumor clinical and/or pathological stage will be collected through the tumor-node-metastasis (TNM) staging system of the Union for International Cancer Control (UICC). | Description | Hormone-receptor expression will be collected | Description | Human Epidermal Growth Factor Receptor 2 (HER-2) expression will be collected | Description | Tumor histologic grade will be collected | Description | Tumor Ki-67 proliferation index will be collected | Description | Number of Participants With Presence of lymphovascular invasion will be collected | Description | Will be collected date of surgery | Description | Number of participants with each type of surgery: mastectomy or lumpectomy or quadrantectomy or lymphadenectomy or sentinel lymph node biopsy will be collected. | Description | Number of Participants With neoadjuvant chemotherapy and adjuvant chemotherapy. | Description | Number of Participants With adjuvant radiotherapy | Description | Number of Participants With hormonotherapy | Description | Number of Participants With other type of anti-cancer treatment. | Description | Number of Participants With each relapse type: local, regional or distant | Description | Number of Participants With site of metastatic disease | Description | Number of Participants With occurrence of other primary tumors whether or not of breast origin (in situ or invasive). | Description | The date of the last review and current clinical condition will be recorded. | Description | Number of Participants With tumor subtypes, luminal profiles (e.g., luminal subtypes M1/M2, intrinsic subtypes) | Description | Number of Participants With risk groups on the reference of breast cancer in women, including morphological analyses and description of the clinical profile (e.g., morphological type, differentiation (histologic grade), Estrogen Receptor (ER), Progesterone Receptor (PgR), Human Epidermal growth factor Receptor 2 (HER2), Androgen Receptor (AR), Ki-67). | Description | Date and cause of death, when applicable. | Description | DFS: it is defined as the time from date of initial breast cancer diagnosis to the date of the first documented relapse event (local, regional and/or distant) of the disease, second breast or non-breast primary tumor, or death due to any cause, whichever occurs first. In the event that none of the previous events were observed, censoring the last contact date will be considered. | Description | DMFS: it is defined as the time from date of initial breast cancer diagnosis to the date of the first documented distant relapse, second invasive non-breast primary tumor, or death due to any cause, whichever occurs first. In the event that none of the previous events were observed, censoring the last contact date will be considered. | Description | PFS: it is defined as the time from the start date of a specific treatment to the documentation of disease progression on such treatment, or death due to any cause, whichever occurs first. In the event that none of the previous events were observed, censoring the last contact date will be considered. | Description | OS: it is defined as the time from the date of initial breast cancer diagnosis to the date of death due to any cause. |
Browse Conditions
Sequence: | 193912576 | Sequence: | 193912577 | Sequence: | 193912578 | Sequence: | 193912579 | Sequence: | 193912580 | Sequence: | 193912581 |
Mesh Term | Breast Neoplasms | Mesh Term | Breast Neoplasms, Male | Mesh Term | Neoplasms by Site | Mesh Term | Neoplasms | Mesh Term | Breast Diseases | Mesh Term | Skin Diseases |
Downcase Mesh Term | breast neoplasms | Downcase Mesh Term | breast neoplasms, male | Downcase Mesh Term | neoplasms by site | Downcase Mesh Term | neoplasms | Downcase Mesh Term | breast diseases | Downcase Mesh Term | skin diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48423391 | Sequence: | 48423392 |
Agency Class | OTHER | Agency Class | UNKNOWN |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | Spanish Breast Cancer Research Group | Name | Fundación ADEY |
Overall Officials
Sequence: | 29345366 | Sequence: | 29345367 |
Role | Study Director | Role | Study Director |
Name | Chief Medical Investigator | Name | Chief Medical Investigator |
Affiliation | Hospital Universitario Ramón y Cajal, Madrid, Spain | Affiliation | Fundación Onkologikoa, San Sebastián, Spain |
Eligibilities
Sequence: | 30830027 |
Sampling Method | Probability Sample |
Gender | Male |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Population | The study target population is all cases of male breast cancer (MBC), diagnosed with invasive breast cancer between the years 2000 and 2019, and treated in the Medical Oncology Departments of participating sites. |
Criteria | Inclusion Criteria:
Male patients diagnosed with primary invasive breast carcinoma between the years 2000-2019, and who have been treated and/or followed up in the Medical Oncology Departments of participating sites. Exclusion Criteria: Male patients who do not wish to participate in the study for any reason. |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254131588 |
Number Of Facilities | 54 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | False |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 26 |
Number Of Secondary Outcomes To Measure | 7 |
Designs
Sequence: | 30575949 |
Observational Model | Case-Only |
Time Perspective | Retrospective |
Links
Sequence: | 4396862 |
Url | http://www.geicam.org |
Description | Spanish Breast Cancer Research Group (GEICAM) is a Spanish Breast Cancer Research Group |
Responsible Parties
Sequence: | 28942357 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03800342
2019-01-22
https://zephyrnet.com/?p=NCT03800342
NCT03800342https://www.clinicaltrials.gov/study/NCT03800342?tab=tableNANANAThe purpose of this protocol is to investigate the role of expired non-metabolic carbon dioxide in the relationship between fatigability and recovery and the response to aerobic exercise training in healthy individuals. Both fatigability and recovery are profoundly influenced by mitochondrial energetics which can be inhibited by ionic by-product accumulation during exercise. Buffering mechanisms of these fatigue-inducing ions releases non-metabolic carbon dioxide (CO2) that can be measured as expired CO2 (VCO2) during cardiopulmonary exercise testing (CPET), however the role of non-metabolic VCO2 in the relationship between fatigability and recovery has yet to be investigated.
Furthermore, this study aims to identify the how the patterns of proteins in healthy individuals respond to aerobic exercise training (e.g. stationary cycling) over approximately one month. The underlying mechanisms of recovery after physical activity, including mechanisms or biological pathways that could be highlighted by analysis of proteins in urine, could add to scientific knowledge regarding physical activity tolerance and potential exercise interventions. This knowledge could eventually assist with designing precise and personalized exercise interventions to improve physical activity performance.
The investigators hypothesize that 1) non-metabolic CO2 will be at least moderately associated with the inverse relationship between fatigability and recovery; and 2) highly active adults, compared to sedentary individuals, will exhibit differential proteomic patterns in response to an initial acute bout and subsequent repeated bouts of aerobic exercise.
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Studies
Study First Submitted Date | 2018-12-18 |
Study First Posted Date | 2019-01-11 |
Last Update Posted Date | 2019-05-16 |
Start Month Year | January 22, 2019 |
Primary Completion Month Year | April 24, 2019 |
Verification Month Year | May 2019 |
Verification Date | 2019-05-31 |
Last Update Posted Date | 2019-05-16 |
Detailed Descriptions
Sequence: | 20548778 |
Description | Subjects will be recruited from the greater Washington D.C. metro area by word of mouth, university classes, healthcare provider referral, social media posting, and by posted fliers. Healthy males and females as determined by the Physical Activity Readiness Questionnaire Plus (PARQ+) will qualify to participate, regardless of their fitness level. The study design and participation will be explained to those who are potentially interested in participating in the study. Individuals interested in participating as subjects will complete the PARQ+ and those answering "no" to all of the PARQ+ questions will qualify for inclusion. Those answering "yes" to one or more of the questions will be asked follow-up questions to determine if they meet inclusion/exclusion criteria. Subjects will then be consented and enrolled for participation.
Visit 1: Subjects meeting all inclusion criteria and no exclusion criterion will be consented and enrolled in the study. Subjects will then complete the International Physical Activity Questionnaire (IPAQ) to describe their current levels of physical activity. Height and weight measurements of the subject will also be taken. Subjects will then complete a standard peak cardiopulmonary exercise test (pkCPET) to volitional exhaustion with near infrared spectroscopy (NIRS) assessment of muscle oxygenation and microvascular reactivity, bioimpedance cardiographic (ZCG) assessment of cardiac output and stroke volume, and electrocardiographic (EKG) measurement of heart rate (HR) at rest and during exercise. After a 10-minute passive recovery period, subjects will perform an endurance based CPET (enCPET) at intensity of 70% of the peak wattage reached during the pkCPET, again to volitional exhaustion followed by a final 10-minute passive recovery period to conclude day one of testing. Visit 2: Subjects will complete a submaximal square-wave test (swCPET) for measurement of oxygen on-kinetics. After a 10-minute recovery period, subjects will complete the same enCPET they performed during Visit 1 testing. This testing will again be followed by a 10-minute recovery period. EKG measurements of HR will be taken during exercise and rest periods. Subjects will receive a urine collection cup to be used prior to visit 3. Subjects will be asked to collect approximately 75-90 mL of urine on the morning of Visit 3 to provide upon arrival. Subjects will be asked to log food intake using the form described below for 48 hours, starting 24 hours prior to Visit 3. Visits 3-19: On days 3-19, subjects will complete a continuous high intensity aerobic exercise training (AET) protocol. Subjects will warm up for approximately 5-minutes, exercise within their predetermined HR range for 45 minutes, followed by a 5-10 min recovery period. HR will be monitored using a Polar chest strap worn by the subject and a paired watch and the heart rate reading on the cycle ergometer monitored by the investigators. The entire training session will take approximately 60 minutes. Following Visit 3, subjects will be provided with a 2nd urine sample cup and asked to collect a "first-morning" urine sample (75-90mL) at home on the day after visit 3. Subjects will be asked to provide subsequent first-morning midstream urine samples at home on the morning of and the morning after visits 7, 11, 15, and 19 (10 total urine samples). Subjects will be provided with a copy of their initial food log and asked to repeat their nutritional intake for the same timeframe as the initial sample for each subsequent sample (24 hours prior to pre-exercise sample until post-exercise sample). Visit 20: Subjects will repeat the same procedures performed at Visit 1 including a pkCPET, 10-minute recovery, enCPET, 10-minute recovery, in that order. NIRS, ZCG, and EKG again will be collected throughout both the active and recovery portions of the testing. Visit 21: Subjects will repeat the same procedures performed on day two of testing including a swCPET, 10-minute recovery, enCPET, 10-minute recovery, in the order. EKG data will again be collected during the active and recovery portions of the testing. |
Facilities
Sequence: | 198402805 |
Name | George Mason University |
City | Fairfax |
State | Virginia |
Zip | 22030 |
Country | United States |
Conditions
Sequence: | 51727240 | Sequence: | 51727241 |
Name | Adult | Name | Fatigue |
Downcase Name | adult | Downcase Name | fatigue |
Id Information
Sequence: | 39805698 |
Id Source | org_study_id |
Id Value | VCO2-Proteomics |
Countries
Sequence: | 42204450 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55147116 |
Group Type | Experimental |
Title | Healthy |
Description | Healthy individuals will participate in two separate days of cardiopulmonary exercise testing (CPET) (separated by a minimum of two, maximum of 7 days apart) prior to starting the aerobic exercise training program (AET). Individuals will then complete a 4-5 week (4x/week x 17 sessions) continuous, high-intensity AET. Each training session will consist of cycling for 3-5 minutes to warm-up, 45 minutes at 70% of heart rate reserve (HRR-determined from pre-training CPET), and 5-10 minutes to cool down. Following the AET, individuals will repeat the two separate days of CPET performed pre-training. |
Interventions
Sequence: | 52048850 |
Intervention Type | Other |
Name | Aerobic Exercise Training |
Description | see arm/group description |
Keywords
Sequence: | 79145065 | Sequence: | 79145066 | Sequence: | 79145067 | Sequence: | 79145068 | Sequence: | 79145069 |
Name | recovery | Name | proteomics | Name | cardiorespiratory fitness | Name | exercise | Name | aerobic exercise training |
Downcase Name | recovery | Downcase Name | proteomics | Downcase Name | cardiorespiratory fitness | Downcase Name | exercise | Downcase Name | aerobic exercise training |
Design Outcomes
Sequence: | 175933172 | Sequence: | 175933171 |
Outcome Type | secondary | Outcome Type | primary |
Measure | Urinary proteome | Measure | Non-metabolic VCO2 |
Time Frame | This outcome will be assessed at 10 time points per participant: each morning of visits 3,4,7,8,11,12,15,16,19, and 20. Data will be collected during these 5 weeks and at post-testing occurring the week following the end of training. | Time Frame | pre and post 5 week (4 training sessions per week, 17 total sessions) aerobic exercise training protocol |
Description | Proteome of urine samples as measured by mass spectrometry | Description | Correlate measures of non-metabolic carbon dioxide (as measured by the contribution of total expired non-metabolic VCO2) with the correlative relationship between fatigability (as measured by total time during an endurance CPET and on-kinetics during a constant square-wave CPET) and recovery (as measured by VO2 and VCO2 following maximal and submaximal CPET). Compare changes in measures of non-metabolic carbon dioxide (as measured by the contribution of total expired non-metabolic VCO2) and changes in oxygen consumption (as measured by VO2) pre and post exercise training. |
Browse Conditions
Sequence: | 191700818 |
Mesh Term | Fatigue |
Downcase Mesh Term | fatigue |
Mesh Type | mesh-list |
Sponsors
Sequence: | 47907154 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | George Mason University |
Overall Officials
Sequence: | 29027134 |
Role | Principal Investigator |
Name | Andrew A Guccione, PT, PhD, DPT |
Affiliation | George Mason University |
Design Group Interventions
Sequence: | 67607873 |
Design Group Id | 55147116 |
Intervention Id | 52048850 |
Eligibilities
Sequence: | 30506618 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 60 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
age 18-60 Exclusion Criteria: diabetes mellitus |
Adult | True |
Child | False |
Older Adult | False |
Calculated Values
Sequence: | 254052888 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 3 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 60 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 1 |
Designs
Sequence: | 30255698 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Basic Science |
Time Perspective | |
Masking | None (Open Label) |
Intervention Model Description | One arm, a single group of healthy individuals, will perform cardiopulmonary exercise testing pre and post an aerobic exercise training program. |
Responsible Parties
Sequence: | 28636188 |
Responsible Party Type | Sponsor |
Study References
Sequence: | 51618354 | Sequence: | 51618355 | Sequence: | 51618356 | Sequence: | 51618357 | Sequence: | 51618358 | Sequence: | 51618359 | Sequence: | 51618360 | Sequence: | 51618361 | Sequence: | 51618362 | Sequence: | 51618363 | Sequence: | 51618364 | Sequence: | 51618365 | Sequence: | 51618366 | Sequence: | 51618367 | Sequence: | 51618369 | Sequence: | 51618368 | Sequence: | 51618370 | Sequence: | 51618371 | Sequence: | 51618372 | Sequence: | 51618373 | Sequence: | 51618374 | Sequence: | 51618375 | Sequence: | 51618399 | Sequence: | 51618376 | Sequence: | 51618377 | Sequence: | 51618378 | Sequence: | 51618379 | Sequence: | 51618380 | Sequence: | 51618381 | Sequence: | 51618382 | Sequence: | 51618383 | Sequence: | 51618384 | Sequence: | 51618385 | Sequence: | 51618386 | Sequence: | 51618387 | Sequence: | 51618388 | Sequence: | 51618389 | Sequence: | 51618390 | Sequence: | 51618391 | Sequence: | 51618392 | Sequence: | 51618393 | Sequence: | 51618394 | Sequence: | 51618395 | Sequence: | 51618396 | Sequence: | 51618397 | Sequence: | 51618398 |
Pmid | 23798298 | Pmid | 22818936 | Pmid | 26606383 | Pmid | 19958872 | Pmid | 17967770 | Pmid | 20345416 | Pmid | 30236049 | Pmid | 9784121 | Pmid | 26014593 | Pmid | 29893975 | Pmid | 23382011 | Pmid | 26542523 | Pmid | 25145492 | Pmid | 29320704 | Pmid | 25663672 | Pmid | 20930125 | Pmid | 26050974 | Pmid | 19268720 | Pmid | 17548726 | Pmid | 23851406 | Pmid | 19222236 | Pmid | 26791624 | Pmid | 25177766 | Pmid | 27461997 | Pmid | 23892338 | Pmid | 10081212 | Pmid | 20656622 | Pmid | 28666548 | Pmid | 25313451 | Pmid | 26565376 | Pmid | 20656616 | Pmid | 11738220 | Pmid | 9216958 | Pmid | 12871687 | Pmid | 9688429 | Pmid | 27701422 | Pmid | 27562396 | Pmid | 22964543 | Pmid | 19176328 | Pmid | 22860899 | Pmid | 20722821 | Pmid | 29368427 | Pmid | 8752810 | Pmid | 27979503 | Pmid | 3087938 | ||
Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background |
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Hydrogel nanoparticle harvesting of plasma or urine for detecting low abundance proteins. J Vis Exp. 2014 Aug 7;(90):e51789. doi: 10.3791/51789. | Citation | Whitham M, Parker BL, Friedrichsen M, Hingst JR, Hjorth M, Hughes WE, Egan CL, Cron L, Watt KI, Kuchel RP, Jayasooriah N, Estevez E, Petzold T, Suter CM, Gregorevic P, Kiens B, Richter EA, James DE, Wojtaszewski JFP, Febbraio MA. Extracellular Vesicles Provide a Means for Tissue Crosstalk during Exercise. Cell Metab. 2018 Jan 9;27(1):237-251.e4. doi: 10.1016/j.cmet.2017.12.001. | Citation | Hecksteden A, Kraushaar J, Scharhag-Rosenberger F, Theisen D, Senn S, Meyer T. Individual response to exercise training – a statistical perspective. J Appl Physiol (1985). 2015 Jun 15;118(12):1450-9. doi: 10.1152/japplphysiol.00714.2014. Epub 2015 Feb 5. | Citation | Keller P, Vollaard NB, Gustafsson T, Gallagher IJ, Sundberg CJ, Rankinen T, Britton SL, Bouchard C, Koch LG, Timmons JA. A transcriptional map of the impact of endurance exercise training on skeletal muscle phenotype. J Appl Physiol (1985). 2011 Jan;110(1):46-59. doi: 10.1152/japplphysiol.00634.2010. Epub 2010 Oct 7. | Citation | Lane RK, Hilsabeck T, Rea SL. The role of mitochondrial dysfunction in age-related diseases. Biochim Biophys Acta. 2015 Nov;1847(11):1387-400. doi: 10.1016/j.bbabio.2015.05.021. Epub 2015 Jun 4. | Citation | Lombardi A, Silvestri E, Cioffi F, Senese R, Lanni A, Goglia F, de Lange P, Moreno M. Defining the transcriptomic and proteomic profiles of rat ageing skeletal muscle by the use of a cDNA array, 2D- and Blue native-PAGE approach. J Proteomics. 2009 May 2;72(4):708-21. doi: 10.1016/j.jprot.2009.02.007. Epub 2009 Mar 5. | Citation | Wisloff U, Stoylen A, Loennechen JP, Bruvold M, Rognmo O, Haram PM, Tjonna AE, Helgerud J, Slordahl SA, Lee SJ, Videm V, Bye A, Smith GL, Najjar SM, Ellingsen O, Skjaerpe T. Superior cardiovascular effect of aerobic interval training versus moderate continuous training in heart failure patients: a randomized study. Circulation. 2007 Jun 19;115(24):3086-94. doi: 10.1161/CIRCULATIONAHA.106.675041. Epub 2007 Jun 4. | Citation | Thompson PD, Arena R, Riebe D, Pescatello LS; American College of Sports Medicine. ACSM's new preparticipation health screening recommendations from ACSM's guidelines for exercise testing and prescription, ninth edition. Curr Sports Med Rep. 2013 Jul-Aug;12(4):215-7. doi: 10.1249/JSR.0b013e31829a68cf. No abstract available. | Citation | Oberg AL, Vitek O. Statistical design of quantitative mass spectrometry-based proteomic experiments. J Proteome Res. 2009 May;8(5):2144-56. doi: 10.1021/pr8010099. | Citation | Gemperline DC, Scalf M, Smith LM, Vierstra RD. Morpheus Spectral Counter: A computational tool for label-free quantitative mass spectrometry using the Morpheus search engine. Proteomics. 2016 Mar;16(6):920-4. doi: 10.1002/pmic.201500420. | Citation | Brooks, G. A., Fahey, T. D. & Baldwin, K. M. Exercise physiology: human bioenergetics and its applications. (McGraw-Hill, 2005). | Citation | Lavallee-Adam M, Rauniyar N, McClatchy DB, Yates JR 3rd. PSEA-Quant: a protein set enrichment analysis on label-free and label-based protein quantification data. J Proteome Res. 2014 Dec 5;13(12):5496-509. doi: 10.1021/pr500473n. Epub 2014 Oct 16. | Citation | Pascovici D, Handler DC, Wu JX, Haynes PA. Multiple testing corrections in quantitative proteomics: A useful but blunt tool. Proteomics. 2016 Sep;16(18):2448-53. doi: 10.1002/pmic.201600044. | Citation | Finsterer J, Mahjoub SZ. Fatigue in healthy and diseased individuals. Am J Hosp Palliat Care. 2014 Aug;31(5):562-75. doi: 10.1177/1049909113494748. Epub 2013 Jul 26. | Citation | Aaronson LS, Teel CS, Cassmeyer V, Neuberger GB, Pallikkathayil L, Pierce J, Press AN, Williams PD, Wingate A. Defining and measuring fatigue. Image J Nurs Sch. 1999;31(1):45-50. doi: 10.1111/j.1547-5069.1999.tb00420.x. | Citation | Eldadah BA. Fatigue and fatigability in older adults. PM R. 2010 May;2(5):406-13. doi: 10.1016/j.pmrj.2010.03.022. | Citation | Kim I, Hacker E, Ferrans CE, Horswill C, Park C, Kapella M. Evaluation of fatigability measurement: Integrative review. Geriatr Nurs. 2018 Jan-Feb;39(1):39-47. doi: 10.1016/j.gerinurse.2017.05.014. Epub 2017 Jun 27. | Citation | Keyser RE, Woolstenhulme JG, Chin LM, Nathan SD, Weir NA, Connors G, Drinkard B, Lamberti J, Chan L. Cardiorespiratory function before and after aerobic exercise training in patients with interstitial lung disease. J Cardiopulm Rehabil Prev. 2015 Jan-Feb;35(1):47-55. doi: 10.1097/HCR.0000000000000083. | Citation | Barbosa JF, Bruno SS, Cruz NS, de Oliveira JS, Ruaro JA, Guerra RO. Perceived fatigability and metabolic and energetic responses to 6-minute walk test in older women. Physiotherapy. 2016 Sep;102(3):294-9. doi: 10.1016/j.physio.2015.08.008. Epub 2015 Sep 28. | Citation | Keyser RE. Peripheral fatigue: high-energy phosphates and hydrogen ions. PM R. 2010 May;2(5):347-58. doi: 10.1016/j.pmrj.2010.04.009. | Citation | Nanas S, Nanas J, Kassiotis C, Nikolaou C, Tsagalou E, Sakellariou D, Terovitis I, Papazachou O, Drakos S, Papamichalopoulos A, Roussos C. Early recovery of oxygen kinetics after submaximal exercise test predicts functional capacity in patients with chronic heart failure. Eur J Heart Fail. 2001 Dec;3(6):685-92. doi: 10.1016/s1388-9842(01)00187-8. | Citation | Short KR, Sedlock DA. Excess postexercise oxygen consumption and recovery rate in trained and untrained subjects. J Appl Physiol (1985). 1997 Jul;83(1):153-9. doi: 10.1152/jappl.1997.83.1.153. | Citation | Belardinelli R, Lacalaprice F, Carle F, Minnucci A, Cianci G, Perna G, D'Eusanio G. Exercise-induced myocardial ischaemia detected by cardiopulmonary exercise testing. Eur Heart J. 2003 Jul;24(14):1304-13. doi: 10.1016/s0195-668x(03)00210-0. | Citation | Scrutinio D, Passantino A, Lagioia R, Napoli F, Ricci A, Rizzon P. Percent achieved of predicted peak exercise oxygen uptake and kinetics of recovery of oxygen uptake after exercise for risk stratification in chronic heart failure. Int J Cardiol. 1998 Apr 1;64(2):117-24. doi: 10.1016/s0167-5273(98)00019-9. | Citation | Thompson RB, Pagano JJ, Mathewson KW, Paterson I, Dyck JR, Kitzman DW, Haykowsky MJ. Differential Responses of Post-Exercise Recovery of Leg Blood Flow and Oxygen Uptake Kinetics in HFpEF versus HFrEF. PLoS One. 2016 Oct 4;11(10):e0163513. doi: 10.1371/journal.pone.0163513. eCollection 2016. | Citation | Fiedler GB, Schmid AI, Goluch S, Schewzow K, Laistler E, Niess F, Unger E, Wolzt M, Mirzahosseini A, Kemp GJ, Moser E, Meyerspeer M. Skeletal muscle ATP synthesis and cellular H(+) handling measured by localized (31)P-MRS during exercise and recovery. Sci Rep. 2016 Aug 26;6:32037. doi: 10.1038/srep32037. | Citation | Bower JE. Fatigue, brain, behavior, and immunity: summary of the 2012 Named Series on fatigue. Brain Behav Immun. 2012 Nov;26(8):1220-3. doi: 10.1016/j.bbi.2012.08.009. Epub 2012 Aug 31. | Citation | Vestergaard S, Nayfield SG, Patel KV, Eldadah B, Cesari M, Ferrucci L, Ceresini G, Guralnik JM. Fatigue in a representative population of older persons and its association with functional impairment, functional limitation, and disability. J Gerontol A Biol Sci Med Sci. 2009 Jan;64(1):76-82. doi: 10.1093/gerona/gln017. Epub 2009 Jan 27. | Citation | Schnelle JF, Buchowski MS, Ikizler TA, Durkin DW, Beuscher L, Simmons SF. Evaluation of two fatigability severity measures in elderly adults. J Am Geriatr Soc. 2012 Aug;60(8):1527-33. doi: 10.1111/j.1532-5415.2012.04062.x. Epub 2012 Aug 2. | Citation | Alexander NB, Taffet GE, Horne FM, Eldadah BA, Ferrucci L, Nayfield S, Studenski S. Bedside-to-Bench conference: research agenda for idiopathic fatigue and aging. J Am Geriatr Soc. 2010 May;58(5):967-75. doi: 10.1111/j.1532-5415.2010.02811.x. | Citation | Distefano G, Standley RA, Zhang X, Carnero EA, Yi F, Cornnell HH, Coen PM. Physical activity unveils the relationship between mitochondrial energetics, muscle quality, and physical function in older adults. J Cachexia Sarcopenia Muscle. 2018 Apr;9(2):279-294. doi: 10.1002/jcsm.12272. Epub 2018 Jan 24. | Citation | de Groote P, Millaire A, Decoulx E, Nugue O, Guimier P, Ducloux. Kinetics of oxygen consumption during and after exercise in patients with dilated cardiomyopathy. New markers of exercise intolerance with clinical implications. J Am Coll Cardiol. 1996 Jul;28(1):168-75. doi: 10.1016/0735-1097(96)00126-x. | Citation | Garcia-Saldivia M, Ilarraza-Lomeli H, Myers J, Lara J, Bueno L. Effect of physical training on the recovery of acute exercise, among patients with cardiovascular disease. Arch Cardiol Mex. 2017 Jul-Sep;87(3):199-204. doi: 10.1016/j.acmx.2016.11.004. Epub 2016 Dec 13. | Citation | Beaver WL, Wasserman K, Whipp BJ. A new method for detecting anaerobic threshold by gas exchange. J Appl Physiol (1985). 1986 Jun;60(6):2020-7. doi: 10.1152/jappl.1986.60.6.2020. |
]]>
https://zephyrnet.com/NCT03800329
2018-03-07
https://zephyrnet.com/?p=NCT03800329
NCT03800329https://www.clinicaltrials.gov/study/NCT03800329?tab=tableNANANAThis study is designed to determine the perceived value of continuous remote monitoring to surgeons and surgical patients at Mayo Clinic in Rochester, MN, and determine whether algorithms can be generated to predict risk of readmission following discharge. This initial study will be conducted through the Department of Cardiovascular Surgery.
<![CDATA[
Studies
Study First Submitted Date | 2018-08-14 |
Study First Posted Date | 2019-01-11 |
Last Update Posted Date | 2021-11-03 |
Start Month Year | March 7, 2018 |
Primary Completion Month Year | October 26, 2021 |
Verification Month Year | November 2021 |
Verification Date | 2021-11-30 |
Last Update Posted Date | 2021-11-03 |
Detailed Descriptions
Sequence: | 20810208 |
Description | The overall aim of this project is to determine the perceived utility and benefit to use of remote monitoring technology in patients being discharged following cardiac surgery at Mayo Clinic in Rochester, MN. The investigators also aim to determine whether machine learning algorithms can predict readmission following cardiac surgery in these patients, which the investigators believe will benefit patients in future studies. |
Facilities
Sequence: | 200859409 |
Name | Mayo Clinic in Rochester |
City | Rochester |
State | Minnesota |
Zip | 55905 |
Country | United States |
Conditions
Sequence: | 52397221 |
Name | Remote Monitoring |
Downcase Name | remote monitoring |
Id Information
Sequence: | 40319156 |
Id Source | org_study_id |
Id Value | 17-008249 |
Countries
Sequence: | 42742492 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55844080 | Sequence: | 55844081 |
Group Type | Active Comparator | Group Type | Placebo Comparator |
Title | Snap40 Monitor | Title | No Monitor |
Description | Patients randomly assigned to wear the Snap40 monitor will wear the device for 48 hours following discharge from the hospital. | Description | Patients randomly assigned to not wear the Snap40 monitor will continue with their follow-up surgical care in the ordinary fashion. |
Interventions
Sequence: | 52706612 | Sequence: | 52706613 |
Intervention Type | Device | Intervention Type | Other |
Name | Snap40 Monitor | Name | No Monitor |
Description | Non-invasive, wearable armband device used to measure change in systolic blood pressure, respiratory rate, heart rate, body temperature, movement, and oxyhemoglobin saturation and streams this information to a cloud-based storage system. Patients will complete a questionnaire. | Description | Patients will be discharged in the ordinary manner, without the Snap40 monitor. Patients will complete a questionnaire. |
Design Outcomes
Sequence: | 178214853 | Sequence: | 178214854 | Sequence: | 178214855 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | other |
Measure | Physician satisfaction in the use of remote monitoring technology. | Measure | Patient satisfaction in the use of remote monitoring technology. | Measure | Algorithms useful in prediction of readmission following cardiac surgery |
Time Frame | 48 hours | Time Frame | 48 hours | Time Frame | 48 hours |
Description | Physician satisfaction survey measure the utility and benefit to the use of remote monitoring technology in patients being discharged following cardiac surgery at Mayo Clinic in Rochester, MN. | Description | Patient satisfaction survey measures the utility and benefit to the use of remote monitoring technology in patients being discharged following cardiac surgery at Mayo Clinic in Rochester, MN. | Description | Measure data collected via machine learning algorithms to predict readmission following cardiac surgery in patients. |
Sponsors
Sequence: | 48529606 | Sequence: | 48529607 |
Agency Class | OTHER | Agency Class | UNKNOWN |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | Mayo Clinic | Name | Snap40 Ltd. |
Overall Officials
Sequence: | 29403396 |
Role | Principal Investigator |
Name | Jordan D Miller |
Affiliation | Mayo Clinic |
Design Group Interventions
Sequence: | 68456190 | Sequence: | 68456191 |
Design Group Id | 55844080 | Design Group Id | 55844081 |
Intervention Id | 52706612 | Intervention Id | 52706613 |
Eligibilities
Sequence: | 30895618 |
Gender | All |
Minimum Age | 40 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Target accrual: 100 patients
Subject population (children, adults, groups): adults undergoing coronary bypass surgery at Mayo Clinic in Rochester, MN Inclusion Criteria: Patients undergoing isolated coronary artery bypass graft (CABG) surgery Exclusion Criteria: Under 40 years of age |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254141736 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 44 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 40 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 1 |
Number Of Other Outcomes To Measure | 1 |
Designs
Sequence: | 30641356 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Other |
Time Perspective | |
Masking | None (Open Label) |
Links
Sequence: | 4405050 |
Url | https://www.mayo.edu/research/clinical-trials |
Description | Mayo Clinic Clinical Trials |
Responsible Parties
Sequence: | 29007965 |
Responsible Party Type | Principal Investigator |
Name | Jordan D. Miller, Ph.D. |
Title | Principal Investigator |
Affiliation | Mayo Clinic |
]]>
https://zephyrnet.com/NCT03800316
2019-01-14
https://zephyrnet.com/?p=NCT03800316
NCT03800316https://www.clinicaltrials.gov/study/NCT03800316?tab=tableNANANAThe study team aims to test connectivity metrics and follow patient outcomes using a new, innovative synchronous video technology in the prehospital setting in three distinct areas:
– 911 Calls
– Pediatric Critical Care Transport
Currently, paramedics and pediatric transport teams seek advice from physicians using a telephone. This project replaces the phone with video consultation where the physicians can directly interact with patients, paramedics and transport teams when care advice is needed.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-10 |
Study First Posted Date | 2019-01-11 |
Last Update Posted Date | 2020-05-04 |
Start Month Year | January 14, 2019 |
Primary Completion Month Year | March 31, 2020 |
Verification Month Year | May 2020 |
Verification Date | 2020-05-31 |
Last Update Posted Date | 2020-05-04 |
Facilities
Sequence: | 198643644 |
Name | Mayo Clinic in Rochester |
City | Rochester |
State | Minnesota |
Zip | 55905 |
Country | United States |
Conditions
Sequence: | 51793075 | Sequence: | 51793076 | Sequence: | 51793077 | Sequence: | 51793078 |
Name | Emergencies | Name | Prehospital | Name | Telemedicine | Name | Telehealth |
Downcase Name | emergencies | Downcase Name | prehospital | Downcase Name | telemedicine | Downcase Name | telehealth |
Id Information
Sequence: | 39858308 |
Id Source | org_study_id |
Id Value | 18-005054 |
Countries
Sequence: | 42256134 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55212457 |
Group Type | Experimental |
Title | Synchronous Video Consultation |
Description | Testing the feasibility of a synchronous video consultation in the field prior to emergency department arrival. |
Interventions
Sequence: | 52115640 |
Intervention Type | Device |
Name | Video Consultation |
Description | Video consultation with emergency medicine physicians for patients that are critically ill prior to arrival in the ED |
Design Outcomes
Sequence: | 176159115 | Sequence: | 176159112 | Sequence: | 176159113 | Sequence: | 176159114 |
Outcome Type | secondary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Emergency Room Length of Stay | Measure | Video Consultations Completed | Measure | Mortality | Measure | Hospital Length of Stay |
Time Frame | 1 year | Time Frame | 1 year | Time Frame | 1 year | Time Frame | 1 year |
Description | Total number of hours subjects were admitted to the emergency room | Description | Total number of video consultations completed | Description | Total number of subject deaths | Description | Total number of hours subjects were admitted to the hospital |
Browse Conditions
Sequence: | 191964291 | Sequence: | 191964292 | Sequence: | 191964293 |
Mesh Term | Emergencies | Mesh Term | Disease Attributes | Mesh Term | Pathologic Processes |
Downcase Mesh Term | emergencies | Downcase Mesh Term | disease attributes | Downcase Mesh Term | pathologic processes |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 47966512 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Mayo Clinic |
Overall Officials
Sequence: | 29062175 |
Role | Principal Investigator |
Name | Christopher S Russi |
Affiliation | Mayo Clinic |
Design Group Interventions
Sequence: | 67692190 |
Design Group Id | 55212457 |
Intervention Id | 52115640 |
Eligibilities
Sequence: | 30543314 |
Gender | All |
Minimum Age | N/A |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Cardiac Arrest Exclusion Criteria: • All other patients not list above |
Adult | True |
Child | True |
Older Adult | True |
Calculated Values
Sequence: | 254212723 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 14 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 3 |
Designs
Sequence: | 30291726 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Health Services Research |
Time Perspective | |
Masking | None (Open Label) |
Links
Sequence: | 4355749 |
Url | https://www.mayo.edu/research/clinical-trials |
Description | Mayo Clinic Clinical Trials |
Responsible Parties
Sequence: | 28670274 |
Responsible Party Type | Principal Investigator |
Name | Christopher S. Russi |
Title | Prinipal Investigator |
Affiliation | Mayo Clinic |
]]>
https://zephyrnet.com/NCT03800303
2018-03-15
https://zephyrnet.com/?p=NCT03800303
NCT03800303https://www.clinicaltrials.gov/study/NCT03800303?tab=tableNANANAIn an effort to understand the effects of evidence-based interventions on children and adolescents, the aims of this study are to:
evaluate the feasibility of utilizing wearable devices to track health information (i.e., sleep, physical activity);
evaluate the effectiveness of evidence-based intervention components on mood and interpersonal functioning, family engagement, and sleep and physical activity level outcomes.
<![CDATA[
Studies
Study First Submitted Date | 2018-03-15 |
Study First Posted Date | 2019-01-11 |
Last Update Posted Date | 2020-12-29 |
Start Month Year | March 15, 2018 |
Primary Completion Month Year | December 31, 2019 |
Verification Month Year | December 2020 |
Verification Date | 2020-12-31 |
Last Update Posted Date | 2020-12-29 |
Facilities
Sequence: | 201290099 | Sequence: | 201290100 | Sequence: | 201290101 |
Name | Mayo Clinic in Arizona | Name | Mayo Clinic in Florida | Name | Mayo Clinic in Rochester |
City | Scottsdale | City | Jacksonville | City | Rochester |
State | Arizona | State | Florida | State | Minnesota |
Zip | 85259 | Zip | 32224 | Zip | 55905 |
Country | United States | Country | United States | Country | United States |
Conditions
Sequence: | 52507864 |
Name | Mood Disorders in Children and Adolescents |
Downcase Name | mood disorders in children and adolescents |
Id Information
Sequence: | 40399424 |
Id Source | org_study_id |
Id Value | 17-010831 |
Countries
Sequence: | 42835751 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55964349 |
Group Type | Experimental |
Title | two-week family-based treatment |
Description | Active treatment includes a two-week family-based partial hospitalization treatment utilizing and integrated therapeutic design. |
Interventions
Sequence: | 52815812 |
Intervention Type | Behavioral |
Name | Family-based treatment |
Description | 2-week family-based treatment |
Keywords
Sequence: | 80325664 | Sequence: | 80325665 | Sequence: | 80325666 | Sequence: | 80325667 | Sequence: | 80325668 | Sequence: | 80325669 | Sequence: | 80325670 |
Name | depression | Name | bipolar | Name | caregivers | Name | children | Name | adolescents | Name | treatment | Name | parents |
Downcase Name | depression | Downcase Name | bipolar | Downcase Name | caregivers | Downcase Name | children | Downcase Name | adolescents | Downcase Name | treatment | Downcase Name | parents |
Design Outcomes
Sequence: | 178632258 |
Outcome Type | primary |
Measure | Conner's Comprehensive Behavior Rating Scales |
Time Frame | 12 months |
Description | Likert scale items measuring symptom presentation |
Browse Conditions
Sequence: | 194770858 | Sequence: | 194770859 |
Mesh Term | Mood Disorders | Mesh Term | Mental Disorders |
Downcase Mesh Term | mood disorders | Downcase Mesh Term | mental disorders |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48630817 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Mayo Clinic |
Overall Officials
Sequence: | 29461031 |
Role | Principal Investigator |
Name | Jarrod M Leffler |
Affiliation | Mayo Clinic |
Design Group Interventions
Sequence: | 68607730 |
Design Group Id | 55964349 |
Intervention Id | 52815812 |
Eligibilities
Sequence: | 30957213 |
Gender | All |
Minimum Age | 10 Years |
Maximum Age | 18 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Children and adolescents between the ages of 10 and 18 years; Exclusion Criteria: Individual's not eligible for admission to the Child and Adolescent Integrated Mood Program (CAIMP)at Mayo Clinic. |
Adult | True |
Child | True |
Older Adult | False |
Calculated Values
Sequence: | 253937766 |
Number Of Facilities | 3 |
Registered In Calendar Year | 2018 |
Actual Duration | 21 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | False |
Minimum Age Num | 10 |
Maximum Age Num | 18 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Designs
Sequence: | 30702789 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Links
Sequence: | 4413777 |
Url | https://www.mayo.edu/research/clinical-trials |
Description | Mayo Clinic Clinical Trials |
Responsible Parties
Sequence: | 29069551 |
Responsible Party Type | Principal Investigator |
Name | Jarrod M. Leffler, Ph.D., L.P. |
Title | Assistant Professor |
Affiliation | Mayo Clinic |
]]>
https://zephyrnet.com/NCT03800290
2019-06-01
https://zephyrnet.com/?p=NCT03800290
NCT03800290https://www.clinicaltrials.gov/study/NCT03800290?tab=tableNANANAThe purpose of this study is to investigate the effect of two weeks clenbuterol/placebo supplementation on skeletal muscle glucose disposal in healthy male volunteers.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-06 |
Study First Posted Date | 2019-01-11 |
Last Update Posted Date | 2022-12-01 |
Start Month Year | June 1, 2019 |
Primary Completion Month Year | April 23, 2021 |
Verification Month Year | July 2020 |
Verification Date | 2020-07-31 |
Last Update Posted Date | 2022-12-01 |
Facilities
Sequence: | 201074330 |
Name | Maastricht University |
City | Maastricht |
State | Limburg |
Zip | 6229ER |
Country | Netherlands |
Browse Interventions
Sequence: | 96480844 | Sequence: | 96480845 | Sequence: | 96480846 | Sequence: | 96480847 | Sequence: | 96480848 | Sequence: | 96480849 | Sequence: | 96480850 | Sequence: | 96480851 | Sequence: | 96480852 | Sequence: | 96480853 | Sequence: | 96480854 | Sequence: | 96480855 | Sequence: | 96480856 |
Mesh Term | Clenbuterol | Mesh Term | Adrenergic beta-Agonists | Mesh Term | Adrenergic Agonists | Mesh Term | Adrenergic Agents | Mesh Term | Neurotransmitter Agents | Mesh Term | Molecular Mechanisms of Pharmacological Action | Mesh Term | Physiological Effects of Drugs | Mesh Term | Bronchodilator Agents | Mesh Term | Autonomic Agents | Mesh Term | Peripheral Nervous System Agents | Mesh Term | Anti-Asthmatic Agents | Mesh Term | Respiratory System Agents | Mesh Term | Sympathomimetics |
Downcase Mesh Term | clenbuterol | Downcase Mesh Term | adrenergic beta-agonists | Downcase Mesh Term | adrenergic agonists | Downcase Mesh Term | adrenergic agents | Downcase Mesh Term | neurotransmitter agents | Downcase Mesh Term | molecular mechanisms of pharmacological action | Downcase Mesh Term | physiological effects of drugs | Downcase Mesh Term | bronchodilator agents | Downcase Mesh Term | autonomic agents | Downcase Mesh Term | peripheral nervous system agents | Downcase Mesh Term | anti-asthmatic agents | Downcase Mesh Term | respiratory system agents | Downcase Mesh Term | sympathomimetics |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52440250 |
Name | Healthy |
Downcase Name | healthy |
Id Information
Sequence: | 40350629 |
Id Source | org_study_id |
Id Value | NL67646.068.18 |
Countries
Sequence: | 42784026 |
Name | Netherlands |
Removed | False |
Design Groups
Sequence: | 55891661 | Sequence: | 55891662 |
Group Type | Experimental | Group Type | Placebo Comparator |
Title | Clenbuterol hydrochloride | Title | Placebos |
Description | Subjects will ingest clenbuterol hydrochloride capsules (20 microgram/each) twice daily (40 microgram/day) for a maximum of 14 days.
Subjects that received the clenbuterol hydrochloride capsules (at random) in the first study period will receive the placebo capsules during the second study period. |
Description | Subjects will ingest placebo capsules matching the clenbuterol hydrochloride capsules one time per day for a maximum of 14 days.
Subjects that received the placebo capsules (at random) in the first study period will receive the clenbuterol hydrochloride capsules during the second study period. |
Interventions
Sequence: | 52749963 | Sequence: | 52749964 |
Intervention Type | Drug | Intervention Type | Drug |
Name | Clenbuterol Hydrochloride | Name | Placebos |
Description | Daily ingestion of clenbuterol hydrochloride capsules (40 microgram/day) for a total period of 14 days with a wash-out period of 4 weeks. | Description | Daily ingestion of placebo capsules for a total period of 14 days with a wash-out period of 4 weeks. |
Keywords
Sequence: | 80233182 | Sequence: | 80233183 | Sequence: | 80233184 | Sequence: | 80233185 |
Name | Beta-2 adrenergic agonist | Name | Glucose homeostasis | Name | Skeletal muscle | Name | Human |
Downcase Name | beta-2 adrenergic agonist | Downcase Name | glucose homeostasis | Downcase Name | skeletal muscle | Downcase Name | human |
Design Outcomes
Sequence: | 178390805 | Sequence: | 178390806 | Sequence: | 178390807 | Sequence: | 178390808 | Sequence: | 178390809 | Sequence: | 178390810 | Sequence: | 178390811 | Sequence: | 178390812 | Sequence: | 178390813 | Sequence: | 178390814 | Sequence: | 178390815 | Sequence: | 178390816 | Sequence: | 178390817 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other |
Measure | Insulin-stimulated peripheral glucose disposal (Rd) | Measure | Skeletal muscle GLUT4 translocation | Measure | Body weight/composition | Measure | Plasma substrates | Measure | Heart rate | Measure | Blood pressure | Measure | Insulin-mediated suppression of hepatic glucose production | Measure | Energy expenditure and substrate oxidation | Measure | Sleeping energy expenditure and substrate oxidation | Measure | Skeletal muscle glycogen | Measure | Skeletal muscle lipid content using wide-field microscopie | Measure | Skeletal muscle gene expression | Measure | Skeletal muscle protein expression using western blotting |
Time Frame | 2 weeks | Time Frame | acute (4 hours) and long-term (2 weeks) | Time Frame | 2 weeks | Time Frame | Acute (4 hours) and long-term (1 and 2 weeks) | Time Frame | Acute (4 hours) and long-term (1 and 2 weeks) | Time Frame | Acute (4 hours) and long-term (1 and 2 weeks) | Time Frame | 2 weeks | Time Frame | Acute (4 hours) and long-term (2 weeks) | Time Frame | 2-weeks | Time Frame | 2 weeks | Time Frame | 2 weeks | Time Frame | Acute (4 hours) and long-term (1 and 2 weeks) | Time Frame | Acute (4 hours) and long-term (1 and 2 weeks) |
Description | Comparison between prolonged (2 weeks) clenbuterol hydrochloride or placebo supplementation on insulin-stimulated peripheral glucose disposal (Rd) during the high-insulin infusion step during the two-step hyperinsulinemic-euglycemic clamp. | Description | Comparison between acute (4h) and prolonged (2 weeks) clenbuterol hydrochloride or placebo supplementation on skeletal muscle GLUT4 translocation as assessed by means of wide-field microscopy in skeletal muscle biopsies | Description | Comparison between prolonged (2 weeks) clenbuterol hydrochloride or placebo supplementation on body weight and composition as assessed by means of a Bodpod measurement. | Description | Comparison between acute (4h) and prolonged (1 and 2 weeks) clenbuterol hydrochloride or placebo supplementation on plasma substrate concentrations, including insulin, glucose, free fatty acids and TAGs. | Description | Comparison between acute (4h) and prolonged (1 and 2 weeks) clenbuterol hydrochloride or placebo supplementation on heart rate as measured by means of an automated cuff. | Description | Comparison between acute (4h) and prolonged (1 and 2 weeks) clenbuterol hydrochloride or placebo supplementation on blood pressure (systolic and diastolic) as measured by means of an automated cuff. | Description | Comparison between prolonged (2 weeks) clenbuterol hydrochloride or placebo supplementation on hepatic glucose production as assessed during the two-step hyperinsulinemic-euglycemic clamp. | Description | Comparison between acute (4h) and prolonged (2 weeks) clenbuterol hydrochloride or placebo supplementation on energy expenditure and substrate oxidation as assessed by means of indirect calorimetry. | Description | Comparison between prolonged (2 weeks) clenbuterol hydrochloride or placebo supplementation on sleeping energy expenditure and substrate oxidation as assessed by means of a metabolic chamber (indirect calorimetry). | Description | Comparison between prolonged (2 weeks) clenbuterol hydrochloride or placebo supplementation on skeletal muscle glycogen as assessed in muscle biopsies. | Description | Comparison between prolonged (2 weeks) clenbuterol hydrochloride or placebo supplementation on skeletal muscle lipid content as assessed in muscle biopsies by wide-field microscopie. | Description | Comparison between acute (4h) and prolonged (2 weeks) clenbuterol hydrochloride or placebo supplementation on skeletal muscle gene expression of specific pathways as determined in muscle biopsies by means of RT-qPCR | Description | Comparison between acute (4h) and prolonged (2 weeks) clenbuterol hydrochloride or placebo supplementation on skeletal muscle protein expression of specific pathways as determined in muscle biopsies as determined by means of Western Blotting |
Sponsors
Sequence: | 48568452 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Maastricht University |
Overall Officials
Sequence: | 29425480 |
Role | Principal Investigator |
Name | Joris Hoeks, PhD |
Affiliation | principle investigator |
Design Group Interventions
Sequence: | 68517416 | Sequence: | 68517417 |
Design Group Id | 55891661 | Design Group Id | 55891662 |
Intervention Id | 52749963 | Intervention Id | 52749964 |
Eligibilities
Sequence: | 30919528 |
Gender | Male |
Minimum Age | 18 Years |
Maximum Age | 30 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
Caucasian; Exclusion Criteria: Not meeting all inclusion criteria |
Adult | True |
Child | False |
Older Adult | False |
Calculated Values
Sequence: | 254187946 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 23 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 30 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 1 |
Number Of Other Outcomes To Measure | 11 |
Designs
Sequence: | 30665204 |
Allocation | Randomized |
Intervention Model | Crossover Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Double |
Intervention Model Description | Randomized, double-blinded, placebo-controlled, cross-over, single-center study |
Subject Masked | True |
Investigator Masked | True |
Responsible Parties
Sequence: | 29031896 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03800277
2018-11-05
https://zephyrnet.com/?p=NCT03800277
NCT03800277https://www.clinicaltrials.gov/study/NCT03800277?tab=tableNANANAThe growing prevalence of obesity and type 2 diabetes (T2D) is a major public health problem. Recent studies have clearly established that the gut microbiota plays a key role in the investigator’s propensity to develop obesity and associated metabolic health disorders. The gut microbiota compositions plays a decisive role in glucose metabolism and the chronic inflammatory state associated with insulin resistance. Consuming prebiotic rich diet, including polyphenol and inulin rich food could help modulate favorably the gut microbiota which could lead to a reduction of endotoxemia and beneficial metabolic health effects.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-06 |
Study First Posted Date | 2019-01-11 |
Last Update Posted Date | 2023-03-21 |
Start Month Year | November 5, 2018 |
Primary Completion Month Year | December 31, 2020 |
Verification Month Year | March 2023 |
Verification Date | 2023-03-31 |
Last Update Posted Date | 2023-03-21 |
Detailed Descriptions
Sequence: | 20600288 |
Description | It is now recognized that overweight individuals have altered microbiota which could lead to intestinal barrier defects and chronic inflammation disorders. Polyphenols such as Proanthocyanidins may modulate the gut microbiota thereby providing beneficial effects on metabolic health. Inulin is a well known prebiotic that could stimulate growth of favorable bacteria in the gut.
The overall goal is to determine the efficacy and synergy of a supplement of polyphenols from cranberry extract with or without a supplement of inulin from agaves to reduce chronic inflammation and endotoxemia and to improve glucose metabolism and insulin sensitivity by modulating microbiota of overweight human subjects with metabolic syndrome symptoms. |
Facilities
Sequence: | 198866359 |
Name | Institute of nutrition and functional foods, Laval University |
City | Québec |
State | Quebec |
Zip | G1V 0A6 |
Country | Canada |
Conditions
Sequence: | 51861283 | Sequence: | 51861284 | Sequence: | 51861285 | Sequence: | 51861286 |
Name | Endotoxemia | Name | Metabolic Syndrome | Name | Glucose Metabolism Disorders | Name | Insulin Resistance |
Downcase Name | endotoxemia | Downcase Name | metabolic syndrome | Downcase Name | glucose metabolism disorders | Downcase Name | insulin resistance |
Id Information
Sequence: | 39910003 |
Id Source | org_study_id |
Id Value | GASTRO-Phenulin (2016-317) |
Countries
Sequence: | 42308736 |
Name | Canada |
Removed | False |
Design Groups
Sequence: | 55288396 | Sequence: | 55288397 | Sequence: | 55288398 | Sequence: | 55288399 |
Group Type | Experimental | Group Type | Experimental | Group Type | Experimental | Group Type | Placebo Comparator |
Title | Cranberry and Agaves | Title | Cranberry and placebo | Title | Placebo and Agaves | Title | Placebo and placebo |
Description | Cranberry extract (2 capsules) + Agaves powder (1 single-dose packet) | Description | Cranberry extract (2 capsules) + Placebo powder (1 single-dose packet) | Description | Placebo (2 capsules) + Agaves powder (1 single-dose packet) | Description | Placebo (2 capsules) + Placebo powder (1 single-dose packet) |
Interventions
Sequence: | 52181049 | Sequence: | 52181050 | Sequence: | 52181051 |
Intervention Type | Dietary Supplement | Intervention Type | Dietary Supplement | Intervention Type | Dietary Supplement |
Name | Cranberry | Name | Agaves | Name | Placebo |
Description | Supplementation of polyphenols from cranberry extract | Description | Supplementation of inulin from Agaves powder | Description | Supplementation with placebo |
Design Outcomes
Sequence: | 176372665 | Sequence: | 176372666 | Sequence: | 176372667 | Sequence: | 176372668 | Sequence: | 176372669 | Sequence: | 176372670 | Sequence: | 176372671 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Change in metabolic endotoxemia: Measure concentration of Lipopolysaccharides (LPS) and Lipopolysaccharide Binding Protein (LBP) in plasma | Measure | Change in intestinal permeability: Measure concentration of zonulin in plasma | Measure | Change in inflammation state of the tissue: Measure concentration of calprotectin and lactoferrin in feces | Measure | Change in systemic inflammation: Measure concentration of inflammation biomarkers in the serum | Measure | Change in glucose serum concentration | Measure | Change in insulin and C-peptide serum concentration | Measure | Change in microbiota diversity: growth of Akkermancia muciniphila, Lactobacillus, Prevotella, Bifdobacterium and inhibition of Clostridium perfringens, C. difficile, Bacteroides spp.) |
Time Frame | At the beginning and the end of treatment (10 weeks) | Time Frame | At the beginning and the end of treatment (10 weeks) | Time Frame | At the beginning and the end of treatment (10 weeks) | Time Frame | At the beginning and the end of treatment (10 weeks) | Time Frame | At the beginning and the end of treatment (10 weeks) | Time Frame | At the beginning and the end of treatment (10 weeks) | Time Frame | At the beginning and the end of treatment (10 weeks) |
Description | effect of the supplements on variation in plasma concentration of LPS and LBP | Description | effect of the supplements on plasma concentration of zonulin | Description | effect of the supplements on fecal calprotectin and lactoferrin | Description | effect of the supplements on chronic inflammation (serum concentration of hsCRP, Il-6, TNF-alpha, IL-1 beta, IL-23) | Description | effect of the supplements on serum concentration of glucose | Description | effect of the supplements on serum concentration of insulin and C-peptide | Description | Global variation of the fecal microbiota and gut microbiota profiling |
Browse Conditions
Sequence: | 192230135 | Sequence: | 192230136 | Sequence: | 192230137 | Sequence: | 192230138 | Sequence: | 192230139 | Sequence: | 192230140 | Sequence: | 192230141 | Sequence: | 192230142 | Sequence: | 192230143 | Sequence: | 192230144 | Sequence: | 192230145 | Sequence: | 192230146 | Sequence: | 192230147 |
Mesh Term | Endotoxemia | Mesh Term | Metabolic Syndrome | Mesh Term | Insulin Resistance | Mesh Term | Metabolic Diseases | Mesh Term | Glucose Metabolism Disorders | Mesh Term | Hyperinsulinism | Mesh Term | Bacteremia | Mesh Term | Sepsis | Mesh Term | Infections | Mesh Term | Toxemia | Mesh Term | Systemic Inflammatory Response Syndrome | Mesh Term | Inflammation | Mesh Term | Pathologic Processes |
Downcase Mesh Term | endotoxemia | Downcase Mesh Term | metabolic syndrome | Downcase Mesh Term | insulin resistance | Downcase Mesh Term | metabolic diseases | Downcase Mesh Term | glucose metabolism disorders | Downcase Mesh Term | hyperinsulinism | Downcase Mesh Term | bacteremia | Downcase Mesh Term | sepsis | Downcase Mesh Term | infections | Downcase Mesh Term | toxemia | Downcase Mesh Term | systemic inflammatory response syndrome | Downcase Mesh Term | inflammation | Downcase Mesh Term | pathologic processes |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48031434 | Sequence: | 48031435 | Sequence: | 48031436 | Sequence: | 48031437 | Sequence: | 48031438 | Sequence: | 48031439 | Sequence: | 48031440 |
Agency Class | OTHER | Agency Class | OTHER_GOV | Agency Class | UNKNOWN | Agency Class | UNKNOWN | Agency Class | INDUSTRY | Agency Class | UNKNOWN | Agency Class | INDUSTRY |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator |
Name | Laval University | Name | Ministry of Agriculture, Fisheries and Food, Quebec | Name | Ministry of economic development, innovation and export trade, Quebec | Name | Diana Food, Symrise | Name | Atrium Innovations | Name | NutriAgaves, Mexico | Name | Société des Produits Nestlé (SPN) |
Overall Officials
Sequence: | 29104169 | Sequence: | 29104170 |
Role | Principal Investigator | Role | Study Director |
Name | Hélène Jacques, PhD | Name | Yves Desjardins, PhD |
Affiliation | Institute of nutrition and functional foods, Laval University | Affiliation | Institute of nutrition and functional foods, Laval University |
Design Group Interventions
Sequence: | 67778465 | Sequence: | 67778466 | Sequence: | 67778467 | Sequence: | 67778468 | Sequence: | 67778469 | Sequence: | 67778470 | Sequence: | 67778471 |
Design Group Id | 55288396 | Design Group Id | 55288397 | Design Group Id | 55288396 | Design Group Id | 55288398 | Design Group Id | 55288397 | Design Group Id | 55288398 | Design Group Id | 55288399 |
Intervention Id | 52181049 | Intervention Id | 52181049 | Intervention Id | 52181050 | Intervention Id | 52181050 | Intervention Id | 52181051 | Intervention Id | 52181051 | Intervention Id | 52181051 |
Eligibilities
Sequence: | 30583568 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 70 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
overweight (BMI 25-39.9 kg/m2) or waist circumference ≥ 80 cm (women) and ≥94 cm (men) Exclusion Criteria: chronic disease |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253859167 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 26 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 70 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 6 |
Designs
Sequence: | 30331732 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Prevention |
Time Perspective | |
Masking | Quadruple |
Subject Masked | True |
Caregiver Masked | True |
Investigator Masked | True |
Outcomes Assessor Masked | True |
Responsible Parties
Sequence: | 28710525 |
Responsible Party Type | Principal Investigator |
Name | Helene Jacques |
Title | Professor |
Affiliation | Laval University |
]]>
https://zephyrnet.com/NCT03800264
2018-05-02
https://zephyrnet.com/?p=NCT03800264
NCT03800264https://www.clinicaltrials.gov/study/NCT03800264?tab=tableNANANABackground: Atrial fibrillation (AF) is the most common cardiac arrhythmia that occurs after on pump coronary artery bypass graft (CABG) surgery. It is associated with postoperative complications, including increased risk of stroke, prolonged hospital stay and increased costs.
Objectives: The aim of this study was to find reliable, effective, safe and well tolerated tools for the prevention of AF after on pump coronary artery bypass surgery.
Patients and methods: The study included 176 patients (age range 40 to 79 years) and scheduled for elective on pump CABG operations without concomitant procedures. The patients were divided randomly into two equal groups. Group (A) in which bisoprolol was used for prophylaxis against atrial fibrillation after surgery. Group (B) in which bisoprolol and hydrocortisone were used for prophylaxis against atrial fibrillation after surgery. For each patient, the following data were collected: gender, preoperative diseases, intraoperative cross clamp time, cardiopulmonary bypass time, and Lt internal mammary Artery usage, incidence of postoperative atrial fibrillation, death, myocardial infarction chest infection and C – reactive protein levels.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-09 |
Study First Posted Date | 2019-01-11 |
Last Update Posted Date | 2019-01-15 |
Start Month Year | May 2, 2018 |
Primary Completion Month Year | November 1, 2018 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-15 |
Detailed Descriptions
Sequence: | 20548777 |
Description | The study was conducted at The Cardiothoracic surgery intensive care unit of Ain Shams University hospitals during a period of 6 months. The study protocol was approved by "research and ethics committee" of anesthesia and intensive care department, Ain Shams University. Informative consent was obtained from the patients before enrolling in the study.
176 Patients were registered in the study. Patients were randomly allocated by computer-generated random number list into two study groups of 88 patients each, with a range of age between 40 and 79 years old and were undergoing elective on pump CABG operations without concomitant procedures. Group A: Patients received bisoprolol 5mg per oral (P.O.) in the evening of the operation and then one dose (5 mg) every twenty four hours during the next two days. Group B: Patients received bisoprolol as group (A) in addition hydrocortisone 100 mg intravenously is given in the evening of the operation and then 100 mg every eight hours during the next two days. Exclusion criteria for the study included: Patients with preoperative rhythm abnormalities (sick sinus syndrome, atrioventricular conduction abnormalities, history of chronic or intermittent AF), pretreatment with classes I and III antiarrhythmic agents, receiving anti-hypertensive drugs except angiotensin convertor enzyme (ACE) inhibitors, thyroid disease, renal or liver disease, peripheral arterial atherosclerotic disease, thrombophlebitis, uncontrolled diabetes mellitus, systemic bacterial or mycotic infection, active tuberculosis, Cushing's syndrome, peptic ulcer, psychotic mental disorder, Herpes Simplex keratitis and chronic obstructive pulmonary disease were not included in the study. Intraoperative technique: After sedation with diazepam (10 mg intramuscular), radial arterial catheterization, intravenous catheters, and a central venous catheter were introduced in the operating theater. Hemodynamic parameters; Heart rate monitoring, mean arterial pressure, rectal temperature, central venous pressure and arterial blood gas throughout the process was observed. Anesthesia was started by fentanyl (35 mg / kg) and muscle relaxation was achieved with pancronium (0.1 mg / kg), then endotracheal intubation using ventilation with 100% oxygen. The median incision of the sternum was used for cardiac exposure. The left internal mammary artery was harvested and the saphenous vein was prepared, if necessary. All operations were performed under cardiopulmonary bypass and moderate hypothermia (28-328C) with flow rates of 2.2-2.4 l / m2 and the mean perfusion pressure of 50-85 mm Hg. Heart failure was assisted by initial crystalloid cardioplegia (48C, 15 cc / kg) and heart preservation was assisted with 400 cc cold blood Cardioplegia every 20 minutes. The hot shut was performed shortly before removing the cross clamp. The venous cannula was inserted through the right atrial appendix. The arterial cannula was placed in the ascending aorta. 2.3. Postoperative Monitoring: All patients were continuously monitored at the ICU with electrocardiography (ECG), invasive blood pressure and with finger probe for oxygen saturation within 48 h. Patients developed atrial fibrillation received treatment according to their condition, if they are haemodynamically unstable electrical cardioversion (synchronized adjusted at 100 joules using biphasic electrical cardiovertor) was applied. If they are haemodynamically stable pharmacological cardioversion (amiodarone 5 mg/kg intravenous over 60 minutes, then 1.2 grams per day by continuous intravenous infusion) was used. (5) |
Facilities
Sequence: | 198402804 |
Name | Ramymahrose |
City | Cairo |
Zip | 02 |
Country | Egypt |
Browse Interventions
Sequence: | 95177231 | Sequence: | 95177232 | Sequence: | 95177233 | Sequence: | 95177234 | Sequence: | 95177235 | Sequence: | 95177236 | Sequence: | 95177237 | Sequence: | 95177238 | Sequence: | 95177239 | Sequence: | 95177240 | Sequence: | 95177241 | Sequence: | 95177242 | Sequence: | 95177243 | Sequence: | 95177244 |
Mesh Term | Hydrocortisone | Mesh Term | Bisoprolol | Mesh Term | Anti-Inflammatory Agents | Mesh Term | Antihypertensive Agents | Mesh Term | Sympatholytics | Mesh Term | Autonomic Agents | Mesh Term | Peripheral Nervous System Agents | Mesh Term | Physiological Effects of Drugs | Mesh Term | Adrenergic beta-1 Receptor Antagonists | Mesh Term | Adrenergic beta-Antagonists | Mesh Term | Adrenergic Antagonists | Mesh Term | Adrenergic Agents | Mesh Term | Neurotransmitter Agents | Mesh Term | Molecular Mechanisms of Pharmacological Action |
Downcase Mesh Term | hydrocortisone | Downcase Mesh Term | bisoprolol | Downcase Mesh Term | anti-inflammatory agents | Downcase Mesh Term | antihypertensive agents | Downcase Mesh Term | sympatholytics | Downcase Mesh Term | autonomic agents | Downcase Mesh Term | peripheral nervous system agents | Downcase Mesh Term | physiological effects of drugs | Downcase Mesh Term | adrenergic beta-1 receptor antagonists | Downcase Mesh Term | adrenergic beta-antagonists | Downcase Mesh Term | adrenergic antagonists | Downcase Mesh Term | adrenergic agents | Downcase Mesh Term | neurotransmitter agents | Downcase Mesh Term | molecular mechanisms of pharmacological action |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 51727237 | Sequence: | 51727238 | Sequence: | 51727239 |
Name | Prevention | Name | Atrial Fibrillation | Name | CABG |
Downcase Name | prevention | Downcase Name | atrial fibrillation | Downcase Name | cabg |
Id Information
Sequence: | 39805697 |
Id Source | org_study_id |
Id Value | Bisoprolol vs corticosteroi |
Countries
Sequence: | 42204449 |
Name | Egypt |
Removed | False |
Design Groups
Sequence: | 55147114 | Sequence: | 55147115 |
Group Type | Active Comparator | Group Type | Active Comparator |
Title | BISOPROLOL | Title | hydrocortisone |
Description | BISOPROLOL 5mg per oral (P.O.) in the evening of the operation and then one dose (5 mg) every twenty four hours during the next two days. | Description | hydrocortisone 100 mg intravenously is given in the evening of the operation and then 100 mg every eight hours during the next two days. |
Interventions
Sequence: | 52048849 |
Intervention Type | Drug |
Name | Bisoprolol |
Description | PREVENTIVE DOUBLE BLINDED |
Keywords
Sequence: | 79145061 | Sequence: | 79145062 | Sequence: | 79145063 | Sequence: | 79145064 |
Name | Bisoprolol, | Name | corticosteroid, | Name | atrial fibrillation | Name | cardiac surgery |
Downcase Name | bisoprolol, | Downcase Name | corticosteroid, | Downcase Name | atrial fibrillation | Downcase Name | cardiac surgery |
Design Outcomes
Sequence: | 175933170 |
Outcome Type | primary |
Measure | HEART RATE |
Time Frame | two days |
Description | atrial fibrillation |
Browse Conditions
Sequence: | 191700813 | Sequence: | 191700814 | Sequence: | 191700815 | Sequence: | 191700816 | Sequence: | 191700817 |
Mesh Term | Atrial Fibrillation | Mesh Term | Arrhythmias, Cardiac | Mesh Term | Heart Diseases | Mesh Term | Cardiovascular Diseases | Mesh Term | Pathologic Processes |
Downcase Mesh Term | atrial fibrillation | Downcase Mesh Term | arrhythmias, cardiac | Downcase Mesh Term | heart diseases | Downcase Mesh Term | cardiovascular diseases | Downcase Mesh Term | pathologic processes |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 47907153 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Ain Shams University |
Design Group Interventions
Sequence: | 67607871 | Sequence: | 67607872 |
Design Group Id | 55147114 | Design Group Id | 55147115 |
Intervention Id | 52048849 | Intervention Id | 52048849 |
Eligibilities
Sequence: | 30506617 |
Gender | All |
Minimum Age | 40 Years |
Maximum Age | 79 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
– .176 Patients were registered in the study. .Range of age between 40 and 79 years old .Undergoing elective on pump CABG operations without concomitant procedures. Exclusion Criteria: : Patients with preoperative rhythm abnormalities (sick sinus syndrome, atrioventricular conduction abnormalities, |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254052887 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 6 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 40 |
Maximum Age Num | 79 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Designs
Sequence: | 30255697 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Prevention |
Time Perspective | |
Masking | Single |
Masking Description | BLINDED |
Intervention Model Description | DOUBLE BLINDED RANDOMIZED STUDY |
Subject Masked | True |
Intervention Other Names
Sequence: | 26456215 |
Intervention Id | 52048849 |
Name | HYDROCORTISONE |
Responsible Parties
Sequence: | 28636187 |
Responsible Party Type | Principal Investigator |
Name | RAMY AHMED |
Title | lecturer |
Affiliation | Ain Shams University |
]]>
https://zephyrnet.com/NCT03800251
2018-06-06
https://zephyrnet.com/?p=NCT03800251
NCT03800251https://www.clinicaltrials.gov/study/NCT03800251?tab=tableMichelle Walshmichowalsh@gmail.com+353 (01) 4085662The aim of the study is to use sequential ultrasound evaluation of the gastric volume to determine how long it takes for the stomach of a fasting pregnant woman at term, admitted for elective cesarean section, to empty after ingesting a 400ml carbohydrate drink (Nutricia preOp).
<![CDATA[
Studies
Study First Submitted Date | 2019-01-06 |
Study First Posted Date | 2019-01-11 |
Last Update Posted Date | 2019-01-11 |
Start Month Year | June 6, 2018 |
Primary Completion Month Year | January 2019 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-11 |
Detailed Descriptions
Sequence: | 20852117 |
Description | Recent research suggests that attention to nutrition before operation leads to a speedier recovery through moderating the metabolic responses to surgery, improving well-being, decreasing post-operative insulin resistance and attenuation loss of lean body mass. On other hand there are fasting guidelines in place to prevent from pulmonary aspiration. The current fasting guidelines of 2hrs for clear fluids come from some small studies performed in healthy non-pregnant adults and consensus agreement.
The aim of the study is to use sequential ultrasound evaluation of the gastric volume to determine how long it takes for the stomach of a fasting pregnant woman at term, admitted for elective cesarean section, to empty after ingesting a 400ml carbohydrate drink (Nutricia preOp – a clear, non-carbonated, lemon flavoured, carbohydrate drink that provides 0.5kcal/ml). Patients who are fasting according to the current guidelines and agree to partake in the study will, on the day of their elective LSCS, be given a 400ml carbohydrate drink at least 2hours before their scheduled theatre time. Patients will then have their gastric volume assessed at 15minutes intervals for 2 hours to determine how long it takes for the ingested fluid to leave the stomach. The results of the study will give us more information regarding gastric emptying in the investigator's patient population and may lead to reduced fasting times, increasing patient comfort and improving the patient experience. |
Facilities
Sequence: | 201287164 |
Status | Recruiting |
Name | Coombe Women and Infants University Hospital |
City | Dublin |
Zip | D08XW7X |
Country | Ireland |
Facility Contacts
Sequence: | 28281678 |
Facility Id | 201287164 |
Contact Type | primary |
Name | Petar Popivanov, Dr |
ppopivanov@coombe.ie | |
Phone | +353 (01) 408 5662 |
Facility Investigators
Sequence: | 18438571 |
Facility Id | 201287164 |
Role | Principal Investigator |
Name | Michelle Walsh, Dr |
Conditions
Sequence: | 52507027 | Sequence: | 52507028 |
Name | Gastric Emptying | Name | Pregnancy |
Downcase Name | gastric emptying | Downcase Name | pregnancy |
Id Information
Sequence: | 40398817 |
Id Source | org_study_id |
Id Value | 8-2018 |
Countries
Sequence: | 42835112 |
Name | Ireland |
Removed | False |
Design Groups
Sequence: | 55963380 |
Group Type | Other |
Title | Fasting parturients at term |
Description | Fasting parturients at term, admitted for elective cesarean section, who consent to partake in the study |
Interventions
Sequence: | 52814912 |
Intervention Type | Dietary Supplement |
Name | Nutricia PreOp – a clear, non-carbonated, lemon flavoured, carbohydrate drink that provides 0.5kcal/ml |
Description | Fasting parturients at term, admitted for elective cesarean section and consent to partake in the study, will be given the intervention drink |
Keywords
Sequence: | 80324583 | Sequence: | 80324584 | Sequence: | 80324585 | Sequence: | 80324586 |
Name | Gastric Emptying | Name | Pregnancy | Name | Elective Cesarean section | Name | Fasting |
Downcase Name | gastric emptying | Downcase Name | pregnancy | Downcase Name | elective cesarean section | Downcase Name | fasting |
Design Outcomes
Sequence: | 178629619 | Sequence: | 178629620 | Sequence: | 178629621 | Sequence: | 178629622 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Time interval required to return to the fasting grade. | Measure | Number of participants with grade 0, 1 and 2 in fasting term parturients attending for elective cesarean section | Measure | Time taken for the antral cross sectional area (measured by ultrasound) to reach <9.6 cm2 (suggested cut off value for ingested volumes < 1.5ml.kg-1) after ingesting 400 ml carbohydrate drink | Measure | Antral cross sectional area at 2 hours |
Time Frame | 2 hours | Time Frame | 10 minutes | Time Frame | 2 hours | Time Frame | 2 hours |
Description | The stomach will be scanned and graded (Perlas grade 0-2) every 15 minutes based on the presence or absence of clear fluid in supine and right lateral decubitus position at 45 degrees elevation of the upper body, after consumption of 400 ml clear carbohydrate drink (Nutricia PreOp). | Description | Initial "fasting" scan will be performed in all patients | Description | Sequential ultrasound scans will be performed at 15 min intervals for 2 hours. | Description | Ultrasound measurement of antral cross sectional area will be performed at 2 hours after consumption of 400 ml clear carbohydrate drink (Nutricia PreOp). |
Sponsors
Sequence: | 48630073 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Coombe Women and Infants University Hospital |
Central Contacts
Sequence: | 12095043 | Sequence: | 12095044 |
Contact Type | primary | Contact Type | backup |
Name | Petar Popivanov | Name | Michelle Walsh |
Phone | +353 (01) 4085662 | Phone | +353 (01) 4085662 |
ppopivanov@coombe.ie | michowalsh@gmail.com | ||
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 68606449 |
Design Group Id | 55963380 |
Intervention Id | 52814912 |
Eligibilities
Sequence: | 30956738 |
Gender | Female |
Minimum Age | 18 Years |
Maximum Age | 50 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
Elective LSCS Exclusion Criteria: Multiple pregnancy |
Adult | True |
Child | False |
Older Adult | False |
Calculated Values
Sequence: | 253953191 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 50 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 3 |
Designs
Sequence: | 30702314 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Intervention Model Description | Patients who are fasting according to the guidelines and agree to partake in the study will, on the day of their elective LSCS, be given a 400ml carbohydrate drink at least 2hrs before their scheduled theatre time and will then have their gastric volume assessed at 15min intervals for 2hrs to determine how long it takes for the ingested fluid to leave the stomach. |
Responsible Parties
Sequence: | 29069081 |
Responsible Party Type | Principal Investigator |
Name | Petar Popivanov |
Title | Consultant Anaesthetist |
Affiliation | Coombe Women and Infants University Hospital |
]]>
https://zephyrnet.com/NCT03800238
2019-02-01
https://zephyrnet.com/?p=NCT03800238
NCT03800238https://www.clinicaltrials.gov/study/NCT03800238?tab=tableNANANAThe purpose of this research is to examine the efficacy of telehealth as a delivery format for an education-based caregiver wellness program focusing on self-care. The study will examine two research questions. 1) Are outcomes equivalent for caregivers in an education based-wellness program delivered via telehealth and one delivered in person as measured by a general rating of health, the Center for Epidemiologic Studies Depression Scale – Revised (CESD-R), self-care behaviors (health self-care neglect, frequency of stress management and relaxation activities, and exercise frequency), self-efficacy, use of community resources, and the Bakas Caregiving Outcomes Scale (BCOS)? 2) Is class attendance equivalent for classes delivered via telehealth and in person? This research involves a specific education-based caregiver wellness program called Powerful Tools for Caregivers (PTC). PTC is an evidence-based six-week program that addresses caregiver health by promoting self-care. Collaborating community organizations offer the program at little to no cost.
This study will employ a quasi-experimental nonequivalent pretest-posttest design to compare outcomes from in-person to telehealth delivered PTC classes. PTC classes are conducted by a pair of class leaders who model concepts. Each pair of class leaders will conduct both a telehealth and in-person PTC class. Collaborating community organizations will recruit 105 caregivers to attend PTC classes delivered by 7 pairs of class leaders.
Telehealth classes will use VSee software to allow caregivers to participate in the PTC program synchronously via secure videoconferencing from their own home. VSee is a free software program designed to deliver secure telehealth services. Class leaders will guide participants in installation of the software on their home computer.
Participants will undergo assessment one week before and one week after the PTC program, and at six-month follow up. Outcome measures replicate previous PTC research and add additional outcomes meaningful to caregiver wellness. Statistical analysis will include descriptive statistics and a mixed design analysis of variance including repeated measures to examine differences in the variables of interest over time.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-07 |
Study First Posted Date | 2019-01-11 |
Last Update Posted Date | 2020-10-29 |
Start Month Year | February 1, 2019 |
Primary Completion Month Year | October 8, 2020 |
Verification Month Year | October 2020 |
Verification Date | 2020-10-31 |
Last Update Posted Date | 2020-10-29 |
Detailed Descriptions
Sequence: | 20721590 |
Description | Purpose
An estimated 43.5 million Americans serve as an unpaid caregiver over the course of a year. Caregivers are a valuable part of healthcare systems, providing a framework for the medical system to work in the home. Caregivers assist in patient follow through with medical advice, transportation to medical appointments, activation of emergency medical services, and promotion of patient quality of life. Caregivers are an asset to the healthcare system, as they reduce overall healthcare costs; in 2013, unpaid care was estimated at 470 billion dollars a year in the United States. Unfortunately, caregivers are at risk for both physical and mental health problems. In-person programs do exist that are designed to help caregivers care for themselves and mitigate their increased health risks. However, many caregivers are unable to attend such programs. Caregivers face barriers to accessing wellness programming due to lack of time, distance from service delivery locations, availability of services, and health or caregiving demands limiting the ability to leave home. Telehealth offers a solution to many of the barriers caregivers report. Telehealth is the use of technology to deliver healthcare services at a distance. Telehealth allows people access to services regardless of physical location, availability of transportation, and availability of respite care. Telehealth also reduces travel related costs for both providers and clients. While telehealth may provide a solution to increase access to services for those who face barriers to in-person services, there is limited information on the efficacy of telehealth delivered services. No studies have been reported that directly compare outcomes from telehealth and in-person wellness programs for caregivers. This research will fill a needed gap to inform service delivery decision making related to telehealth delivered programming for caregivers. Consequently, the overall goal of this proposed research is to determine the efficacy of translating the PTC program to a telehealth delivery format. The specific objectives are: 1) To determine whether the outcomes are different for caregivers in a PTC program delivered via telehealth compared to one delivered in person. 2) To examine program attendance and reasons for missed sessions. These objectives will be addressed by examining the following outcomes: 1) a general rating of health, 2) the Center for Epidemiologic Studies Depression Scale – Revised (CESD-R), 3) self-care behaviors (health self-care neglect, frequency of stress management and relaxation activities, and exercise frequency), self-efficacy, use of community resources, 4) the overall caregiving experience as measured by the Bakas Caregiving Outcomes Scale (BCOS), and 5) class attendance including reasons for missed classes. The existing program that this study proposes to examine is Powerful Tools for Caregivers, which has demonstrated positive outcomes for caregivers when delivered in-person. These benefits include reduced health risk behaviors; increased frequency in participation in self-care activities such as relaxation, exercise, and use of stress management techniques; demonstrate increased self-efficacy; lower stress levels; and report decreased caregiver burden. If the telehealth delivery method is proven effective by this research, more caregivers will be able to receive these benefits, thereby promoting positive health behaviors that prevent physical and mental health problems in this at-risk population. PTC is an evidence-based six-week program that addresses caregiver health by promoting self-care. Collaborating community organizations offer the program at little to no cost. A preliminary feasibility study was done to prepare for the proposed research. The feasibility study involved four caregivers. Consistent class attendance and Telehealth Usability Questionnaire scores demonstrated the telehealth delivery format was feasible, and qualitative themes indicated caregivers had a positive experience. A pilot study was then conducted involving 18 caregivers in four PTC groups in four different states and examined both caregiver outcomes and the class leader experience of delivering PTC via telehealth. Results have informed the design of this proposed study. Methodology The proposed study is a collaboration between the National PTC Office, collaborating community agencies, and the principal investigator (PI) at Concordia University Wisconsin (CUW). The National PTC Office will provide supervision to assure fidelity to the PTC program. The National PTC Office will assist with recruiting existing PTC Class Leaders who are certified Master Trainers (those who are both certified PTC class leaders and certified to train other class leaders) to conduct PTC classes. PTC class leaders will be selected through an application process to meet criteria for experience in leading classes and to represent a diverse geographical region. These class leaders will undergo human subjects research training and work with the PI to assure compliance with the research protocol. The proposed study will employ a quasi-experimental nonequivalent pretest-posttest design to compare outcomes from in-person to telehealth delivered PTC classes. PTC classes are conducted by a pair of class leaders who model concepts. Each pair of class leaders will conduct both a telehealth and in-person PTC class. This will control for the influence of class leader personality on outcomes. Collaborating community organizations will recruit 105 caregivers to attend PTC classes delivered by seven pairs of class leaders. Class sizes will be unequal due to necessity. Traditional in-person PTC programs are delivered to groups of 10 caregivers. Telehealth classes are limited to five participants due to limitations in screen views and internet bandwidth. Class leaders require a video screen, as do each participant. It is distracting to view more than six video screens at once; furthermore, adding more than six participants degrades the video and audio quality due to limitations in home internet connection bandwidths. The in-person classes include partner discussions. Telehealth technology does not allow private partner discussions; however, the smaller group format is conducive to full group conversations for these aspects of the program. To control for the effect of class leaders' personality, class leaders will deliver one telehealth PTC program and one in-person PTC program. This creates unequal group sizes of 35 participants in the telehealth PTC group and 70 participants in the in-person PTC group. The sample of 105 caregivers was determined based on a power analysis calculated using G Power software and effect sizes and attrition rates from the pilot study data. In the pilot study the CESD-R had a large effect size, while the BCOS and the other health and self-care related variables on the survey had medium to small effect sizes. The PI selected the BCOS with a Cohen's d = 0.26 for the power analysis, an alpha error probability of 0.05, and power of 0.80 to calculate sample size using G Power software. The result was a recommended sample size of 82 participants. The pilot study had a 33% rate of attrition. Planning for this level of drop out at posttest and another 33% at 6-months required an additional 15 participants be added to the sample size for a total of 97 participants in each group. Participants will be recruited through the partnering community organizations of the PTC class leaders. Participants will be informal (unpaid) caregivers, speak English, have the cognitive ability to participate in PTC classes, and for the telehealth delivered classes have a home internet connection, computer with a camera and microphone, and demonstrate the cognitive ability to use a computer and participate in the program. PTC class leaders will screen participants to be sure they meet eligibility criteria. Telehealth classes will use VSee software to allow caregivers to participate in the PTC program synchronously via secure videoconferencing from their own home. VSee is a free software program designed to deliver secure telehealth services. Class leaders will guide participants in installation of the software on their home computer. The telehealth process was developed and tested in earlier phases of this research. Participants will undergo assessment one week before and one week after the PTC program, and at a six-month follow up. Outcome measures replicate previous PTC research and offer additional outcome measures meaningful to caregiver wellness. Assessments include: the Center for Epidemiologic Studies Depression Scale – Revised (CESD-R), the Bakas Caregiving Outcomes Scale (BCOS), and a PTC Taking Care of You Survey which includes items from the original PTC program outcomes research related to caregiver self-efficacy, health self-care neglect, exercise frequency, relaxation frequency, and service utilization. The survey will also include caregiver demographics and questions related to socialization. The CESD-R is an established tool to assess symptoms of depression and the BCOS captures both positive and negative aspects of the caregiver experience. Both tools have established reliability and validity. The three assessment tools will be delivered via one secure electronic survey link issued by the PI. PTC class leaders will record attendance and reasons for any missed classes. Data Analysis Microsoft Excel and SPSS version 25 software will be used for statistical analysis. Statistical analysis will include descriptive statistics, and a mixed design or split plot analysis of variance (ANOVA), which includes repeated measures, to examine differences in the variables of interest over time: CESD-R score, BCOS score, class attendance, caregiver self-efficacy, health self-care neglect, exercise frequency, relaxation frequency, frequency of service utilization, and frequency of socialization. Groups (telehealth delivered group n = 35 and in-person delivery model n = 70) will be analyzed for differences prior to running ANOVA. |
Facilities
Sequence: | 200107886 | Sequence: | 200107887 | Sequence: | 200107888 | Sequence: | 200107889 | Sequence: | 200107890 | Sequence: | 200107891 | Sequence: | 200107892 | Sequence: | 200107893 | Sequence: | 200107894 | Sequence: | 200107895 | Sequence: | 200107896 | Sequence: | 200107897 | Sequence: | 200107898 |
Name | OPICA Adult Day Program | Name | Health Projects Center | Name | Tampa General Hospital | Name | Southeast Idaho Council of Governments Inc | Name | Iowa State University (ISU) Extension and Outreach | Name | Michigan State University | Name | Lutheran Social Service | Name | Executive Services Corps – NE | Name | Concord Regional Visiting Nurse Association (VNA) | Name | Kettering Health Network | Name | Hope Grows and UPMC Health Plan | Name | Jane Joyce | Name | Central East Local Health Integration Network |
City | Los Angeles | City | Santa Cruz | City | Tampa | City | Pocatello | City | Webster City | City | Grand Rapids | City | Moorhead | City | Plattsmouth | City | Concord | City | Beavercreek | City | Allegheny | City | Morristown | City | Whitby |
State | California | State | California | State | Florida | State | Idaho | State | Iowa | State | Michigan | State | Minnesota | State | Nebraska | State | New Hampshire | State | Ohio | State | Pennsylvania | State | Tennessee | State | Ontario |
Zip | 90025 | Zip | 95060 | Zip | 33606 | Zip | 83201 | Zip | 50248 | Zip | 49503 | Zip | 56560 | Zip | 68048 | Zip | 03301 | Zip | 45431 | Zip | 15108 | Zip | 37814 | Zip | L1N 6K9 |
Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | Canada |
Conditions
Sequence: | 52171115 |
Name | Caregivers |
Downcase Name | caregivers |
Id Information
Sequence: | 40158557 |
Id Source | org_study_id |
Id Value | ConcordiaUW |
Countries
Sequence: | 42568860 | Sequence: | 42568861 |
Name | United States | Name | Canada |
Removed | False | Removed | False |
Design Groups
Sequence: | 55593063 | Sequence: | 55593064 |
Group Type | Experimental | Group Type | Active Comparator |
Title | Telehealth Delivery Format | Title | Standard Delivery Format |
Description | This group will participate in the Powerful Tools for Caregivers program using a telehealth delivery method. | Description | This group will participate in the Powerful Tools for Caregivers program in person. |
Interventions
Sequence: | 52485362 | Sequence: | 52485363 |
Intervention Type | Behavioral | Intervention Type | Behavioral |
Name | Telehealth Delivery Format | Name | Standard Delivery Format |
Description | Participants will engage in a 6-week Powerful Tools for Caregivers program delivered via telehealth. | Description | Participants will engage in a 6-week Powerful Tools for Caregivers program delivered in the traditional in-person format. |
Keywords
Sequence: | 79868352 | Sequence: | 79868353 | Sequence: | 79868354 |
Name | caregiver | Name | wellness | Name | telehealth |
Downcase Name | caregiver | Downcase Name | wellness | Downcase Name | telehealth |
Design Outcomes
Sequence: | 177378456 | Sequence: | 177378457 | Sequence: | 177378458 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary |
Measure | Center for Epidemiologic Studies Depression Scale – Revised (CESD-R) | Measure | Bakas Caregiving Outcomes Scale (BCOS) | Measure | Custom created questionnaire: PTC Taking Care of You Survey |
Time Frame | Assessing change in response to participation in the Powerful Tools for Caregivers (PTC program): Baseline/ 1 week prior to participation in PTC program, 1 week after completion of the PTC program, and 6-months after completion of PTC program. | Time Frame | Assessing change in response to participation in the Powerful Tools for Caregivers (PTC program): Baseline/ 1 week prior to participation in PTC program, 1 week after completion of the PTC program, and 6-months after completion of PTC program. | Time Frame | Assessing change in response to participation in the Powerful Tools for Caregivers (PTC program): Baseline/ 1 week prior to participation in PTC program, 1 week after completion of the PTC program, and 6-months after completion of PTC program. |
Description | Questionnaire assessing symptoms of depression; each question is rated on a 5-point Likert scale; total scores range from zero to 80 with a higher score indicating greater symptoms of depression. | Description | Questionnaire assessing the caregiving experience (includes both positive and negative changes related to caregiver role); each question is rated on a 7-point Likert scale; total scores can range from 15 10 105 with a higher score indicating a more positive caregiving experience. | Description | PTC Taking Care of You Survey which includes questions related to caregiver self-efficacy, health self-care neglect, exercise frequency, relaxation frequency, and service utilization. The survey will also include caregiver demographics and questions related to socialization. |
Sponsors
Sequence: | 48319189 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Concordia University Wisconsin |
Overall Officials
Sequence: | 29285297 |
Role | Principal Investigator |
Name | Katrina M Serwe, PhD |
Affiliation | Concordia University Wisconsin |
Design Group Interventions
Sequence: | 68148993 | Sequence: | 68148994 |
Design Group Id | 55593063 | Design Group Id | 55593064 |
Intervention Id | 52485362 | Intervention Id | 52485363 |
Eligibilities
Sequence: | 30765284 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
informal (unpaid) caregivers for an adult with a chronic condition Exclusion Criteria: • non-English speaking (the PTC program and materials will be delivered in English; participants will need to be proficient in English to engage with the other members of the class) |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253877867 |
Number Of Facilities | 13 |
Registered In Calendar Year | 2019 |
Actual Duration | 20 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | False |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 3 |
Designs
Sequence: | 30511451 |
Allocation | Non-Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Single |
Masking Description | Data will be collected via survey and data analysis will be conducted blinded to study group assignment. |
Outcomes Assessor Masked | True |
Responsible Parties
Sequence: | 28877745 |
Responsible Party Type | Principal Investigator |
Name | Katrina Serwe |
Title | Associate Professor |
Affiliation | Concordia University Wisconsin |
Study References
Sequence: | 52063162 | Sequence: | 52063163 | Sequence: | 52063161 | Sequence: | 52063160 | Sequence: | 52063164 | Sequence: | 52063165 | Sequence: | 52063166 | Sequence: | 52063167 | Sequence: | 52063168 | Sequence: | 52063169 | Sequence: | 52063170 | Sequence: | 52063171 | Sequence: | 52063172 | Sequence: | 52063173 |
Pmid | 12677080 | Pmid | 16980835 | Pmid | 25945189 | Pmid | 20652873 | Pmid | 28814991 | Pmid | 28661387 | Pmid | 17467080 | Pmid | 34233538 | ||||||||||||
Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | derived |
Citation | Boise, L., Congleton, L., & Shannon, K. (2005). Empowering family caregivers: The powerful tools for caregiving program. Educational Gerontology, 31, 573-586. https://doi.org/10.1080/03601270590962523 | Citation | Burton LC, Zdaniuk B, Schulz R, Jackson S, Hirsch C. Transitions in spousal caregiving. Gerontologist. 2003 Apr;43(2):230-41. doi: 10.1093/geront/43.2.230. | Citation | Bakas T, Champion V, Perkins SM, Farran CJ, Williams LS. Psychometric testing of the revised 15-item Bakas Caregiving Outcomes Scale. Nurs Res. 2006 Sep-Oct;55(5):346-55. doi: 10.1097/00006199-200609000-00007. | Citation | American Occupational Therapy Association. (2013). Telehealth [Position paper]. American Journal of Occupational Therapy, 67(6, Suppl.), S69-S90. https://doi.org/10.5014/ajot.2013.67S69 | Citation | Cohn ER, Brannon JA, Cason J. Resolving barriers to licensure portability for telerehabilitation professionals. Int J Telerehabil. 2011 Dec 20;3(2):31-4. doi: 10.5195/ijt.2011.6078. eCollection 2011 Fall. No abstract available. | Citation | Eaton, W. W., Smith, C., Ybarra, M., Muntaner, C., & Tien, A. (2004). Center of Epidemiologic Studies Depression Scale: Review and revision (CESD and CESD-R). In M.E. Maruish (Ed.), The use of psychological testing for treatment planning and outcomes assessment (3rd ed.) (pp. 363-377). Mahwah, NJ: Lawrence Erlbaum. | Citation | National Alliance for Caregiving, & American Associate of Retired Persons Public Policy Institute. (2015, June). Executive summary: Caregiving in the U.S. Retrieved from http://www.caregiving.org/wp-content/uploads/2015/05/2015_CaregivingintheUS_Executive-Summary-June-4_WEB.pdf | Citation | Reinhard, S. C., Feinberg, L. F., Choula, R. & Houser, A. (2015). Valuing the invaluable: 2015 update, undeniable progress, but big gaps remain (AARP Public Policy Institute Report). Retrieved from http://www.aarp.org/content/dam/aarp/ppi/2015/valuing-the-invaluable-2015-update-new.pdf | Citation | Savundranayagam MY, Montgomery RJ, Kosloski K, Little TD. Impact of a psychoeducational program on three types of caregiver burden among spouses. Int J Geriatr Psychiatry. 2011 Apr;26(4):388-96. doi: 10.1002/gps.2538. | Citation | Serwe KM, Hersch GI, Pancheri K. Feasibility of Using Telehealth to Deliver the "Powerful Tools for Caregivers" Program. Int J Telerehabil. 2017 Jun 29;9(1):15-22. doi: 10.5195/ijt.2017.6214. eCollection 2017 Spring. | Citation | Serwe KM, Hersch GI, Pickens ND, Pancheri K. Caregiver Perceptions of a Telehealth Wellness Program. Am J Occup Ther. 2017 Jul/Aug;71(4):7104350010p1-7104350010p5. doi: 10.5014/ajot.2017.025619. | Citation | VSee. (2018). HIPAA and VSee video conferencing. Retrieved from https://vsee.com/hipaa/ | Citation | Won CW, Fitts SS, Favaro S, Olsen P, Phelan EA. Community-based "powerful tools" intervention enhances health of caregivers. Arch Gerontol Geriatr. 2008 Jan-Feb;46(1):89-100. doi: 10.1016/j.archger.2007.02.009. Epub 2007 Apr 27. | Citation | Serwe KM, Walmsley AL. The effectiveness of telehealth for a caregiver wellness program. J Telemed Telecare. 2021 Jul 7:1357633X21994009. doi: 10.1177/1357633X21994009. Online ahead of print. |
]]>
https://zephyrnet.com/NCT03800225
2019-01-03
https://zephyrnet.com/?p=NCT03800225
NCT03800225https://www.clinicaltrials.gov/study/NCT03800225?tab=tableNANANAThe purpose of this study is to determine whether anterior cruciate ligament injury in patients wishing to return to sports activities may be treated with repair supplemented with internal brace compared with a standard operation using a patella tendon autograft.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-09 |
Study First Posted Date | 2019-01-11 |
Last Update Posted Date | 2019-10-02 |
Start Month Year | January 3, 2019 |
Primary Completion Month Year | September 4, 2019 |
Verification Month Year | September 2019 |
Verification Date | 2019-09-30 |
Last Update Posted Date | 2019-10-02 |
Facilities
Sequence: | 201290103 |
Name | Division of Sports Trauma, Palle Juul-Jensens Boulevard 99 |
City | Aarhus N |
Zip | 8200 |
Country | Denmark |
Conditions
Sequence: | 52507868 | Sequence: | 52507869 |
Name | Ligament; Laxity, Knee | Name | Anterior Cruciate Ligament Injury |
Downcase Name | ligament; laxity, knee | Downcase Name | anterior cruciate ligament injury |
Id Information
Sequence: | 40399426 |
Id Source | org_study_id |
Id Value | Danish EC – 1-10-72-223-18. |
Countries
Sequence: | 42835753 |
Name | Denmark |
Removed | False |
Design Groups
Sequence: | 55964353 | Sequence: | 55964354 |
Group Type | Experimental | Group Type | Active Comparator |
Title | Repair | Title | Patella tendon graft |
Description | Anterior cruciate ligament repair with internal brace after anterior ligament rupture. | Description | The Patella tendon graft is harvested and used as a knew anterior cruciate ligament after rupture. |
Interventions
Sequence: | 52815813 |
Intervention Type | Procedure |
Name | Repair |
Description | Anterior ligament repair with internal brace. |
Design Outcomes
Sequence: | 178632266 | Sequence: | 178632267 | Sequence: | 178632268 | Sequence: | 178632269 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Knee Laxity | Measure | Patient reported outcome scores | Measure | Patient reported outcome scores | Measure | Pain measurement |
Time Frame | 12 Months | Time Frame | 12 Months | Time Frame | 12 Months | Time Frame | 12 Months |
Description | KT-1000 arthrometer | Description | Koos (Knee injury and Osteoarthritis Outcome Score) | Description | IKDC (International Knee Documentation Committee) | Description | NRS-pain score (Numeric rating scale) (10 worst pain – 0 No pain) |
Browse Conditions
Sequence: | 194770866 | Sequence: | 194770867 | Sequence: | 194770868 | Sequence: | 194770869 | Sequence: | 194770870 |
Mesh Term | Rupture | Mesh Term | Anterior Cruciate Ligament Injuries | Mesh Term | Wounds and Injuries | Mesh Term | Knee Injuries | Mesh Term | Leg Injuries |
Downcase Mesh Term | rupture | Downcase Mesh Term | anterior cruciate ligament injuries | Downcase Mesh Term | wounds and injuries | Downcase Mesh Term | knee injuries | Downcase Mesh Term | leg injuries |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48630819 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Aarhus University Hospital |
Design Group Interventions
Sequence: | 68607731 | Sequence: | 68607732 |
Design Group Id | 55964354 | Design Group Id | 55964353 |
Intervention Id | 52815813 | Intervention Id | 52815813 |
Eligibilities
Sequence: | 30957215 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 65 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Anterior cruciate ligament rupture Exclusion Criteria: Current malignant disease |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253940370 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 8 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 65 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 3 |
Designs
Sequence: | 30702791 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Health Services Research |
Time Perspective | |
Masking | Single |
Subject Masked | True |
Responsible Parties
Sequence: | 29069553 |
Responsible Party Type | Principal Investigator |
Name | Martin Lind |
Title | Professor |
Affiliation | Aarhus University Hospital |
]]>
https://zephyrnet.com/NCT03800212
2017-07-07
https://zephyrnet.com/?p=NCT03800212
NCT03800212https://www.clinicaltrials.gov/study/NCT03800212?tab=tableJulien TAIEB, Prjtaieb75@gmail.com01 56 09 35 56A Vater’s ampulloma is a rare digestive tumour which accounts for under 1% of all digestive tumours. The only curative treatment is complete excision (surgical or endoscopic) of the lesions which is possible in 80% of cases , with or without adjuvant treatment. The reference radical treatment is cephalic duodenopancreatectomy (CDP). The indication for adjuvant treatment is still debated: in view of the aggressive nature of the disease and the high recurrence rate, it would appear appropriate to offer adjuvant treatment, although several studies have failed to find any benefit on survival with post-operative radio-chemotherapy, the most widely studied treatment at present, compared to excision alone. At present there are no phase II studies specifically examining medical treatment of degenerated, inoperable Vater’s ampullomas. Some groups propose chemotherapies with 5-FU or gemcitabine, analogous to the treatments used for intestinal, pancreatic or biliary tumours, although neither one has been shown to date to be superior to the other, nor have decision-making criteria been clearly established.In conclusion, a national cohort study is proposed to undertake a prospective analysis of the outcome of all patients treated for ampullary adenocarcinoma (particularly survival without recurrence and prognostic indicators for excised tumours and the duration of disease control for tumours treated with palliative chemotherapy). The treatment methods will be left to the free choice of the investigator and all patients may be included, regardless of stage of their disease. In this study, freezing of tumour fragments is encouraged, as this cohort will be supplemented by a later biological study. In order to recruit sufficient patient numbers, the study will be based on participation of the cooperative groups involved in the management of digestive cancers.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-31 |
Study First Posted Date | 2019-01-11 |
Last Update Posted Date | 2022-03-24 |
Start Month Year | July 7, 2017 |
Primary Completion Month Year | December 15, 2022 |
Verification Month Year | March 2022 |
Verification Date | 2022-03-31 |
Last Update Posted Date | 2022-03-24 |
Detailed Descriptions
Sequence: | 20826200 |
Description | A Vater's ampulloma is a rare digestive tumour which accounts for under 1% of all digestive tumours. In terms of incidence, it is the 3rd most common biliary tract tumour after gallbladder cancer and common bile duct cancer. The incidence of ampullary adenocarcinoma is not well known although it is estimated to be around 0.49 per 100,000 people. The known risk factors are familial adenomatous polyposis (FAP) and Gardner's syndrome, HNPCC (Hereditary Non-Polyposis Colorectal Cancer) syndrome, Peutz-Jeghers syndrome, Crohn's disease and coeliac disease.
Except in its highly localised forms, ampulla of Vater carcinoma carries a poor prognosis. It is a highly lymphophilic disease which commonly metastasises, particularly to the lymph nodes and liver. The prognosis is however considerably better than that of pancreatic adenocarcinoma. In one study which compared 71 ampullomas with 144 adenocarcinomas of pancreatic head, the 5-year survival was 60% for the ampullary carcinomas compared to 20% for pancreatic adenocarcinomas. More generally, the 5-year survival rate in the literature is between 40-60% and, depending on the study, 10-year survival is approximately 38% . The only curative treatment is complete excision (surgical or endoscopic) of the lesions which is possible in 80% of cases , with or without adjuvant treatment. The reference radical treatment is cephalic duodenopancreatectomy (CDP). The 5-year survival rate in cases of adenocarcinoma excised by CPD is in the region of 50%, rising to 60-70% if no lymph node invasion is present, compared to 30% when lymph nodes are invaded and median survival is approximately 4.5 years . The indication for adjuvant treatment is still debated: in view of the aggressive nature of the disease and the high recurrence rate, it would appear appropriate to offer adjuvant treatment, although several studies have failed to find any benefit on survival with post-operative radio-chemotherapy, the most widely studied treatment at present, compared to excision alone . There is only one single randomised study comparing these two forms of management, which shows no benefit in terms of 2 and 5-year survival, although only a small number of patients had an ampullary tumour in this study . The conclusions of several retrospective studies are more subtle, showing results in favour of adjuvant treatment in patients with lymph node disease or a large tumour (T3/T4) . Some groups have tested the merits of peroperative irradiation. It would appear that this technique does not improve survival, although data on this subject are extremely patchy . Administration of exclusive adjuvant chemotherapy has been examined in a single randomised study. In this phase III study (ESPAC 3), median overall survival of patients who received adjuvant chemotherapy with FUFOL Mayo for 6 months (n=101) or gemcitabine (n=98) was not significantly improved compared to survival in patients undergoing surgery and not receiving complementary treatment (57.1 versus 43 months, HR= 0.85, p=0.32). A subgroup analysis suggested that the benefit of chemotherapy could be greater in the subgroup of patients with RO resection (p= 0.057, 91% of cases). Mean survival in patients suffering inoperable tumours is between 9 and 20.4 months depending on the study . It should be noted however that most of these studies have included tumours other than ampullomas (particularly small bowel adenocarcinomas), making it more difficult to interpret these results, and also that many are old results dating from before the era of modern chemotherapies. At present there are no phase II studies specifically examining medical treatment of degenerated, inoperable Vater's ampullomas. Some groups propose chemotherapies with 5-FU or gemcitabine, analogous to the treatments used for intestinal, pancreatic or biliary tumours, although neither one has been shown to date to be superior to the other, nor have decision-making criteria been clearly established. One phase II study published in 2009 proposed CAPOX as the reference treatment in light of the promising results obtained. Patients suffering from ampullary cancer in this study however were combined with patients who were suffering from small bowel adenocarcinoma. In conclusion, a national cohort study is proposed to undertake a prospective analysis of the outcome of all patients treated for ampullary adenocarcinoma (particularly survival without recurrence and prognostic indicators for excised tumours and the duration of disease control for tumours treated with palliative chemotherapy). The treatment methods will be left to the free choice of the investigator and all patients may be included, regardless of stage of their disease. In this study, freezing of tumour fragments is encouraged, as this cohort will be supplemented by a later biological study. In order to recruit sufficient patient numbers, the study will be based on participation of the cooperative groups involved in the management of digestive cancers. |
Facilities
Sequence: | 201073544 | Sequence: | 201073545 | Sequence: | 201073546 | Sequence: | 201073547 | Sequence: | 201073548 | Sequence: | 201073549 | Sequence: | 201073550 | Sequence: | 201073551 | Sequence: | 201073552 | Sequence: | 201073553 | Sequence: | 201073554 | Sequence: | 201073555 | Sequence: | 201073556 | Sequence: | 201073557 | Sequence: | 201073558 | Sequence: | 201073559 | Sequence: | 201073560 | Sequence: | 201073561 | Sequence: | 201073562 | Sequence: | 201073563 | Sequence: | 201073564 | Sequence: | 201073565 | Sequence: | 201073566 | Sequence: | 201073567 | Sequence: | 201073568 | Sequence: | 201073569 | Sequence: | 201073570 | Sequence: | 201073571 | Sequence: | 201073572 | Sequence: | 201073573 | Sequence: | 201073574 | Sequence: | 201073575 | Sequence: | 201073576 | Sequence: | 201073577 | Sequence: | 201073578 | Sequence: | 201073579 |
Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting |
Name | Ch D'Abbeville | Name | Chu Hotel Dieu | Name | Ch Annecy Genevois | Name | Ch Cote Basque | Name | Chu Saint Andre | Name | Polyclinique Bordeaux Nord Aquitaine | Name | Clinique Champeau | Name | Chu Estaing | Name | Hopitaux Civils de Colmar | Name | Ch – Sud Francilien | Name | Chu Francois Mitterrand | Name | Chd Vendee | Name | Le Kremlin Bicetre | Name | Chu Claude Huriez | Name | Hôpital Dupuytren | Name | Ch Nord Essonne | Name | Chu La Croix Rousse | Name | Hcl Edouard Herriot | Name | Hcl Pierre Benite | Name | Hopital de La Timone | Name | Hopital Saint Joseph | Name | Ch de Meaux | Name | CH MACON | Name | Chu Caremeau | Name | Chr Orleans | Name | Chu Avicenne | Name | Chu Cochin | Name | Chu La Pitie Salpetriere | Name | Hopital Europeen Georges Pompidou | Name | Ch Saint Jean | Name | CHU Hôpital de la Milétrie | Name | Ch Cornouaille | Name | CH | Name | Ch Saint Malo | Name | CLINIQUE | Name | Ch Bretagne Atlantique |
City | Abbeville | City | Angers | City | Annecy | City | Bayonne | City | Bordeaux | City | Bordeaux | City | Béziers | City | Clermont-Ferrand | City | Colmar | City | Corbeil-Essonnes | City | Dijon | City | La Roche-sur-Yon | City | Le Kremlin-Bicêtre | City | Lille | City | Limoges | City | Longjumeau | City | Lyon | City | Lyon | City | Lyon | City | Marseille | City | Marseille | City | Meaux | City | Mâcon | City | Nîmes | City | Orléans | City | Paris | City | Paris | City | Paris | City | Paris | City | Perpignan | City | Poitiers | City | Quimper | City | Reims | City | Saint-Malo | City | Strasbourg | City | Vannes |
Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France |
Facility Contacts
Sequence: | 28254257 | Sequence: | 28254258 | Sequence: | 28254259 | Sequence: | 28254260 | Sequence: | 28254261 | Sequence: | 28254262 | Sequence: | 28254263 | Sequence: | 28254264 | Sequence: | 28254265 | Sequence: | 28254266 | Sequence: | 28254267 | Sequence: | 28254268 | Sequence: | 28254269 | Sequence: | 28254270 | Sequence: | 28254271 | Sequence: | 28254272 | Sequence: | 28254273 | Sequence: | 28254274 | Sequence: | 28254275 | Sequence: | 28254276 | Sequence: | 28254277 | Sequence: | 28254278 | Sequence: | 28254279 | Sequence: | 28254280 | Sequence: | 28254281 | Sequence: | 28254282 | Sequence: | 28254283 | Sequence: | 28254284 | Sequence: | 28254285 | Sequence: | 28254286 | Sequence: | 28254287 | Sequence: | 28254288 | Sequence: | 28254289 | Sequence: | 28254290 | Sequence: | 28254291 | Sequence: | 28254292 |
Facility Id | 201073544 | Facility Id | 201073545 | Facility Id | 201073546 | Facility Id | 201073547 | Facility Id | 201073548 | Facility Id | 201073549 | Facility Id | 201073550 | Facility Id | 201073551 | Facility Id | 201073552 | Facility Id | 201073553 | Facility Id | 201073554 | Facility Id | 201073555 | Facility Id | 201073556 | Facility Id | 201073557 | Facility Id | 201073558 | Facility Id | 201073559 | Facility Id | 201073560 | Facility Id | 201073561 | Facility Id | 201073562 | Facility Id | 201073563 | Facility Id | 201073564 | Facility Id | 201073565 | Facility Id | 201073566 | Facility Id | 201073567 | Facility Id | 201073568 | Facility Id | 201073569 | Facility Id | 201073570 | Facility Id | 201073571 | Facility Id | 201073572 | Facility Id | 201073573 | Facility Id | 201073574 | Facility Id | 201073575 | Facility Id | 201073576 | Facility Id | 201073577 | Facility Id | 201073578 | Facility Id | 201073579 |
Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary |
Name | JOEL BUTEL | Name | NATHALIE BAIZE | Name | ROMAN COMBES | Name | FRANCK AUDEMAR | Name | CHABRUN | Name | BALHADERE | Name | MICHAEL HUMMELSBERGER | Name | DENIS PEZET | Name | LAURIANNE PLASTARAS | Name | SAMY LOUAFI | Name | SYLVAIN MANFREDI | Name | MORGAN AMIL | Name | Stéphane BENOIST | Name | christophe MARIETTE | Name | STEPHANE BOUVIER | Name | YOUNES ZEKRI | Name | MARIELLE GUILLET | Name | MUSTAPHA ADHAM | Name | OLIVIER GLEHEN | Name | MARINE BARRAUD BLANC | Name | HERVE PERRIER | Name | CHRISTOPHE LOCHER | Name | MARIE MARTIN BELLECOSTE | Name | CLAIRE PHILIPPE | Name | BRAHIM OUAHRANI | Name | THOMAS APARICIO | Name | ROMAIN CORIAT | Name | JEAN BAPTISTE BACHET | Name | ORIANNE COLUSSI | Name | FAIZA KHEMISSA AKOUZ | Name | David TOUGERON | Name | KARINE BIDEAU | Name | Olivier BOUCHE | Name | ROMAIN DESGRIPPES | Name | YOUSSEF TAZI | Name | DENIS GRASSET |
david.tougeron@chu-poitiers.fr | obouche@chu-reims.fr | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Facility Investigators
Sequence: | 18423508 | Sequence: | 18423509 | Sequence: | 18423510 | Sequence: | 18423511 | Sequence: | 18423512 | Sequence: | 18423513 | Sequence: | 18423514 | Sequence: | 18423515 | Sequence: | 18423516 | Sequence: | 18423517 | Sequence: | 18423518 | Sequence: | 18423519 |
Facility Id | 201073552 | Facility Id | 201073552 | Facility Id | 201073554 | Facility Id | 201073554 | Facility Id | 201073555 | Facility Id | 201073555 | Facility Id | 201073557 | Facility Id | 201073561 | Facility Id | 201073570 | Facility Id | 201073572 | Facility Id | 201073574 | Facility Id | 201073576 |
Role | Sub-Investigator | Role | Sub-Investigator | Role | Sub-Investigator | Role | Sub-Investigator | Role | Sub-Investigator | Role | Sub-Investigator | Role | Sub-Investigator | Role | Sub-Investigator | Role | Sub-Investigator | Role | Sub-Investigator | Role | Principal Investigator | Role | Principal Investigator |
Name | CAMARA | Name | BREYSACHER | Name | ANTOINE DROUILLARD | Name | JEAN LOUIS JOUVE | Name | RAME | Name | LALY | Name | GUILLAUME PIESSEN | Name | GRAILLOT | Name | CROMBE | Name | PERKINS | Name | David TOUGERON | Name | Olivier BOUCHE |
Conditions
Sequence: | 52439979 |
Name | Ampullary Adenocarcinoma |
Downcase Name | ampullary adenocarcinoma |
Id Information
Sequence: | 40350419 |
Id Source | org_study_id |
Id Value | AMPULLOMA COHORT |
Countries
Sequence: | 42783793 |
Name | France |
Removed | False |
Interventions
Sequence: | 52749667 |
Intervention Type | Drug |
Name | treatment for ampullary adenocarcinoma |
Description | all patients treated for ampullary adenocarcinoma (particularly survival without recurrence and prognostic indicators for excised tumours and the duration of disease control for tumours treated with palliative chemotherapy). |
Design Outcomes
Sequence: | 178389880 | Sequence: | 178389881 | Sequence: | 178389882 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Overall survival | Measure | RECURRENCE FREE SURVIVAL | Measure | PROGRESSION FREE SURVIVAL |
Time Frame | 5 years | Time Frame | 3 years | Time Frame | 5 years |
Description | The time interval between the date of diagnosis of the disease and date of death (all causes). Patients who are alive will be censured at the date of last news. | Description | The time interval between the date of diagnosis of the disease and the date of the recurrence or death (all causes). Patients who are alive without recurrence will be censured at the date of last news. | Description | Time interval between the date of starting treatment and the date of first progression (local or remote, clinical or radiological) or death (all causes). Patients who are alive without progression will be censured at the date of last news. Radiological progression will be defined according to RECIST version 1.1 criteria. |
Browse Conditions
Sequence: | 194511317 | Sequence: | 194511318 | Sequence: | 194511319 | Sequence: | 194511320 | Sequence: | 194511321 |
Mesh Term | Adenocarcinoma | Mesh Term | Carcinoma | Mesh Term | Neoplasms, Glandular and Epithelial | Mesh Term | Neoplasms by Histologic Type | Mesh Term | Neoplasms |
Downcase Mesh Term | adenocarcinoma | Downcase Mesh Term | carcinoma | Downcase Mesh Term | neoplasms, glandular and epithelial | Downcase Mesh Term | neoplasms by histologic type | Downcase Mesh Term | neoplasms |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48568192 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Federation Francophone de Cancerologie Digestive |
Overall Officials
Sequence: | 29425335 |
Role | Principal Investigator |
Name | Julien TAIEB |
Affiliation | Federation Francophone de Cancerologie Digestive |
Central Contacts
Sequence: | 12078922 |
Contact Type | primary |
Name | Julien TAIEB, Pr |
Phone | 01 56 09 35 56 |
jtaieb75@gmail.com | |
Phone Extension | +33 |
Role | Contact |
Eligibilities
Sequence: | 30919362 |
Sampling Method | Probability Sample |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Population | all patients treated for ampullary adenocarcinoma (particularly survival without recurrence and prognostic indicators for excised tumours and the duration of disease control for tumours treated with palliative chemotherapy). |
Criteria | Inclusion Criteria:
Patients aged 18 years and older. Exclusion Criteria: Patients who cannot be followed up regularly for psychological, social, family or geographical reasons. |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254187710 |
Number Of Facilities | 36 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | False |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 2 |
Designs
Sequence: | 30665038 |
Observational Model | Cohort |
Time Perspective | Prospective |
Intervention Other Names
Sequence: | 26807036 |
Intervention Id | 52749667 |
Name | no other intervention name to add |
Links
Sequence: | 4408587 |
Url | http://www.ffcd.fr/index.php/essais-therapeutiques/pancreas/283-ampullome |
Description | FFCD page |
Responsible Parties
Sequence: | 29031730 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03800199
2019-04-13
https://zephyrnet.com/?p=NCT03800199
NCT03800199https://www.clinicaltrials.gov/study/NCT03800199?tab=tableEmine H. Tüzün, Prof. Dr.handan.tuzun@gmail.com+903926301370The aim of the investigator’s study is to determine the validity and reliability of the Turkish version of the Combined Index of Severity (ICAF) in Turkish patients with Fibromyalgia Syndrome (FMS).
<![CDATA[
Studies
Study First Submitted Date | 2019-01-07 |
Study First Posted Date | 2019-01-11 |
Last Update Posted Date | 2022-08-16 |
Start Month Year | April 13, 2019 |
Primary Completion Month Year | June 2024 |
Verification Month Year | August 2022 |
Verification Date | 2022-08-31 |
Last Update Posted Date | 2022-08-16 |
Detailed Descriptions
Sequence: | 20827239 |
Description | The original form of the Combined Index of Severity of Fibromyalgia (ICAF) will be translated into Turkish by two Turkish mother tongue translators who also speak English in advanced level. Then these translations will be combined into one translation and translated back to English. These translations will send to 7 different health professions who had experience working with FMS patients. The pre-final version will be composed and tested on a group of patients with FMS. If necessary, readjustments will be made, and the final version will be investigated in FMS patients. Acceptability was assessed in terms of refusal rate, rates of missing responses, and administration time. Reliability was assessed using Cronbach's alpha and test-retest assessments. Re-test assessments will be conducted after one week from first assessment. Content validity was assessed by examining the floor and ceiling effects and skew of the distributions. Convergent and divergent validity was assessed by examining the Pearson's correlation coefficients. In addition, the confirmatory factor analysis will be done to evaluate the validity of ICAF. Responsiveness was determined by examining effect size (ES), standardized response means (SRM) and P values generated using Wilcoxon's test. |
Facilities
Sequence: | 201086948 |
Status | Recruiting |
Name | Eastern Mediterranean University |
City | Famagusta |
Country | Cyprus |
Facility Contacts
Sequence: | 28255017 |
Facility Id | 201086948 |
Contact Type | primary |
Name | Emine H Tuzun, Prof |
Phone | +903926301370 |
Phone Extension | 1370 |
Conditions
Sequence: | 52442549 |
Name | Fibromyalgia |
Downcase Name | fibromyalgia |
Id Information
Sequence: | 40352622 |
Id Source | org_study_id |
Id Value | ETK00-2018-0281 |
Countries
Sequence: | 42786433 |
Name | Cyprus |
Removed | False |
Design Groups
Sequence: | 55894551 |
Group Type | Experimental |
Title | Perceptive Rehabilitation (PR-group) |
Description | Perceptive rehabilitation group will receive a treatment that, as described by on Paolucci et al. (2015). This treatment will include small latex cones with different resistance. In each session there will be over 100 cones will be placed on a rigid wood with using elastic strips. The patient will be asked to lie down supine on the material. Patients weigh will create pressure and reaction force to his/her body. Treatments will be 2 times a week till 8 weeks. There will be in total 16 sessions. |
Interventions
Sequence: | 52752567 |
Intervention Type | Other |
Name | Perceptive rehabilitation |
Description | The first session will be an education session. Spinous processes will be reference line of the body and patient will lie down on cones. The therapist will ask the patient first to breathe normally and feel the pressure. This will lead the patient to relax and understand cones. Then, the patient will start with the diagrammatic breathing. After breath exercises patient will perform active exercises (include stretching, warming up and cooling down) on supervision. Exercises will include the whole body. Additional to this during the session therapist will ask about the pressure of cones and she will correct the patients' posture. At the end of all the session, the therapist will take a photo of the patients back with the aim of to document the pressure and hyperaemic areas. |
Keywords
Sequence: | 80236849 | Sequence: | 80236850 | Sequence: | 80236851 |
Name | health statues | Name | observational study | Name | questionnaire |
Downcase Name | health statues | Downcase Name | observational study | Downcase Name | questionnaire |
Design Outcomes
Sequence: | 178400131 | Sequence: | 178400132 | Sequence: | 178400133 | Sequence: | 178400134 | Sequence: | 178400135 | Sequence: | 178400136 | Sequence: | 178400137 | Sequence: | 178400138 |
Outcome Type | primary | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other |
Measure | Combined Index of Severity of Fibromyalgia | Measure | Revised-Fibromyalgia Impact Questionnaire (FIQR) | Measure | Socio-demographic and clinical characteristics | Measure | Body Mass Index (BMI) | Measure | Stanford Health Assessment Questionnaire (HAQ) | Measure | Fatigue Severity Scale (FSS) | Measure | Short-Form 36 (SF-36) | Measure | Pittsburgh Sleep Quality Index (PSQI) |
Time Frame | Changes from baseline severity at 12 weeks. | Time Frame | Changes from baseline at 12 weeks. | Time Frame | Changes from baseline at 12 weeks. | Time Frame | Changes from baseline at 12 weeks. | Time Frame | Changes from baseline at 12 weeks. | Time Frame | Changes from baseline at 12 weeks. | Time Frame | Changes from baseline at 12 weeks. | Time Frame | Changes from baseline at 12 weeks. |
Description | Composed of 59 items, measures the combined severity index of fibromyalgia divided into 4 factors: physical, emotional, social and active and passive coping.The ICAF score ranges from 0 to 84, with higher values indicating higher severity. | Description | The Turkish version of FIQR will be used in this study. This questionnaire has 21 individual questions. All these questions should be answered according to the past 7 days. FIQR has divided into three sections; 'function, overall impact and symptoms'. The total FIQR score will be calculated with the sum of the three domain scores. The total score will be out of 100. The higher score means a severe impact. | Description | Date of birth, sex, marital status, profession, education status and time of the diagnosis of FMS will be noted. | Description | Weight and height will be combined to report BMI in kg/m^2. | Description | This questionnaire will be use to asses general health of the participants.There are 20 questions in 8 sub categories of functioning (dressing, rising, eating, walking, hygiene, reach, grip, and usual activities), 1 question is about pain and 1 question is about general health. Disability index questions has four possible answers (without any difficulty: 0, with some difficulty: 1, with much difficulty: 2, unable to do: 3). Highest score represent the worsening. | Description | Turkish version of Fatigue Severity Scale (FSS) will be used in this study. This scale has 9 items. Each item should be scored (strongly disagrees) 0 to 7 (strongly agrees). The minimum score=9 and maximum score possible=63. Higher score=greater fatigue severity. The average score for all 9 items constitutes the FSS score. | Description | The quality of life questionnaire Short Form 36 (SF-36) is multidimensional, consisting of 36 items, divided into eight scales, each scale assesses a health concept, they are: limitations in physical activities because of health problems, limitations in social activities due to physical or emotional problems, limitations in daily activities due to health problems, body pain, mental health, limitations in daily activities due to emotional problems, vitality, perception of general health. All categories have their own score out of 100. Higher scores mean a better quality of life. | Description | Turkish version of Pittsburgh Sleep Quality Index (PSQI) will be used in this study. This is a self-reported index that has 19 items with Likert and open-ended response formats. This index should be answered according to the past month. Minimum Score "0" means "good sleep" and Maximum Score "30" means "disrupted sleep". |
Browse Conditions
Sequence: | 194522234 | Sequence: | 194522235 | Sequence: | 194522236 | Sequence: | 194522237 | Sequence: | 194522238 | Sequence: | 194522239 | Sequence: | 194522240 |
Mesh Term | Fibromyalgia | Mesh Term | Myofascial Pain Syndromes | Mesh Term | Muscular Diseases | Mesh Term | Musculoskeletal Diseases | Mesh Term | Rheumatic Diseases | Mesh Term | Neuromuscular Diseases | Mesh Term | Nervous System Diseases |
Downcase Mesh Term | fibromyalgia | Downcase Mesh Term | myofascial pain syndromes | Downcase Mesh Term | muscular diseases | Downcase Mesh Term | musculoskeletal diseases | Downcase Mesh Term | rheumatic diseases | Downcase Mesh Term | neuromuscular diseases | Downcase Mesh Term | nervous system diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48570825 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | European University of Lefke |
Overall Officials
Sequence: | 29426932 | Sequence: | 29426933 | Sequence: | 29426934 | Sequence: | 29426935 |
Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator |
Name | Beraat Alptug, MSc | Name | Emine H. Tüzün, Prof. Dr. | Name | Levent Eker, M. D. | Name | Gülbin Ergin, PhD |
Affiliation | European University of Lefke | Affiliation | Eastern Mediterranean University | Affiliation | Eastern Mediterranean University | Affiliation | European University of Lefke |
Central Contacts
Sequence: | 12079362 | Sequence: | 12079363 |
Contact Type | primary | Contact Type | backup |
Name | Beraat Alptug, MSc | Name | Emine H. Tüzün, Prof. Dr. |
Phone | 05338498379 | Phone | +903926301370 |
balptug@eul.edu.tr | handan.tuzun@gmail.com | ||
Phone Extension | 1370 | ||
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 68521051 |
Design Group Id | 55894551 |
Intervention Id | 52752567 |
Eligibilities
Sequence: | 30920962 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 60 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Having a Fibromyalgia diagnosis according to Wolfe et al. (2016) criteria. Exclusion Criteria: Having physical and functional problems with FMS |
Adult | True |
Child | False |
Older Adult | False |
Calculated Values
Sequence: | 254190292 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 60 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Other Outcomes To Measure | 7 |
Designs
Sequence: | 30666634 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Other |
Time Perspective | |
Masking | None (Open Label) |
Intervention Model Description | Questionnaire: Combined Index of Severity of Fibromyalgia (ICAF)
Intervention: Perceptive rehabilitation Procedure: Assessment of reliability, acceptability, validity and responsiveness. |
Responsible Parties
Sequence: | 29033331 |
Responsible Party Type | Principal Investigator |
Name | Beraat Alptug |
Title | Master Physiotherapist/ Principal Investigator |
Affiliation | European University of Lefke |
Study References
Sequence: | 52350530 |
Pmid | 26884794 |
Reference Type | background |
Citation | Paolucci T, Baldari C, Di Franco M, Didona D, Reis V, Vetrano M, Iosa M, Trifoglio D, Zangrando F, Spadini E, Saraceni VM, Guidetti L. A New Rehabilitation Tool in Fibromyalgia: The Effects of Perceptive Rehabilitation on Pain and Function in a Clinical Randomized Controlled Trial. Evid Based Complement Alternat Med. 2016;2016:7574589. doi: 10.1155/2016/7574589. Epub 2016 Jan 13. |
]]>
https://zephyrnet.com/NCT03800186
2018-06-01
https://zephyrnet.com/?p=NCT03800186
NCT03800186https://www.clinicaltrials.gov/study/NCT03800186?tab=tableNANANAThis study aimed to determine the influence of ageing on the incidence and site of femoral fractures in trauma patients, by taking the sex, body weight, and trauma mechanisms into account.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-06 |
Study First Posted Date | 2019-01-11 |
Last Update Posted Date | 2019-01-11 |
Start Month Year | June 1, 2018 |
Primary Completion Month Year | December 30, 2018 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-11 |
Detailed Descriptions
Sequence: | 20548775 |
Description | This retrospective study reviewed data from adult trauma patients aged ≥ 20 years who were admitted into a Level I trauma center, between January 1, 2009 and December 31, 2016. According to the femoral fracture locations, 3859 adult patients with 4011 fracture sites were grouped into five subgroups: proximal type A (n = 1,359), proximal type B (n= 1,487), proximal type C (n = 59), femoral shaft (n = 640), and distal femur (n = 466) groups. A multivariate logistic regression analysis was applied to identify independent effects of the univariate predictive variables on the occurrence of fracture at a specific site. The propensity score accounts for the risk of a fracture at a specific femoral site was calculated and presented visually with age in a two-dimensional plot. |
Facilities
Sequence: | 198402803 |
Name | Kaohsiung Chang Gung Memorial Hospital |
City | Kaohsiung |
Zip | 83301 |
Country | Taiwan |
Conditions
Sequence: | 51727234 |
Name | FEMORAL FRACTURES |
Downcase Name | femoral fractures |
Id Information
Sequence: | 39805695 |
Id Source | org_study_id |
Id Value | CDRPG8H0011 |
Countries
Sequence: | 42204448 |
Name | Taiwan |
Removed | False |
Design Groups
Sequence: | 55147111 |
Title | Trauma femoral fracture |
Description | Patients to be aged ≥20 years and hospitalized for the treatment of femoral fracture following injury. Patients were grouping into five subgroups as patients with fracture of proximal type A, proximal type B, proximal type C, femoral shaft, and distal femur. |
Interventions
Sequence: | 52048842 | Sequence: | 52048843 | Sequence: | 52048844 | Sequence: | 52048845 | Sequence: | 52048846 |
Intervention Type | Other | Intervention Type | Other | Intervention Type | Other | Intervention Type | Other | Intervention Type | Other |
Name | Proximal type A | Name | Proximal type B | Name | Proximal type C | Name | femoral shaft | Name | distal femur |
Description | Patients with fracture of proximal type A | Description | Patients with fracture of proximal type B | Description | Patients with fracture of proximal type C | Description | Patients with fracture of femoral shaft | Description | Patients with fracture of distal femur |
Design Outcomes
Sequence: | 175933168 |
Outcome Type | primary |
Measure | Locations of femoral fracture |
Time Frame | up tp 2 months |
Description | To provide a summary of covariate information regarding the occurrence of femur Fractures at a specific site. |
Browse Conditions
Sequence: | 191700795 | Sequence: | 191700796 | Sequence: | 191700797 | Sequence: | 191700798 |
Mesh Term | Fractures, Bone | Mesh Term | Femoral Fractures | Mesh Term | Wounds and Injuries | Mesh Term | Leg Injuries |
Downcase Mesh Term | fractures, bone | Downcase Mesh Term | femoral fractures | Downcase Mesh Term | wounds and injuries | Downcase Mesh Term | leg injuries |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 47907151 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Chang Gung Memorial Hospital |
Overall Officials
Sequence: | 29027132 |
Role | Study Chair |
Name | TSANG-TANG Hsieh, MD |
Affiliation | Chang Gung Memorial Hospital |
Design Group Interventions
Sequence: | 67607864 | Sequence: | 67607865 | Sequence: | 67607866 | Sequence: | 67607867 | Sequence: | 67607868 |
Design Group Id | 55147111 | Design Group Id | 55147111 | Design Group Id | 55147111 | Design Group Id | 55147111 | Design Group Id | 55147111 |
Intervention Id | 52048842 | Intervention Id | 52048843 | Intervention Id | 52048844 | Intervention Id | 52048845 | Intervention Id | 52048846 |
Eligibilities
Sequence: | 30506615 |
Sampling Method | Probability Sample |
Gender | All |
Minimum Age | 20 Years |
Maximum Age | 100 Years |
Healthy Volunteers | No |
Population | This retrospective study reviewed data from 27,462 trauma patients registered between January 1, 2009 and December 31, 2016. The inclusion criteria required patients to be aged ≥20 years and hospitalized for the treatment of femoral fracture following injury. Patients with incomplete data were excluded. |
Criteria | Inclusion Criteria:
Patients to be aged ≥20 years and hospitalized for the treatment of femoral fracture following injury Exclusion Criteria: Patients with incomplete data were excluded |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254052885 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 7 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 20 |
Maximum Age Num | 100 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Designs
Sequence: | 30255695 |
Observational Model | Case-Control |
Time Perspective | Retrospective |
Responsible Parties
Sequence: | 28636185 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03800173
2018-12-10
https://zephyrnet.com/?p=NCT03800173
NCT03800173https://www.clinicaltrials.gov/study/NCT03800173?tab=tableNANANAThis is a placebo-controlled, randomized, double-blind study to evaluate the pharmacokinetics of galidesivir following administration of single doses by IV infusion
<![CDATA[
Studies
Study First Submitted Date | 2018-12-12 |
Study First Posted Date | 2019-01-11 |
Last Update Posted Date | 2021-07-23 |
Start Month Year | December 10, 2018 |
Primary Completion Month Year | April 30, 2019 |
Verification Month Year | July 2021 |
Verification Date | 2021-07-31 |
Last Update Posted Date | 2021-07-23 |
Results First Posted Date | 2021-07-23 |
Detailed Descriptions
Sequence: | 20730177 |
Description | This single ascending dose study will evaluate the safety, tolerability, and PK of single doses of galidesivir vs. placebo administered as IV infusions in healthy subjects enrolled in up to four dose cohorts of 8 subjects each. A single dose of study drug will be administered per cohort: 6 subjects will receive galidesivir IV, and 2 subjects will receive matching placebo. |
Facilities
Sequence: | 200188252 |
Name | PRA Health Sciences |
City | Lenexa |
State | Kansas |
Zip | 66219 |
Country | United States |
Browse Interventions
Sequence: | 96089218 | Sequence: | 96089219 | Sequence: | 96089220 |
Mesh Term | Galidesivir | Mesh Term | Antiviral Agents | Mesh Term | Anti-Infective Agents |
Downcase Mesh Term | galidesivir | Downcase Mesh Term | antiviral agents | Downcase Mesh Term | anti-infective agents |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52193274 |
Name | Marburg Virus Disease |
Downcase Name | marburg virus disease |
Id Information
Sequence: | 40175231 | Sequence: | 40175232 | Sequence: | 40175233 |
Id Source | org_study_id | Id Source | secondary_id | Id Source | secondary_id |
Id Value | BCX4430-106 | Id Value | DMID18-0013 | Id Value | 272201300017C-18-0-1 |
Id Type | Other Identifier | Id Type | U.S. NIH Grant/Contract | ||
Id Type Description | NIAID | ||||
Id Link | https://reporter.nih.gov/quickSearch/272201300017C-18-0-1 |
Countries
Sequence: | 42587495 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55618629 | Sequence: | 55618630 |
Group Type | Experimental | Group Type | Placebo Comparator |
Title | Galidesivir | Title | placebo |
Description | Galidesivir IV infusion | Description | Placebo IV infusion |
Interventions
Sequence: | 52507892 | Sequence: | 52507893 |
Intervention Type | Drug | Intervention Type | Drug |
Name | galidesivir | Name | placebo |
Description | galidesivir IV infusion | Description | placebo IV infusion |
Design Outcomes
Sequence: | 177461163 | Sequence: | 177461164 | Sequence: | 177461165 | Sequence: | 177461166 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. | Measure | Plasma PK – Galidesivir Cmax (Maximum Observed Concentration of Drug) | Measure | Plasma PK – Galidesivir AUC (Area Under the Concentration vs. Time Curve) | Measure | Galidesivir Renal Clearance |
Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up period, up to 23 days from IMP dosing on Day 1. | Time Frame | Plasma PK parameters are based on sampling over a 21 day period | Time Frame | Plasma PK parameters are based on sampling over a 21 day period | Time Frame | Urine PK parameters are based on sampling over a 96 hour period. |
Description | Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE). | Description | Serial blood samples for PK assessment of plasma galidesivir were collected at the following time points:
Day 1 to Day 5: 0 hour (pre dose), halfway through the infusion (0.5 hour), 1 hour (end of the infusion), 1.25, 1.50, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, and 96 hours post dose. Cmax for galidesivir was estimated using non compartmental methods with Phoenix® WinNonlin® v8.1 or higher (Certara, Inc.). |
Description | Serial blood samples for PK assessment of plasma galidesivir were collected at the following time points:
Day 1 to Day 5: 0 hour (pre dose), halfway through the infusion (0.5 hour), 1 hour (end of the infusion), 1.25, 1.50, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, and 96 hours post dose. AUC0-inf (AUC from time 0 extrapolated to infinite time) and AUC0-t (AUC from time 0 to time t, where "t" = the last quantifiable concentration) for galidesivir was estimated using non compartmental methods with Phoenix® WinNonlin® v8.1 or higher (Certara, Inc.). |
Description | Urine was collected from subjects over a 96 hour period per protocol, analyzed for galidesivir concentrations. Urine PK parameters including CLR (renal clearance of unchanged drug cumulatively over all collection intervals or in a specific interval) were estimated in SAS for Windows v9.4 or higher (SAS Institute, Inc.) based on the recorded urine concentrations and volumes. |
Browse Conditions
Sequence: | 193570784 | Sequence: | 193570785 | Sequence: | 193570786 | Sequence: | 193570787 | Sequence: | 193570788 | Sequence: | 193570789 | Sequence: | 193570790 |
Mesh Term | Virus Diseases | Mesh Term | Marburg Virus Disease | Mesh Term | Infections | Mesh Term | Hemorrhagic Fevers, Viral | Mesh Term | RNA Virus Infections | Mesh Term | Filoviridae Infections | Mesh Term | Mononegavirales Infections |
Downcase Mesh Term | virus diseases | Downcase Mesh Term | marburg virus disease | Downcase Mesh Term | infections | Downcase Mesh Term | hemorrhagic fevers, viral | Downcase Mesh Term | rna virus infections | Downcase Mesh Term | filoviridae infections | Downcase Mesh Term | mononegavirales infections |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48339929 | Sequence: | 48339930 |
Agency Class | INDUSTRY | Agency Class | NIH |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | BioCryst Pharmaceuticals | Name | National Institute of Allergy and Infectious Diseases (NIAID) |
Overall Officials
Sequence: | 29297742 |
Role | Principal Investigator |
Name | Daniel Dickerson, MD, PhD |
Affiliation | PRA Health Sciences |
Design Group Interventions
Sequence: | 68179717 | Sequence: | 68179718 |
Design Group Id | 55618629 | Design Group Id | 55618630 |
Intervention Id | 52507892 | Intervention Id | 52507893 |
Eligibilities
Sequence: | 30778377 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 55 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Key Inclusion Criteria:
written informed consent Exclusion Criteria: clinically significant medical condition or medical history or psychiatric condition or history of psychiatric condition |
Adult | True |
Child | False |
Older Adult | False |
Calculated Values
Sequence: | 253970969 |
Number Of Facilities | 1 |
Number Of Nsae Subjects | 17 |
Number Of Sae Subjects | 2 |
Registered In Calendar Year | 2018 |
Actual Duration | 4 |
Were Results Reported | True |
Months To Report Results | 25 |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 55 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 3 |
Designs
Sequence: | 30524481 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Double |
Subject Masked | True |
Investigator Masked | True |
Drop Withdrawals
Sequence: | 29004049 | Sequence: | 29004050 | Sequence: | 29004051 | Sequence: | 29004052 | Sequence: | 29004053 |
Result Group Id | 56112260 | Result Group Id | 56112261 | Result Group Id | 56112262 | Result Group Id | 56112263 | Result Group Id | 56112264 |
Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 |
Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study |
Reason | Lost to Follow-up | Reason | Lost to Follow-up | Reason | Lost to Follow-up | Reason | Lost to Follow-up | Reason | Lost to Follow-up |
Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 1 |
Milestones
Sequence: | 41027449 | Sequence: | 41027450 | Sequence: | 41027451 | Sequence: | 41027452 | Sequence: | 41027453 | Sequence: | 41027454 | Sequence: | 41027455 | Sequence: | 41027456 | Sequence: | 41027457 | Sequence: | 41027458 | Sequence: | 41027459 | Sequence: | 41027460 | Sequence: | 41027461 | Sequence: | 41027462 | Sequence: | 41027463 | Sequence: | 41027464 | Sequence: | 41027465 | Sequence: | 41027466 | Sequence: | 41027467 | Sequence: | 41027468 | Sequence: | 41027469 | Sequence: | 41027470 | Sequence: | 41027471 | Sequence: | 41027472 | Sequence: | 41027473 |
Result Group Id | 56112260 | Result Group Id | 56112261 | Result Group Id | 56112262 | Result Group Id | 56112263 | Result Group Id | 56112264 | Result Group Id | 56112260 | Result Group Id | 56112261 | Result Group Id | 56112262 | Result Group Id | 56112263 | Result Group Id | 56112264 | Result Group Id | 56112260 | Result Group Id | 56112261 | Result Group Id | 56112262 | Result Group Id | 56112263 | Result Group Id | 56112264 | Result Group Id | 56112260 | Result Group Id | 56112261 | Result Group Id | 56112262 | Result Group Id | 56112263 | Result Group Id | 56112264 | Result Group Id | 56112260 | Result Group Id | 56112261 | Result Group Id | 56112262 | Result Group Id | 56112263 | Result Group Id | 56112264 |
Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 |
Title | STARTED | Title | STARTED | Title | STARTED | Title | STARTED | Title | STARTED | Title | Safety Population | Title | Safety Population | Title | Safety Population | Title | Safety Population | Title | Safety Population | Title | PK Population | Title | PK Population | Title | PK Population | Title | PK Population | Title | PK Population | Title | COMPLETED | Title | COMPLETED | Title | COMPLETED | Title | COMPLETED | Title | COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED |
Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study |
Count | 8 | Count | 6 | Count | 6 | Count | 6 | Count | 6 | Count | 8 | Count | 6 | Count | 6 | Count | 6 | Count | 6 | Count | 0 | Count | 6 | Count | 6 | Count | 6 | Count | 6 | Count | 8 | Count | 6 | Count | 6 | Count | 6 | Count | 5 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 1 |
Milestone Description | Safety Population includes all subjects who received study drug. | Milestone Description | Safety Population includes all subjects who received study drug. | Milestone Description | Safety Population includes all subjects who received study drug. | Milestone Description | Safety Population includes all subjects who received study drug. | Milestone Description | Safety Population includes all subjects who received study drug. | Milestone Description | PK population included all subjects from whom at least 1 galidesivir PK parameter was estimated. | Milestone Description | PK population included all subjects from whom at least 1 galidesivir PK parameter was estimated. | Milestone Description | PK population included all subjects from whom at least 1 galidesivir PK parameter was estimated. | Milestone Description | PK population included all subjects from whom at least 1 galidesivir PK parameter was estimated. | Milestone Description | PK population included all subjects from whom at least 1 galidesivir PK parameter was estimated. | ||||||||||||||||||||||||||||||
Outcome Analyses
Sequence: | 16581196 | Sequence: | 16581197 | Sequence: | 16581198 |
Outcome Id | 30820261 | Outcome Id | 30820262 | Outcome Id | 30820262 |
Non Inferiority Type | Other | Non Inferiority Type | Other | Non Inferiority Type | Other |
Param Type | Slope | Param Type | Slope | Param Type | Slope |
Param Value | 0.982 | Param Value | 1.0 | Param Value | 1.086 |
P Value Modifier | P Value Modifier | P Value Modifier | |||
Ci N Sides | 2-Sided | Ci N Sides | 2-Sided | Ci N Sides | 2-Sided |
Ci Percent | 90.0 | Ci Percent | 90.0 | Ci Percent | 90.0 |
Ci Lower Limit | 0.868 | Ci Lower Limit | 0.872 | Ci Lower Limit | 0.952 |
Ci Upper Limit | 1.096 | Ci Upper Limit | 1.128 | Ci Upper Limit | 1.219 |
Groups Description | A model with In-transformed dose (dose continuous) as a fixed effect & subject as a random effect was applied to In-transformed Cmax. Dose proportionality was assessed by restricted max likelihood using SAS PROC MIXED. The mean slope was estimated from the power model & the corresponding 90% CI calculated. Although there was no formal statistical hypothesis tested for this secondary objective, there was evidence for dose proportionality if the 90% CI of the fixed slope for In-dose contained 1. | Groups Description | A model with In-transformed dose (dose continuous) as a fixed effect & subject as a random effect was applied to In-transformed AUC0-inf Dose proportionality was assessed by restricted max likelihood using SAS PROC MIXED. The mean slope was estimated from the power model & the corresponding 90% CI calculated. Although there was no formal statistical hypothesis tested for this secondary objective, there was evidence for dose proportionality if the 90% CI of the fixed slope for In-dose contained 1 | Groups Description | A model with In-transformed dose (dose continuous) as a fixed effect & subject as a random effect was applied to In-transformed AUC0-t. Dose proportionality was assessed by restricted max likelihood using SAS PROC MIXED. The mean slope was estimated from the power model & the corresponding 90% CI calculated. Although there was no formal statistical hypothesis tested for this secondary objective, there was evidence for dose proportionality if the 90% CI of the fixed slope for In-dose contained 1. |
Outcome Analysis Groups
Sequence: | 32157965 | Sequence: | 32157966 | Sequence: | 32157967 | Sequence: | 32157968 | Sequence: | 32157969 | Sequence: | 32157970 | Sequence: | 32157971 | Sequence: | 32157972 | Sequence: | 32157973 | Sequence: | 32157974 | Sequence: | 32157975 | Sequence: | 32157976 |
Outcome Analysis Id | 16581196 | Outcome Analysis Id | 16581196 | Outcome Analysis Id | 16581196 | Outcome Analysis Id | 16581196 | Outcome Analysis Id | 16581197 | Outcome Analysis Id | 16581197 | Outcome Analysis Id | 16581197 | Outcome Analysis Id | 16581197 | Outcome Analysis Id | 16581198 | Outcome Analysis Id | 16581198 | Outcome Analysis Id | 16581198 | Outcome Analysis Id | 16581198 |
Result Group Id | 56112270 | Result Group Id | 56112271 | Result Group Id | 56112272 | Result Group Id | 56112273 | Result Group Id | 56112270 | Result Group Id | 56112271 | Result Group Id | 56112272 | Result Group Id | 56112273 | Result Group Id | 56112270 | Result Group Id | 56112271 | Result Group Id | 56112272 | Result Group Id | 56112273 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 |
Participant Flows
Sequence: | 3922836 |
Pre Assignment Details | A single dose of study drug was administered to subjects in each of cohorts 1 to 4. In each cohort, 6 subjects received galidesivir and 2 subjects received matching placebo. |
Outcome Counts
Sequence: | 74038503 | Sequence: | 74038504 | Sequence: | 74038505 | Sequence: | 74038506 | Sequence: | 74038507 | Sequence: | 74038508 | Sequence: | 74038509 | Sequence: | 74038510 | Sequence: | 74038511 | Sequence: | 74038512 | Sequence: | 74038513 | Sequence: | 74038514 | Sequence: | 74038515 | Sequence: | 74038516 | Sequence: | 74038517 | Sequence: | 74038518 | Sequence: | 74038519 |
Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820261 | Outcome Id | 30820261 | Outcome Id | 30820261 | Outcome Id | 30820261 | Outcome Id | 30820262 | Outcome Id | 30820262 | Outcome Id | 30820262 | Outcome Id | 30820262 | Outcome Id | 30820263 | Outcome Id | 30820263 | Outcome Id | 30820263 | Outcome Id | 30820263 |
Result Group Id | 56112265 | Result Group Id | 56112266 | Result Group Id | 56112267 | Result Group Id | 56112268 | Result Group Id | 56112269 | Result Group Id | 56112270 | Result Group Id | 56112271 | Result Group Id | 56112272 | Result Group Id | 56112273 | Result Group Id | 56112270 | Result Group Id | 56112271 | Result Group Id | 56112272 | Result Group Id | 56112273 | Result Group Id | 56112270 | Result Group Id | 56112271 | Result Group Id | 56112272 | Result Group Id | 56112273 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 |
Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure |
Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants |
Count | 8 | Count | 6 | Count | 6 | Count | 6 | Count | 6 | Count | 6 | Count | 6 | Count | 6 | Count | 6 | Count | 6 | Count | 6 | Count | 6 | Count | 6 | Count | 6 | Count | 6 | Count | 6 | Count | 5 |
Provided Documents
Sequence: | 2581550 | Sequence: | 2581551 |
Document Type | Study Protocol | Document Type | Statistical Analysis Plan |
Has Protocol | True | Has Protocol | False |
Has Icf | False | Has Icf | False |
Has Sap | False | Has Sap | True |
Document Date | 2019-01-11 | Document Date | 2019-04-10 |
Url | https://ClinicalTrials.gov/ProvidedDocs/73/NCT03800173/Prot_000.pdf | Url | https://ClinicalTrials.gov/ProvidedDocs/73/NCT03800173/SAP_001.pdf |
Reported Event Totals
Sequence: | 27955633 | Sequence: | 27955634 | Sequence: | 27955635 | Sequence: | 27955636 | Sequence: | 27955637 | Sequence: | 27955638 | Sequence: | 27955639 | Sequence: | 27955640 | Sequence: | 27955641 | Sequence: | 27955642 | Sequence: | 27955643 | Sequence: | 27955644 | Sequence: | 27955645 | Sequence: | 27955646 | Sequence: | 27955647 |
Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG001 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG002 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG003 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG004 | Ctgov Group Code | EG004 |
Event Type | serious | Event Type | other | Event Type | deaths | Event Type | serious | Event Type | other | Event Type | deaths | Event Type | serious | Event Type | other | Event Type | deaths | Event Type | serious | Event Type | other | Event Type | deaths | Event Type | serious | Event Type | other | Event Type | deaths |
Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality | Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality | Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality | Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality | Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality |
Subjects Affected | 0 | Subjects Affected | 2 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 4 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 |
Subjects At Risk | 8 | Subjects At Risk | 8 | Subjects At Risk | 8 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 |
Created At | 2023-08-09 03:53:25.778295 | Created At | 2023-08-09 03:53:25.778295 | Created At | 2023-08-09 03:53:25.778295 | Created At | 2023-08-09 03:53:25.778295 | Created At | 2023-08-09 03:53:25.778295 | Created At | 2023-08-09 03:53:25.778295 | Created At | 2023-08-09 03:53:25.778295 | Created At | 2023-08-09 03:53:25.778295 | Created At | 2023-08-09 03:53:25.778295 | Created At | 2023-08-09 03:53:25.778295 | Created At | 2023-08-09 03:53:25.778295 | Created At | 2023-08-09 03:53:25.778295 | Created At | 2023-08-09 03:53:25.778295 | Created At | 2023-08-09 03:53:25.778295 | Created At | 2023-08-09 03:53:25.778295 |
Updated At | 2023-08-09 03:53:25.778295 | Updated At | 2023-08-09 03:53:25.778295 | Updated At | 2023-08-09 03:53:25.778295 | Updated At | 2023-08-09 03:53:25.778295 | Updated At | 2023-08-09 03:53:25.778295 | Updated At | 2023-08-09 03:53:25.778295 | Updated At | 2023-08-09 03:53:25.778295 | Updated At | 2023-08-09 03:53:25.778295 | Updated At | 2023-08-09 03:53:25.778295 | Updated At | 2023-08-09 03:53:25.778295 | Updated At | 2023-08-09 03:53:25.778295 | Updated At | 2023-08-09 03:53:25.778295 | Updated At | 2023-08-09 03:53:25.778295 | Updated At | 2023-08-09 03:53:25.778295 | Updated At | 2023-08-09 03:53:25.778295 |
Reported Events
Sequence: | 528498131 | Sequence: | 528498063 | Sequence: | 528498064 | Sequence: | 528498065 | Sequence: | 528498066 | Sequence: | 528498067 | Sequence: | 528498068 | Sequence: | 528498069 | Sequence: | 528498070 | Sequence: | 528498071 | Sequence: | 528498072 | Sequence: | 528498073 | Sequence: | 528498074 | Sequence: | 528498075 | Sequence: | 528498076 | Sequence: | 528498077 | Sequence: | 528498078 | Sequence: | 528498079 | Sequence: | 528498080 | Sequence: | 528498081 | Sequence: | 528498082 | Sequence: | 528498083 | Sequence: | 528498084 | Sequence: | 528498085 | Sequence: | 528498086 | Sequence: | 528498087 | Sequence: | 528498088 | Sequence: | 528498089 | Sequence: | 528498090 | Sequence: | 528498091 | Sequence: | 528498092 | Sequence: | 528498093 | Sequence: | 528498094 | Sequence: | 528498095 | Sequence: | 528498096 | Sequence: | 528498097 | Sequence: | 528498098 | Sequence: | 528498099 | Sequence: | 528498100 | Sequence: | 528498101 | Sequence: | 528498102 | Sequence: | 528498103 | Sequence: | 528498104 | Sequence: | 528498105 | Sequence: | 528498106 | Sequence: | 528498107 | Sequence: | 528498108 | Sequence: | 528498109 | Sequence: | 528498110 | Sequence: | 528498111 | Sequence: | 528498112 | Sequence: | 528498113 | Sequence: | 528498114 | Sequence: | 528498115 | Sequence: | 528498116 | Sequence: | 528498117 | Sequence: | 528498118 | Sequence: | 528498119 | Sequence: | 528498120 | Sequence: | 528498121 | Sequence: | 528498122 | Sequence: | 528498123 | Sequence: | 528498124 | Sequence: | 528498125 | Sequence: | 528498126 | Sequence: | 528498127 | Sequence: | 528498128 | Sequence: | 528498129 | Sequence: | 528498130 | Sequence: | 528498132 | Sequence: | 528498133 | Sequence: | 528498134 | Sequence: | 528498135 | Sequence: | 528498136 | Sequence: | 528498137 | Sequence: | 528498138 | Sequence: | 528498139 | Sequence: | 528498140 | Sequence: | 528498141 | Sequence: | 528498142 | Sequence: | 528498143 | Sequence: | 528498144 | Sequence: | 528498145 | Sequence: | 528498146 | Sequence: | 528498147 |
Result Group Id | 56112277 | Result Group Id | 56112274 | Result Group Id | 56112275 | Result Group Id | 56112276 | Result Group Id | 56112277 | Result Group Id | 56112278 | Result Group Id | 56112274 | Result Group Id | 56112275 | Result Group Id | 56112276 | Result Group Id | 56112277 | Result Group Id | 56112278 | Result Group Id | 56112274 | Result Group Id | 56112275 | Result Group Id | 56112276 | Result Group Id | 56112277 | Result Group Id | 56112278 | Result Group Id | 56112274 | Result Group Id | 56112275 | Result Group Id | 56112276 | Result Group Id | 56112277 | Result Group Id | 56112278 | Result Group Id | 56112274 | Result Group Id | 56112275 | Result Group Id | 56112276 | Result Group Id | 56112277 | Result Group Id | 56112278 | Result Group Id | 56112274 | Result Group Id | 56112275 | Result Group Id | 56112276 | Result Group Id | 56112277 | Result Group Id | 56112278 | Result Group Id | 56112274 | Result Group Id | 56112275 | Result Group Id | 56112276 | Result Group Id | 56112277 | Result Group Id | 56112278 | Result Group Id | 56112274 | Result Group Id | 56112275 | Result Group Id | 56112276 | Result Group Id | 56112277 | Result Group Id | 56112278 | Result Group Id | 56112274 | Result Group Id | 56112275 | Result Group Id | 56112276 | Result Group Id | 56112277 | Result Group Id | 56112278 | Result Group Id | 56112274 | Result Group Id | 56112275 | Result Group Id | 56112276 | Result Group Id | 56112277 | Result Group Id | 56112278 | Result Group Id | 56112274 | Result Group Id | 56112275 | Result Group Id | 56112276 | Result Group Id | 56112277 | Result Group Id | 56112278 | Result Group Id | 56112274 | Result Group Id | 56112275 | Result Group Id | 56112276 | Result Group Id | 56112277 | Result Group Id | 56112278 | Result Group Id | 56112274 | Result Group Id | 56112275 | Result Group Id | 56112276 | Result Group Id | 56112277 | Result Group Id | 56112278 | Result Group Id | 56112274 | Result Group Id | 56112275 | Result Group Id | 56112276 | Result Group Id | 56112278 | Result Group Id | 56112274 | Result Group Id | 56112275 | Result Group Id | 56112276 | Result Group Id | 56112277 | Result Group Id | 56112278 | Result Group Id | 56112274 | Result Group Id | 56112275 | Result Group Id | 56112276 | Result Group Id | 56112277 | Result Group Id | 56112278 | Result Group Id | 56112274 | Result Group Id | 56112275 | Result Group Id | 56112276 | Result Group Id | 56112277 | Result Group Id | 56112278 |
Ctgov Group Code | EG003 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG004 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 |
Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). |
Event Type | other | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other |
Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 2 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 |
Subjects At Risk | 6 | Subjects At Risk | 8 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 8 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 8 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 8 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 8 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 8 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 8 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 8 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 8 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 8 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 8 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 8 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 8 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 8 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 8 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 8 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 8 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 |
Event Count | 1 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 2 | Event Count | 1 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 |
Organ System | Blood and lymphatic system disorders | Organ System | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Organ System | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Organ System | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Organ System | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Organ System | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Organ System | Pregnancy, puerperium and perinatal conditions | Organ System | Pregnancy, puerperium and perinatal conditions | Organ System | Pregnancy, puerperium and perinatal conditions | Organ System | Pregnancy, puerperium and perinatal conditions | Organ System | Pregnancy, puerperium and perinatal conditions | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Hepatobiliary disorders | Organ System | Hepatobiliary disorders | Organ System | Hepatobiliary disorders | Organ System | Hepatobiliary disorders | Organ System | Hepatobiliary disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders |
Adverse Event Term | Iron deficiency anaemia | Adverse Event Term | gastrooesophageal cancer | Adverse Event Term | gastrooesophageal cancer | Adverse Event Term | gastrooesophageal cancer | Adverse Event Term | gastrooesophageal cancer | Adverse Event Term | gastrooesophageal cancer | Adverse Event Term | Abortion spontaneous | Adverse Event Term | Abortion spontaneous | Adverse Event Term | Abortion spontaneous | Adverse Event Term | Abortion spontaneous | Adverse Event Term | Abortion spontaneous | Adverse Event Term | Headache | Adverse Event Term | Headache | Adverse Event Term | Headache | Adverse Event Term | Headache | Adverse Event Term | Headache | Adverse Event Term | Syncope | Adverse Event Term | Syncope | Adverse Event Term | Syncope | Adverse Event Term | Syncope | Adverse Event Term | Syncope | Adverse Event Term | Abdominal Distension | Adverse Event Term | Abdominal Distension | Adverse Event Term | Abdominal Distension | Adverse Event Term | Abdominal Distension | Adverse Event Term | Abdominal Distension | Adverse Event Term | Abdominal pain | Adverse Event Term | Abdominal pain | Adverse Event Term | Abdominal pain | Adverse Event Term | Abdominal pain | Adverse Event Term | Abdominal pain | Adverse Event Term | Nausea | Adverse Event Term | Nausea | Adverse Event Term | Nausea | Adverse Event Term | Nausea | Adverse Event Term | Nausea | Adverse Event Term | Vomiting | Adverse Event Term | Vomiting | Adverse Event Term | Vomiting | Adverse Event Term | Vomiting | Adverse Event Term | Vomiting | Adverse Event Term | Arthralgia | Adverse Event Term | Arthralgia | Adverse Event Term | Arthralgia | Adverse Event Term | Arthralgia | Adverse Event Term | Arthralgia | Adverse Event Term | Back pain | Adverse Event Term | Back pain | Adverse Event Term | Back pain | Adverse Event Term | Back pain | Adverse Event Term | Back pain | Adverse Event Term | Gastroenteritis | Adverse Event Term | Gastroenteritis | Adverse Event Term | Gastroenteritis | Adverse Event Term | Gastroenteritis | Adverse Event Term | Gastroenteritis | Adverse Event Term | Urticaria | Adverse Event Term | Urticaria | Adverse Event Term | Urticaria | Adverse Event Term | Urticaria | Adverse Event Term | Urticaria | Adverse Event Term | Hepatic lesion | Adverse Event Term | Hepatic lesion | Adverse Event Term | Hepatic lesion | Adverse Event Term | Hepatic lesion | Adverse Event Term | Hepatic lesion | Adverse Event Term | Iron deficiency anaemia | Adverse Event Term | Iron deficiency anaemia | Adverse Event Term | Iron deficiency anaemia | Adverse Event Term | Iron deficiency anaemia | Adverse Event Term | Leukocytosis | Adverse Event Term | Leukocytosis | Adverse Event Term | Leukocytosis | Adverse Event Term | Leukocytosis | Adverse Event Term | Leukocytosis | Adverse Event Term | Decreased appetite | Adverse Event Term | Decreased appetite | Adverse Event Term | Decreased appetite | Adverse Event Term | Decreased appetite | Adverse Event Term | Decreased appetite | Adverse Event Term | Upper airway cough syndrome | Adverse Event Term | Upper airway cough syndrome | Adverse Event Term | Upper airway cough syndrome | Adverse Event Term | Upper airway cough syndrome | Adverse Event Term | Upper airway cough syndrome |
Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 |
Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) |
Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment |
Responsible Parties
Sequence: | 28890791 |
Responsible Party Type | Sponsor |
Result Agreements
Sequence: | 3853580 |
Pi Employee | No |
Result Contacts
Sequence: | 3853545 |
Organization | BioCryst Pharmaceuticals Inc |
Name | Study Director |
Phone | +1 919-859-1302 |
clinicaltrials@biocryst.com | |
Outcomes
Sequence: | 30820260 | Sequence: | 30820261 | Sequence: | 30820262 | Sequence: | 30820263 |
Outcome Type | Primary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary |
Title | Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. | Title | Plasma PK – Galidesivir Cmax (Maximum Observed Concentration of Drug) | Title | Plasma PK – Galidesivir AUC (Area Under the Concentration vs. Time Curve) | Title | Galidesivir Renal Clearance |
Description | Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE). | Description | Serial blood samples for PK assessment of plasma galidesivir were collected at the following time points:
Day 1 to Day 5: 0 hour (pre dose), halfway through the infusion (0.5 hour), 1 hour (end of the infusion), 1.25, 1.50, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, and 96 hours post dose. Cmax for galidesivir was estimated using non compartmental methods with Phoenix® WinNonlin® v8.1 or higher (Certara, Inc.). |
Description | Serial blood samples for PK assessment of plasma galidesivir were collected at the following time points:
Day 1 to Day 5: 0 hour (pre dose), halfway through the infusion (0.5 hour), 1 hour (end of the infusion), 1.25, 1.50, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, and 96 hours post dose. AUC0-inf (AUC from time 0 extrapolated to infinite time) and AUC0-t (AUC from time 0 to time t, where "t" = the last quantifiable concentration) for galidesivir was estimated using non compartmental methods with Phoenix® WinNonlin® v8.1 or higher (Certara, Inc.). |
Description | Urine was collected from subjects over a 96 hour period per protocol, analyzed for galidesivir concentrations. Urine PK parameters including CLR (renal clearance of unchanged drug cumulatively over all collection intervals or in a specific interval) were estimated in SAS for Windows v9.4 or higher (SAS Institute, Inc.) based on the recorded urine concentrations and volumes. |
Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up period, up to 23 days from IMP dosing on Day 1. | Time Frame | Plasma PK parameters are based on sampling over a 21 day period | Time Frame | Plasma PK parameters are based on sampling over a 21 day period | Time Frame | Urine PK parameters are based on sampling over a 96 hour period. |
Population | The safety population included all randomized subjects who received any amount of study drug (i.e. a partial infusion). | Population | The PK population included subjects for whom at least 1 PK parameter was estimated. The PK population was the primary population for the PK analysis. | Population | The PK population included subjects for whom at least 1 PK parameter was estimated. The PK population was the primary population for the PK analysis. Only 5 subjects were included in the 20 mg/kg cohort for AUC0-t analysis, as 1 subject was lost to follow-up after discharge from clinic on Day 5. | Population | The PK population included subjects for whom at least 1 PK parameter was estimated. The PK population was the primary population for the PK analysis. There were only 5 subjects in the 20 mg/kg cohort as 1 subject was lost to follow-up after discharge from clinic on Day 5. |
Units | participants | Units | ng/mL | Units | ng*h/mL | Units | L/hr |
Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | ||
Param Type | Number | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean |
Outcome Measurements
Sequence: | 235798870 | Sequence: | 235798869 | Sequence: | 235798866 | Sequence: | 235798867 | Sequence: | 235798868 | Sequence: | 235798871 | Sequence: | 235798872 | Sequence: | 235798873 | Sequence: | 235798874 | Sequence: | 235798875 | Sequence: | 235798876 | Sequence: | 235798877 | Sequence: | 235798878 | Sequence: | 235798879 | Sequence: | 235798880 | Sequence: | 235798881 | Sequence: | 235798882 | Sequence: | 235798883 | Sequence: | 235798884 | Sequence: | 235798885 | Sequence: | 235798886 | Sequence: | 235798887 | Sequence: | 235798888 | Sequence: | 235798889 | Sequence: | 235798890 | Sequence: | 235798891 | Sequence: | 235798892 | Sequence: | 235798893 | Sequence: | 235798894 | Sequence: | 235798895 | Sequence: | 235798896 | Sequence: | 235798897 | Sequence: | 235798898 | Sequence: | 235798899 | Sequence: | 235798900 | Sequence: | 235798901 | Sequence: | 235798902 | Sequence: | 235798903 | Sequence: | 235798904 | Sequence: | 235798905 | Sequence: | 235798906 | Sequence: | 235798907 | Sequence: | 235798908 | Sequence: | 235798909 | Sequence: | 235798910 | Sequence: | 235798911 | Sequence: | 235798912 | Sequence: | 235798913 | Sequence: | 235798914 | Sequence: | 235798915 | Sequence: | 235798916 | Sequence: | 235798917 | Sequence: | 235798918 | Sequence: | 235798919 | Sequence: | 235798920 | Sequence: | 235798921 |
Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820261 | Outcome Id | 30820261 | Outcome Id | 30820261 | Outcome Id | 30820261 | Outcome Id | 30820262 | Outcome Id | 30820262 | Outcome Id | 30820262 | Outcome Id | 30820262 | Outcome Id | 30820262 | Outcome Id | 30820262 | Outcome Id | 30820262 | Outcome Id | 30820262 | Outcome Id | 30820263 | Outcome Id | 30820263 | Outcome Id | 30820263 | Outcome Id | 30820263 |
Result Group Id | 56112269 | Result Group Id | 56112268 | Result Group Id | 56112265 | Result Group Id | 56112266 | Result Group Id | 56112267 | Result Group Id | 56112265 | Result Group Id | 56112266 | Result Group Id | 56112267 | Result Group Id | 56112268 | Result Group Id | 56112269 | Result Group Id | 56112265 | Result Group Id | 56112266 | Result Group Id | 56112267 | Result Group Id | 56112268 | Result Group Id | 56112269 | Result Group Id | 56112265 | Result Group Id | 56112266 | Result Group Id | 56112267 | Result Group Id | 56112268 | Result Group Id | 56112269 | Result Group Id | 56112265 | Result Group Id | 56112266 | Result Group Id | 56112267 | Result Group Id | 56112268 | Result Group Id | 56112269 | Result Group Id | 56112265 | Result Group Id | 56112266 | Result Group Id | 56112267 | Result Group Id | 56112268 | Result Group Id | 56112269 | Result Group Id | 56112265 | Result Group Id | 56112266 | Result Group Id | 56112267 | Result Group Id | 56112268 | Result Group Id | 56112269 | Result Group Id | 56112265 | Result Group Id | 56112266 | Result Group Id | 56112267 | Result Group Id | 56112268 | Result Group Id | 56112269 | Result Group Id | 56112270 | Result Group Id | 56112271 | Result Group Id | 56112272 | Result Group Id | 56112273 | Result Group Id | 56112270 | Result Group Id | 56112271 | Result Group Id | 56112272 | Result Group Id | 56112273 | Result Group Id | 56112270 | Result Group Id | 56112271 | Result Group Id | 56112272 | Result Group Id | 56112273 | Result Group Id | 56112270 | Result Group Id | 56112271 | Result Group Id | 56112272 | Result Group Id | 56112273 |
Ctgov Group Code | OG004 | Ctgov Group Code | OG003 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 |
Classification | Subjects with at least 1 TEAE | Classification | Subjects with at least 1 TEAE | Classification | Subjects with at least 1 TEAE | Classification | Subjects with at least 1 TEAE | Classification | Subjects with at least 1 TEAE | Classification | Not related TEAEs | Classification | Not related TEAEs | Classification | Not related TEAEs | Classification | Not related TEAEs | Classification | Not related TEAEs | Classification | Related TEAEs | Classification | Related TEAEs | Classification | Related TEAEs | Classification | Related TEAEs | Classification | Related TEAEs | Classification | Mild TEAE | Classification | Mild TEAE | Classification | Mild TEAE | Classification | Mild TEAE | Classification | Mild TEAE | Classification | Moderate TEAE | Classification | Moderate TEAE | Classification | Moderate TEAE | Classification | Moderate TEAE | Classification | Moderate TEAE | Classification | Severe TEAE | Classification | Severe TEAE | Classification | Severe TEAE | Classification | Severe TEAE | Classification | Severe TEAE | Classification | Subjects with at least 1 SAE | Classification | Subjects with at least 1 SAE | Classification | Subjects with at least 1 SAE | Classification | Subjects with at least 1 SAE | Classification | Subjects with at least 1 SAE | Classification | Subject Discontinuation due to AE | Classification | Subject Discontinuation due to AE | Classification | Subject Discontinuation due to AE | Classification | Subject Discontinuation due to AE | Classification | Subject Discontinuation due to AE | Classification | AUC0-inf | Classification | AUC0-inf | Classification | AUC0-inf | Classification | AUC0-inf | Classification | AUC0-t | Classification | AUC0-t | Classification | AUC0-t | Classification | AUC0-t | ||||||||||||||||
Title | Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. | Title | Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. | Title | Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. | Title | Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. | Title | Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. | Title | Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. | Title | Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. | Title | Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. | Title | Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. | Title | Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. | Title | Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. | Title | Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. | Title | Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. | Title | Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. | Title | Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. | Title | Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. | Title | Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. | Title | Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. | Title | Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. | Title | Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. | Title | Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. | Title | Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. | Title | Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. | Title | Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. | Title | Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. | Title | Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. | Title | Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. | Title | Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. | Title | Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. | Title | Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. | Title | Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. | Title | Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. | Title | Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. | Title | Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. | Title | Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. | Title | Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. | Title | Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. | Title | Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. | Title | Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. | Title | Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. | Title | Plasma PK – Galidesivir Cmax (Maximum Observed Concentration of Drug) | Title | Plasma PK – Galidesivir Cmax (Maximum Observed Concentration of Drug) | Title | Plasma PK – Galidesivir Cmax (Maximum Observed Concentration of Drug) | Title | Plasma PK – Galidesivir Cmax (Maximum Observed Concentration of Drug) | Title | Plasma PK – Galidesivir AUC (Area Under the Concentration vs. Time Curve) | Title | Plasma PK – Galidesivir AUC (Area Under the Concentration vs. Time Curve) | Title | Plasma PK – Galidesivir AUC (Area Under the Concentration vs. Time Curve) | Title | Plasma PK – Galidesivir AUC (Area Under the Concentration vs. Time Curve) | Title | Plasma PK – Galidesivir AUC (Area Under the Concentration vs. Time Curve) | Title | Plasma PK – Galidesivir AUC (Area Under the Concentration vs. Time Curve) | Title | Plasma PK – Galidesivir AUC (Area Under the Concentration vs. Time Curve) | Title | Plasma PK – Galidesivir AUC (Area Under the Concentration vs. Time Curve) | Title | Galidesivir Renal Clearance | Title | Galidesivir Renal Clearance | Title | Galidesivir Renal Clearance | Title | Galidesivir Renal Clearance |
Description | Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE). | Description | Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE). | Description | Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE). | Description | Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE). | Description | Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE). | Description | Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE). | Description | Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE). | Description | Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE). | Description | Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE). | Description | Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE). | Description | Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE). | Description | Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE). | Description | Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE). | Description | Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE). | Description | Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE). | Description | Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE). | Description | Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE). | Description | Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE). | Description | Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE). | Description | Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE). | Description | Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE). | Description | Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE). | Description | Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE). | Description | Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE). | Description | Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE). | Description | Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE). | Description | Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE). | Description | Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE). | Description | Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE). | Description | Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE). | Description | Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE). | Description | Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE). | Description | Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE). | Description | Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE). | Description | Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE). | Description | Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE). | Description | Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE). | Description | Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE). | Description | Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE). | Description | Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE). | Description | Serial blood samples for PK assessment of plasma galidesivir were collected at the following time points:
Day 1 to Day 5: 0 hour (pre dose), halfway through the infusion (0.5 hour), 1 hour (end of the infusion), 1.25, 1.50, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, and 96 hours post dose. Cmax for galidesivir was estimated using non compartmental methods with Phoenix® WinNonlin® v8.1 or higher (Certara, Inc.). |
Description | Serial blood samples for PK assessment of plasma galidesivir were collected at the following time points:
Day 1 to Day 5: 0 hour (pre dose), halfway through the infusion (0.5 hour), 1 hour (end of the infusion), 1.25, 1.50, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, and 96 hours post dose. Cmax for galidesivir was estimated using non compartmental methods with Phoenix® WinNonlin® v8.1 or higher (Certara, Inc.). |
Description | Serial blood samples for PK assessment of plasma galidesivir were collected at the following time points:
Day 1 to Day 5: 0 hour (pre dose), halfway through the infusion (0.5 hour), 1 hour (end of the infusion), 1.25, 1.50, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, and 96 hours post dose. Cmax for galidesivir was estimated using non compartmental methods with Phoenix® WinNonlin® v8.1 or higher (Certara, Inc.). |
Description | Serial blood samples for PK assessment of plasma galidesivir were collected at the following time points:
Day 1 to Day 5: 0 hour (pre dose), halfway through the infusion (0.5 hour), 1 hour (end of the infusion), 1.25, 1.50, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, and 96 hours post dose. Cmax for galidesivir was estimated using non compartmental methods with Phoenix® WinNonlin® v8.1 or higher (Certara, Inc.). |
Description | Serial blood samples for PK assessment of plasma galidesivir were collected at the following time points:
Day 1 to Day 5: 0 hour (pre dose), halfway through the infusion (0.5 hour), 1 hour (end of the infusion), 1.25, 1.50, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, and 96 hours post dose. AUC0-inf (AUC from time 0 extrapolated to infinite time) and AUC0-t (AUC from time 0 to time t, where "t" = the last quantifiable concentration) for galidesivir was estimated using non compartmental methods with Phoenix® WinNonlin® v8.1 or higher (Certara, Inc.). |
Description | Serial blood samples for PK assessment of plasma galidesivir were collected at the following time points:
Day 1 to Day 5: 0 hour (pre dose), halfway through the infusion (0.5 hour), 1 hour (end of the infusion), 1.25, 1.50, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, and 96 hours post dose. AUC0-inf (AUC from time 0 extrapolated to infinite time) and AUC0-t (AUC from time 0 to time t, where "t" = the last quantifiable concentration) for galidesivir was estimated using non compartmental methods with Phoenix® WinNonlin® v8.1 or higher (Certara, Inc.). |
Description | Serial blood samples for PK assessment of plasma galidesivir were collected at the following time points:
Day 1 to Day 5: 0 hour (pre dose), halfway through the infusion (0.5 hour), 1 hour (end of the infusion), 1.25, 1.50, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, and 96 hours post dose. AUC0-inf (AUC from time 0 extrapolated to infinite time) and AUC0-t (AUC from time 0 to time t, where "t" = the last quantifiable concentration) for galidesivir was estimated using non compartmental methods with Phoenix® WinNonlin® v8.1 or higher (Certara, Inc.). |
Description | Serial blood samples for PK assessment of plasma galidesivir were collected at the following time points:
Day 1 to Day 5: 0 hour (pre dose), halfway through the infusion (0.5 hour), 1 hour (end of the infusion), 1.25, 1.50, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, and 96 hours post dose. AUC0-inf (AUC from time 0 extrapolated to infinite time) and AUC0-t (AUC from time 0 to time t, where "t" = the last quantifiable concentration) for galidesivir was estimated using non compartmental methods with Phoenix® WinNonlin® v8.1 or higher (Certara, Inc.). |
Description | Serial blood samples for PK assessment of plasma galidesivir were collected at the following time points:
Day 1 to Day 5: 0 hour (pre dose), halfway through the infusion (0.5 hour), 1 hour (end of the infusion), 1.25, 1.50, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, and 96 hours post dose. AUC0-inf (AUC from time 0 extrapolated to infinite time) and AUC0-t (AUC from time 0 to time t, where "t" = the last quantifiable concentration) for galidesivir was estimated using non compartmental methods with Phoenix® WinNonlin® v8.1 or higher (Certara, Inc.). |
Description | Serial blood samples for PK assessment of plasma galidesivir were collected at the following time points:
Day 1 to Day 5: 0 hour (pre dose), halfway through the infusion (0.5 hour), 1 hour (end of the infusion), 1.25, 1.50, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, and 96 hours post dose. AUC0-inf (AUC from time 0 extrapolated to infinite time) and AUC0-t (AUC from time 0 to time t, where "t" = the last quantifiable concentration) for galidesivir was estimated using non compartmental methods with Phoenix® WinNonlin® v8.1 or higher (Certara, Inc.). |
Description | Serial blood samples for PK assessment of plasma galidesivir were collected at the following time points:
Day 1 to Day 5: 0 hour (pre dose), halfway through the infusion (0.5 hour), 1 hour (end of the infusion), 1.25, 1.50, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, and 96 hours post dose. AUC0-inf (AUC from time 0 extrapolated to infinite time) and AUC0-t (AUC from time 0 to time t, where "t" = the last quantifiable concentration) for galidesivir was estimated using non compartmental methods with Phoenix® WinNonlin® v8.1 or higher (Certara, Inc.). |
Description | Serial blood samples for PK assessment of plasma galidesivir were collected at the following time points:
Day 1 to Day 5: 0 hour (pre dose), halfway through the infusion (0.5 hour), 1 hour (end of the infusion), 1.25, 1.50, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, and 96 hours post dose. AUC0-inf (AUC from time 0 extrapolated to infinite time) and AUC0-t (AUC from time 0 to time t, where "t" = the last quantifiable concentration) for galidesivir was estimated using non compartmental methods with Phoenix® WinNonlin® v8.1 or higher (Certara, Inc.). |
Description | Urine was collected from subjects over a 96 hour period per protocol, analyzed for galidesivir concentrations. Urine PK parameters including CLR (renal clearance of unchanged drug cumulatively over all collection intervals or in a specific interval) were estimated in SAS for Windows v9.4 or higher (SAS Institute, Inc.) based on the recorded urine concentrations and volumes. | Description | Urine was collected from subjects over a 96 hour period per protocol, analyzed for galidesivir concentrations. Urine PK parameters including CLR (renal clearance of unchanged drug cumulatively over all collection intervals or in a specific interval) were estimated in SAS for Windows v9.4 or higher (SAS Institute, Inc.) based on the recorded urine concentrations and volumes. | Description | Urine was collected from subjects over a 96 hour period per protocol, analyzed for galidesivir concentrations. Urine PK parameters including CLR (renal clearance of unchanged drug cumulatively over all collection intervals or in a specific interval) were estimated in SAS for Windows v9.4 or higher (SAS Institute, Inc.) based on the recorded urine concentrations and volumes. | Description | Urine was collected from subjects over a 96 hour period per protocol, analyzed for galidesivir concentrations. Urine PK parameters including CLR (renal clearance of unchanged drug cumulatively over all collection intervals or in a specific interval) were estimated in SAS for Windows v9.4 or higher (SAS Institute, Inc.) based on the recorded urine concentrations and volumes. |
Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | ng/mL | Units | ng/mL | Units | ng/mL | Units | ng/mL | Units | ng*h/mL | Units | ng*h/mL | Units | ng*h/mL | Units | ng*h/mL | Units | ng*h/mL | Units | ng*h/mL | Units | ng*h/mL | Units | ng*h/mL | Units | L/hr | Units | L/hr | Units | L/hr | Units | L/hr |
Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean |
Param Value | 1 | Param Value | 4 | Param Value | 2 | Param Value | 0 | Param Value | 1 | Param Value | 2 | Param Value | 0 | Param Value | 1 | Param Value | 2 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 2 | Param Value | 1 | Param Value | 2 | Param Value | 0 | Param Value | 1 | Param Value | 3 | Param Value | 1 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 1 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 1 | Param Value | 1 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 5540 | Param Value | 10300 | Param Value | 17730 | Param Value | 20490 | Param Value | 21160 | Param Value | 37080 | Param Value | 65860 | Param Value | 81230 | Param Value | 17150 | Param Value | 32360 | Param Value | 59590 | Param Value | 73350 | Param Value | 9.305 | Param Value | 11.66 | Param Value | 11.51 | Param Value | 7.131 |
Param Value Num | 1.0 | Param Value Num | 4.0 | Param Value Num | 2.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 2.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 2.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 2.0 | Param Value Num | 1.0 | Param Value Num | 2.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 3.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 5540.0 | Param Value Num | 10300.0 | Param Value Num | 17730.0 | Param Value Num | 20490.0 | Param Value Num | 21160.0 | Param Value Num | 37080.0 | Param Value Num | 65860.0 | Param Value Num | 81230.0 | Param Value Num | 17150.0 | Param Value Num | 32360.0 | Param Value Num | 59590.0 | Param Value Num | 73350.0 | Param Value Num | 9.305 | Param Value Num | 11.66 | Param Value Num | 11.51 | Param Value Num | 7.131 |
Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dispersion Value | 7.8 | Dispersion Value | 22.3 | Dispersion Value | 17.5 | Dispersion Value | 16.2 | Dispersion Value | 23.0 | Dispersion Value | 14.5 | Dispersion Value | 21.9 | Dispersion Value | 14.3 | Dispersion Value | 21.0 | Dispersion Value | 17.4 | Dispersion Value | 22.0 | Dispersion Value | 14.1 | Dispersion Value | 16.7 | Dispersion Value | 17.8 | Dispersion Value | 14.5 | Dispersion Value | 90.4 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dispersion Value Num | 7.8 | Dispersion Value Num | 22.3 | Dispersion Value Num | 17.5 | Dispersion Value Num | 16.2 | Dispersion Value Num | 23.0 | Dispersion Value Num | 14.5 | Dispersion Value Num | 21.9 | Dispersion Value Num | 14.3 | Dispersion Value Num | 21.0 | Dispersion Value Num | 17.4 | Dispersion Value Num | 22.0 | Dispersion Value Num | 14.1 | Dispersion Value Num | 16.7 | Dispersion Value Num | 17.8 | Dispersion Value Num | 14.5 | Dispersion Value Num | 90.4 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Study References
Sequence: | 52087405 |
Pmid | 35182042 |
Reference Type | derived |
Citation | Mathis A, Collins D, Dobo S, Walling DM, Sheridan WP, Taylor R. Pharmacokinetics and Safety of the Nucleoside Analog Antiviral Drug Galidesivir Administered to Healthy Adult Subjects. Clin Pharmacol Drug Dev. 2022 Apr;11(4):467-474. doi: 10.1002/cpdd.1037. Epub 2022 Feb 19. |
Baseline Counts
Sequence: | 11388279 | Sequence: | 11388280 | Sequence: | 11388281 | Sequence: | 11388282 | Sequence: | 11388283 | Sequence: | 11388284 |
Result Group Id | 56112254 | Result Group Id | 56112255 | Result Group Id | 56112256 | Result Group Id | 56112257 | Result Group Id | 56112258 | Result Group Id | 56112259 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG003 | Ctgov Group Code | BG004 | Ctgov Group Code | BG005 |
Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants |
Scope | overall | Scope | overall | Scope | overall | Scope | overall | Scope | overall | Scope | overall |
Count | 8 | Count | 6 | Count | 6 | Count | 6 | Count | 6 | Count | 32 |
Result Groups
Sequence: | 56112272 | Sequence: | 56112273 | Sequence: | 56112274 | Sequence: | 56112275 | Sequence: | 56112276 | Sequence: | 56112277 | Sequence: | 56112278 | Sequence: | 56112259 | Sequence: | 56112260 | Sequence: | 56112261 | Sequence: | 56112262 | Sequence: | 56112263 | Sequence: | 56112264 | Sequence: | 56112265 | Sequence: | 56112266 | Sequence: | 56112267 | Sequence: | 56112268 | Sequence: | 56112269 | Sequence: | 56112270 | Sequence: | 56112271 | Sequence: | 56112254 | Sequence: | 56112255 | Sequence: | 56112256 | Sequence: | 56112257 | Sequence: | 56112258 |
Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | BG005 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG003 | Ctgov Group Code | BG004 |
Result Type | Outcome | Result Type | Outcome | Result Type | Reported Event | Result Type | Reported Event | Result Type | Reported Event | Result Type | Reported Event | Result Type | Reported Event | Result Type | Baseline | Result Type | Participant Flow | Result Type | Participant Flow | Result Type | Participant Flow | Result Type | Participant Flow | Result Type | Participant Flow | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Baseline | Result Type | Baseline | Result Type | Baseline | Result Type | Baseline | Result Type | Baseline |
Title | 15 mg/kg Galidesivir | Title | 20 mg/kg Galidesivir | Title | Placebo | Title | 5 mg/kg Galidesivir | Title | 10 mg/kg Galidesivir | Title | 15 mg/kg Galidesivir | Title | 20 mg/kg Galidesivir | Title | Total | Title | Placebo | Title | 5 mg/kg Galidesivir | Title | 10 mg/kg Galidesivir | Title | 15 mg/kg Galidesivir | Title | 20 mg/kg Galidesivir | Title | Placebo | Title | 5 mg/kg Galidesivir | Title | 10 mg/kg Galidesivir | Title | 15 mg/kg Galidesivir | Title | 20 mg/kg Galidesivir | Title | 5 mg/kg Galidesivir | Title | 10 mg/kg Galidesivir | Title | Placebo | Title | 5 mg/kg Galidesivir | Title | 10 mg/kg Galidesivir | Title | 15 mg/kg Galidesivir | Title | 20 mg/kg Galidesivir |
Description | Single IV infusion 15 mg/kg galidesivir | Description | Single IV infusion 20 mg/kg galidesivir | Description | single placebo IV infusion | Description | Single IV infusion 5 mg/kg galidesivir | Description | Single IV infusion 10 mg/kg galidesivir | Description | Single IV infusion 15 mg/kg galidesivir | Description | Single IV infusion 20 mg/kg galidesivir | Description | Total of all reporting groups | Description | single placebo IV infusion | Description | Single IV infusion 5 mg/kg galidesivir | Description | Single IV infusion 10 mg/kg galidesivir | Description | Single IV infusion 15 mg/kg galidesivir | Description | Single IV infusion 20 mg/kg galidesivir | Description | single placebo IV infusion | Description | Single IV infusion 5 mg/kg galidesivir | Description | Single IV infusion 10 mg/kg galidesivir | Description | Single IV infusion 15 mg/kg galidesivir | Description | Single IV infusion 20 mg/kg galidesivir | Description | Single IV infusion 5 mg/kg galidesivir | Description | Single IV infusion 10 mg/kg galidesivir | Description | single placebo IV infusion | Description | Single IV infusion 5 mg/kg galidesivir | Description | Single IV infusion 10 mg/kg galidesivir | Description | Single IV infusion 15 mg/kg galidesivir | Description | Single IV infusion 20 mg/kg galidesivir |
Baseline Measurements
Sequence: | 125654190 | Sequence: | 125654191 | Sequence: | 125654192 | Sequence: | 125654193 | Sequence: | 125654194 | Sequence: | 125654195 | Sequence: | 125654196 | Sequence: | 125654197 | Sequence: | 125654198 | Sequence: | 125654199 | Sequence: | 125654200 | Sequence: | 125654201 | Sequence: | 125654202 | Sequence: | 125654203 | Sequence: | 125654204 | Sequence: | 125654205 | Sequence: | 125654206 | Sequence: | 125654207 | Sequence: | 125654208 | Sequence: | 125654209 | Sequence: | 125654210 | Sequence: | 125654211 | Sequence: | 125654212 | Sequence: | 125654213 | Sequence: | 125654214 | Sequence: | 125654215 | Sequence: | 125654216 | Sequence: | 125654217 | Sequence: | 125654218 | Sequence: | 125654219 | Sequence: | 125654220 | Sequence: | 125654221 | Sequence: | 125654222 | Sequence: | 125654223 | Sequence: | 125654224 | Sequence: | 125654225 | Sequence: | 125654226 | Sequence: | 125654227 | Sequence: | 125654228 | Sequence: | 125654229 | Sequence: | 125654230 | Sequence: | 125654231 | Sequence: | 125654232 | Sequence: | 125654233 | Sequence: | 125654234 | Sequence: | 125654235 | Sequence: | 125654236 | Sequence: | 125654237 | Sequence: | 125654238 | Sequence: | 125654239 | Sequence: | 125654240 | Sequence: | 125654241 | Sequence: | 125654242 | Sequence: | 125654243 | Sequence: | 125654244 | Sequence: | 125654245 | Sequence: | 125654246 | Sequence: | 125654247 | Sequence: | 125654248 | Sequence: | 125654249 |
Result Group Id | 56112254 | Result Group Id | 56112255 | Result Group Id | 56112256 | Result Group Id | 56112257 | Result Group Id | 56112258 | Result Group Id | 56112259 | Result Group Id | 56112254 | Result Group Id | 56112255 | Result Group Id | 56112256 | Result Group Id | 56112257 | Result Group Id | 56112258 | Result Group Id | 56112259 | Result Group Id | 56112254 | Result Group Id | 56112255 | Result Group Id | 56112256 | Result Group Id | 56112257 | Result Group Id | 56112258 | Result Group Id | 56112259 | Result Group Id | 56112254 | Result Group Id | 56112255 | Result Group Id | 56112256 | Result Group Id | 56112257 | Result Group Id | 56112258 | Result Group Id | 56112259 | Result Group Id | 56112254 | Result Group Id | 56112255 | Result Group Id | 56112256 | Result Group Id | 56112257 | Result Group Id | 56112258 | Result Group Id | 56112259 | Result Group Id | 56112254 | Result Group Id | 56112255 | Result Group Id | 56112256 | Result Group Id | 56112257 | Result Group Id | 56112258 | Result Group Id | 56112259 | Result Group Id | 56112254 | Result Group Id | 56112255 | Result Group Id | 56112256 | Result Group Id | 56112257 | Result Group Id | 56112258 | Result Group Id | 56112259 | Result Group Id | 56112254 | Result Group Id | 56112255 | Result Group Id | 56112256 | Result Group Id | 56112257 | Result Group Id | 56112258 | Result Group Id | 56112259 | Result Group Id | 56112254 | Result Group Id | 56112255 | Result Group Id | 56112256 | Result Group Id | 56112257 | Result Group Id | 56112258 | Result Group Id | 56112259 | Result Group Id | 56112254 | Result Group Id | 56112255 | Result Group Id | 56112256 | Result Group Id | 56112257 | Result Group Id | 56112258 | Result Group Id | 56112259 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG003 | Ctgov Group Code | BG004 | Ctgov Group Code | BG005 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG003 | Ctgov Group Code | BG004 | Ctgov Group Code | BG005 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG003 | Ctgov Group Code | BG004 | Ctgov Group Code | BG005 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG003 | Ctgov Group Code | BG004 | Ctgov Group Code | BG005 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG003 | Ctgov Group Code | BG004 | Ctgov Group Code | BG005 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG003 | Ctgov Group Code | BG004 | Ctgov Group Code | BG005 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG003 | Ctgov Group Code | BG004 | Ctgov Group Code | BG005 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG003 | Ctgov Group Code | BG004 | Ctgov Group Code | BG005 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG003 | Ctgov Group Code | BG004 | Ctgov Group Code | BG005 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG003 | Ctgov Group Code | BG004 | Ctgov Group Code | BG005 |
Category | Female | Category | Female | Category | Female | Category | Female | Category | Female | Category | Female | Category | Male | Category | Male | Category | Male | Category | Male | Category | Male | Category | Male | Category | American Indian or Alaska Native | Category | American Indian or Alaska Native | Category | American Indian or Alaska Native | Category | American Indian or Alaska Native | Category | American Indian or Alaska Native | Category | American Indian or Alaska Native | Category | Asian | Category | Asian | Category | Asian | Category | Asian | Category | Asian | Category | Asian | Category | Native Hawaiian or Other Pacific Islander | Category | Native Hawaiian or Other Pacific Islander | Category | Native Hawaiian or Other Pacific Islander | Category | Native Hawaiian or Other Pacific Islander | Category | Native Hawaiian or Other Pacific Islander | Category | Native Hawaiian or Other Pacific Islander | Category | Black or African American | Category | Black or African American | Category | Black or African American | Category | Black or African American | Category | Black or African American | Category | Black or African American | Category | White | Category | White | Category | White | Category | White | Category | White | Category | White | Category | More than one race | Category | More than one race | Category | More than one race | Category | More than one race | Category | More than one race | Category | More than one race | Category | Unknown or Not Reported | Category | Unknown or Not Reported | Category | Unknown or Not Reported | Category | Unknown or Not Reported | Category | Unknown or Not Reported | Category | Unknown or Not Reported | ||||||||||||
Title | Age, Continuous | Title | Age, Continuous | Title | Age, Continuous | Title | Age, Continuous | Title | Age, Continuous | Title | Age, Continuous | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) |
Units | years | Units | years | Units | years | Units | years | Units | years | Units | years | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants |
Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants |
Param Value | 31.1 | Param Value | 39.8 | Param Value | 33.5 | Param Value | 41.7 | Param Value | 31.8 | Param Value | 35.3 | Param Value | 5 | Param Value | 3 | Param Value | 1 | Param Value | 2 | Param Value | 2 | Param Value | 13 | Param Value | 3 | Param Value | 3 | Param Value | 5 | Param Value | 4 | Param Value | 4 | Param Value | 19 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 5 | Param Value | 1 | Param Value | 3 | Param Value | 0 | Param Value | 3 | Param Value | 12 | Param Value | 2 | Param Value | 5 | Param Value | 3 | Param Value | 6 | Param Value | 3 | Param Value | 19 | Param Value | 1 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 1 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 |
Param Value Num | 31.1 | Param Value Num | 39.8 | Param Value Num | 33.5 | Param Value Num | 41.7 | Param Value Num | 31.8 | Param Value Num | 35.3 | Param Value Num | 5.0 | Param Value Num | 3.0 | Param Value Num | 1.0 | Param Value Num | 2.0 | Param Value Num | 2.0 | Param Value Num | 13.0 | Param Value Num | 3.0 | Param Value Num | 3.0 | Param Value Num | 5.0 | Param Value Num | 4.0 | Param Value Num | 4.0 | Param Value Num | 19.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 5.0 | Param Value Num | 1.0 | Param Value Num | 3.0 | Param Value Num | 0.0 | Param Value Num | 3.0 | Param Value Num | 12.0 | Param Value Num | 2.0 | Param Value Num | 5.0 | Param Value Num | 3.0 | Param Value Num | 6.0 | Param Value Num | 3.0 | Param Value Num | 19.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 |
Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dispersion Value | 6.88 | Dispersion Value | 10.76 | Dispersion Value | 8.76 | Dispersion Value | 12.04 | Dispersion Value | 8.98 | Dispersion Value | 9.87 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dispersion Value Num | 6.88 | Dispersion Value Num | 10.76 | Dispersion Value Num | 8.76 | Dispersion Value Num | 12.04 | Dispersion Value Num | 8.98 | Dispersion Value Num | 9.87 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Number Analyzed | 8 | Number Analyzed | 6 | Number Analyzed | 6 | Number Analyzed | 6 | Number Analyzed | 6 | Number Analyzed | 32 | Number Analyzed | 8 | Number Analyzed | 6 | Number Analyzed | 6 | Number Analyzed | 6 | Number Analyzed | 6 | Number Analyzed | 32 | Number Analyzed | 8 | Number Analyzed | 6 | Number Analyzed | 6 | Number Analyzed | 6 | Number Analyzed | 6 | Number Analyzed | 32 | Number Analyzed | 8 | Number Analyzed | 6 | Number Analyzed | 6 | Number Analyzed | 6 | Number Analyzed | 6 | Number Analyzed | 32 | Number Analyzed | 8 | Number Analyzed | 6 | Number Analyzed | 6 | Number Analyzed | 6 | Number Analyzed | 6 | Number Analyzed | 32 | Number Analyzed | 8 | Number Analyzed | 6 | Number Analyzed | 6 | Number Analyzed | 6 | Number Analyzed | 6 | Number Analyzed | 32 | Number Analyzed | 8 | Number Analyzed | 6 | Number Analyzed | 6 | Number Analyzed | 6 | Number Analyzed | 6 | Number Analyzed | 32 | Number Analyzed | 8 | Number Analyzed | 6 | Number Analyzed | 6 | Number Analyzed | 6 | Number Analyzed | 6 | Number Analyzed | 32 | Number Analyzed | 8 | Number Analyzed | 6 | Number Analyzed | 6 | Number Analyzed | 6 | Number Analyzed | 6 | Number Analyzed | 32 | Number Analyzed | 8 | Number Analyzed | 6 | Number Analyzed | 6 | Number Analyzed | 6 | Number Analyzed | 6 | Number Analyzed | 32 |
]]>
https://zephyrnet.com/NCT03800160
2018-04-01
https://zephyrnet.com/?p=NCT03800160
NCT03800160https://www.clinicaltrials.gov/study/NCT03800160?tab=tableNANANAMetabolic surgery, as a recognition treatment option for patients with clinical morbid obesity, is gaining increasing appreciation. In addition to substantial weight loss, emerging studies have highlighted that metabolic surgery can substantially ameliorate obesity-related metabolic diseases, including but not limited to type 2 diabetes mellitus (T2DM), hypertension, dyslipidemia, obstructive sleep apnea-hypopnea syndrome (OSAHS) and polycystic ovary syndrome (PCOS)in severely obese patients. However, further investigations with larger sample size and longer observation time still needed to clarity the efficacy and safety of metabolic surgery in Chinese patients with obesity and encouraging future research in this field.
<![CDATA[
Studies
Study First Submitted Date | 2018-05-14 |
Study First Posted Date | 2019-01-11 |
Last Update Posted Date | 2020-05-05 |
Start Month Year | April 1, 2018 |
Primary Completion Month Year | April 1, 2028 |
Verification Month Year | May 2020 |
Verification Date | 2020-05-31 |
Last Update Posted Date | 2020-05-05 |
Facilities
Sequence: | 200389533 |
Name | Beijing Friendship Hospital |
City | Beijing |
State | Beijing |
Zip | 100050 |
Country | China |
Conditions
Sequence: | 52256601 |
Name | Metabolic Surgery |
Downcase Name | metabolic surgery |
Id Information
Sequence: | 40220832 |
Id Source | org_study_id |
Id Value | GC-MBD |
Countries
Sequence: | 42636416 |
Name | China |
Removed | False |
Keywords
Sequence: | 79989912 | Sequence: | 79989913 | Sequence: | 79989914 |
Name | metabolic surgery | Name | metabolic disease | Name | multicenter |
Downcase Name | metabolic surgery | Downcase Name | metabolic disease | Downcase Name | multicenter |
Design Outcomes
Sequence: | 177692279 | Sequence: | 177692278 | Sequence: | 177692280 | Sequence: | 177692281 | Sequence: | 177692282 | Sequence: | 177692283 | Sequence: | 177692284 | Sequence: | 177692285 | Sequence: | 177692286 |
Outcome Type | secondary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | the adverse events rate of different metabolic surgeries | Measure | the excess weight loss effect of different metabolic surgeries after 1year | Measure | the excess weight loss effect of metabolic surgery with long-time follow-ups | Measure | the excess weight loss effect of metabolic surgery with long-time follow-ups | Measure | the excess weight loss effect of metabolic surgery with long-time follow-ups | Measure | the glycemic control level of metabolic surgery with long-time follow-ups | Measure | the glycemic control level of metabolic surgery with long-time follow-ups | Measure | the glycemic control level of metabolic surgery with long-time follow-ups | Measure | the glycemic control level of metabolic surgery with long-time follow-ups |
Time Frame | 30 days after surgery | Time Frame | 1 year after surgery | Time Frame | 3 years | Time Frame | 5 years | Time Frame | 10 years | Time Frame | 1 year after surgery | Time Frame | 3 year after surgery | Time Frame | 5 year after surgery | Time Frame | 10 year after surgery |
Description | show the surgical safety by 30 days follow-up according to guideline(such as: bleeding, leak, obstruction, re-operation for complication) | Description | Percent excess weight loss (%EWL), %EWL=[(initial weight)-(post-op weight)]/[(initial weight)-(ideal weight)] (in which "ideal weight" is defined by the weight corresponding to a BMI of 25 kg/m2) | Description | Percent excess weight loss (%EWL), %EWL=[(initial weight)-(post-op weight)]/[(initial weight)-(ideal weight)] (in which "ideal weight" is defined by the weight corresponding to a BMI of 25 kg/m2) | Description | Percent excess weight loss (%EWL), %EWL=[(initial weight)-(post-op weight)]/[(initial weight)-(ideal weight)] (in which "ideal weight" is defined by the weight corresponding to a BMI of 25 kg/m2) | Description | Percent excess weight loss (%EWL), %EWL=[(initial weight)-(post-op weight)]/[(initial weight)-(ideal weight)] (in which "ideal weight" is defined by the weight corresponding to a BMI of 25 kg/m2) | Description | the change of HbA1c, glucose level, C-peptide and insulin levels | Description | the change of HbA1c, glucose level, C-peptide and insulin levels | Description | the change of HbA1c, glucose level, C-peptide and insulin levels | Description | the change of HbA1c, glucose level, C-peptide and insulin levels |
Sponsors
Sequence: | 48399141 | Sequence: | 48399142 | Sequence: | 48399143 | Sequence: | 48399144 | Sequence: | 48399145 | Sequence: | 48399146 | Sequence: | 48399147 | Sequence: | 48399148 | Sequence: | 48399149 | Sequence: | 48399150 | Sequence: | 48399151 | Sequence: | 48399152 | Sequence: | 48399153 | Sequence: | 48399154 | Sequence: | 48399155 | Sequence: | 48399156 |
Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER_GOV | Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER | Agency Class | UNKNOWN | Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator |
Name | Beijing Friendship Hospital | Name | Beijing Tiantan Hospital | Name | Beijing Shijitan Hospital, Capital Medical University | Name | Beijing Hospital | Name | Peking Union Medical College Hospital | Name | Shanxi Dayi Hospital | Name | The Second Hospital of Hebei Medical University | Name | Tianjin Medical University General Hospital | Name | Inner Mongolia People's Hospital | Name | Henan Provincial People's Hospital | Name | Qilu Hospital of Shandong University | Name | The First Hospital of Hebei Medical University | Name | The Second People's Hospital of Xinxiang Henan | Name | Tangshan Gongren Hospital | Name | Tianjin Nankai Hospital | Name | Tianjin First Central Hospital |
Eligibilities
Sequence: | 30815016 |
Sampling Method | Non-Probability Sample |
Gender | All |
Minimum Age | N/A |
Maximum Age | N/A |
Healthy Volunteers | No |
Population | patients with morbid obesity who are suitable and willing to accept metabolic surgical procedure and also agree with the registry |
Criteria | Inclusion Criteria:
be able to receive metabolic surgery, including but not limit to LSG and LRYGB Exclusion Criteria: can not be able to understand and willing to participate in this registry with signature |
Adult | True |
Child | True |
Older Adult | True |
Calculated Values
Sequence: | 254076071 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 8 |
Designs
Sequence: | 30560979 |
Observational Model | Case-Only |
Time Perspective | Prospective |
Responsible Parties
Sequence: | 28927383 |
Responsible Party Type | Principal Investigator |
Name | Zhongtao Zhang |
Title | Director of general surgery, principal investigator |
Affiliation | Beijing Friendship Hospital |
]]>
https://zephyrnet.com/NCT03800147
2019-01-24
https://zephyrnet.com/?p=NCT03800147
NCT03800147https://www.clinicaltrials.gov/study/NCT03800147?tab=tableWolf-Dietrich Hardt, Prof. Dr.hardt@micro.biol.ethz.ch+41 44 632 51 43Recent experiments in the lab of Prof. WD Hardt revealed, that in mice, 24 h exposure to a high-fat diet results in a breakdown of colonization resistance against Salmonella typhimurium. Mechanistic experiments identified bile acids as the mediator for reduced colonization resistance. Exposure to a high fat diet leads to increased bile acid secretion which in turn modify the intestinal microbiota.
It is now the aim to verify the results of this study in human healthy volunteers. The nutritional habits of all participants will carefully be evaluated. In the intervention phase, participants will be exposed to either high-fat or low-fat diet and a controlled dose of the non-pathogenic bacteria E. coli Nissle. E. coli Nissle is the active compound for “Mutaflor®” and other probiotics.
It is planned to enumerate E. coli Nissle counts in the stool after Mutaflor ingestion and to quantify other changes of the human microbiota. The hypothesis is that a high-fat diet leads to increased bile acid secretion results in favorable growth conditions for E. coli Nissle, resulting in high bacterial counts in the stool.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-13 |
Study First Posted Date | 2019-01-11 |
Last Update Posted Date | 2019-01-11 |
Start Month Year | January 24, 2019 |
Primary Completion Month Year | September 24, 2019 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-11 |
Detailed Descriptions
Sequence: | 20852442 |
Description | Infectious diarrhea causes substantial morbidity in Western countries and the developing world and leads to the use of considerable health resources. Antibiotic resistance continues to increase, potentially leading to a decrease in therapeutic options in the future. Important pathogens include Salmonella typhimurium (S. typhimurium) and pathogenic Escherichia coli (E. coli) which are genetically closely related.
The human intestine has considerable colonization resistance against bacterial pathogens. This resistance is largely mediated by the gut microbiota. Therefore, previous exposure to antibiotics or immunosuppression leading to a breakdown of the intestinal defense systems increase the risk for subsequent infection with S. typhimurium. The composition of the human microbiome undergoes dramatic changes upon exposure to various factors including nutrition, physical activity, drugs and much more. Most studies focused on long-term exposure to various factors; however, since bacterial growth is rapid (doubling time of S. typhimurium under optimal conditions = 20min), even short-term variations in the environment could dramatically influence the human microbiota. In the lab of Prof. WD Hardt, a mouse model of S. typhimurium enterocolitis has been established. Since most mouse strains are resistant against colonization with S. typhimurium, pretreatment with antibiotics is a requirement for induction of S. typhimurium enterolitis. However, recent experiments in the Hardt lab revealed, that in mice, 24 h exposure to a high-fat diet also results in a breakdown of colonization resistance, leading to Salmonella enterocolitis upon S. typhimurium infection. The same is true for E. coli strains. Subsequent experiments demonstrated that exposure to fatty acids is sufficient to overcome colonization resistance. Mechanistic experiments identified fat-elicited bile-release as the underlying mechanism: Exposure to a high fat diet leads to increased bile acid secretion; S. typhimurium can tolerate 10-fold higher bile acid concentrations than commensal bacterial, leading to a growth advantage of S. typhimurium compared to competing bacteria (WD Hardt et al., unpublished data). The aim of this study is to verify the results of this study in human healthy volunteers. The nutritional habits of all participants will be carefully evaluated. In the intervention phase, participants will be exposed to either high-fat or low-fat diet and a controlled dose of the non-pathogenic bacteria E. coli Nissle. E. coli Nissle is the active compound for "Mutaflor®" and other probiotics. E. coli Nissle has therapeutic effects for the treatment of chronic inflammatory intestinal diseases. In contrast to other non-pathogenic E. coli strains, it exhibits a specific pattern of fitness factors but lacks prominent virulence factors. In vivo and in vitro experiments demonstrated both, protective effects against infection with intestinal pathogens as well as potent immunomodulatory properties. Growth of E. coli Nissle in the human gut resembles growth of S. typhimurium. Both bacteriae also share metabolic requirements for intestinal growth. Therefore, growth E. coli Nissle in the human intestine can be used as a marker for growth of E. coli strains, Salmonella typhimurium and related pathogens. It is planned to enumerate E. coli Nissle counts in the stool after Mutaflor ingestion and to quantify other changes of the human microbiota. The hypothesize is that a high-fat diet, leading to increased bile acid secretion results in favorable growth conditions for E. coli Nissle, resulting in high bacterial counts in the stool. The results of the study will help improving the understanding of the consequences of nutritional composition on the vulnerability of the human organism to bacterial infections. Such an improved understanding might enable designing preventive measures for the growth of unwanted E. coli strains (e.g. ESBL, pathogenic) or S. typhimurium infection and/ or a severe disease course and might ultimately help limiting antibiotic use and the evolution of antibiotic resistant pathogens. |
Facilities
Sequence: | 201290098 |
Name | Institute of Microbiology (D-BIOL), ETH Zurich |
City | Zürich |
Zip | 8093 |
Country | Switzerland |
Facility Contacts
Sequence: | 28281942 |
Facility Id | 201290098 |
Contact Type | primary |
Name | Wolf-Dietrich Hardt, Prof. Dr. |
hardt@micro.biol.ethz.ch | |
Phone | +41446325143 |
Phone Extension | +41446325143 |
Conditions
Sequence: | 52507863 |
Name | Escherichia Coli Infections |
Downcase Name | escherichia coli infections |
Id Information
Sequence: | 40399423 |
Id Source | org_study_id |
Id Value | FAT Study |
Countries
Sequence: | 42835750 |
Name | Switzerland |
Removed | False |
Design Groups
Sequence: | 55964347 | Sequence: | 55964348 |
Group Type | Active Comparator | Group Type | Active Comparator |
Title | High-fat diet | Title | Low-fat diet |
Description | Participants will follow a high-fat diet. During the intervention phase, they will inoculate "Mutaflor Suspension" (E. coli Nissle 1917) (Single dose, 5 ml = 5×10^8 CFU).
Blood samples, stool samples and clinical information will be collected during the study. |
Description | Participants will follow a low-fat diet. During the intervention phase, they will inoculate "Mutaflor Suspension" (E. coli Nissle 1917) (Single dose, 5 ml = 5×10^8 CFU).
Blood samples, stool samples and clinical information will be collected during the study. |
Interventions
Sequence: | 52815808 | Sequence: | 52815809 | Sequence: | 52815810 | Sequence: | 52815811 |
Intervention Type | Drug | Intervention Type | Other | Intervention Type | Other | Intervention Type | Other |
Name | "Mutaflor Suspension" (E. coli Nissle 1917) | Name | Blood samples | Name | Stool samples | Name | Clinical information |
Description | Inoculation of "Mutaflor Suspension" (E. coli Nissle 1917) | Description | Blood samples will be collected and analyzed at different study time points | Description | Stool samples will be collected and analyzed at different study time points | Description | Clinical information will be collected at different study time points using questionnaires |
Design Outcomes
Sequence: | 178632250 | Sequence: | 178632251 | Sequence: | 178632252 | Sequence: | 178632253 | Sequence: | 178632254 | Sequence: | 178632255 | Sequence: | 178632256 | Sequence: | 178632257 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Maximum concentration of E. coli Nissle bacteriae in all stool samples of each participant | Measure | Comparison of E. coli Nissle concentration in feces between high-fat diet and low-fat diet | Measure | Chemical composition of blood | Measure | Chemical composition of stool | Measure | Microbiota composition: taxonomic composition | Measure | Microbiota composition: metagenomic properties | Measure | Microbiota composition: E. coli content | Measure | Antibody response against E. coli Nissle |
Time Frame | 1, 2 and 5 days after E. coli Nissle inoculation | Time Frame | 1, 2 and 5 days after E. coli Nissle inoculation | Time Frame | Week 1 – 8 | Time Frame | Week 1 – 8 | Time Frame | Week 1 – 8 | Time Frame | Week 1 – 8 | Time Frame | Week 1 – 8 | Time Frame | 3 weeks after inoculation of E. coli Nissle |
Description | Each participant's fecal samples will be analyzed for E. coli Nissle bacteriae. Only the stool samples acquired in intervention phase 1 will be considered. For each participant, the maximum concentration of E. coli Nissle in all stool samples (assessed by qPCR) will be used for the calculation of the primary outcome. | Description | The concentration of E. coli Nissle bacteriae (CFU per g feces) in participants exposed to high-fat diet will be compared to the concentration of E. coli Nissle bacteriae in individuals exposed to low-fat diet (Mann-Whitney U test, a p-value <0.05 will be considered significant). | Description | For each participant's blood samples the chemical composition including bile acids, lipids, cholesterol and other compounds related to fat, cholesterol and bile acid metabolism will be determined (concentration, per μl blood). Samples at baseline, during intervention phase and the washout phase will be analyzed. For each compound the group exposed to low-fat diet and high-fat diet will be compared, respectively (intervention phase) or the group with the lowest and highest fat ingestion according to the nutritional protocol. | Description | For each participant's stool samples the chemical composition including bile acids, lipids, cholesterol and other compounds related to fat, cholesterol and bile acid metabolism will be determined (concentration, per g stool). Samples at baseline, during intervention phase and the washout phase will be analyzed. For each compound the group exposed to low-fat diet and high-fat diet will be compared, respectively (intervention phase) or the group with the lowest and highest fat ingestion according to the nutritional protocol. | Description | Same as 4, only the microbiota taxonomic composition in stool samples will be analyzed by ribosomal RNA gene sequencing. Analysis will also include tests for microbiota diversity (i.e. number of bacteria species identified). Findings will be compared to changes occurring in the microbiota of participants in the other study group. | Description | Same as 4, only the metagenomic properties of the microbiota in stool samples will be analyzed by whole genome shotgun sequencing. Analyses will also test for metabolic pathways used by the microbiota. Microbiological and molecular biology methods will also be used to characterize bacteria strains associated with high-fat diet, low-fat diet and/ or changes in bile acid concentration. | Description | Same as 4, only the E. coli content of stool samples will be analyzed by sequencing and conventional plating techniques. This will quantify E. coli Nissle and also all endogenous E. coli strains present in the sample. | Description | Antibody titers against E. coli Nissle will be determined by bacterial FACS or other appropriate techniques. Antibody titers at baseline, at 2 weeks and at 3 weeks will be determined. Individuals exposed to low-fat diet and high-fat diet will be compared. Measured variable: Antibody titers against E. coli Nissle and various E. coli strains. |
Browse Conditions
Sequence: | 194770852 | Sequence: | 194770853 | Sequence: | 194770854 | Sequence: | 194770855 | Sequence: | 194770856 | Sequence: | 194770857 |
Mesh Term | Escherichia coli Infections | Mesh Term | Enterobacteriaceae Infections | Mesh Term | Gram-Negative Bacterial Infections | Mesh Term | Bacterial Infections | Mesh Term | Bacterial Infections and Mycoses | Mesh Term | Infections |
Downcase Mesh Term | escherichia coli infections | Downcase Mesh Term | enterobacteriaceae infections | Downcase Mesh Term | gram-negative bacterial infections | Downcase Mesh Term | bacterial infections | Downcase Mesh Term | bacterial infections and mycoses | Downcase Mesh Term | infections |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48630816 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | University of Zurich |
Overall Officials
Sequence: | 29461030 |
Role | Principal Investigator |
Name | Wolf-Dietrich Hardt, Prof. Dr. |
Affiliation | ETH Zurich, Institute of Microbiology |
Central Contacts
Sequence: | 12095168 | Sequence: | 12095169 |
Contact Type | primary | Contact Type | backup |
Name | Benjamin Misselwitz, MD | Name | Wolf-Dietrich Hardt, Prof. Dr. |
Phone | +41 44 255 1111 | Phone | +41 44 632 51 43 |
benjamin.misselwitz@usz.ch | hardt@micro.biol.ethz.ch | ||
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 68607722 | Sequence: | 68607723 | Sequence: | 68607724 | Sequence: | 68607725 | Sequence: | 68607726 | Sequence: | 68607727 | Sequence: | 68607728 | Sequence: | 68607729 |
Design Group Id | 55964347 | Design Group Id | 55964348 | Design Group Id | 55964347 | Design Group Id | 55964348 | Design Group Id | 55964347 | Design Group Id | 55964348 | Design Group Id | 55964347 | Design Group Id | 55964348 |
Intervention Id | 52815808 | Intervention Id | 52815808 | Intervention Id | 52815809 | Intervention Id | 52815809 | Intervention Id | 52815810 | Intervention Id | 52815810 | Intervention Id | 52815811 | Intervention Id | 52815811 |
Eligibilities
Sequence: | 30957212 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 85 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
Individuals free of abdominal complaints or symptoms Exclusion Criteria: Previous history of gastrointestinal disease or surgery (excludes appendectomy, hernia repair and surgery for anorectal disorders) |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253937720 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 85 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 2 |
Number Of Secondary Outcomes To Measure | 6 |
Designs
Sequence: | 30702788 |
Allocation | Randomized |
Intervention Model | Crossover Assignment |
Observational Model | |
Primary Purpose | Basic Science |
Time Perspective | |
Masking | Single |
Masking Description | Participants will not be blinded regarding the composition of their nutrition. Investigators performing stool and blood analyses will be blinded to the group assignment of the participants. |
Intervention Model Description | randomized controlled crossover clinical study |
Investigator Masked | True |
Intervention Other Names
Sequence: | 26841617 |
Intervention Id | 52815808 |
Name | Mutaflor Suspension |
Responsible Parties
Sequence: | 29069550 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03800134
2018-12-06
https://zephyrnet.com/?p=NCT03800134
NCT03800134https://www.clinicaltrials.gov/study/NCT03800134?tab=tableNANANAThis is a Phase III, randomized, double-blind, placebo-controlled, multi-center international study assessing the activity of durvalumab and chemotherapy administered prior to surgery compared with placebo and chemotherapy administered prior to surgery in terms of pathological complete response.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-07 |
Study First Posted Date | 2019-01-11 |
Last Update Posted Date | 2023-07-19 |
Start Month Year | December 6, 2018 |
Primary Completion Month Year | April 30, 2024 |
Verification Month Year | July 2023 |
Verification Date | 2023-07-31 |
Last Update Posted Date | 2023-07-19 |
Facilities
Sequence: | 199022230 | Sequence: | 199022231 | Sequence: | 199022232 | Sequence: | 199022233 | Sequence: | 199022234 | Sequence: | 199022235 | Sequence: | 199022236 | Sequence: | 199022237 | Sequence: | 199022238 | Sequence: | 199022239 | Sequence: | 199022240 | Sequence: | 199022241 | Sequence: | 199022242 | Sequence: | 199022243 | Sequence: | 199022244 | Sequence: | 199022245 | Sequence: | 199022246 | Sequence: | 199022247 | Sequence: | 199022248 | Sequence: | 199022249 | Sequence: | 199022250 | Sequence: | 199022251 | Sequence: | 199022252 | Sequence: | 199022253 | Sequence: | 199022254 | Sequence: | 199022255 | Sequence: | 199022256 | Sequence: | 199022257 | Sequence: | 199022258 | Sequence: | 199022259 | Sequence: | 199022260 | Sequence: | 199022261 | Sequence: | 199022262 | Sequence: | 199022263 | Sequence: | 199022264 | Sequence: | 199022265 | Sequence: | 199022266 | Sequence: | 199022267 | Sequence: | 199022268 | Sequence: | 199022269 | Sequence: | 199022270 | Sequence: | 199022271 | Sequence: | 199022272 | Sequence: | 199022273 | Sequence: | 199022274 | Sequence: | 199022275 | Sequence: | 199022276 | Sequence: | 199022277 | Sequence: | 199022278 | Sequence: | 199022279 | Sequence: | 199022280 | Sequence: | 199022281 | Sequence: | 199022282 | Sequence: | 199022283 | Sequence: | 199022284 | Sequence: | 199022285 | Sequence: | 199022286 | Sequence: | 199022287 | Sequence: | 199022288 | Sequence: | 199022289 | Sequence: | 199022290 | Sequence: | 199022291 | Sequence: | 199022292 | Sequence: | 199022293 | Sequence: | 199022294 | Sequence: | 199022295 | Sequence: | 199022296 | Sequence: | 199022297 | Sequence: | 199022298 | Sequence: | 199022299 | Sequence: | 199022300 | Sequence: | 199022301 | Sequence: | 199022302 | Sequence: | 199022303 | Sequence: | 199022304 | Sequence: | 199022305 | Sequence: | 199022306 | Sequence: | 199022307 | Sequence: | 199022308 | Sequence: | 199022309 | Sequence: | 199022310 | Sequence: | 199022311 | Sequence: | 199022312 | Sequence: | 199022313 | Sequence: | 199022314 | Sequence: | 199022315 | Sequence: | 199022316 | Sequence: | 199022317 | Sequence: | 199022318 | Sequence: | 199022319 | Sequence: | 199022320 | Sequence: | 199022321 | Sequence: | 199022322 | Sequence: | 199022323 | Sequence: | 199022324 | Sequence: | 199022325 | Sequence: | 199022326 | Sequence: | 199022327 | Sequence: | 199022328 | Sequence: | 199022329 | Sequence: | 199022330 | Sequence: | 199022331 | Sequence: | 199022332 | Sequence: | 199022333 | Sequence: | 199022334 | Sequence: | 199022335 | Sequence: | 199022336 | Sequence: | 199022337 | Sequence: | 199022338 | Sequence: | 199022339 | Sequence: | 199022340 | Sequence: | 199022341 | Sequence: | 199022342 | Sequence: | 199022343 | Sequence: | 199022344 | Sequence: | 199022345 | Sequence: | 199022346 | Sequence: | 199022347 | Sequence: | 199022348 | Sequence: | 199022349 | Sequence: | 199022350 | Sequence: | 199022351 | Sequence: | 199022352 | Sequence: | 199022353 | Sequence: | 199022354 | Sequence: | 199022355 | Sequence: | 199022356 | Sequence: | 199022357 | Sequence: | 199022358 | Sequence: | 199022359 | Sequence: | 199022360 | Sequence: | 199022361 | Sequence: | 199022362 | Sequence: | 199022363 | Sequence: | 199022364 | Sequence: | 199022365 | Sequence: | 199022366 | Sequence: | 199022367 | Sequence: | 199022368 | Sequence: | 199022414 | Sequence: | 199022369 | Sequence: | 199022370 | Sequence: | 199022371 | Sequence: | 199022372 | Sequence: | 199022373 | Sequence: | 199022374 | Sequence: | 199022375 | Sequence: | 199022376 | Sequence: | 199022377 | Sequence: | 199022378 | Sequence: | 199022379 | Sequence: | 199022380 | Sequence: | 199022381 | Sequence: | 199022382 | Sequence: | 199022383 | Sequence: | 199022384 | Sequence: | 199022385 | Sequence: | 199022386 | Sequence: | 199022387 | Sequence: | 199022388 | Sequence: | 199022389 | Sequence: | 199022390 | Sequence: | 199022391 | Sequence: | 199022392 | Sequence: | 199022393 | Sequence: | 199022394 | Sequence: | 199022395 | Sequence: | 199022396 | Sequence: | 199022397 | Sequence: | 199022398 | Sequence: | 199022399 | Sequence: | 199022400 | Sequence: | 199022401 | Sequence: | 199022402 | Sequence: | 199022403 | Sequence: | 199022404 | Sequence: | 199022405 | Sequence: | 199022406 | Sequence: | 199022407 | Sequence: | 199022408 | Sequence: | 199022409 | Sequence: | 199022410 | Sequence: | 199022411 | Sequence: | 199022412 | Sequence: | 199022413 | Sequence: | 199022415 | Sequence: | 199022416 | Sequence: | 199022417 | Sequence: | 199022418 | Sequence: | 199022419 | Sequence: | 199022420 | Sequence: | 199022421 | Sequence: | 199022422 | Sequence: | 199022423 | Sequence: | 199022424 | Sequence: | 199022425 | Sequence: | 199022426 | Sequence: | 199022427 | Sequence: | 199022428 | Sequence: | 199022429 | Sequence: | 199022430 | Sequence: | 199022431 | Sequence: | 199022432 | Sequence: | 199022433 | Sequence: | 199022434 | Sequence: | 199022435 | Sequence: | 199022436 | Sequence: | 199022437 | Sequence: | 199022438 | Sequence: | 199022439 | Sequence: | 199022440 | Sequence: | 199022441 | Sequence: | 199022442 | Sequence: | 199022443 | Sequence: | 199022444 | Sequence: | 199022445 | Sequence: | 199022446 | Sequence: | 199022447 | Sequence: | 199022448 | Sequence: | 199022449 | Sequence: | 199022450 | Sequence: | 199022451 | Sequence: | 199022452 | Sequence: | 199022453 | Sequence: | 199022454 | Sequence: | 199022455 | Sequence: | 199022456 | Sequence: | 199022457 | Sequence: | 199022458 | Sequence: | 199022459 | Sequence: | 199022460 |
Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | 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City | Phoenix | City | Duarte | City | Orange | City | Aurora | City | Boca Raton | City | Jacksonville | City | Chicago | City | Wichita | City | Ashland | City | Lexington | City | Silver Spring | City | Towson | City | Duluth | City | Minneapolis | City | Morristown | City | New York | City | New York | City | Port Jefferson Station | City | Durham | City | Bend | City | Medford | City | Pittsburgh | City | Charleston | City | Charleston | City | Austin | City | Fort Worth | City | Houston | City | Houston | City | Fairfax | City | Kirkland | City | Seattle | City | Buenos Aires | City | Caba | City | Caba | City | La Plata | City | Pergamino | City | Rosario | City | San Salvador de Jujuy | City | Viedma | City | Graz | City | Innsbruck | City | Rankweil | City | Wien | City | Wien | City | Gent | City | Liège | City | Mons | City | Barretos | City | Belo Horizonte | City | Campinas | City | Curitiba | City | Florianópolis | City | Natal | City | Porto Alegre | City | Santa Maria | City | Sao Paulo | City | Sao Paulo | City | São José do Rio Preto | City | Teresina | City | Vitoria | City | Plovdiv | City | Sofia | City | Sofia | City | Sofia | City | Edmonton | City | Kitchener | City | Levis | City | Montreal | City | Montreal | City | Saskatoon | City | Quebec | City | Santiago | City | Santiago | City | Temuco | City | Viña del Mar | City | Beijing | City | Beijing | City | Beijing | City | Beijing | City | Changsha | City | Changsha | City | Changzhou | City | Chengdu | City | Guangzhou | City | Guangzhou | City | Guiyang | City | Hangzhou | City | Hangzhou | City | Hangzhou | City | Hangzhou | City | Hefei | City | Kunming | City | Linhai | City | Nanchang | City | Ningbo | City | Shanghai | City | Shanghai | City | Shenyang | City | Shenyang | City | Shenzhen | City | Shenzhen | City | Tianjin | City | Urumqi | City | Wuhan | City | Wuhan | City | Xiamen | City | Xintai | City | Yangzhou | City | Zhengzhou | City | San José | City | San José | City | Avignon Cedex | City | Lyon Cedex 08 | City | Nice | City | Toulon Cedex 9 | City | Vantoux | City | Bielefeld | City | Frankfurt am Main | City | Immenstadt | City | Köln | City | Budapest | City | Gyöngyös – Mátraháza | City | Győr | City | Székesfehérvár | City | Törökbálint | City | Ahmedabad | City | Gurgaon | City | Gurgaon | City | Kolkata | City | Manipal | City | Mumbai | City | Mumbai | City | Mysuru | City | Namakkal | City | Nashik | City | New Delhi | City | New Delhi | City | Thane | City | Vishakhapatnam | City | Davao City | City | Ancona | City | Bari | City | Bergamo | City | Firenze | City | Milano | City | Monza | City | Padova | City | Roma | City | Verona | City | Habikino-shi | City | Himeji-shi | City | Hiroshima-shi | City | Hiroshima-shi | City | Iwakuni-shi | City | Kitaadachi-gun | City | Kitakyushu-shi | City | Kurashiki shi | City | Nagoya-shi | City | Niigata-shi | City | Okayama-shi | City | Osakasayama-shi | City | Toyoake-shi | City | Wakayama-shi | City | Busan | City | Cheongju-si | City | Seongnam-si | City | Seoul | City | Seoul | City | Suwon-si | City | Suwon | City | Aguascalientes | City | Chihuahua | City | Guadalajara | City | Monterrey | City | Monterrey | City | México | City | México | City | Pachuca de Soto | City | Arnhem | City | Nijmegen | City | Bellavista | City | Lima | City | Lima | City | Lima | City | Lima | City | Iloilo City | City | Makati | City | Quezon City | City | Białystok | City | Olsztyn | City | Warszawa | City | Warszawa | City | Suceava | City | Kazan | City | Krasnoyarsk | City | Moscow | City | Moscow | City | Moscow | City | Moscow | City | Nizhniy Novgorod | City | Obninsk | City | Rostov-on-Don | City | St. Petersburg | City | Tomsk | City | Yaroslavl | City | Alicante | City | Barcelona | City | Madrid | City | Málaga | City | Oviedo | City | Pamplona | City | San Sebastian | City | Santiago De Compostela (A Coruña) | City | Changhua | City | Taichung City | City | Taichung | City | Tainan City | City | Tainan City | City | Taipei City | City | Taipei | City | Taipei | City | Bangkok | City | Bangkok | City | Chiang Mai | City | Chiang Rai | City | Khon Kaen | City | Lampang | City | Hanoi | City | Ho Chi Minh | City | Ho Chi Minh | City | Ho Chi Minh |
State | Arizona | State | California | State | California | State | Colorado | State | Florida | State | Florida | State | Illinois | State | Kansas | State | Kentucky | State | Kentucky | State | Maryland | State | Maryland | State | Minnesota | State | Minnesota | State | New Jersey | State | New York | State | New York | State | New York | State | North Carolina | State | Oregon | State | Oregon | State | Pennsylvania | State | South Carolina | State | South Carolina | State | Texas | State | Texas | State | Texas | State | Texas | State | Virginia | State | Washington | State | Washington | State | Alberta | State | Ontario | State | Quebec | State | Quebec | State | Quebec | State | Saskatchewan | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | Argentina | Country | Argentina | Country | Argentina | Country | Argentina | Country | Argentina | Country | Argentina | Country | Argentina | Country | Argentina | Country | Austria | Country | Austria | Country | Austria | Country | Austria | Country | Austria | Country | Belgium | Country | Belgium | Country | Belgium | Country | Brazil | Country | Brazil | Country | Brazil | Country | Brazil | Country | Brazil | Country | Brazil | Country | Brazil | Country | Brazil | Country | Brazil | Country | Brazil | Country | Brazil | Country | Brazil | Country | Brazil | Country | Bulgaria | Country | Bulgaria | Country | Bulgaria | Country | Bulgaria | Country | Canada | Country | Canada | Country | Canada | Country | Canada | Country | Canada | Country | Canada | Country | Canada | Country | Chile | Country | Chile | Country | Chile | Country | Chile | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | Costa Rica | Country | Costa Rica | Country | France | Country | France | Country | France | Country | France | Country | France | Country | Germany | Country | Germany | Country | Germany | Country | Germany | Country | Hungary | Country | Hungary | Country | Hungary | Country | Hungary | Country | Hungary | Country | India | Country | India | Country | India | Country | India | Country | India | Country | India | Country | India | Country | India | Country | India | Country | India | Country | India | Country | India | Country | India | Country | India | Country | Philippines | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Japan | Country | Japan | Country | Japan | Country | Japan | Country | Japan | Country | Japan | Country | Japan | Country | Japan | Country | Japan | Country | Japan | Country | Japan | Country | Japan | Country | Japan | Country | Japan | Country | Korea, Republic of | Country | Korea, Republic of | Country | Korea, Republic of | Country | Korea, Republic of | Country | Korea, Republic of | Country | Korea, Republic of | Country | Korea, Republic of | Country | Mexico | Country | Mexico | Country | Mexico | Country | Mexico | Country | Mexico | Country | Mexico | Country | Mexico | Country | Mexico | Country | Netherlands | Country | Netherlands | Country | Peru | Country | Peru | Country | Peru | Country | Peru | Country | Peru | Country | Philippines | Country | Philippines | Country | Philippines | Country | Poland | Country | Poland | Country | Poland | Country | Poland | Country | Romania | Country | Russian Federation | Country | Russian Federation | Country | Russian Federation | Country | Russian Federation | Country | Russian Federation | Country | Russian Federation | Country | Russian Federation | Country | Russian Federation | Country | Russian Federation | Country | Russian Federation | Country | Russian Federation | Country | Russian Federation | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Taiwan | Country | Taiwan | Country | Taiwan | Country | Taiwan | Country | Taiwan | Country | Taiwan | Country | Taiwan | Country | Taiwan | Country | Thailand | Country | Thailand | Country | Thailand | Country | Thailand | Country | Thailand | Country | Thailand | Country | Vietnam | Country | Vietnam | Country | Vietnam | Country | Vietnam |
Browse Interventions
Sequence: | 95520962 | Sequence: | 95520961 | Sequence: | 95520963 | Sequence: | 95520964 | Sequence: | 95520965 | Sequence: | 95520966 | Sequence: | 95520967 | Sequence: | 95520968 | Sequence: | 95520969 | Sequence: | 95520970 | Sequence: | 95520971 | Sequence: | 95520972 | Sequence: | 95520973 | Sequence: | 95520974 | Sequence: | 95520975 | Sequence: | 95520976 | Sequence: | 95520977 | Sequence: | 95520978 |
Mesh Term | Cisplatin | Mesh Term | Paclitaxel | Mesh Term | Carboplatin | Mesh Term | Gemcitabine | Mesh Term | Pemetrexed | Mesh Term | Durvalumab | Mesh Term | Antineoplastic Agents, Phytogenic | Mesh Term | Antineoplastic Agents | Mesh Term | Tubulin Modulators | Mesh Term | Antimitotic Agents | Mesh Term | Mitosis Modulators | Mesh Term | Molecular Mechanisms of Pharmacological Action | Mesh Term | Antimetabolites, Antineoplastic | Mesh Term | Antimetabolites | Mesh Term | Enzyme Inhibitors | Mesh Term | Folic Acid Antagonists | Mesh Term | Nucleic Acid Synthesis Inhibitors | Mesh Term | Antineoplastic Agents, Immunological |
Downcase Mesh Term | cisplatin | Downcase Mesh Term | paclitaxel | Downcase Mesh Term | carboplatin | Downcase Mesh Term | gemcitabine | Downcase Mesh Term | pemetrexed | Downcase Mesh Term | durvalumab | Downcase Mesh Term | antineoplastic agents, phytogenic | Downcase Mesh Term | antineoplastic agents | Downcase Mesh Term | tubulin modulators | Downcase Mesh Term | antimitotic agents | Downcase Mesh Term | mitosis modulators | Downcase Mesh Term | molecular mechanisms of pharmacological action | Downcase Mesh Term | antimetabolites, antineoplastic | Downcase Mesh Term | antimetabolites | Downcase Mesh Term | enzyme inhibitors | Downcase Mesh Term | folic acid antagonists | Downcase Mesh Term | nucleic acid synthesis inhibitors | Downcase Mesh Term | antineoplastic agents, immunological |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 51900090 |
Name | Non-Small Cell Lung Cancer |
Downcase Name | non-small cell lung cancer |
Id Information
Sequence: | 39945662 | Sequence: | 39945663 |
Id Source | org_study_id | Id Source | secondary_id |
Id Value | D9106C00001 | Id Value | 2018-002997-29 |
Id Type | EudraCT Number | ||
Countries
Sequence: | 42338381 | Sequence: | 42338382 | Sequence: | 42338383 | Sequence: | 42338384 | Sequence: | 42338385 | Sequence: | 42338386 | Sequence: | 42338387 | Sequence: | 42338388 | Sequence: | 42338389 | Sequence: | 42338390 | Sequence: | 42338391 | Sequence: | 42338392 | Sequence: | 42338393 | Sequence: | 42338394 | Sequence: | 42338395 | Sequence: | 42338396 | Sequence: | 42338397 | Sequence: | 42338398 | Sequence: | 42338399 | Sequence: | 42338400 | Sequence: | 42338401 | Sequence: | 42338402 | Sequence: | 42338403 | Sequence: | 42338404 | Sequence: | 42338405 | Sequence: | 42338406 | Sequence: | 42338407 | Sequence: | 42338408 | Sequence: | 42338409 | Sequence: | 42338410 |
Name | United States | Name | Argentina | Name | Austria | Name | Belgium | Name | Brazil | Name | Bulgaria | Name | Canada | Name | Chile | Name | China | Name | Costa Rica | Name | France | Name | Germany | Name | Hungary | Name | India | Name | Italy | Name | Japan | Name | Korea, Republic of | Name | Mexico | Name | Netherlands | Name | Peru | Name | Philippines | Name | Poland | Name | Romania | Name | Russian Federation | Name | Spain | Name | Taiwan | Name | Thailand | Name | Vietnam | Name | Puerto Rico | Name | Ukraine |
Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | True | Removed | True |
Design Groups
Sequence: | 55310918 | Sequence: | 55310919 |
Group Type | Experimental | Group Type | Placebo Comparator |
Title | Arm 1: Durvalumab + platinum-based chemotherapy | Title | Arm 2: Placebo + platinum-based chemotherapy |
Description | Durvalumab (MEDI4736) in concurrence with platinum-based chemotherapy.
All patients will receive 1 of the following platinum-based standard of care chemotherapy options, based on tumour histology and Investigator discretion: carboplatin/paclitaxel |
Description | Placebo in concurrence with platinum-based chemotherapy.
All patients will receive 1 of the following platinum-based standard of care chemotherapy options, based on tumour histology and Investigator discretion: carboplatin/paclitaxel |
Interventions
Sequence: | 52215666 | Sequence: | 52215667 | Sequence: | 52215668 | Sequence: | 52215669 | Sequence: | 52215670 | Sequence: | 52215671 |
Intervention Type | Drug | Intervention Type | Other | Intervention Type | Drug | Intervention Type | Drug | Intervention Type | Drug | Intervention Type | Drug |
Name | Durvalumab | Name | Placebo | Name | Carboplatin/Paclitaxel | Name | Cisplatin/Gemcitabine | Name | Pemetrexed/Cisplatin | Name | Pemetrexed/Carboplatin |
Description | Durvalumab IV (intravenous infusion) | Description | Placebo IV (intravenous infusion) | Description | Carboplatin/Paclitaxel, as per standard of care | Description | Cisplatin/Gemcitabine, as per standard of care | Description | Pemetrexed/Cisplatin, as per standard of care | Description | Pemetrexed/Carboplatin, as per standard of care |
Keywords
Sequence: | 79435392 |
Name | Resectable Non-small Cell Lung Cancer, NSCLC, Carcinoma, Non-small Cell Lung Cancer |
Downcase Name | resectable non-small cell lung cancer, nsclc, carcinoma, non-small cell lung cancer |
Design Outcomes
Sequence: | 176456741 | Sequence: | 176456742 | Sequence: | 176456743 | Sequence: | 176456744 | Sequence: | 176456745 | Sequence: | 176456746 | Sequence: | 176456747 | Sequence: | 176456748 | Sequence: | 176456749 | Sequence: | 176456750 | Sequence: | 176456751 | Sequence: | 176456752 | Sequence: | 176456753 | Sequence: | 176456754 | Sequence: | 176456755 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | other |
Measure | Pathological Complete Response (pCR) in modified intent-to-treat (mITT) | Measure | Event-Free Survival (EFS) | Measure | Disease-free survival (DFS) in modified resected population | Measure | Major Pathological Response (mPR) | Measure | Overall Survival (OS) | Measure | Event-free survival (EFS) in PD-L1-TC ≥1% positive patients | Measure | pCR in PD-L1-TC ≥1% positive patients | Measure | Disease-Free Survival (DFS) in PD-L1-TC ≥1% positive patients | Measure | Major Pathological Response (mPR) in PD-L1-TC ≥1% positive patients | Measure | Overall Survival (OS) in PD-L1-TC ≥1% positive patients | Measure | To assess disease-related symptoms and HRQoL (EORTC QLQ-C30) in patients treated with durva + chemo prior to surgery followed by durva post-surgery compared with placebo + chemo prior to surgery followed by placebo post-surgery | Measure | To assess disease-related symptoms and HRQoL (EORTC QLQ-LC13) in patients treated with durva + chemo prior to surgery followed by durva post-surgery compared with placebo + chemo prior to surgery followed by placebo post-surgery | Measure | To assess the PK of durvalumab in blood (through concentration) | Measure | Presence of ADA for durvalumab | Measure | Number of participants with all adverse events as assessed by CTCAE v5.0 |
Time Frame | From screening pathology to an average of 15 weeks after first dose. | Time Frame | Up to 5.5 years after first patient randomized. | Time Frame | From date of randomization to 5.5 years after date of resection | Time Frame | From screening pathology to an average of 15 weeks after first dose. | Time Frame | From date of randomization to 5.5 years after randomization | Time Frame | From date of randomization to 5.5 years after randomization | Time Frame | From screening pathology to an average of 15 weeks after first dose | Time Frame | From date of randomization to 5.5 years after date of resection | Time Frame | From screening pathology to an average of 15 weeks after first dose. | Time Frame | From date of randomization to 5.5 years after randomization. | Time Frame | From date of screening to 6 months after last dose of IP | Time Frame | From date of screening to 6 months after last dose of IP | Time Frame | From date of randomization to 2 months after resection | Time Frame | From date of randomization to 3 months after last dose of IP | Time Frame | 64 months |
Description | Defined as the lack of any viable tumour cells after complete evaluation in the resected lung cancer specimen and all sampled regional lymph nodes. | Description | An event defined as documented RECIST 1.1 local or distant recurrence of lung cancer; death due to any cause; disease progression that precludes surgery or discovered upon attempting surgery that prevents completion of surgery. | Description | To assess disease-related symptoms, functioning, and global health status/quality of life in patients. | Description | To assess disease-related symptoms, functioning, and global health status/quality of life in patients. | Description | To assess concentration of durvalumab in bloodstream. | Description | To evaluate the presence of antibodies following treatment with study medications. |
Browse Conditions
Sequence: | 192394941 | Sequence: | 192394942 | Sequence: | 192394947 | Sequence: | 192394943 | Sequence: | 192394944 | Sequence: | 192394945 | Sequence: | 192394946 | Sequence: | 192394948 | Sequence: | 192394949 | Sequence: | 192394950 |
Mesh Term | Lung Neoplasms | Mesh Term | Carcinoma, Non-Small-Cell Lung | Mesh Term | Lung Diseases | Mesh Term | Respiratory Tract Neoplasms | Mesh Term | Thoracic Neoplasms | Mesh Term | Neoplasms by Site | Mesh Term | Neoplasms | Mesh Term | Respiratory Tract Diseases | Mesh Term | Carcinoma, Bronchogenic | Mesh Term | Bronchial Neoplasms |
Downcase Mesh Term | lung neoplasms | Downcase Mesh Term | carcinoma, non-small-cell lung | Downcase Mesh Term | lung diseases | Downcase Mesh Term | respiratory tract neoplasms | Downcase Mesh Term | thoracic neoplasms | Downcase Mesh Term | neoplasms by site | Downcase Mesh Term | neoplasms | Downcase Mesh Term | respiratory tract diseases | Downcase Mesh Term | carcinoma, bronchogenic | Downcase Mesh Term | bronchial neoplasms |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48064101 |
Agency Class | INDUSTRY |
Lead Or Collaborator | lead |
Name | AstraZeneca |
Overall Officials
Sequence: | 29125433 |
Role | Principal Investigator |
Name | John Heymach, MD |
Affiliation | UT MD Anderson Cancer Institute |
Design Group Interventions
Sequence: | 67808131 | Sequence: | 67808132 | Sequence: | 67808133 | Sequence: | 67808134 | Sequence: | 67808135 | Sequence: | 67808136 | Sequence: | 67808137 | Sequence: | 67808138 | Sequence: | 67808139 | Sequence: | 67808140 |
Design Group Id | 55310918 | Design Group Id | 55310919 | Design Group Id | 55310918 | Design Group Id | 55310919 | Design Group Id | 55310918 | Design Group Id | 55310919 | Design Group Id | 55310918 | Design Group Id | 55310919 | Design Group Id | 55310918 | Design Group Id | 55310919 |
Intervention Id | 52215666 | Intervention Id | 52215667 | Intervention Id | 52215668 | Intervention Id | 52215668 | Intervention Id | 52215669 | Intervention Id | 52215669 | Intervention Id | 52215670 | Intervention Id | 52215670 | Intervention Id | 52215671 | Intervention Id | 52215671 |
Eligibilities
Sequence: | 30604343 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 120 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Age ≥18 years Exclusion Criteria: History of allogeneic organ transplantation |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253923711 |
Number Of Facilities | 231 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | False |
Minimum Age Num | 18 |
Maximum Age Num | 120 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 2 |
Number Of Secondary Outcomes To Measure | 12 |
Number Of Other Outcomes To Measure | 1 |
Designs
Sequence: | 30351704 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Double |
Subject Masked | True |
Caregiver Masked | True |
Intervention Other Names
Sequence: | 26543156 |
Intervention Id | 52215666 |
Name | MEDI4736 |
Responsible Parties
Sequence: | 28725073 |
Responsible Party Type | Sponsor |
Ipd Information Types
Sequence: | 3318216 | Sequence: | 3318217 |
Name | Study Protocol | Name | Statistical Analysis Plan (SAP) |
]]>
https://zephyrnet.com/NCT03800121
2018-11-19
https://zephyrnet.com/?p=NCT03800121
NCT03800121https://www.clinicaltrials.gov/study/NCT03800121?tab=tableEmilie REDERSTORFFerederstorff@cgfl.fr03 80 73 75 00Sarcomas are rare cancers with a high risk of metastatic progression and a major pejorative factor with respect to patient survival. The estimation of the metastatic risk of sarcomas is very complex given the histological heterogeneity of this entity. It is therefore essential that, at diagnosis, a reliable evaluation of this metastatic potential be made, in order to adapt the therapeutic strategy as well as possible.
It has recently been discovered that sarcomas secrete many exosomes that appear to play an important role in tumorogenesis, growth, tumor progression and the onset of metastases. They contain many proteins and nucleic acids (DNA, RNA, microRNA), reflecting the characteristics of the tumor. It has been shown that the amount of exosomes can be correlated with the grade of malignancy of the tumor. Present in the blood, exosomes offer the possibility of non-invasively analyzing the molecular information of the cancer cell. As a result, the study of serum exosomes derived from sarcomas has a high potential as a liquid biopsy to evaluate cancer pathogenesis, progression, and treatment efficacy.
The purpose of this study is to demonstrate in patients with sarcomas that exosomes can be used to monitor their disease and be used as a predictor of the risk of recurrence.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-03 |
Study First Posted Date | 2019-01-11 |
Last Update Posted Date | 2022-04-05 |
Start Month Year | November 19, 2018 |
Primary Completion Month Year | November 19, 2022 |
Verification Month Year | March 2022 |
Verification Date | 2022-03-31 |
Last Update Posted Date | 2022-04-05 |
Detailed Descriptions
Sequence: | 20838609 |
Description | The main objective of this pilot study is to quantify exosomes and analyze their protein and RNA content in patients with sarcoma with disease:
localized before and after treatment with surgery, The secondary objectives are: Determine whether the initial exosome concentration and the protein and RNA profile they contain vary with the localized or metastatic stage of the disease. |
Facilities
Sequence: | 201181501 | Sequence: | 201181502 | Sequence: | 201181503 |
Status | Recruiting | Status | Recruiting | Status | Recruiting |
Name | CHU de Besançon | Name | Centre Georges François Leclerc | Name | CHU de Poitiers |
City | Besançon | City | Dijon | City | Poitiers |
Zip | 25000 | Zip | 21000 | Zip | 86000 |
Country | France | Country | France | Country | France |
Facility Contacts
Sequence: | 28264829 | Sequence: | 28264830 | Sequence: | 28264831 | Sequence: | 28264832 |
Facility Id | 201181501 | Facility Id | 201181501 | Facility Id | 201181502 | Facility Id | 201181503 |
Contact Type | primary | Contact Type | backup | Contact Type | primary | Contact Type | primary |
Name | Loic CHAIGNEAU | Name | Alice HERVIEU | Name | Nicolas ISAMBERT, PU-PH | ||
echaigneau@chu-besancon.fr | ahervieu@cgfl.fr | nicolas.isambert@chu-poitiers.fr | |||||
Phone | 03 80 73 75 00 | Phone | 05 49 44 45 38 | ||||
Facility Investigators
Sequence: | 18429402 | Sequence: | 18429403 | Sequence: | 18429404 | Sequence: | 18429405 | Sequence: | 18429406 | Sequence: | 18429407 |
Facility Id | 201181501 | Facility Id | 201181501 | Facility Id | 201181502 | Facility Id | 201181502 | Facility Id | 201181503 | Facility Id | 201181503 |
Role | Sub-Investigator | Role | Sub-Investigator | Role | Sub-Investigator | Role | Sub-Investigator | Role | Sub-Investigator | Role | Sub-Investigator |
Name | Elsa KALBACHER | Name | Guillaume MEYNARD | Name | Sylvain CAUSERET | Name | Isabelle DESMOULINS | Name | Sheik EMAMBUX | Name | Camille EVRARD |
Conditions
Sequence: | 52470947 |
Name | Sarcoma |
Downcase Name | sarcoma |
Id Information
Sequence: | 40373524 |
Id Source | org_study_id |
Id Value | 2018-A01393-52 |
Countries
Sequence: | 42809047 |
Name | France |
Removed | False |
Design Groups
Sequence: | 55926253 | Sequence: | 55926254 |
Title | Localized sarcoma with neoadjuvant chemotherapy | Title | Metastatic or locally advanced sarcoma |
Description | In total, several blood tests specific to the EXOSARC study will be necessary:
A first blood test of 7 mL during the initial assessment (inclusion) |
Description | In total, several blood tests specific to the EXOSARC study will be necessary :
A first blood of 7 mL during the initial assessment (inclusion) |
Interventions
Sequence: | 52781179 |
Intervention Type | Biological |
Name | Blood samples |
Description | Localized sarcoma group : 1 blood sample during inclusion (7 ml) + 1 blood sample before surgery (32 ml) + 1 blood sample 1 month after surgery (32 ml) + 1 blood sample 3 month after surgery (32 ml) + 1 blood sample 6 month after surgery (32 ml)
Metastatic sarcoma group : 1 blood sample during inclusion (7 ml) + 1 blood sample during chemotherapy cure 1 (32 ml) + 1 blood sample during chemotherapy cure 3 (32 ml) + 1 blood sample during chemotherapy cure 6 (32 ml) |
Keywords
Sequence: | 80275626 |
Name | exosomes |
Downcase Name | exosomes |
Design Outcomes
Sequence: | 178503443 |
Outcome Type | primary |
Measure | concentration of exosomes in blood |
Time Frame | up to 6 months after inclusion |
Description | blood samples |
Browse Conditions
Sequence: | 194632159 | Sequence: | 194632160 | Sequence: | 194632161 | Sequence: | 194632162 |
Mesh Term | Sarcoma | Mesh Term | Neoplasms, Connective and Soft Tissue | Mesh Term | Neoplasms by Histologic Type | Mesh Term | Neoplasms |
Downcase Mesh Term | sarcoma | Downcase Mesh Term | neoplasms, connective and soft tissue | Downcase Mesh Term | neoplasms by histologic type | Downcase Mesh Term | neoplasms |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48597856 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Centre Georges Francois Leclerc |
Central Contacts
Sequence: | 12085491 | Sequence: | 12085492 |
Contact Type | primary | Contact Type | backup |
Name | Alice HERVIEU | Name | Emilie REDERSTORFF |
Phone | 03 80 73 75 00 | Phone | 03 80 73 75 00 |
ahervieu@cgfl.fr | erederstorff@cgfl.fr | ||
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 68560360 | Sequence: | 68560361 |
Design Group Id | 55926253 | Design Group Id | 55926254 |
Intervention Id | 52781179 | Intervention Id | 52781179 |
Eligibilities
Sequence: | 30937356 |
Sampling Method | Probability Sample |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Population | Patients with soft tissue sarcoma |
Criteria | Inclusion Criteria:
Men and women newly diagnosed with localized, metastatic or locally advanced soft tissue sarcoma Exclusion Criteria: Patients who meet at least one of the following criteria will not be eligible: Patient with another synchronous tumor, |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254246486 |
Number Of Facilities | 3 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | False |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Designs
Sequence: | 30682977 |
Observational Model | Cohort |
Time Perspective | Prospective |
Intervention Other Names
Sequence: | 26822672 | Sequence: | 26822673 |
Intervention Id | 52781179 | Intervention Id | 52781179 |
Name | Localized sarcoma | Name | Metastatic sarcoma |
Responsible Parties
Sequence: | 29049706 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03800108
2018-05-30
https://zephyrnet.com/?p=NCT03800108
NCT03800108https://www.clinicaltrials.gov/study/NCT03800108?tab=tableNANANAThis study evaluates the role of subthalamic nucleus (STN) stimulation location and frequency on a range of cognitive processes in Parkinson’s patients who have undergone Deep Brain Stimulation (DBS).
<![CDATA[
Studies
Study First Submitted Date | 2018-05-23 |
Study First Posted Date | 2019-01-11 |
Last Update Posted Date | 2022-08-31 |
Start Month Year | May 30, 2018 |
Primary Completion Month Year | September 30, 2023 |
Verification Month Year | August 2022 |
Verification Date | 2022-08-31 |
Last Update Posted Date | 2022-08-31 |
Detailed Descriptions
Sequence: | 20850603 |
Description | Pre- and post- DBS implantation brain scans will be reviewed by the study team to see if patients' DBS settings can be personalized. If so, study subjects will undergo adjustments to their DBS settings and be asked to perform cognitive tests. Some patients will be asked to come back for a second visit for brain scans. |
Facilities
Sequence: | 201277247 |
Name | Cleveland Clinic |
City | Cleveland |
State | Ohio |
Zip | 44195 |
Country | United States |
Conditions
Sequence: | 52503084 |
Name | Parkinson Disease |
Downcase Name | parkinson disease |
Id Information
Sequence: | 40395924 |
Id Source | org_study_id |
Id Value | 17-1350 |
Countries
Sequence: | 42832463 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55959191 |
Group Type | Other |
Title | Personalized DBS adjustments |
Description | Individualized stimulation adjustments based on pre- and post- DBS implantation MRIs |
Interventions
Sequence: | 52811073 |
Intervention Type | Procedure |
Name | Personalized DBS adjustments |
Description | Individualized stimulation adjustments based on pre- and post- DBS implantation MRIs |
Design Outcomes
Sequence: | 178616979 | Sequence: | 178616980 | Sequence: | 178616981 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary |
Measure | Reaction time | Measure | Verbal Fluency | Measure | Finger tapping speed |
Time Frame | 30-60 minutes after stimulation adjustment | Time Frame | 30-60 minutes after stimulation adjustment | Time Frame | 30-60 minutes after stimulation adjustment |
Description | Subjects will complete one or more measures of cognitive processing requiring speeded responses to stimuli. Changes in reaction time will be compared to 'off stimulation' | Description | Change in the number words that patients generate to letter or semantic category cues will be compared to 'off stimulation' | Description | Change in upper extremity speed (# of taps in 10 seconds) will be compared to 'off stimulation' |
Browse Conditions
Sequence: | 194752853 | Sequence: | 194752854 | Sequence: | 194752855 | Sequence: | 194752856 | Sequence: | 194752857 | Sequence: | 194752858 | Sequence: | 194752859 | Sequence: | 194752860 | Sequence: | 194752861 |
Mesh Term | Parkinson Disease | Mesh Term | Parkinsonian Disorders | Mesh Term | Basal Ganglia Diseases | Mesh Term | Brain Diseases | Mesh Term | Central Nervous System Diseases | Mesh Term | Nervous System Diseases | Mesh Term | Movement Disorders | Mesh Term | Synucleinopathies | Mesh Term | Neurodegenerative Diseases |
Downcase Mesh Term | parkinson disease | Downcase Mesh Term | parkinsonian disorders | Downcase Mesh Term | basal ganglia diseases | Downcase Mesh Term | brain diseases | Downcase Mesh Term | central nervous system diseases | Downcase Mesh Term | nervous system diseases | Downcase Mesh Term | movement disorders | Downcase Mesh Term | synucleinopathies | Downcase Mesh Term | neurodegenerative diseases |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48626626 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Darlene Floden |
Overall Officials
Sequence: | 29458469 |
Role | Principal Investigator |
Name | Darlene Floden, PhD |
Affiliation | The Cleveland Clinic |
Design Group Interventions
Sequence: | 68601126 |
Design Group Id | 55959191 |
Intervention Id | 52811073 |
Eligibilities
Sequence: | 30954615 |
Gender | All |
Minimum Age | 40 Years |
Maximum Age | 70 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Between 40 and 70 years of age, Exclusion Criteria: History of prior neurosurgical intervention for PD (e.g., DBS, thalamotomy, pallidotomy) Hearing or visual impairment precluding cognitive testing. Exclusion criteria for Day 2 procedures: Inability to safely undergo MRI procedure (i.e., metal objects like prostheses, pacemakers) |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253909874 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 40 |
Maximum Age Num | 70 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 3 |
Designs
Sequence: | 30700195 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Other |
Time Perspective | |
Masking | None (Open Label) |
Responsible Parties
Sequence: | 29066961 |
Responsible Party Type | Sponsor-Investigator |
Name | Darlene Floden |
Title | Staff Neuropsychologist |
Affiliation | The Cleveland Clinic |
]]>
https://zephyrnet.com/NCT03800095
2019-03-14
https://zephyrnet.com/?p=NCT03800095
NCT03800095https://www.clinicaltrials.gov/study/NCT03800095?tab=tableLise LACLAUTREdrci@chu-clermontferrand.fr0473754963Patients suffering from haematological disease present symptoms of discomfort and currently benefit from palliative care skills only for the management of their end-of-life. However, in medical oncology, more and more studies tend to demonstrate the benefit on the quality of life of an early collaboration between the two specialties.
Investigator did the hypothesis that early integration of palliative care with conventional haematological care could decrease discomfort symptoms and add a real benefit on the patients’ quality of life .
<![CDATA[
Studies
Study First Submitted Date | 2018-09-13 |
Study First Posted Date | 2019-01-11 |
Last Update Posted Date | 2021-03-24 |
Start Month Year | March 14, 2019 |
Primary Completion Month Year | August 14, 2023 |
Verification Month Year | March 2021 |
Verification Date | 2021-03-31 |
Last Update Posted Date | 2021-03-24 |
Detailed Descriptions
Sequence: | 20852120 |
Description | Patients suffering from haematological disease present symptoms of discomfort and currently benefit from palliative care skills only for the management of their end-of-life. However, in medical oncology, more and more studies tend to demonstrate the benefit on the quality of life of an early collaboration between the two specialties.
Investigator did the hypothesis that early integration of palliative care with conventional haematological care could decrease discomfort symptoms and add a real benefit on the patients' quality of life . |
Facilities
Sequence: | 201287202 | Sequence: | 201287203 | Sequence: | 201287204 | Sequence: | 201287205 | Sequence: | 201287206 | Sequence: | 201287207 |
Status | Not yet recruiting | Status | Recruiting | Status | Recruiting | Status | Not yet recruiting | Status | Recruiting | Status | Not yet recruiting |
Name | Centre Hospitalier Métropole Savoie | Name | Chu Clermont-Ferrand | Name | Chu Limoges | Name | Centre Léon Bérard | Name | Institut de Cancérologie de la Loire | Name | CH Jacques Lacarin |
City | Chambéry | City | Clermont-Ferrand | City | Limoges | City | Lyon | City | Saint-Priest-en-Jarez | City | Vichy |
Zip | 73000 | Zip | 63003 | Zip | 87042 | Zip | 69008 | Zip | 42271 | Zip | 03200 |
Country | France | Country | France | Country | France | Country | France | Country | France | Country | France |
Facility Contacts
Sequence: | 28281681 | Sequence: | 28281682 | Sequence: | 28281683 | Sequence: | 28281684 | Sequence: | 28281685 | Sequence: | 28281686 |
Facility Id | 201287202 | Facility Id | 201287203 | Facility Id | 201287204 | Facility Id | 201287205 | Facility Id | 201287206 | Facility Id | 201287207 |
Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary |
Name | Laurent SUTTON | Name | Lise LACLAUTRE | Name | Stéphane MOREAU | Name | Anne-Sophie MICHALLET | Name | Denis GUYOTAT | Name | Karine SOULIER-GUERIN |
drci@chu-clermontferrand.fr | |||||||||||
Phone | 0473754963 | ||||||||||
Facility Investigators
Sequence: | 18438572 | Sequence: | 18438573 | Sequence: | 18438574 | Sequence: | 18438575 | Sequence: | 18438576 | Sequence: | 18438577 | Sequence: | 18438578 | Sequence: | 18438579 | Sequence: | 18438580 | Sequence: | 18438581 | Sequence: | 18438582 | Sequence: | 18438583 |
Facility Id | 201287202 | Facility Id | 201287202 | Facility Id | 201287203 | Facility Id | 201287203 | Facility Id | 201287204 | Facility Id | 201287204 | Facility Id | 201287205 | Facility Id | 201287205 | Facility Id | 201287206 | Facility Id | 201287206 | Facility Id | 201287207 | Facility Id | 201287207 |
Role | Principal Investigator | Role | Sub-Investigator | Role | Principal Investigator | Role | Sub-Investigator | Role | Principal Investigator | Role | Sub-Investigator | Role | Principal Investigator | Role | Sub-Investigator | Role | Principal Investigator | Role | Sub-Investigator | Role | Principal Investigator | Role | Sub-Investigator |
Name | Laurent SUTTON | Name | Matthieu CRETINON | Name | Virginie GUASTELLA | Name | Jacques-Olivier BAY | Name | Stéphane MOREAU | Name | Bertrand SARDIN | Name | Anne-Sophie MICHALLET | Name | Gisèle CHVETZOF | Name | Denis GUYOTAT | Name | Stéphanie MORISSON | Name | Karine SOULIER-GUERIN | Name | Franck DELPRETTI |
Conditions
Sequence: | 52507033 | Sequence: | 52507034 | Sequence: | 52507035 | Sequence: | 52507036 |
Name | Acute Myeloid Leukemia | Name | Myelodysplastic Syndrome | Name | Diffuse Large B Cell Lymphoma | Name | Palliative Care |
Downcase Name | acute myeloid leukemia | Downcase Name | myelodysplastic syndrome | Downcase Name | diffuse large b cell lymphoma | Downcase Name | palliative care |
Id Information
Sequence: | 40398822 | Sequence: | 40398823 |
Id Source | org_study_id | Id Source | secondary_id |
Id Value | CHU-406 | Id Value | 2017-A02515-48 |
Id Type | Other Identifier | ||
Id Type Description | 2017-A02515-48 | ||
Countries
Sequence: | 42835119 |
Name | France |
Removed | False |
Design Groups
Sequence: | 55963389 | Sequence: | 55963390 |
Group Type | Experimental | Group Type | Experimental |
Title | Conventional haematological care | Title | Conventional care associated with a monthly consultation |
Description | Patients with haematological malignancy Conventional haematological care | Description | Patients with haematological malignancy Conventional care associated with a monthly consultation realized by a palliative and supportive care team |
Interventions
Sequence: | 52814921 |
Intervention Type | Drug |
Name | Early palliative care integration |
Description | The follow-up time for each patient is 12 months with evaluation of the main objective by a standardized questionnaire: The Functional Assessment of Cancer Therapy-Anaemia (FACT-An) Scale at 6 months. Throughout the study, patients included will receive conventional haematological care and the interventional arm will benefit in addition to a monthly consultation by a palliative care team. |
Keywords
Sequence: | 80324598 | Sequence: | 80324599 | Sequence: | 80324600 | Sequence: | 80324601 | Sequence: | 80324602 |
Name | Supportive care | Name | Early palliative care | Name | Quality of life | Name | Symptoms management | Name | Haematological malignancy |
Downcase Name | supportive care | Downcase Name | early palliative care | Downcase Name | quality of life | Downcase Name | symptoms management | Downcase Name | haematological malignancy |
Design Outcomes
Sequence: | 178629639 | Sequence: | 178629637 | Sequence: | 178629638 | Sequence: | 178629640 | Sequence: | 178629641 |
Outcome Type | secondary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | overall survival | Measure | Quality of life evaluation: standardized questionnaire | Measure | Presence of discomfort symptoms | Measure | Satisfaction of the care pathwaydesired by the patient | Measure | cost-effectiveness analysis |
Time Frame | at day 1 : from the randomization until the date of death or until 1 year [study end]. | Time Frame | at 6 months | Time Frame | at Day 0, 3 months, 6 months, 9 months, 12 months | Time Frame | at 12 months or death | Time Frame | at 12 months or death |
Description | Evaluation of quality of life by a standardized questionnaire : Functional Assessment of Cancer Therapy-Anemia (FACT-An). The higher is the score the better is the quality of life. FACT-An is composed by five subscales: Physical Well-Being [score range 0-28], Social/Family Well-Being [score range 0-28], Emotional Well-Being [score range 0-24], and Functional Well-Being [score range 0-28] and specific questions concerning anemia [score range 0-80]. The score at each items is summed. The sum is multiplied par the number of items in the subscale and then divided by the number of items answered. This produces the subscale score. The subscale scores are added to derive total score [score range 0-188]. | Description | evaluated by Edmonton scale (depressive syndrome measured by the geriatric depression scale GDS) | Description | matching between patients desires writing in the medical file and the providing care | Description | The cost criteria selected will be all the direct medical costs inherent in care in both arms (costs of hospitalizations, consultations, treatments, medical devices). |
Browse Conditions
Sequence: | 194767661 | Sequence: | 194767662 | Sequence: | 194767663 | Sequence: | 194767664 | Sequence: | 194767665 | Sequence: | 194767666 | Sequence: | 194767667 | Sequence: | 194767668 | Sequence: | 194767669 | Sequence: | 194767670 | Sequence: | 194767671 | Sequence: | 194767672 | Sequence: | 194767673 | Sequence: | 194767674 | Sequence: | 194767675 |
Mesh Term | Neoplasms | Mesh Term | Lymphoma, Large B-Cell, Diffuse | Mesh Term | Hematologic Neoplasms | Mesh Term | Myelodysplastic Syndromes | Mesh Term | Neoplasms by Histologic Type | Mesh Term | Bone Marrow Diseases | Mesh Term | Hematologic Diseases | Mesh Term | Lymphoma, B-Cell | Mesh Term | Lymphoma, Non-Hodgkin | Mesh Term | Lymphoma | Mesh Term | Lymphoproliferative Disorders | Mesh Term | Lymphatic Diseases | Mesh Term | Immunoproliferative Disorders | Mesh Term | Immune System Diseases | Mesh Term | Neoplasms by Site |
Downcase Mesh Term | neoplasms | Downcase Mesh Term | lymphoma, large b-cell, diffuse | Downcase Mesh Term | hematologic neoplasms | Downcase Mesh Term | myelodysplastic syndromes | Downcase Mesh Term | neoplasms by histologic type | Downcase Mesh Term | bone marrow diseases | Downcase Mesh Term | hematologic diseases | Downcase Mesh Term | lymphoma, b-cell | Downcase Mesh Term | lymphoma, non-hodgkin | Downcase Mesh Term | lymphoma | Downcase Mesh Term | lymphoproliferative disorders | Downcase Mesh Term | lymphatic diseases | Downcase Mesh Term | immunoproliferative disorders | Downcase Mesh Term | immune system diseases | Downcase Mesh Term | neoplasms by site |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48630078 | Sequence: | 48630079 | Sequence: | 48630080 | Sequence: | 48630081 | Sequence: | 48630082 |
Agency Class | OTHER | Agency Class | OTHER | Agency Class | UNKNOWN | Agency Class | UNKNOWN | Agency Class | UNKNOWN |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator |
Name | University Hospital, Clermont-Ferrand | Name | Fondation Apicil | Name | Association des foulées de la Haute Lozère | Name | Association CEMSBM | Name | Connaître et Combattre les Myélodysplasies |
Central Contacts
Sequence: | 12095048 |
Contact Type | primary |
Name | Lise LACLAUTRE |
Phone | 0473754963 |
drci@chu-clermontferrand.fr | |
Role | Contact |
Design Group Interventions
Sequence: | 68606459 | Sequence: | 68606460 |
Design Group Id | 55963390 | Design Group Id | 55963389 |
Intervention Id | 52814921 | Intervention Id | 52814921 |
Eligibilities
Sequence: | 30956743 |
Gender | All |
Minimum Age | 70 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Patients are over 70 years old Exclusion Criteria: All patients with a curative project (induction chemotherapy ou allogenic transplantation) |
Adult | False |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253953286 |
Number Of Facilities | 6 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | False |
Minimum Age Num | 70 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 4 |
Designs
Sequence: | 30702319 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Masking Description | no masking |
Responsible Parties
Sequence: | 29069086 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03800082
2021-08-01
https://zephyrnet.com/?p=NCT03800082
NCT03800082https://www.clinicaltrials.gov/study/NCT03800082?tab=tableMyra Leyden, MAmyra.leyden@utoronto.ca416.978.1327The overall goal of this program of research is to develop and systematically evaluate an integrated smartphone and web-based intervention (at heart [formerly called HEARTPA♀N]) to provide evidence-informed symptom triage and self-management support to reduce pain and increase health-related quality of life (HRQoL) in women with heart disease. The investigators will use the individual and family self-management theory, mobile device functionality and the pervasive information architecture of mHealth interventions, and follow the sequential phased approach recommended by the Medical Research Council (MRC) to develop at heart (progressive WebApp). Funding was received from the Canadian Institutes of Health Research to develop the architecture and conduct usability testing (Phase 2, complete) to ensure it is easy to use, efficient and satisfying to operate. In Phase 3 (current proposal), feasibility in terms of implementation (accrual rates, acceptability and level of engagement) and initial estimation of effectiveness outcomes (estimates of magnitude of effect) will be evaluated in a pilot randomized controlled trial (RCT). The Phase 3 pilot study will enable the investigators to refine the prototype, inform the methodology, and calculate the sample size for a larger multi-site RCT (Phase 4, future work).
<![CDATA[
Studies
Study First Submitted Date | 2019-01-04 |
Study First Posted Date | 2019-01-11 |
Last Update Posted Date | 2021-07-28 |
Start Month Year | August 1, 2021 |
Primary Completion Month Year | August 31, 2022 |
Verification Month Year | July 2021 |
Verification Date | 2021-07-31 |
Last Update Posted Date | 2021-07-28 |
Detailed Descriptions
Sequence: | 20721654 |
Description | Phase 3 (Study 3): Pilot Randomized Controlled Trial of the at heart (formerly called HEARTPA♀N) Intervention.
The at heart intervention is the first of its kind; there are no previous trials of the efficacy of such an intervention to decrease pain and improve HRQoL in women with heart disease. The investigators will undertake a process and preliminary effect evaluation of the intervention for women with heart disease, as guided by the MRC framework. The primary objective is to determine the feasibility of implementing an RCT of the intervention. A process evaluation will be conducted to examine: 1) the feasibility of randomization, recruitment and retention, 2) acceptability and barriers to implementing the intervention (including the symptom triage algorithms), and 3) the extent of engagement with the intervention. The investigators will also undertake a preliminary efficacy evaluation of the primary outcomes. Based on the investigator's theorized mechanism of change, they hypothesize that the intervention will reduce pain and improve HRQoL (primary outcomes). The investigators will assess the variability and sensitivity to change for both outcomes. Prior to conducting a full scale RCT of a complex intervention, such as at heart, the MRC recommends that a pilot trial be performed. Results from this pilot trial will inform the success of a future RCT in three ways: 1) help determine sample size calculation for the full-scale trial, 2) test procedures (recruitment, randomization, follow-up), which will make up the design of the full-scale trial, and 3) test feasibility of implementing the intervention, particularly by estimating rates of recruitment and retention. Triage algorithms and self-management interventions will be developed using a strong theoretical framework, informed by needs assessments and a comprehensive integrated mixed methods systematic review, with preliminary acceptability and usability testing by end-users. The investigators anticipate minimal risk to safety but will track adverse events using the Adverse Event Form. Moreover, latest WebApp technologies have been integrated through the use of a Chatbot named 'Holly'. |
Facilities
Sequence: | 200108476 |
Status | Recruiting |
Name | Monica Parry |
City | Toronto |
State | Ontario |
Zip | M5T 1P8 |
Country | Canada |
Facility Contacts
Sequence: | 28106426 | Sequence: | 28106427 |
Facility Id | 200108476 | Facility Id | 200108476 |
Contact Type | primary | Contact Type | backup |
Name | Monica Parry, PhD | Name | Arland O'Hara, BA |
monica.parry@utoronto.ca | arland.ohara@utoronto.ca | ||
Phone | 416.946.3561 | ||
Conditions
Sequence: | 52171271 | Sequence: | 52171272 | Sequence: | 52171273 | Sequence: | 52171274 |
Name | Pain | Name | Cardiac Ischemia | Name | Women | Name | Pain, Chronic |
Downcase Name | pain | Downcase Name | cardiac ischemia | Downcase Name | women | Downcase Name | pain, chronic |
Id Information
Sequence: | 40158662 |
Id Source | org_study_id |
Id Value | 389044 |
Countries
Sequence: | 42568966 |
Name | Canada |
Removed | False |
Design Groups
Sequence: | 55593212 | Sequence: | 55593213 |
Group Type | No Intervention | Group Type | Experimental |
Title | Control | Title | Treatment |
Description | Participants allocated to the control group will receive the usual care and supports provided to women with cardiac pain, including usual clinic appointments and follow-up. | Description | Participants allocated to the treatment group will also learn how to use the progressive WebApp intervention. The intervention will be delivered on restricted password-protected applications that will permit tracking of adherence (number of logins to app and website using Google Analytics). Participants will be encouraged to log-in regularly to the progressive WebApp (via automated alerts) over the 3-month period to complete a Heart and/or Wellness Check. A Chatbot named 'Holly' will assist women with log-in and maintaining health and wellness. Participants will be directed to the PC for technical problems. |
Interventions
Sequence: | 52485518 |
Intervention Type | Behavioral |
Name | at heart (changed from HEARTPA♀N during usability testing) |
Description | An integrated smartphone and web-based intervention (at heart) to provide evidence-informed symptom triage and self-management support to reduce pain and increase health-related quality of life (HRQoL) in women with heart disease. The intervention for participants randomized to the treatment group will consist of regular use of a progressive WebApp that is managed by a Chatbot named 'Holly', in addition to usual care, for a period of 3 months. |
Keywords
Sequence: | 79868598 |
Name | Women, Self-Management, Cardiac Pain |
Downcase Name | women, self-management, cardiac pain |
Design Outcomes
Sequence: | 177378994 | Sequence: | 177378995 | Sequence: | 177378996 | Sequence: | 177378997 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Feasibility (recruitment, retention, engagement) | Measure | Feasibility (acceptability, satisfaction) | Measure | Pain (Brief Pain Inventory) | Measure | Health-related quality of life (HRQOL) |
Time Frame | 3 months | Time Frame | 3 months | Time Frame | 3 months | Time Frame | 3 months |
Description | A process evaluation will be used to assess the feasibility of the implementation of the intervention. The PC will track any issues or difficulties encountered during trial implementation, such as problems using the app. Engagement will be assessed using Google Analytics, which will track patterns of app and website usage. Engagement with the app diary will be defined as 100% with daily entries for 3 months. Engagement with goal setting will be defined as 100% when 12 goals are identified over the 3-month period. Criteria for implementation success: recruitment rates > 70%, retention > 85%, minimal technical difficulties reported by < 10%, engagement > 80%, and minimal missed responses. Prevalence of refusal, retention, engagement and technical difficulties reported will be calculated with their 95% confidence intervals. | Description | The investigators will also assess acceptability and satisfaction in all participants in the intervention group using a modified Acceptability e-Scale (AES). The modified AES includes 9 items, each with a 5-point Likert response. Higher scores represent better acceptability/satisfaction. Responses are summed and averaged. Criteria for implementation success: AES mean summary score > 4. | Description | A preliminary efficacy evaluation will also be undertaken focusing on the outcomes of pain. Pain will be measured using the Brief Pain Inventory-Short Form (BPI-SF), which rates pain severity and the degree to which pain interferes with mood, sleep, and other physical activities such as work, social activity and relations with others. We will investigate the variability and sensitivity to change for pain (T2-T1). We will calculate the number of participants who report clinically meaningful decreases in pain, which has been defined for the BPI-SF as a two-point difference in worst pain. Variability will be estimated using the mean/median scores and standard deviation, in each group separately, at pre and post-test. | Description | A preliminary efficacy evaluation will also be undertaken focusing on the outcomes of HRQOL. HRQOL will be measured using the SF-36v2TM, which contains 36 items and yields a score for each of the 8 domains of health: physical functioning, role limitations due to physical health (role-physical), bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems (role emotional), and mental health. We will investigate the variability and sensitivity to change for HRQOL (T2-T1). Sensitivity to change will be assessed by determining the number of participants who had a clinically meaningful increase in HRQOL: ≥ 15 points in physical functioning, general health and mental health; ≥ 16.7 in role emotional functioning; ≥ 18.5 points in role physical functioning and vitality; ≥ 20 points in bodily pain; and ≥ 25 points in social functioning. |
Browse Conditions
Sequence: | 193486879 | Sequence: | 193486880 | Sequence: | 193486881 | Sequence: | 193486882 | Sequence: | 193486883 | Sequence: | 193486884 | Sequence: | 193486885 | Sequence: | 193486886 | Sequence: | 193486887 | Sequence: | 193486888 | Sequence: | 193486889 | Sequence: | 193486890 | Sequence: | 193486891 |
Mesh Term | Heart Diseases | Mesh Term | Coronary Artery Disease | Mesh Term | Myocardial Ischemia | Mesh Term | Ischemia | Mesh Term | Chronic Pain | Mesh Term | Cardiovascular Diseases | Mesh Term | Pathologic Processes | Mesh Term | Pain | Mesh Term | Neurologic Manifestations | Mesh Term | Coronary Disease | Mesh Term | Arteriosclerosis | Mesh Term | Arterial Occlusive Diseases | Mesh Term | Vascular Diseases |
Downcase Mesh Term | heart diseases | Downcase Mesh Term | coronary artery disease | Downcase Mesh Term | myocardial ischemia | Downcase Mesh Term | ischemia | Downcase Mesh Term | chronic pain | Downcase Mesh Term | cardiovascular diseases | Downcase Mesh Term | pathologic processes | Downcase Mesh Term | pain | Downcase Mesh Term | neurologic manifestations | Downcase Mesh Term | coronary disease | Downcase Mesh Term | arteriosclerosis | Downcase Mesh Term | arterial occlusive diseases | Downcase Mesh Term | vascular diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48319324 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | University of Toronto |
Overall Officials
Sequence: | 29285370 |
Role | Principal Investigator |
Name | Monica Parry, PhD |
Affiliation | University of Toronto |
Central Contacts
Sequence: | 12008886 | Sequence: | 12008887 |
Contact Type | primary | Contact Type | backup |
Name | Monica Parry, PhD | Name | Myra Leyden, MA |
Phone | 416.946-3561 | Phone | 416.978.1327 |
monica.parry@utoronto.ca | myra.leyden@utoronto.ca | ||
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 68149175 |
Design Group Id | 55593213 |
Intervention Id | 52485518 |
Eligibilities
Sequence: | 30765374 |
Gender | Female |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
women greater than 18 years of age with obstructive and non-obstructive CAD pain, post PCI/cardiac surgery pain lasting greater than 3 months Exclusion Criteria: severe cognitive impairment assessed using the Six-Item Screener |
Gender Description | We will use the PRAXY Gender Questionnaire – Short Form |
Gender Based | True |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253884876 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 2 |
Number Of Secondary Outcomes To Measure | 2 |
Designs
Sequence: | 30511540 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Supportive Care |
Time Perspective | |
Masking | Single |
Masking Description | It is not possible to blind the participants to group allocation due to the specific nature of the intervention; however, a data analyst at the University of Toronto's Faculty of Nursing who is blinded to treatment allocation will conduct the analysis ensuring neutrality of the outcome assessment. |
Intervention Model Description | A two group parallel single blind pilot RCT. |
Outcomes Assessor Masked | True |
Responsible Parties
Sequence: | 28877835 |
Responsible Party Type | Principal Investigator |
Name | Monica Parry |
Title | Associate Professor and Coordinator, Nurse Practitioner Programs |
Affiliation | University of Toronto |
Study References
Sequence: | 52063423 |
Pmid | 32156763 |
Reference Type | derived |
Citation | Parry M, Dhukai A, Clarke H, Bjornnes AK, Cafazzo JA, Cooper L, Harvey P, Katz J, Lalloo C, Leegaard M, Legare F, Lovas M, McFetridge-Durdle J, McGillion M, Norris C, Parente L, Patterson R, Pilote L, Pink L, Price J, Stinson J, Uddin A, Victor JC, Watt-Watson J, Auld C, Faubert C, Park D, Park M, Rickard B, DeBonis VS. Development and usability testing of HEARTPAfemale symbolN: protocol for a mixed methods strategy to develop an integrated smartphone and web-based intervention for women with cardiac pain. BMJ Open. 2020 Mar 9;10(3):e033092. doi: 10.1136/bmjopen-2019-033092. |
]]>
https://zephyrnet.com/NCT03800069
2018-12-03
https://zephyrnet.com/?p=NCT03800069
NCT03800069https://www.clinicaltrials.gov/study/NCT03800069?tab=tableNANANAThis study is testing the accuracy of a point of care device that tests liver function within 20 minutes. The target population will be any adult who had liver function tests ordered and to be drawn on the same day as enrollment.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-07 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2020-12-04 |
Start Month Year | December 3, 2018 |
Primary Completion Month Year | May 30, 2019 |
Verification Month Year | December 2020 |
Verification Date | 2020-12-31 |
Last Update Posted Date | 2020-12-04 |
Detailed Descriptions
Sequence: | 20852135 |
Description | Outpatient diagnostics are slow and expensive due to turnaround times, complex workflows and high cost. Sometimes patients do not make it to laboratory testing if a lab is not available on site. Delays in testing can affect medical outcomes or patients can be lost to follow up.
Group K developed a paper microfluidic platform with an accompanying mobile application(app). The paper microfluidic device is a simple, inexpensive wax backed device with three testing areas. These areas have a mix of dried proprietary reagents that when combined with a patients drop of blood, or in the future, saliva or urine, will produce results in a color change. An app is then used to interpret the color change and output results to a doctor. The target population is adults who have an indication to collect a liver function panel that will be drawn on the same day as their clinic visit or during their inpatient hospital |
Facilities
Sequence: | 201287245 |
Name | The Hospital of the University of Pennslyvania |
City | Philadelphia |
State | Pennsylvania |
Zip | 19104 |
Country | United States |
Conditions
Sequence: | 52507071 | Sequence: | 52507072 | Sequence: | 52507073 | Sequence: | 52507074 |
Name | Liver Diseases | Name | Healthy | Name | Cirrhosis, Liver | Name | Fibrosis |
Downcase Name | liver diseases | Downcase Name | healthy | Downcase Name | cirrhosis, liver | Downcase Name | fibrosis |
Id Information
Sequence: | 40398844 |
Id Source | org_study_id |
Id Value | 829476 |
Countries
Sequence: | 42835140 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55963432 |
Title | Arm 1 |
Description | A finger stick sample is collected and tested on the study device. |
Interventions
Sequence: | 52814958 |
Intervention Type | Device |
Name | Group K Diagnostic point of care device |
Description | Arm 1 will have a finger prick sample collected to test the ability of Group K Diagnostic point of care device and app to identify liver function values. |
Design Outcomes
Sequence: | 178629740 | Sequence: | 178629741 |
Outcome Type | primary | Outcome Type | secondary |
Measure | Regression curve and correlation coefficient | Measure | The consistent accuracy of the diagnostic device |
Time Frame | 1 year | Time Frame | 1 year |
Description | Each data point will represent one observation or one test run. The investigators will use regression methods to determine the linear relationship between standard lab results and Group K diagnostic's device. | Description | Lowest level frequency of detection must be detected 90% of the time. This will become the functional lower limit. The same with the highest level of frequency. |
Browse Conditions
Sequence: | 194767797 | Sequence: | 194767798 | Sequence: | 194767799 | Sequence: | 194767800 | Sequence: | 194767801 |
Mesh Term | Liver Diseases | Mesh Term | Liver Cirrhosis | Mesh Term | Fibrosis | Mesh Term | Pathologic Processes | Mesh Term | Digestive System Diseases |
Downcase Mesh Term | liver diseases | Downcase Mesh Term | liver cirrhosis | Downcase Mesh Term | fibrosis | Downcase Mesh Term | pathologic processes | Downcase Mesh Term | digestive system diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48630106 | Sequence: | 48630107 |
Agency Class | OTHER | Agency Class | INDUSTRY |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | University of Pennsylvania | Name | Group K Diagnostics Inc. |
Overall Officials
Sequence: | 29460580 |
Role | Principal Investigator |
Name | Vandana Khungar, MD, MSc |
Affiliation | Director of Inpatient Hepatology |
Design Group Interventions
Sequence: | 68606505 |
Design Group Id | 55963432 |
Intervention Id | 52814958 |
Eligibilities
Sequence: | 30956762 |
Sampling Method | Non-Probability Sample |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | Accepts Healthy Volunteers |
Population | Study population will be selected from inpatient and clinic setting at The Hospital of the University of Pennsylvania. |
Criteria | Inclusion Criteria:
Have a liver function testing for the required 6 tests completed (Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), albumin, bilirubin, and total protein) Exclusion Criteria: Inadequate blood sample obtained from finger stick |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253953380 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 5 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 1 |
Designs
Sequence: | 30702338 |
Observational Model | Cohort |
Time Perspective | Cross-Sectional |
Provided Documents
Sequence: | 2602663 | Sequence: | 2602664 |
Document Type | Study Protocol | Document Type | Informed Consent Form |
Has Protocol | True | Has Protocol | False |
Has Icf | False | Has Icf | True |
Has Sap | False | Has Sap | False |
Document Date | 2018-11-28 | Document Date | 2018-11-28 |
Url | https://ClinicalTrials.gov/ProvidedDocs/69/NCT03800069/Prot_000.pdf | Url | https://ClinicalTrials.gov/ProvidedDocs/69/NCT03800069/ICF_001.pdf |
Responsible Parties
Sequence: | 29069105 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03800056
2021-04-23
https://zephyrnet.com/?p=NCT03800056
NCT03800056https://www.clinicaltrials.gov/study/NCT03800056?tab=tableMarie-Christine VANTYGHEM, MD,PhDmc-vantyghem@chru-lille.fr320 44 45 17Autoimmune polyendocrinopathy candidiasis ectodermal dystrophy (APECED) is an autosomal recessive disease caused by mutations in the autoimmune regulator (AIRE) gene, characterized by the clinical triad of chronic mucocutaneous candidiasis (CMC), hypoparathyroidism, and adrenal insufficiency. CMC can be complicated by systemic candidiasis or oral squamous cell carcinomas (SCCs) and may lead to death. The role of chronic Candida infection in the etiopathogenesis of oral SCC is unclear. Long term use of fluconazole lead to emergence of C. albicans strains with azoles decreased susceptibility. CMC is associated with an impaired Th17 cell response, however, it remains unclear whether decreased serum IL-17 and IL-22 levels are related to a defect in cytokine production or to neutralizing autoantibodies resulting from mutations in the AIRE gene
<![CDATA[
Studies
Study First Submitted Date | 2019-01-08 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2022-02-16 |
Start Month Year | April 23, 2021 |
Primary Completion Month Year | April 2026 |
Verification Month Year | February 2022 |
Verification Date | 2022-02-28 |
Last Update Posted Date | 2022-02-16 |
Facilities
Sequence: | 199355800 |
Status | Recruiting |
Name | Hop Claude Huriez Chu Lille |
City | Lille |
Zip | 59037 |
Country | France |
Facility Contacts
Sequence: | 28021724 |
Facility Id | 199355800 |
Contact Type | primary |
Phone | 0320445962 |
Facility Investigators
Sequence: | 18278777 |
Facility Id | 199355800 |
Role | Principal Investigator |
Name | Marie-Christine VANTIGHEM, MD,PhD |
Conditions
Sequence: | 51993306 |
Name | Polyendocrinopathies, Autoimmune |
Downcase Name | polyendocrinopathies, autoimmune |
Id Information
Sequence: | 40019989 | Sequence: | 40019990 |
Id Source | org_study_id | Id Source | secondary_id |
Id Value | 2017_36 | Id Value | 2017-A03135-48 |
Id Type | Other Identifier | ||
Id Type Description | ID-RCB number, ANSM | ||
Countries
Sequence: | 42415115 |
Name | France |
Removed | False |
Design Groups
Sequence: | 55396646 | Sequence: | 55396647 |
Title | Group 1 APS 1 | Title | Group 2 APS2 |
Description | Patients with a APS type 1 whose molecular diagnosis (mutation of the AIRE gene) has been established in the diagnosis of the disease, regardless of their mycological status (history of mycosis) or the presence of antifungal treatment. | Description | Patients with APS type 2: – with adrenal insufficiency for 50% of them. – a delay of two weeks after stopping antifungal or antibiotic treatment in patients is to be respected. |
Keywords
Sequence: | 79586390 | Sequence: | 79586391 | Sequence: | 79586392 |
Name | APECED syndrome | Name | autoimmune polyendocrinopathy | Name | chronic mucocutaneous candidiasis |
Downcase Name | apeced syndrome | Downcase Name | autoimmune polyendocrinopathy | Downcase Name | chronic mucocutaneous candidiasis |
Design Outcomes
Sequence: | 176753772 |
Outcome Type | primary |
Measure | the frequency of appearance of Candida yeast strains |
Time Frame | Baseline: one session |
Description | the frequency of appearance of Candida yeast strains found in mycological samples from both urinary and oral patients. |
Browse Conditions
Sequence: | 192782881 | Sequence: | 192782882 | Sequence: | 192782883 | Sequence: | 192782884 |
Mesh Term | Polyendocrinopathies, Autoimmune | Mesh Term | Endocrine System Diseases | Mesh Term | Autoimmune Diseases | Mesh Term | Immune System Diseases |
Downcase Mesh Term | polyendocrinopathies, autoimmune | Downcase Mesh Term | endocrine system diseases | Downcase Mesh Term | autoimmune diseases | Downcase Mesh Term | immune system diseases |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48152566 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | University Hospital, Lille |
Overall Officials
Sequence: | 29183115 |
Role | Principal Investigator |
Name | Marie-Christine VANTYGHEM, MD,PhD |
Affiliation | University Hospital, Lille |
Central Contacts
Sequence: | 11969112 |
Contact Type | primary |
Name | Marie-Christine VANTYGHEM, MD,PhD |
Phone | 320 44 45 17 |
mc-vantyghem@chru-lille.fr | |
Phone Extension | +33 |
Role | Contact |
Eligibilities
Sequence: | 30660803 |
Sampling Method | Non-Probability Sample |
Gender | All |
Minimum Age | N/A |
Maximum Age | 85 Years |
Healthy Volunteers | No |
Population | Patients will be included during their routine follow-up for adrenal insufficiency or hypoparathyroidism in the endocrinology department of the University Hospital of Lille, in adult or pediatric endocrinology. |
Criteria | Inclusion Criteria:
For both of groups, inclusion criteria are : children aged 0 to 17 years old with the consent of both parents, and men and women between the ages of 18 and 85. Exclusion Criteria: impossibility to receive informed information for adults, or impossibility to receive enlightened information for the holders of parental authority if minor subject |
Adult | True |
Child | True |
Older Adult | True |
Calculated Values
Sequence: | 254273703 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Maximum Age Num | 85 |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Designs
Sequence: | 30407622 |
Observational Model | Cohort |
Time Perspective | Prospective |
Responsible Parties
Sequence: | 28774142 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03800043
2019-01-15
https://zephyrnet.com/?p=NCT03800043
NCT03800043https://www.clinicaltrials.gov/study/NCT03800043?tab=tableNANANAThis study evaluates the social impact of children’s dental perception from children with or without caries experience. For this, children and their parents are shown pictures of child faces with healthy teeth, decayed teeth and teeth after dental treatment.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-08 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2021-06-23 |
Start Month Year | January 15, 2019 |
Primary Completion Month Year | July 31, 2019 |
Verification Month Year | June 2021 |
Verification Date | 2021-06-30 |
Last Update Posted Date | 2021-06-23 |
Detailed Descriptions
Sequence: | 20762922 |
Description | Appearance and abnormalities in the face influences the life of children: attractive children get estimated as more competent and find friends easier than those with a less attractive appearance. Therefore this study aimes to evaluate the social impact of children's dental perception from children with or without own caries experience (and their parents). Both groups (with/without caries experience) are shown pictures of children with different dental status (healthy teeth, decayed teeth and teeth after dental treatment) and asked to complete established questionnaires.The division into the groups is based on photos of the children with visible teeth.
The results should be evaluated descriptively and graphically. Also the comparison between the answers of both groups for the three different dental status is planned. |
Facilities
Sequence: | 200458043 |
Name | Department of Preventive Dentistry, Periodontology and Cariology, University Medical Center Goettingen, Germany |
City | Göttingen |
State | Lower Saxony |
Zip | 37075 |
Country | Germany |
Conditions
Sequence: | 52277450 |
Name | Dental Caries in Children |
Downcase Name | dental caries in children |
Id Information
Sequence: | 40235456 |
Id Source | org_study_id |
Id Value | 25/2/18 |
Countries
Sequence: | 42653033 |
Name | Germany |
Removed | False |
Design Groups
Sequence: | 55711570 | Sequence: | 55711571 |
Title | Children with own caries experience | Title | Children without own caries experience |
Description | Children with own caries experience (visible on a photo; teeth clearly visible), sufficient compliance | Description | Children without own caries experience (visible on a photo; teeth clearly visible), sufficient compliance |
Keywords
Sequence: | 80018954 | Sequence: | 80018955 | Sequence: | 80018956 | Sequence: | 80018957 | Sequence: | 80018958 |
Name | Early Childhood Caries | Name | children | Name | dentistry | Name | face perception | Name | dental appearance |
Downcase Name | early childhood caries | Downcase Name | children | Downcase Name | dentistry | Downcase Name | face perception | Downcase Name | dental appearance |
Design Outcomes
Sequence: | 177770630 | Sequence: | 177770631 | Sequence: | 177770632 | Sequence: | 177770633 | Sequence: | 177770634 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary |
Measure | Children: Evaluation of the whole photos | Measure | Children: Evaluation of the mouth on the photo | Measure | Children: Evaluation of their own teeth | Measure | Why do you feel like this? | Measure | Related parents: Evaluation of the whole photos |
Time Frame | 2-3 minutes | Time Frame | 2-3 minutes | Time Frame | 1-2 minutes | Time Frame | 1-2 minutes | Time Frame | 1-2 minutes |
Description | Questionnaire: "How would you feel having a friend looking like this?" (showing the photos of the three different dental status) (4 point face scale of Soares et al. 2015) | Description | Questionnaire: "How would you feel having a friend with a mouth looking like this" (showing the photos of the three different dental status) (4 point face scale of Soares et al. 2015) | Description | Questionnaire: "How do you feel when thinking about your own teeth?" (4 point face scale of Soares et al. 2015) | Description | Questionnaire: Evaluate the pictures with the adjectives: clever, rude, kind, honest, confident, careful, helpful, stupid, naughty (4 point scale. 'strongly agree' = 4; 'agree' = 3; 'disagree' = 2; 'strongly disagree' = 1) |
Browse Conditions
Sequence: | 193892724 | Sequence: | 193892725 | Sequence: | 193892726 | Sequence: | 193892727 |
Mesh Term | Dental Caries | Mesh Term | Tooth Demineralization | Mesh Term | Tooth Diseases | Mesh Term | Stomatognathic Diseases |
Downcase Mesh Term | dental caries | Downcase Mesh Term | tooth demineralization | Downcase Mesh Term | tooth diseases | Downcase Mesh Term | stomatognathic diseases |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48418635 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | University of Göttingen |
Overall Officials
Sequence: | 29342606 |
Role | Study Director |
Name | Annette Wiegand, Prof. Dr. |
Affiliation | Dept. of Prev. Dentistry, Periodontology and Cariology, University Medical Center Göttingen, Germany |
Eligibilities
Sequence: | 30827025 |
Sampling Method | Probability Sample |
Gender | All |
Minimum Age | 4 Years |
Maximum Age | 9 Years |
Population | children with or without caries experience and their parents |
Criteria | Inclusion Criteria:
(parent of an child of) age 4-9 years Exclusion Criteria: missing agreement to participate in the study |
Adult | False |
Child | True |
Older Adult | False |
Calculated Values
Sequence: | 254123706 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 6 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 4 |
Maximum Age Num | 9 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 4 |
Number Of Secondary Outcomes To Measure | 1 |
Designs
Sequence: | 30572955 |
Observational Model | Cohort |
Time Perspective | Prospective |
Responsible Parties
Sequence: | 28939377 |
Responsible Party Type | Principal Investigator |
Name | Claudia Tschammler |
Title | Dr. Claudia Tschammler, Principal Investigator |
Affiliation | University of Göttingen |
]]>
https://zephyrnet.com/NCT03800030
2018-10-07
https://zephyrnet.com/?p=NCT03800030
NCT03800030https://www.clinicaltrials.gov/study/NCT03800030?tab=tableNANANAInvestigation of frequency specific transcranial alternating current stimulation on cognitive control signals in frontal cortex
<![CDATA[
Studies
Study First Submitted Date | 2018-12-18 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2020-05-18 |
Start Month Year | October 7, 2018 |
Primary Completion Month Year | July 25, 2019 |
Verification Month Year | September 2019 |
Verification Date | 2019-09-30 |
Last Update Posted Date | 2020-05-18 |
Results First Posted Date | 2020-05-18 |
Detailed Descriptions
Sequence: | 20562938 |
Description | Previous evidence suggests that there are specific frequency bands associated with different aspects of cognitive control. In specific delta (2-4Hz) and beta (15-30Hz) are associated with increased levels of abstraction for learned rules; and theta (5-8Hz) and gamma (30-50Hz) has been associated with increased set-size or number of learned rules. Here we aim to find causal evidence in support of these previous correlational findings by applying cross-frequency transcranial alternating current stimulation (tACS) in the specific frequency bands previously shown to be task-relevant. In a crossover design, we stimulate subjects with either delta-beta or theta-gamma tACS during performance of a hierarchical cognitive control task that manipulates the level of abstraction and set-size of rules that must be learned in order to make the correct button press. |
Facilities
Sequence: | 198527940 |
Name | University of North Carolina, Chapel Hill |
City | Chapel Hill |
State | North Carolina |
Zip | 27599 |
Country | United States |
Conditions
Sequence: | 51763009 | Sequence: | 51763010 |
Name | Cognitive Control | Name | Executive Function |
Downcase Name | cognitive control | Downcase Name | executive function |
Id Information
Sequence: | 39832110 | Sequence: | 39832111 |
Id Source | org_study_id | Id Source | secondary_id |
Id Value | 18-0003 | Id Value | R01MH101547 |
Id Type | U.S. NIH Grant/Contract | ||
Id Link | https://reporter.nih.gov/quickSearch/R01MH101547 |
Countries
Sequence: | 42231925 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55184003 | Sequence: | 55184004 | Sequence: | 55184005 | Sequence: | 55184006 | Sequence: | 55184007 | Sequence: | 55184008 |
Group Type | Experimental | Group Type | Experimental | Group Type | Experimental | Group Type | Experimental | Group Type | Experimental | Group Type | Experimental |
Title | Theta-gamma, Delta-beta, Sham | Title | Theta-gamma, Sham, Delta-beta | Title | Delta-beta, Theta-gamma, Sham tACS | Title | Delta-beta, Sham, Theta-gamma tACS | Title | Sham, Delta-beta, Theta-gamma tACS | Title | Sham, Theta-gamma, Delta-beta tACS |
Description | Every participant will receive Theta-gamma tACS, Delta-beta tACS, and Sham tACS on separate sessions during performance of a computerized task.
Sequence: Theta-gamma tACS, then Delta-beta tACS, then Sham tACS |
Description | Every participant will receive Theta-gamma tACS, Delta-beta tACS, and Sham tACS on separate sessions during performance of a computerized task.
Sequence: Theta-gamma tACS, then Sham tACS, then Delta-beta tACS |
Description | Every participant will receive Theta-gamma tACS, Delta-beta tACS, and Sham tACS on separate sessions during performance of a computerized task.
Sequence: Delta-beta tACS, then Theta-gamma tACS, then Sham tACS |
Description | Every participant will receive Theta-gamma tACS, Delta-beta tACS, and Sham tACS on separate sessions during performance of a computerized task.
Sequence: Delta-beta tACS, then Sham tACS, then Theta-gamma tACS |
Description | Every participant will receive Theta-gamma tACS, Delta-beta tACS, and Sham tACS on separate sessions during performance of a computerized task.
Sequence: Sham tACS, then Delta-beta tACS, then Theta-gamma tACS |
Description | Every participant will receive Theta-gamma tACS, Delta-beta tACS, and Sham tACS on separate sessions during performance of a computerized task.
Sequence: Sham tACS, then Theta-gamma tACS, then Delta-beta tACS |
Interventions
Sequence: | 52084248 | Sequence: | 52084249 | Sequence: | 52084250 |
Intervention Type | Device | Intervention Type | Device | Intervention Type | Device |
Name | Theta-gamma tACS | Name | Delta-beta tACS | Name | Sham tACS |
Description | NeuroConn technologies, direct current-stimulator plus | Description | NeuroConn technologies, direct current-stimulator plus | Description | NeuroConn technologies, direct current-stimulator plus |
Keywords
Sequence: | 79195444 | Sequence: | 79195445 | Sequence: | 79195446 |
Name | tACS | Name | Cognitive Control | Name | Executive Function |
Downcase Name | tacs | Downcase Name | cognitive control | Downcase Name | executive function |
Design Outcomes
Sequence: | 176064988 | Sequence: | 176064989 | Sequence: | 176064990 | Sequence: | 176064991 | Sequence: | 176064992 | Sequence: | 176064993 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary |
Measure | Reaction Time for Trials With High Abstraction Relative to Low Abstraction | Measure | Reaction Time for Trials With High Set-size Relative to Low Set-size | Measure | Delta Phase to Beta Amplitude Coupling Strength | Measure | Theta Phase to Gamma Amplitude Coupling Strength | Measure | Percent Correct for Trials With High Abstraction Relative to Low Abstraction | Measure | Percent Correct for Trials With High Set-size Relative to Low Set-size |
Time Frame | through study completion, an average of 3 weeks | Time Frame | through study completion, an average of 3 weeks | Time Frame | through study completion, an average of 3 weeks | Time Frame | through study completion, an average of 3 weeks | Time Frame | through study completion, an average of 3 weeks | Time Frame | through study completion, an average of 3 weeks |
Description | For low abstraction conditions, subjects must memorize a color to button mapping. For high abstraction conditions, subject must make a perceptual judgement on the similarity of two objects based on either texture or shape as cued by a color. The reaction time difference between high and low abstraction conditions was hypothesized to decrease when delta-beta tACS was delivered. As a control for the placebo effect of stimulation, the difference between delta-beta tACS and sham tACS, or placebo, was used for statistical analysis. | Description | The reaction time difference between high and low set-size conditions was hypothesized to decrease when theta-gamma tACS is delivered. As a control for the placebo effect of stimulation, the difference between theta-gamma tACS and sham tACS, or placebo, was used for statistical analysis. | Description | Delta-beta tACS was hypothesized to increase cross frequency coupling strength (higher value) between the targeted frequency bands. Phase amplitude coupling between delta phase and beta amplitude was calculated for the two minute electrical brain recordings after stimulation. A null distribution was calculated by shuffling the beta amplitude time series relative to the delta phase time series and then calculating coupling strength. The outcome measure is the z-transformed value of the genuine phase amplitude coupling relative to the null distribution. | Description | Theta-gamma tACS was hypothesized to increase cross frequency coupling strength (higher value) between the targeted frequency bands. Phase amplitude coupling between theta phase and gamma amplitude was calculated for the two minute electrical brain recordings after stimulation. A null distribution was calculated by shuffling the gamma amplitude time series relative to the theta phase time series and then calculating coupling strength. The outcome measure is the z-transformed value of the genuine phase amplitude coupling relative to the null distribution. | Description | For low abstraction conditions, subjects must memorize a color to button mapping. For high abstraction conditions, subject must make a perceptual judgement on the similarity of two objects based on either texture or shape as cued by a color. The accuracy difference between high and low abstraction conditions was hypothesized to decrease when delta-beta tACS was delivered. As a control for the placebo effect of stimulation, the difference between delta-beta tACS and sham tACS, or placebo, was used for statistical analysis. | Description | The accuracy difference between high and low set-size conditions was hypothesized to decrease when theta-gamma tACS is delivered. As a control for the placebo effect of stimulation, the difference between theta-gamma tACS and sham tACS, or placebo, was used for statistical analysis. |
Sponsors
Sequence: | 47939520 | Sequence: | 47939521 |
Agency Class | OTHER | Agency Class | NIH |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | University of North Carolina, Chapel Hill | Name | National Institute of Mental Health (NIMH) |
Overall Officials
Sequence: | 29045812 |
Role | Principal Investigator |
Name | Flavio Frohlich, PhD |
Affiliation | University of North Carolina, Chapel Hill |
Design Group Interventions
Sequence: | 67654547 | Sequence: | 67654548 | Sequence: | 67654549 | Sequence: | 67654550 | Sequence: | 67654551 | Sequence: | 67654552 | Sequence: | 67654553 | Sequence: | 67654554 | Sequence: | 67654555 | Sequence: | 67654556 | Sequence: | 67654557 | Sequence: | 67654558 | Sequence: | 67654559 | Sequence: | 67654560 | Sequence: | 67654561 | Sequence: | 67654562 | Sequence: | 67654563 | Sequence: | 67654564 |
Design Group Id | 55184006 | Design Group Id | 55184005 | Design Group Id | 55184007 | Design Group Id | 55184008 | Design Group Id | 55184003 | Design Group Id | 55184004 | Design Group Id | 55184006 | Design Group Id | 55184005 | Design Group Id | 55184007 | Design Group Id | 55184008 | Design Group Id | 55184003 | Design Group Id | 55184004 | Design Group Id | 55184006 | Design Group Id | 55184005 | Design Group Id | 55184007 | Design Group Id | 55184008 | Design Group Id | 55184003 | Design Group Id | 55184004 |
Intervention Id | 52084248 | Intervention Id | 52084248 | Intervention Id | 52084248 | Intervention Id | 52084248 | Intervention Id | 52084248 | Intervention Id | 52084248 | Intervention Id | 52084249 | Intervention Id | 52084249 | Intervention Id | 52084249 | Intervention Id | 52084249 | Intervention Id | 52084249 | Intervention Id | 52084249 | Intervention Id | 52084250 | Intervention Id | 52084250 | Intervention Id | 52084250 | Intervention Id | 52084250 | Intervention Id | 52084250 | Intervention Id | 52084250 |
Eligibilities
Sequence: | 30526476 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 35 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
Between the ages of 18 and 35 years Exclusion Criteria: Attention Deficit Hyperactivity Disorder (currently under treatment) |
Adult | True |
Child | False |
Older Adult | False |
Calculated Values
Sequence: | 254093109 |
Number Of Facilities | 1 |
Number Of Nsae Subjects | 81 |
Registered In Calendar Year | 2018 |
Actual Duration | 9 |
Were Results Reported | True |
Months To Report Results | 9 |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 35 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 6 |
Designs
Sequence: | 30275383 |
Allocation | Randomized |
Intervention Model | Crossover Assignment |
Observational Model | |
Primary Purpose | Basic Science |
Time Perspective | |
Masking | Double |
Masking Description | Double-blinded. Neither the investigator nor the participants knows which form of stimulation is received. |
Intervention Model Description | Healthy participants will receive three waveforms of transcranial alternating current stimulation (tACS). Delta-beta, Theta-gamma, and Sham. |
Subject Masked | True |
Investigator Masked | True |
Milestones
Sequence: | 40753428 | Sequence: | 40753429 | Sequence: | 40753430 | Sequence: | 40753431 | Sequence: | 40753432 | Sequence: | 40753433 | Sequence: | 40753434 | Sequence: | 40753435 | Sequence: | 40753436 | Sequence: | 40753437 | Sequence: | 40753438 | Sequence: | 40753439 | Sequence: | 40753440 | Sequence: | 40753441 | Sequence: | 40753442 | Sequence: | 40753443 | Sequence: | 40753444 | Sequence: | 40753445 | Sequence: | 40753446 | Sequence: | 40753447 | Sequence: | 40753448 | Sequence: | 40753449 | Sequence: | 40753450 | Sequence: | 40753451 | Sequence: | 40753452 | Sequence: | 40753453 | Sequence: | 40753454 | Sequence: | 40753455 | Sequence: | 40753456 | Sequence: | 40753457 | Sequence: | 40753458 | Sequence: | 40753459 | Sequence: | 40753460 | Sequence: | 40753461 | Sequence: | 40753462 | Sequence: | 40753463 | Sequence: | 40753464 | Sequence: | 40753465 | Sequence: | 40753466 | Sequence: | 40753467 | Sequence: | 40753468 | Sequence: | 40753469 | Sequence: | 40753470 | Sequence: | 40753471 | Sequence: | 40753472 | Sequence: | 40753473 | Sequence: | 40753474 | Sequence: | 40753475 | Sequence: | 40753476 | Sequence: | 40753477 | Sequence: | 40753478 | Sequence: | 40753479 | Sequence: | 40753480 | Sequence: | 40753481 | Sequence: | 40753482 | Sequence: | 40753483 | Sequence: | 40753484 | Sequence: | 40753485 | Sequence: | 40753486 | Sequence: | 40753487 | Sequence: | 40753488 | Sequence: | 40753489 | Sequence: | 40753490 | Sequence: | 40753491 | Sequence: | 40753492 | Sequence: | 40753493 | Sequence: | 40753494 | Sequence: | 40753495 | Sequence: | 40753496 | Sequence: | 40753497 | Sequence: | 40753498 | Sequence: | 40753499 | Sequence: | 40753500 | Sequence: | 40753501 | Sequence: | 40753502 | Sequence: | 40753503 | Sequence: | 40753504 | Sequence: | 40753505 | Sequence: | 40753506 | Sequence: | 40753507 | Sequence: | 40753508 | Sequence: | 40753509 | Sequence: | 40753510 | Sequence: | 40753511 | Sequence: | 40753512 | Sequence: | 40753513 | Sequence: | 40753514 | Sequence: | 40753515 | Sequence: | 40753516 | Sequence: | 40753517 | Sequence: | 40753518 | Sequence: | 40753519 | Sequence: | 40753520 | Sequence: | 40753521 | Sequence: | 40753522 | Sequence: | 40753523 | Sequence: | 40753524 | Sequence: | 40753525 | Sequence: | 40753526 | Sequence: | 40753527 | Sequence: | 40753528 | Sequence: | 40753529 | Sequence: | 40753530 | Sequence: | 40753531 | Sequence: | 40753532 | Sequence: | 40753533 | Sequence: | 40753534 | Sequence: | 40753535 | Sequence: | 40753536 | Sequence: | 40753537 | Sequence: | 40753538 | Sequence: | 40753539 | Sequence: | 40753540 | Sequence: | 40753541 | Sequence: | 40753542 | Sequence: | 40753543 | Sequence: | 40753544 | Sequence: | 40753545 | Sequence: | 40753546 | Sequence: | 40753547 | Sequence: | 40753548 | Sequence: | 40753549 | Sequence: | 40753550 | Sequence: | 40753551 | Sequence: | 40753552 | Sequence: | 40753553 |
Result Group Id | 55825933 | Result Group Id | 55825934 | Result Group Id | 55825935 | Result Group Id | 55825936 | Result Group Id | 55825937 | Result Group Id | 55825938 | Result Group Id | 55825933 | Result Group Id | 55825934 | Result Group Id | 55825935 | Result Group Id | 55825936 | Result Group Id | 55825937 | Result Group Id | 55825938 | Result Group Id | 55825933 | Result Group Id | 55825934 | Result Group Id | 55825935 | Result Group Id | 55825936 | Result Group Id | 55825937 | Result Group Id | 55825938 | Result Group Id | 55825933 | Result Group Id | 55825934 | Result Group Id | 55825935 | Result Group Id | 55825936 | Result Group Id | 55825937 | Result Group Id | 55825938 | Result Group Id | 55825933 | Result Group Id | 55825934 | Result Group Id | 55825935 | Result Group Id | 55825936 | Result Group Id | 55825937 | Result Group Id | 55825938 | Result Group Id | 55825933 | Result Group Id | 55825934 | Result Group Id | 55825935 | Result Group Id | 55825936 | Result Group Id | 55825937 | Result Group Id | 55825938 | Result Group Id | 55825933 | Result Group Id | 55825934 | Result Group Id | 55825935 | Result Group Id | 55825936 | Result Group Id | 55825937 | Result Group Id | 55825938 | Result Group Id | 55825933 | Result Group Id | 55825934 | Result Group Id | 55825935 | Result Group Id | 55825936 | Result Group Id | 55825937 | Result Group Id | 55825938 | Result Group Id | 55825933 | Result Group Id | 55825934 | Result Group Id | 55825935 | Result Group Id | 55825936 | Result Group Id | 55825937 | Result Group Id | 55825938 | Result Group Id | 55825933 | Result Group Id | 55825934 | Result Group Id | 55825935 | Result Group Id | 55825936 | Result Group Id | 55825937 | Result Group Id | 55825938 | Result Group Id | 55825933 | Result Group Id | 55825934 | Result Group Id | 55825935 | Result Group Id | 55825936 | Result Group Id | 55825937 | Result Group Id | 55825938 | Result Group Id | 55825933 | Result Group Id | 55825934 | Result Group Id | 55825935 | Result Group Id | 55825936 | Result Group Id | 55825937 | Result Group Id | 55825938 | Result Group Id | 55825933 | Result Group Id | 55825934 | Result Group Id | 55825935 | Result Group Id | 55825936 | Result Group Id | 55825937 | Result Group Id | 55825938 | Result Group Id | 55825933 | Result Group Id | 55825934 | Result Group Id | 55825935 | Result Group Id | 55825936 | Result Group Id | 55825937 | Result Group Id | 55825938 | Result Group Id | 55825933 | Result Group Id | 55825934 | Result Group Id | 55825935 | Result Group Id | 55825936 | Result Group Id | 55825937 | Result Group Id | 55825938 | Result Group Id | 55825933 | Result Group Id | 55825934 | Result Group Id | 55825935 | Result Group Id | 55825936 | Result Group Id | 55825937 | Result Group Id | 55825938 | Result Group Id | 55825933 | Result Group Id | 55825934 | Result Group Id | 55825935 | Result Group Id | 55825936 | Result Group Id | 55825937 | Result Group Id | 55825938 | Result Group Id | 55825933 | Result Group Id | 55825934 | Result Group Id | 55825935 | Result Group Id | 55825936 | Result Group Id | 55825937 | Result Group Id | 55825938 | Result Group Id | 55825933 | Result Group Id | 55825934 | Result Group Id | 55825935 | Result Group Id | 55825936 | Result Group Id | 55825937 | Result Group Id | 55825938 | Result Group Id | 55825933 | Result Group Id | 55825934 | Result Group Id | 55825935 | Result Group Id | 55825936 | Result Group Id | 55825937 | Result Group Id | 55825938 | Result Group Id | 55825933 | Result Group Id | 55825934 | Result Group Id | 55825935 | Result Group Id | 55825936 | Result Group Id | 55825937 | Result Group Id | 55825938 |
Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 |
Title | STARTED | Title | STARTED | Title | STARTED | Title | STARTED | Title | STARTED | Title | STARTED | Title | COMPLETED | Title | COMPLETED | Title | COMPLETED | Title | COMPLETED | Title | COMPLETED | Title | COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | STARTED | Title | STARTED | Title | STARTED | Title | STARTED | Title | STARTED | Title | STARTED | Title | COMPLETED | Title | COMPLETED | Title | COMPLETED | Title | COMPLETED | Title | COMPLETED | Title | COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | STARTED | Title | STARTED | Title | STARTED | Title | STARTED | Title | STARTED | Title | STARTED | Title | COMPLETED | Title | COMPLETED | Title | COMPLETED | Title | COMPLETED | Title | COMPLETED | Title | COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | STARTED | Title | STARTED | Title | STARTED | Title | STARTED | Title | STARTED | Title | STARTED | Title | COMPLETED | Title | COMPLETED | Title | COMPLETED | Title | COMPLETED | Title | COMPLETED | Title | COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | STARTED | Title | STARTED | Title | STARTED | Title | STARTED | Title | STARTED | Title | STARTED | Title | COMPLETED | Title | COMPLETED | Title | COMPLETED | Title | COMPLETED | Title | COMPLETED | Title | COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | STARTED | Title | STARTED | Title | STARTED | Title | STARTED | Title | STARTED | Title | STARTED | Title | COMPLETED | Title | COMPLETED | Title | COMPLETED | Title | COMPLETED | Title | COMPLETED | Title | COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | STARTED | Title | STARTED | Title | STARTED | Title | STARTED | Title | STARTED | Title | STARTED | Title | COMPLETED | Title | COMPLETED | Title | COMPLETED | Title | COMPLETED | Title | COMPLETED | Title | COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED |
Period | Baseline | Period | Baseline | Period | Baseline | Period | Baseline | Period | Baseline | Period | Baseline | Period | Baseline | Period | Baseline | Period | Baseline | Period | Baseline | Period | Baseline | Period | Baseline | Period | Baseline | Period | Baseline | Period | Baseline | Period | Baseline | Period | Baseline | Period | Baseline | Period | Pre-Randomization Period (1 Week) | Period | Pre-Randomization Period (1 Week) | Period | Pre-Randomization Period (1 Week) | Period | Pre-Randomization Period (1 Week) | Period | Pre-Randomization Period (1 Week) | Period | Pre-Randomization Period (1 Week) | Period | Pre-Randomization Period (1 Week) | Period | Pre-Randomization Period (1 Week) | Period | Pre-Randomization Period (1 Week) | Period | Pre-Randomization Period (1 Week) | Period | Pre-Randomization Period (1 Week) | Period | Pre-Randomization Period (1 Week) | Period | Pre-Randomization Period (1 Week) | Period | Pre-Randomization Period (1 Week) | Period | Pre-Randomization Period (1 Week) | Period | Pre-Randomization Period (1 Week) | Period | Pre-Randomization Period (1 Week) | Period | Pre-Randomization Period (1 Week) | Period | First Intervention | Period | First Intervention | Period | First Intervention | Period | First Intervention | Period | First Intervention | Period | First Intervention | Period | First Intervention | Period | First Intervention | Period | First Intervention | Period | First Intervention | Period | First Intervention | Period | First Intervention | Period | First Intervention | Period | First Intervention | Period | First Intervention | Period | First Intervention | Period | First Intervention | Period | First Intervention | Period | First Washout (1 Week) | Period | First Washout (1 Week) | Period | First Washout (1 Week) | Period | First Washout (1 Week) | Period | First Washout (1 Week) | Period | First Washout (1 Week) | Period | First Washout (1 Week) | Period | First Washout (1 Week) | Period | First Washout (1 Week) | Period | First Washout (1 Week) | Period | First Washout (1 Week) | Period | First Washout (1 Week) | Period | First Washout (1 Week) | Period | First Washout (1 Week) | Period | First Washout (1 Week) | Period | First Washout (1 Week) | Period | First Washout (1 Week) | Period | First Washout (1 Week) | Period | Second Intervention | Period | Second Intervention | Period | Second Intervention | Period | Second Intervention | Period | Second Intervention | Period | Second Intervention | Period | Second Intervention | Period | Second Intervention | Period | Second Intervention | Period | Second Intervention | Period | Second Intervention | Period | Second Intervention | Period | Second Intervention | Period | Second Intervention | Period | Second Intervention | Period | Second Intervention | Period | Second Intervention | Period | Second Intervention | Period | Second Washout (1 Week) | Period | Second Washout (1 Week) | Period | Second Washout (1 Week) | Period | Second Washout (1 Week) | Period | Second Washout (1 Week) | Period | Second Washout (1 Week) | Period | Second Washout (1 Week) | Period | Second Washout (1 Week) | Period | Second Washout (1 Week) | Period | Second Washout (1 Week) | Period | Second Washout (1 Week) | Period | Second Washout (1 Week) | Period | Second Washout (1 Week) | Period | Second Washout (1 Week) | Period | Second Washout (1 Week) | Period | Second Washout (1 Week) | Period | Second Washout (1 Week) | Period | Second Washout (1 Week) | Period | Third Intervention | Period | Third Intervention | Period | Third Intervention | Period | Third Intervention | Period | Third Intervention | Period | Third Intervention | Period | Third Intervention | Period | Third Intervention | Period | Third Intervention | Period | Third Intervention | Period | Third Intervention | Period | Third Intervention | Period | Third Intervention | Period | Third Intervention | Period | Third Intervention | Period | Third Intervention | Period | Third Intervention | Period | Third Intervention |
Count | 4 | Count | 4 | Count | 4 | Count | 6 | Count | 4 | Count | 4 | Count | 4 | Count | 4 | Count | 4 | Count | 6 | Count | 4 | Count | 4 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 4 | Count | 4 | Count | 4 | Count | 6 | Count | 4 | Count | 4 | Count | 4 | Count | 4 | Count | 4 | Count | 6 | Count | 4 | Count | 4 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 4 | Count | 4 | Count | 4 | Count | 6 | Count | 4 | Count | 4 | Count | 4 | Count | 4 | Count | 4 | Count | 6 | Count | 4 | Count | 4 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 4 | Count | 4 | Count | 4 | Count | 6 | Count | 4 | Count | 4 | Count | 4 | Count | 4 | Count | 4 | Count | 6 | Count | 4 | Count | 4 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 4 | Count | 4 | Count | 4 | Count | 6 | Count | 4 | Count | 4 | Count | 4 | Count | 4 | Count | 4 | Count | 5 | Count | 4 | Count | 4 | Count | 0 | Count | 0 | Count | 0 | Count | 1 | Count | 0 | Count | 0 | Count | 4 | Count | 4 | Count | 4 | Count | 5 | Count | 4 | Count | 4 | Count | 4 | Count | 4 | Count | 4 | Count | 4 | Count | 4 | Count | 4 | Count | 0 | Count | 0 | Count | 0 | Count | 1 | Count | 0 | Count | 0 | Count | 4 | Count | 4 | Count | 4 | Count | 4 | Count | 4 | Count | 4 | Count | 4 | Count | 4 | Count | 4 | Count | 4 | Count | 4 | Count | 4 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 |
Outcome Analyses
Sequence: | 16453000 | Sequence: | 16453001 | Sequence: | 16453002 | Sequence: | 16453003 | Sequence: | 16453004 | Sequence: | 16453005 |
Outcome Id | 30603521 | Outcome Id | 30603522 | Outcome Id | 30603523 | Outcome Id | 30603524 | Outcome Id | 30603525 | Outcome Id | 30603526 |
Non Inferiority Type | Superiority | Non Inferiority Type | Superiority | Non Inferiority Type | Superiority | Non Inferiority Type | Superiority | Non Inferiority Type | Superiority | Non Inferiority Type | Superiority |
P Value Modifier | P Value Modifier | P Value Modifier | P Value Modifier | P Value Modifier | P Value Modifier | ||||||
P Value | 0.031 | P Value | 0.935 | P Value | 0.04 | P Value | 0.02 | P Value | 0.54 | P Value | 0.007 |
Method | t-test, 2 sided | Method | t-test, 2 sided | Method | t-test, 1 sided | Method | t-test, 1 sided | Method | t-test, 2 sided | Method | t-test, 2 sided |
Method Description | degrees of freedom = 22 t-statistic = 2.305 | Method Description | degrees of freedom = 22 t-statistic = 0.083 | Method Description | degrees of freedom = 22 t-statistic = 1.833 | Method Description | degrees of freedom = 22 t-statistic = 2.174 | Method Description | degrees of freedom = 22 t-statistic = -0.623 | Method Description | degrees of freedom = 22 t-statistic = 2.989 |
Outcome Analysis Groups
Sequence: | 31908775 | Sequence: | 31908776 | Sequence: | 31908777 | Sequence: | 31908778 | Sequence: | 31908779 | Sequence: | 31908780 | Sequence: | 31908781 | Sequence: | 31908782 | Sequence: | 31908783 | Sequence: | 31908784 | Sequence: | 31908785 | Sequence: | 31908786 | Sequence: | 31908787 |
Outcome Analysis Id | 16453000 | Outcome Analysis Id | 16453000 | Outcome Analysis Id | 16453001 | Outcome Analysis Id | 16453001 | Outcome Analysis Id | 16453002 | Outcome Analysis Id | 16453002 | Outcome Analysis Id | 16453002 | Outcome Analysis Id | 16453003 | Outcome Analysis Id | 16453003 | Outcome Analysis Id | 16453004 | Outcome Analysis Id | 16453004 | Outcome Analysis Id | 16453005 | Outcome Analysis Id | 16453005 |
Result Group Id | 55825940 | Result Group Id | 55825941 | Result Group Id | 55825939 | Result Group Id | 55825941 | Result Group Id | 55825939 | Result Group Id | 55825940 | Result Group Id | 55825941 | Result Group Id | 55825939 | Result Group Id | 55825941 | Result Group Id | 55825940 | Result Group Id | 55825941 | Result Group Id | 55825939 | Result Group Id | 55825941 |
Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG002 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG002 |
Participant Flows
Sequence: | 3897728 |
Outcome Counts
Sequence: | 73515587 | Sequence: | 73515588 | Sequence: | 73515589 | Sequence: | 73515590 | Sequence: | 73515591 | Sequence: | 73515592 | Sequence: | 73515593 | Sequence: | 73515594 | Sequence: | 73515595 | Sequence: | 73515596 | Sequence: | 73515597 | Sequence: | 73515598 | Sequence: | 73515599 | Sequence: | 73515600 | Sequence: | 73515601 | Sequence: | 73515602 | Sequence: | 73515603 | Sequence: | 73515604 |
Outcome Id | 30603521 | Outcome Id | 30603521 | Outcome Id | 30603521 | Outcome Id | 30603522 | Outcome Id | 30603522 | Outcome Id | 30603522 | Outcome Id | 30603523 | Outcome Id | 30603523 | Outcome Id | 30603523 | Outcome Id | 30603524 | Outcome Id | 30603524 | Outcome Id | 30603524 | Outcome Id | 30603525 | Outcome Id | 30603525 | Outcome Id | 30603525 | Outcome Id | 30603526 | Outcome Id | 30603526 | Outcome Id | 30603526 |
Result Group Id | 55825939 | Result Group Id | 55825940 | Result Group Id | 55825941 | Result Group Id | 55825939 | Result Group Id | 55825940 | Result Group Id | 55825941 | Result Group Id | 55825939 | Result Group Id | 55825940 | Result Group Id | 55825941 | Result Group Id | 55825939 | Result Group Id | 55825940 | Result Group Id | 55825941 | Result Group Id | 55825939 | Result Group Id | 55825940 | Result Group Id | 55825941 | Result Group Id | 55825939 | Result Group Id | 55825940 | Result Group Id | 55825941 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 |
Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure |
Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants |
Count | 23 | Count | 23 | Count | 23 | Count | 23 | Count | 23 | Count | 23 | Count | 23 | Count | 23 | Count | 23 | Count | 23 | Count | 23 | Count | 23 | Count | 23 | Count | 23 | Count | 23 | Count | 23 | Count | 23 | Count | 23 |
Provided Documents
Sequence: | 2565769 |
Document Type | Study Protocol and Statistical Analysis Plan |
Has Protocol | True |
Has Icf | False |
Has Sap | True |
Document Date | 2020-01-09 |
Url | https://ClinicalTrials.gov/ProvidedDocs/30/NCT03800030/Prot_SAP_000.pdf |
Reported Event Totals
Sequence: | 27770413 | Sequence: | 27770414 | Sequence: | 27770415 | Sequence: | 27770416 | Sequence: | 27770417 | Sequence: | 27770418 | Sequence: | 27770419 | Sequence: | 27770420 | Sequence: | 27770421 |
Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG001 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG002 | Ctgov Group Code | EG002 |
Event Type | serious | Event Type | other | Event Type | deaths | Event Type | serious | Event Type | other | Event Type | deaths | Event Type | serious | Event Type | other | Event Type | deaths |
Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality | Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality | Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality |
Subjects Affected | 0 | Subjects Affected | 11 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 15 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 10 | Subjects Affected | 0 |
Subjects At Risk | 24 | Subjects At Risk | 24 | Subjects At Risk | 24 | Subjects At Risk | 26 | Subjects At Risk | 26 | Subjects At Risk | 26 | Subjects At Risk | 26 | Subjects At Risk | 26 | Subjects At Risk | 26 |
Created At | 2023-08-06 14:23:55.652996 | Created At | 2023-08-06 14:23:55.652996 | Created At | 2023-08-06 14:23:55.652996 | Created At | 2023-08-06 14:23:55.652996 | Created At | 2023-08-06 14:23:55.652996 | Created At | 2023-08-06 14:23:55.652996 | Created At | 2023-08-06 14:23:55.652996 | Created At | 2023-08-06 14:23:55.652996 | Created At | 2023-08-06 14:23:55.652996 |
Updated At | 2023-08-06 14:23:55.652996 | Updated At | 2023-08-06 14:23:55.652996 | Updated At | 2023-08-06 14:23:55.652996 | Updated At | 2023-08-06 14:23:55.652996 | Updated At | 2023-08-06 14:23:55.652996 | Updated At | 2023-08-06 14:23:55.652996 | Updated At | 2023-08-06 14:23:55.652996 | Updated At | 2023-08-06 14:23:55.652996 | Updated At | 2023-08-06 14:23:55.652996 |
Reported Events
Sequence: | 524306661 | Sequence: | 524306662 | Sequence: | 524306663 | Sequence: | 524306664 | Sequence: | 524306665 | Sequence: | 524306666 | Sequence: | 524306667 | Sequence: | 524306668 | Sequence: | 524306669 | Sequence: | 524306670 | Sequence: | 524306671 | Sequence: | 524306672 | Sequence: | 524306673 | Sequence: | 524306674 | Sequence: | 524306675 | Sequence: | 524306676 | Sequence: | 524306677 | Sequence: | 524306678 | Sequence: | 524306679 | Sequence: | 524306680 | Sequence: | 524306681 | Sequence: | 524306682 | Sequence: | 524306683 | Sequence: | 524306684 | Sequence: | 524306685 | Sequence: | 524306686 | Sequence: | 524306687 | Sequence: | 524306688 | Sequence: | 524306689 | Sequence: | 524306690 | Sequence: | 524306691 | Sequence: | 524306692 | Sequence: | 524306693 | Sequence: | 524306694 | Sequence: | 524306695 | Sequence: | 524306696 |
Result Group Id | 55825942 | Result Group Id | 55825943 | Result Group Id | 55825944 | Result Group Id | 55825942 | Result Group Id | 55825943 | Result Group Id | 55825944 | Result Group Id | 55825942 | Result Group Id | 55825943 | Result Group Id | 55825944 | Result Group Id | 55825942 | Result Group Id | 55825943 | Result Group Id | 55825944 | Result Group Id | 55825942 | Result Group Id | 55825943 | Result Group Id | 55825944 | Result Group Id | 55825942 | Result Group Id | 55825943 | Result Group Id | 55825944 | Result Group Id | 55825942 | Result Group Id | 55825943 | Result Group Id | 55825944 | Result Group Id | 55825942 | Result Group Id | 55825943 | Result Group Id | 55825944 | Result Group Id | 55825942 | Result Group Id | 55825943 | Result Group Id | 55825944 | Result Group Id | 55825942 | Result Group Id | 55825943 | Result Group Id | 55825944 | Result Group Id | 55825942 | Result Group Id | 55825943 | Result Group Id | 55825944 | Result Group Id | 55825942 | Result Group Id | 55825943 | Result Group Id | 55825944 |
Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 |
Time Frame | Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention. | Time Frame | Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention. | Time Frame | Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention. | Time Frame | Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention. | Time Frame | Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention. | Time Frame | Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention. | Time Frame | Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention. | Time Frame | Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention. | Time Frame | Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention. | Time Frame | Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention. | Time Frame | Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention. | Time Frame | Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention. | Time Frame | Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention. | Time Frame | Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention. | Time Frame | Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention. | Time Frame | Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention. | Time Frame | Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention. | Time Frame | Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention. | Time Frame | Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention. | Time Frame | Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention. | Time Frame | Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention. | Time Frame | Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention. | Time Frame | Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention. | Time Frame | Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention. | Time Frame | Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention. | Time Frame | Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention. | Time Frame | Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention. | Time Frame | Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention. | Time Frame | Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention. | Time Frame | Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention. | Time Frame | Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention. | Time Frame | Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention. | Time Frame | Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention. | Time Frame | Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention. | Time Frame | Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention. | Time Frame | Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention. |
Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other |
Subjects Affected | 9 | Subjects Affected | 10 | Subjects Affected | 7 | Subjects Affected | 2 | Subjects Affected | 4 | Subjects Affected | 2 | Subjects Affected | 2 | Subjects Affected | 5 | Subjects Affected | 4 | Subjects Affected | 3 | Subjects Affected | 3 | Subjects Affected | 5 | Subjects Affected | 3 | Subjects Affected | 3 | Subjects Affected | 2 | Subjects Affected | 1 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 3 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 3 | Subjects Affected | 1 | Subjects Affected | 3 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 1 |
Subjects At Risk | 24 | Subjects At Risk | 26 | Subjects At Risk | 26 | Subjects At Risk | 24 | Subjects At Risk | 26 | Subjects At Risk | 26 | Subjects At Risk | 24 | Subjects At Risk | 26 | Subjects At Risk | 26 | Subjects At Risk | 24 | Subjects At Risk | 26 | Subjects At Risk | 26 | Subjects At Risk | 24 | Subjects At Risk | 26 | Subjects At Risk | 26 | Subjects At Risk | 24 | Subjects At Risk | 26 | Subjects At Risk | 26 | Subjects At Risk | 24 | Subjects At Risk | 26 | Subjects At Risk | 26 | Subjects At Risk | 24 | Subjects At Risk | 26 | Subjects At Risk | 26 | Subjects At Risk | 24 | Subjects At Risk | 26 | Subjects At Risk | 26 | Subjects At Risk | 24 | Subjects At Risk | 26 | Subjects At Risk | 26 | Subjects At Risk | 24 | Subjects At Risk | 26 | Subjects At Risk | 26 | Subjects At Risk | 24 | Subjects At Risk | 26 | Subjects At Risk | 26 |
Event Count | 9 | Event Count | 10 | Event Count | 7 | Event Count | 2 | Event Count | 4 | Event Count | 2 | Event Count | 2 | Event Count | 5 | Event Count | 4 | Event Count | 3 | Event Count | 3 | Event Count | 5 | Event Count | 3 | Event Count | 3 | Event Count | 2 | Event Count | 1 | Event Count | 1 | Event Count | 0 | Event Count | 0 | Event Count | 3 | Event Count | 0 | Event Count | 1 | Event Count | 1 | Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 0 | Event Count | 3 | Event Count | 1 | Event Count | 3 | Event Count | 1 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 1 |
Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations |
Adverse Event Term | Tingling | Adverse Event Term | Tingling | Adverse Event Term | Tingling | Adverse Event Term | Flickering lights | Adverse Event Term | Flickering lights | Adverse Event Term | Flickering lights | Adverse Event Term | Itching | Adverse Event Term | Itching | Adverse Event Term | Itching | Adverse Event Term | Burning sensation | Adverse Event Term | Burning sensation | Adverse Event Term | Burning sensation | Adverse Event Term | Scalp pain | Adverse Event Term | Scalp pain | Adverse Event Term | Scalp pain | Adverse Event Term | Neck pain | Adverse Event Term | Neck pain | Adverse Event Term | Neck pain | Adverse Event Term | Dizziness | Adverse Event Term | Dizziness | Adverse Event Term | Dizziness | Adverse Event Term | Local redness | Adverse Event Term | Local redness | Adverse Event Term | Local redness | Adverse Event Term | Sleepiness | Adverse Event Term | Sleepiness | Adverse Event Term | Sleepiness | Adverse Event Term | Headache | Adverse Event Term | Headache | Adverse Event Term | Headache | Adverse Event Term | Ringing noise | Adverse Event Term | Ringing noise | Adverse Event Term | Ringing noise | Adverse Event Term | Blurred vision | Adverse Event Term | Blurred vision | Adverse Event Term | Blurred vision |
Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 |
Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment |
Responsible Parties
Sequence: | 28655290 |
Responsible Party Type | Sponsor |
Result Agreements
Sequence: | 3828472 |
Pi Employee | Yes |
Result Contacts
Sequence: | 3828437 |
Organization | University of North Carolina at Chapel Hill |
Name | Justin Riddle, PhD |
Phone | 6617131602 |
justin_riddle@med.unc.edu | |
Outcomes
Sequence: | 30603521 | Sequence: | 30603522 | Sequence: | 30603523 | Sequence: | 30603524 | Sequence: | 30603525 | Sequence: | 30603526 |
Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Primary |
Title | Reaction Time for Trials With High Abstraction Relative to Low Abstraction | Title | Reaction Time for Trials With High Set-size Relative to Low Set-size | Title | Delta Phase to Beta Amplitude Coupling Strength | Title | Theta Phase to Gamma Amplitude Coupling Strength | Title | Percent Correct for Trials With High Abstraction Relative to Low Abstraction | Title | Percent Correct for Trials With High Set-size Relative to Low Set-size |
Description | For low abstraction conditions, subjects must memorize a color to button mapping. For high abstraction conditions, subject must make a perceptual judgement on the similarity of two objects based on either texture or shape as cued by a color. The reaction time difference between high and low abstraction conditions was hypothesized to decrease when delta-beta tACS was delivered. As a control for the placebo effect of stimulation, the difference between delta-beta tACS and sham tACS, or placebo, was used for statistical analysis. | Description | The reaction time difference between high and low set-size conditions was hypothesized to decrease when theta-gamma tACS is delivered. As a control for the placebo effect of stimulation, the difference between theta-gamma tACS and sham tACS, or placebo, was used for statistical analysis. | Description | Delta-beta tACS was hypothesized to increase cross frequency coupling strength (higher value) between the targeted frequency bands. Phase amplitude coupling between delta phase and beta amplitude was calculated for the two minute electrical brain recordings after stimulation. A null distribution was calculated by shuffling the beta amplitude time series relative to the delta phase time series and then calculating coupling strength. The outcome measure is the z-transformed value of the genuine phase amplitude coupling relative to the null distribution. | Description | Theta-gamma tACS was hypothesized to increase cross frequency coupling strength (higher value) between the targeted frequency bands. Phase amplitude coupling between theta phase and gamma amplitude was calculated for the two minute electrical brain recordings after stimulation. A null distribution was calculated by shuffling the gamma amplitude time series relative to the theta phase time series and then calculating coupling strength. The outcome measure is the z-transformed value of the genuine phase amplitude coupling relative to the null distribution. | Description | For low abstraction conditions, subjects must memorize a color to button mapping. For high abstraction conditions, subject must make a perceptual judgement on the similarity of two objects based on either texture or shape as cued by a color. The accuracy difference between high and low abstraction conditions was hypothesized to decrease when delta-beta tACS was delivered. As a control for the placebo effect of stimulation, the difference between delta-beta tACS and sham tACS, or placebo, was used for statistical analysis. | Description | The accuracy difference between high and low set-size conditions was hypothesized to decrease when theta-gamma tACS is delivered. As a control for the placebo effect of stimulation, the difference between theta-gamma tACS and sham tACS, or placebo, was used for statistical analysis. |
Time Frame | through study completion, an average of 3 weeks | Time Frame | through study completion, an average of 3 weeks | Time Frame | through study completion, an average of 3 weeks | Time Frame | through study completion, an average of 3 weeks | Time Frame | through study completion, an average of 3 weeks | Time Frame | through study completion, an average of 3 weeks |
Population | One participant excluded from behavioral analysis because they did not follow task instructions. | Population | One participant excluded from behavioral analysis because they did not follow task instructions. | Population | One participant excluded from coupling analysis because they did not follow task instructions. | Population | One participant was excluded from coupling analysis because they did not follow task instructions. | Population | One participant excluded from behavioral analysis because they did not follow task instructions. | Population | One participant excluded from behavioral analysis because they did not follow task instructions. |
Units | seconds | Units | seconds | Units | Z-score | Units | Z-score | Units | percent correct | Units | percent correct |
Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation |
Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean |
Outcome Measurements
Sequence: | 234047562 | Sequence: | 234047563 | Sequence: | 234047564 | Sequence: | 234047565 | Sequence: | 234047566 | Sequence: | 234047567 | Sequence: | 234047568 | Sequence: | 234047569 | Sequence: | 234047570 | Sequence: | 234047571 | Sequence: | 234047572 | Sequence: | 234047573 | Sequence: | 234047574 | Sequence: | 234047575 | Sequence: | 234047576 | Sequence: | 234047577 | Sequence: | 234047578 | Sequence: | 234047579 |
Outcome Id | 30603521 | Outcome Id | 30603521 | Outcome Id | 30603521 | Outcome Id | 30603522 | Outcome Id | 30603522 | Outcome Id | 30603522 | Outcome Id | 30603523 | Outcome Id | 30603523 | Outcome Id | 30603523 | Outcome Id | 30603524 | Outcome Id | 30603524 | Outcome Id | 30603524 | Outcome Id | 30603525 | Outcome Id | 30603525 | Outcome Id | 30603525 | Outcome Id | 30603526 | Outcome Id | 30603526 | Outcome Id | 30603526 |
Result Group Id | 55825939 | Result Group Id | 55825940 | Result Group Id | 55825941 | Result Group Id | 55825939 | Result Group Id | 55825940 | Result Group Id | 55825941 | Result Group Id | 55825939 | Result Group Id | 55825940 | Result Group Id | 55825941 | Result Group Id | 55825939 | Result Group Id | 55825940 | Result Group Id | 55825941 | Result Group Id | 55825939 | Result Group Id | 55825940 | Result Group Id | 55825941 | Result Group Id | 55825939 | Result Group Id | 55825940 | Result Group Id | 55825941 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 |
Title | Reaction Time for Trials With High Abstraction Relative to Low Abstraction | Title | Reaction Time for Trials With High Abstraction Relative to Low Abstraction | Title | Reaction Time for Trials With High Abstraction Relative to Low Abstraction | Title | Reaction Time for Trials With High Set-size Relative to Low Set-size | Title | Reaction Time for Trials With High Set-size Relative to Low Set-size | Title | Reaction Time for Trials With High Set-size Relative to Low Set-size | Title | Delta Phase to Beta Amplitude Coupling Strength | Title | Delta Phase to Beta Amplitude Coupling Strength | Title | Delta Phase to Beta Amplitude Coupling Strength | Title | Theta Phase to Gamma Amplitude Coupling Strength | Title | Theta Phase to Gamma Amplitude Coupling Strength | Title | Theta Phase to Gamma Amplitude Coupling Strength | Title | Percent Correct for Trials With High Abstraction Relative to Low Abstraction | Title | Percent Correct for Trials With High Abstraction Relative to Low Abstraction | Title | Percent Correct for Trials With High Abstraction Relative to Low Abstraction | Title | Percent Correct for Trials With High Set-size Relative to Low Set-size | Title | Percent Correct for Trials With High Set-size Relative to Low Set-size | Title | Percent Correct for Trials With High Set-size Relative to Low Set-size |
Description | For low abstraction conditions, subjects must memorize a color to button mapping. For high abstraction conditions, subject must make a perceptual judgement on the similarity of two objects based on either texture or shape as cued by a color. The reaction time difference between high and low abstraction conditions was hypothesized to decrease when delta-beta tACS was delivered. As a control for the placebo effect of stimulation, the difference between delta-beta tACS and sham tACS, or placebo, was used for statistical analysis. | Description | For low abstraction conditions, subjects must memorize a color to button mapping. For high abstraction conditions, subject must make a perceptual judgement on the similarity of two objects based on either texture or shape as cued by a color. The reaction time difference between high and low abstraction conditions was hypothesized to decrease when delta-beta tACS was delivered. As a control for the placebo effect of stimulation, the difference between delta-beta tACS and sham tACS, or placebo, was used for statistical analysis. | Description | For low abstraction conditions, subjects must memorize a color to button mapping. For high abstraction conditions, subject must make a perceptual judgement on the similarity of two objects based on either texture or shape as cued by a color. The reaction time difference between high and low abstraction conditions was hypothesized to decrease when delta-beta tACS was delivered. As a control for the placebo effect of stimulation, the difference between delta-beta tACS and sham tACS, or placebo, was used for statistical analysis. | Description | The reaction time difference between high and low set-size conditions was hypothesized to decrease when theta-gamma tACS is delivered. As a control for the placebo effect of stimulation, the difference between theta-gamma tACS and sham tACS, or placebo, was used for statistical analysis. | Description | The reaction time difference between high and low set-size conditions was hypothesized to decrease when theta-gamma tACS is delivered. As a control for the placebo effect of stimulation, the difference between theta-gamma tACS and sham tACS, or placebo, was used for statistical analysis. | Description | The reaction time difference between high and low set-size conditions was hypothesized to decrease when theta-gamma tACS is delivered. As a control for the placebo effect of stimulation, the difference between theta-gamma tACS and sham tACS, or placebo, was used for statistical analysis. | Description | Delta-beta tACS was hypothesized to increase cross frequency coupling strength (higher value) between the targeted frequency bands. Phase amplitude coupling between delta phase and beta amplitude was calculated for the two minute electrical brain recordings after stimulation. A null distribution was calculated by shuffling the beta amplitude time series relative to the delta phase time series and then calculating coupling strength. The outcome measure is the z-transformed value of the genuine phase amplitude coupling relative to the null distribution. | Description | Delta-beta tACS was hypothesized to increase cross frequency coupling strength (higher value) between the targeted frequency bands. Phase amplitude coupling between delta phase and beta amplitude was calculated for the two minute electrical brain recordings after stimulation. A null distribution was calculated by shuffling the beta amplitude time series relative to the delta phase time series and then calculating coupling strength. The outcome measure is the z-transformed value of the genuine phase amplitude coupling relative to the null distribution. | Description | Delta-beta tACS was hypothesized to increase cross frequency coupling strength (higher value) between the targeted frequency bands. Phase amplitude coupling between delta phase and beta amplitude was calculated for the two minute electrical brain recordings after stimulation. A null distribution was calculated by shuffling the beta amplitude time series relative to the delta phase time series and then calculating coupling strength. The outcome measure is the z-transformed value of the genuine phase amplitude coupling relative to the null distribution. | Description | Theta-gamma tACS was hypothesized to increase cross frequency coupling strength (higher value) between the targeted frequency bands. Phase amplitude coupling between theta phase and gamma amplitude was calculated for the two minute electrical brain recordings after stimulation. A null distribution was calculated by shuffling the gamma amplitude time series relative to the theta phase time series and then calculating coupling strength. The outcome measure is the z-transformed value of the genuine phase amplitude coupling relative to the null distribution. | Description | Theta-gamma tACS was hypothesized to increase cross frequency coupling strength (higher value) between the targeted frequency bands. Phase amplitude coupling between theta phase and gamma amplitude was calculated for the two minute electrical brain recordings after stimulation. A null distribution was calculated by shuffling the gamma amplitude time series relative to the theta phase time series and then calculating coupling strength. The outcome measure is the z-transformed value of the genuine phase amplitude coupling relative to the null distribution. | Description | Theta-gamma tACS was hypothesized to increase cross frequency coupling strength (higher value) between the targeted frequency bands. Phase amplitude coupling between theta phase and gamma amplitude was calculated for the two minute electrical brain recordings after stimulation. A null distribution was calculated by shuffling the gamma amplitude time series relative to the theta phase time series and then calculating coupling strength. The outcome measure is the z-transformed value of the genuine phase amplitude coupling relative to the null distribution. | Description | For low abstraction conditions, subjects must memorize a color to button mapping. For high abstraction conditions, subject must make a perceptual judgement on the similarity of two objects based on either texture or shape as cued by a color. The accuracy difference between high and low abstraction conditions was hypothesized to decrease when delta-beta tACS was delivered. As a control for the placebo effect of stimulation, the difference between delta-beta tACS and sham tACS, or placebo, was used for statistical analysis. | Description | For low abstraction conditions, subjects must memorize a color to button mapping. For high abstraction conditions, subject must make a perceptual judgement on the similarity of two objects based on either texture or shape as cued by a color. The accuracy difference between high and low abstraction conditions was hypothesized to decrease when delta-beta tACS was delivered. As a control for the placebo effect of stimulation, the difference between delta-beta tACS and sham tACS, or placebo, was used for statistical analysis. | Description | For low abstraction conditions, subjects must memorize a color to button mapping. For high abstraction conditions, subject must make a perceptual judgement on the similarity of two objects based on either texture or shape as cued by a color. The accuracy difference between high and low abstraction conditions was hypothesized to decrease when delta-beta tACS was delivered. As a control for the placebo effect of stimulation, the difference between delta-beta tACS and sham tACS, or placebo, was used for statistical analysis. | Description | The accuracy difference between high and low set-size conditions was hypothesized to decrease when theta-gamma tACS is delivered. As a control for the placebo effect of stimulation, the difference between theta-gamma tACS and sham tACS, or placebo, was used for statistical analysis. | Description | The accuracy difference between high and low set-size conditions was hypothesized to decrease when theta-gamma tACS is delivered. As a control for the placebo effect of stimulation, the difference between theta-gamma tACS and sham tACS, or placebo, was used for statistical analysis. | Description | The accuracy difference between high and low set-size conditions was hypothesized to decrease when theta-gamma tACS is delivered. As a control for the placebo effect of stimulation, the difference between theta-gamma tACS and sham tACS, or placebo, was used for statistical analysis. |
Units | seconds | Units | seconds | Units | seconds | Units | seconds | Units | seconds | Units | seconds | Units | Z-score | Units | Z-score | Units | Z-score | Units | Z-score | Units | Z-score | Units | Z-score | Units | percent correct | Units | percent correct | Units | percent correct | Units | percent correct | Units | percent correct | Units | percent correct |
Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean |
Param Value | 0.1247 | Param Value | 0.1444 | Param Value | 0.1022 | Param Value | 0.1905 | Param Value | 0.1853 | Param Value | 0.1888 | Param Value | -0.0873 | Param Value | 0.1123 | Param Value | -0.1250 | Param Value | 0.1615 | Param Value | 0.0706 | Param Value | 0.0577 | Param Value | 0.5661 | Param Value | -0.2944 | Param Value | 0.7246 | Param Value | -2.2871 | Param Value | -4.3252 | Param Value | -4.1667 |
Param Value Num | 0.1247 | Param Value Num | 0.1444 | Param Value Num | 0.1022 | Param Value Num | 0.1905 | Param Value Num | 0.1853 | Param Value Num | 0.1888 | Param Value Num | -0.0873 | Param Value Num | 0.1123 | Param Value Num | -0.125 | Param Value Num | 0.1615 | Param Value Num | 0.0706 | Param Value Num | 0.0577 | Param Value Num | 0.5661 | Param Value Num | -0.2944 | Param Value Num | 0.7246 | Param Value Num | -2.2871 | Param Value Num | -4.3252 | Param Value Num | -4.1667 |
Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation |
Dispersion Value | 0.0800 | Dispersion Value | 0.0832 | Dispersion Value | 0.0947 | Dispersion Value | 0.0676 | Dispersion Value | 0.1057 | Dispersion Value | 0.0760 | Dispersion Value | 0.3035 | Dispersion Value | 0.2939 | Dispersion Value | 0.2651 | Dispersion Value | 0.3563 | Dispersion Value | 0.3496 | Dispersion Value | 0.4043 | Dispersion Value | 3.1678 | Dispersion Value | 7.4718 | Dispersion Value | 6.6416 | Dispersion Value | 2.9242 | Dispersion Value | 6.8997 | Dispersion Value | 4.3264 |
Dispersion Value Num | 0.08 | Dispersion Value Num | 0.0832 | Dispersion Value Num | 0.0947 | Dispersion Value Num | 0.0676 | Dispersion Value Num | 0.1057 | Dispersion Value Num | 0.076 | Dispersion Value Num | 0.3035 | Dispersion Value Num | 0.2939 | Dispersion Value Num | 0.2651 | Dispersion Value Num | 0.3563 | Dispersion Value Num | 0.3496 | Dispersion Value Num | 0.4043 | Dispersion Value Num | 3.1678 | Dispersion Value Num | 7.4718 | Dispersion Value Num | 6.6416 | Dispersion Value Num | 2.9242 | Dispersion Value Num | 6.8997 | Dispersion Value Num | 4.3264 |
Study References
Sequence: | 51655900 |
Pmid | 33741402 |
Reference Type | derived |
Citation | Riddle J, McFerren A, Frohlich F. Causal role of cross-frequency coupling in distinct components of cognitive control. Prog Neurobiol. 2021 Jul;202:102033. doi: 10.1016/j.pneurobio.2021.102033. Epub 2021 Mar 16. |
Baseline Counts
Sequence: | 11314640 |
Result Group Id | 55825932 |
Ctgov Group Code | BG000 |
Units | Participants |
Scope | overall |
Count | 26 |
Result Groups
Sequence: | 55825934 | Sequence: | 55825935 | Sequence: | 55825932 | Sequence: | 55825933 | Sequence: | 55825936 | Sequence: | 55825937 | Sequence: | 55825938 | Sequence: | 55825939 | Sequence: | 55825940 | Sequence: | 55825941 | Sequence: | 55825942 | Sequence: | 55825943 | Sequence: | 55825944 |
Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | BG000 | Ctgov Group Code | FG000 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 |
Result Type | Participant Flow | Result Type | Participant Flow | Result Type | Baseline | Result Type | Participant Flow | Result Type | Participant Flow | Result Type | Participant Flow | Result Type | Participant Flow | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Reported Event | Result Type | Reported Event | Result Type | Reported Event |
Title | Theta-gamma, Sham, Delta-beta | Title | Delta-beta, Theta-gamma, Sham tACS | Title | All Participants | Title | Theta-gamma, Delta-beta, Sham | Title | Delta-beta, Sham, Theta-gamma tACS | Title | Sham, Delta-beta, Theta-gamma tACS | Title | Sham, Theta-gamma, Delta-beta tACS | Title | Theta-gamma tACS | Title | Delta-beta tACS | Title | Sham tACS | Title | Theta-gamma tACS | Title | Delta-beta tACS | Title | Sham tACS |
Description | Every participant will receive Theta-gamma tACS, Delta-beta tACS, and Sham tACS on separate sessions during performance of a computerized task.
Sequence: Theta-gamma tACS, then Sham tACS, then Delta-beta tACS Theta-gamma tACS: NeuroConn technologies, direct current-stimulator plus Delta-beta tACS: NeuroConn technologies, direct current-stimulator plus Sham tACS: NeuroConn technologies, direct current-stimulator plus |
Description | Every participant will receive Theta-gamma tACS, Delta-beta tACS, and Sham tACS on separate sessions during performance of a computerized task.
Sequence: Delta-beta tACS, then Theta-gamma tACS, then Sham tACS Theta-gamma tACS: NeuroConn technologies, direct current-stimulator plus Delta-beta tACS: NeuroConn technologies, direct current-stimulator plus Sham tACS: NeuroConn technologies, direct current-stimulator plus |
Description | Every participant will receive Theta-gamma tACS, Delta-beta tACS, and Sham tACS on separate sessions during performance of a computerized task. | Description | Every participant will receive Theta-gamma tACS, Delta-beta tACS, and Sham tACS on separate sessions during performance of a computerized task.
Sequence: Theta-gamma tACS, then Delta-beta tACS, then Sham tACS Theta-gamma tACS: NeuroConn technologies, direct current-stimulator plus Delta-beta tACS: NeuroConn technologies, direct current-stimulator plus Sham tACS: NeuroConn technologies, direct current-stimulator plus |
Description | Every participant will receive Theta-gamma tACS, Delta-beta tACS, and Sham tACS on separate sessions during performance of a computerized task.
Sequence: Delta-beta tACS, then Sham tACS, then Theta-gamma tACS Theta-gamma tACS: NeuroConn technologies, direct current-stimulator plus Delta-beta tACS: NeuroConn technologies, direct current-stimulator plus Sham tACS: NeuroConn technologies, direct current-stimulator plus |
Description | Every participant will receive Theta-gamma tACS, Delta-beta tACS, and Sham tACS on separate sessions during performance of a computerized task.
Sequence: Sham tACS, then Delta-beta tACS, then Theta-gamma tACS Theta-gamma tACS: NeuroConn technologies, direct current-stimulator plus Delta-beta tACS: NeuroConn technologies, direct current-stimulator plus Sham tACS: NeuroConn technologies, direct current-stimulator plus |
Description | Every participant will receive Theta-gamma tACS, Delta-beta tACS, and Sham tACS on separate sessions during performance of a computerized task.
Sequence: Sham tACS, then Theta-gamma tACS, then Delta-beta tACS Theta-gamma tACS: NeuroConn technologies, direct current-stimulator plus Delta-beta tACS: NeuroConn technologies, direct current-stimulator plus Sham tACS: NeuroConn technologies, direct current-stimulator plus |
Description | Every participant will receive Theta-gamma tACS during performance of a computerized task using NeuroConn technologies, direct current-stimulator plus | Description | Every participant will receive Delta-beta tACS during performance of a computerized task using NeuroConn technologies, direct current-stimulator plus | Description | Every participant will receive Sham tACS during performance of a computerized task using NeuroConn technologies, direct current-stimulator plus | Description | Every participant will receive Theta-gamma tACS during performance of a computerized task using NeuroConn technologies, direct current-stimulator plus | Description | Every participant will receive Delta-beta tACS during performance of a computerized task using NeuroConn technologies, direct current-stimulator plus | Description | Every participant will receive Sham tACS during performance of a computerized task using NeuroConn technologies, direct current-stimulator plus |
Baseline Measurements
Sequence: | 124852607 | Sequence: | 124852608 | Sequence: | 124852609 | Sequence: | 124852610 | Sequence: | 124852611 | Sequence: | 124852612 | Sequence: | 124852613 | Sequence: | 124852614 | Sequence: | 124852615 | Sequence: | 124852616 | Sequence: | 124852617 | Sequence: | 124852618 | Sequence: | 124852619 | Sequence: | 124852620 | Sequence: | 124852621 | Sequence: | 124852622 | Sequence: | 124852623 | Sequence: | 124852624 | Sequence: | 124852625 | Sequence: | 124852626 |
Result Group Id | 55825932 | Result Group Id | 55825932 | Result Group Id | 55825932 | Result Group Id | 55825932 | Result Group Id | 55825932 | Result Group Id | 55825932 | Result Group Id | 55825932 | Result Group Id | 55825932 | Result Group Id | 55825932 | Result Group Id | 55825932 | Result Group Id | 55825932 | Result Group Id | 55825932 | Result Group Id | 55825932 | Result Group Id | 55825932 | Result Group Id | 55825932 | Result Group Id | 55825932 | Result Group Id | 55825932 | Result Group Id | 55825932 | Result Group Id | 55825932 | Result Group Id | 55825932 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 |
Classification | United States | ||||||||||||||||||||||||||||||||||||||
Category | Female | Category | Male | Category | Hispanic or Latino | Category | Not Hispanic or Latino | Category | Unknown or Not Reported | Category | American Indian or Alaska Native | Category | Asian | Category | Native Hawaiian or Other Pacific Islander | Category | Black or African American | Category | White | Category | More than one race | Category | Unknown or Not Reported | ||||||||||||||||
Title | Age, Continuous | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Ethnicity (NIH/OMB) | Title | Ethnicity (NIH/OMB) | Title | Ethnicity (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Region of Enrollment | Title | Baseline Reaction Time Difference for Abstraction | Title | Baseline Reaction Time Difference for Set-Size | Title | Baseline Percent Correct Difference for Abstraction | Title | Baseline Percent Correct Difference for Set-Size | Title | Baseline Delta Phase to Beta Amplitude Coupling | Title | Theta Phase to Gamma Amplitude Coupling Strength |
Description | There are four task conditions in a two-by-two design for high and low set-size and high and low abstraction. The reaction time for both high abstraction conditions are averaged and the average reaction time for both low abstraction conditions is subtracted. Thus, a single reaction metric is derived that is the relative change in reaction time as a function of the abstraction of the task. | Description | There are four task conditions in a two-by-two design for high and low set-size and high and low abstraction. The reaction time for both high set-size conditions are averaged and the average reaction time for both low set-size conditions is subtracted. Thus, a single reaction metric is derived that is the relative change in reaction time as a function of the set-size of the task. | Description | There are four task conditions in a two-by-two design for high and low set-size and high and low abstraction. The percent correct for both high abstraction conditions are averaged and the average percent correct for both low abstraction conditions is subtracted. Thus, a single metric is derived that is the relative change in percent correct as a function of the abstraction of the task. | Description | There are four task conditions in a two-by-two design for high and low set-size and high and low abstraction. The percent correct for both high st-size conditions are averaged and the average percent correct for both low set-size conditions is subtracted. Thus, a single metric is derived that is the relative change in percent correct as a function of the set-size of the task. | Description | During resting-state EEG, the Hilbert transform is applied at delta (2-3 Hz) and beta (18-22 Hz) frequency band. The phase of delta and the amplitude of beta frequency oscillations are combined into a single hybrid signal. Then, this signal is averaged and the magnitude of the resulting vector is taken as the coupling strength. To account for spurious findings, a null distribution is calculated by randomly shifting the time series of amplitude values. The final coupling measure is z-transformed by subtracting the mean and dividing by the standard deviation of the null distribution. | Description | During resting-state EEG, the Hilbert transform is applied at theta (4-8 Hz) and gamma (30-50 Hz) frequency band. The phase of theta and the amplitude of gamma frequency oscillations are combined into a single hybrid signal. Then, this signal is averaged and the magnitude of the resulting vector is taken as the coupling strength. To account for spurious findings, a null distribution is calculated by randomly shifting the time series of amplitude values. The final coupling measure is z-transformed by subtracting the mean and dividing by the standard deviation of the null distribution. | ||||||||||||||||||||||||||||
Units | years | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | seconds | Units | seconds | Units | percent correct | Units | percent correct | Units | Z-score | Units | Z-score |
Param Type | Mean | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean |
Param Value | 19.654 | Param Value | 21 | Param Value | 5 | Param Value | 5 | Param Value | 17 | Param Value | 4 | Param Value | 0 | Param Value | 5 | Param Value | 1 | Param Value | 1 | Param Value | 15 | Param Value | 0 | Param Value | 4 | Param Value | 26 | Param Value | 0.1637 | Param Value | 0.2272 | Param Value | 0.0679 | Param Value | -1.0190 | Param Value | 0.0406 | Param Value | 0.0739 |
Param Value Num | 19.654 | Param Value Num | 21.0 | Param Value Num | 5.0 | Param Value Num | 5.0 | Param Value Num | 17.0 | Param Value Num | 4.0 | Param Value Num | 0.0 | Param Value Num | 5.0 | Param Value Num | 1.0 | Param Value Num | 1.0 | Param Value Num | 15.0 | Param Value Num | 0.0 | Param Value Num | 4.0 | Param Value Num | 26.0 | Param Value Num | 0.1637 | Param Value Num | 0.2272 | Param Value Num | 0.0679 | Param Value Num | -1.019 | Param Value Num | 0.0406 | Param Value Num | 0.0739 |
Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | ||||||||||||||||||||||||||
Dispersion Value | 1.4951 | Dispersion Value | 0.1012 | Dispersion Value | 0.0844 | Dispersion Value | 4.9692 | Dispersion Value | 4.4569 | Dispersion Value | 0.3232 | Dispersion Value | 0.4214 | ||||||||||||||||||||||||||
Dispersion Value Num | 1.4951 | Dispersion Value Num | 0.1012 | Dispersion Value Num | 0.0844 | Dispersion Value Num | 4.9692 | Dispersion Value Num | 4.4569 | Dispersion Value Num | 0.3232 | Dispersion Value Num | 0.4214 | ||||||||||||||||||||||||||
Number Analyzed | 26 | Number Analyzed | 26 | Number Analyzed | 26 | Number Analyzed | 26 | Number Analyzed | 26 | Number Analyzed | 26 | Number Analyzed | 26 | Number Analyzed | 26 | Number Analyzed | 26 | Number Analyzed | 26 | Number Analyzed | 26 | Number Analyzed | 26 | Number Analyzed | 26 | Number Analyzed | 26 | Number Analyzed | 26 | Number Analyzed | 26 | Number Analyzed | 26 | Number Analyzed | 26 | Number Analyzed | 26 | Number Analyzed | 26 |
Population Description | One participant excluded from behavioral analysis because they did not follow task instructions. Two participants did not complete the full study and thus were excluded from analysis. | Population Description | One participant excluded from behavioral analysis because they did not follow task instructions. Two participants did not complete the full study and thus were excluded from analysis. | Population Description | One participant excluded from behavioral analysis because they did not follow task instructions. Two participants did not complete the full study and thus were excluded from analysis. | Population Description | One participant excluded from behavioral analysis because they did not follow task instructions. Two participants did not complete the full study and thus were excluded from analysis. | Population Description | One participant excluded from behavioral analysis because they did not follow task instructions. Two participants did not complete the full study and thus were excluded from analysis. | Population Description | One participant excluded from behavioral analysis because they did not follow task instructions. Two participants did not complete the full study and thus were excluded from analysis. | ||||||||||||||||||||||||||||
]]>
https://zephyrnet.com/NCT03800017
2023-01-01
https://zephyrnet.com/?p=NCT03800017
NCT03800017https://www.clinicaltrials.gov/study/NCT03800017?tab=tableSatvir S Dhillon, MScSatvir.Dhillon@hli.ubc.ca1-604-806-8835Dyspnea (i.e. breathlessness) and exercise intolerance are common symptoms for patients with interstitial lung disease (ILD), yet it is not known why. It has been suggested that muscle dysfunction may contribute to dyspnea and exercise intolerance in ILD. Our study aims to: i) examine differences in the structure and function of the leg muscles in ILD patients, ii) determine if leg muscle fatigue contributes to dyspnea and exercise limitation in patients with ILD, and iii) determine the effects of breathing extra oxygen on leg muscle fatigue, as well as ability to exercise in ILD patients.
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Studies
Study First Submitted Date | 2018-11-21 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2022-11-03 |
Start Month Year | January 1, 2023 |
Primary Completion Month Year | December 31, 2024 |
Verification Month Year | November 2022 |
Verification Date | 2022-11-30 |
Last Update Posted Date | 2022-11-03 |
Detailed Descriptions
Sequence: | 20852142 |
Description | PURPOSE:
The primary purpose of the proposed work is to characterize skeletal muscle function in patients with interstitial lung disease (ILD), and to determine the physiological and sensory consequences of impaired skeletal muscle function in ILD during exercise. HYPOTHESES: The hypotheses are threefold; i) patients with ILD will have impaired skeletal muscle function when compared to healthy controls, ii) impairments in skeletal muscle function predispose ILD patients to exercise-induced quadriceps muscle fatigue, increase the perception of exertional dyspnea, as well as reduce exercise tolerance, and iii) delivery of supplemental oxygen during exercise mitigates exercise-induced quadriceps muscle fatigue, attenuates the perceived intensity of dyspnea, and improves exercise tolerance. OBJECTIVE: The objective of the proposed study is to comprehensively investigate skeletal muscle dysfunction in patients with ILD and characterize its impact on dyspnea and exercise tolerance. In doing so, the proposed work will be the first to comprehensively assess skeletal muscle function in patients with ILD as well as determine its functional consequences. The results will provide important insight into the putative role of skeletal muscle dysfunction on exercise limitation in patient with ILD. JUSTIFICATION: ILD refers to a diverse group of diseases that share common physiological characteristics resulting from inflammation and/or fibrosis of the lung parenchyma. ILD has an estimated prevalence of approximately 67-81 cases per 100 000 individuals. Given the heterogeneity of disease sub-types, it is difficult to determine a precise median survival for patients with ILD, however; in patients with idiopathic pulmonary fibrosis, the most common ILD sub-type, have a median survival of only 2-3 years from the time of diagnosis. For patients with ILD, dyspnea (i.e. breathlessness) is the most common symptom. Dyspnea can be extremely debilitating, particularly during physical exertion. The clinical significance of dyspnea in ILD is underscored by its strong correlation with quality of life and mortality. Patients attempt to minimize dyspnea by avoiding physical activity, resulting in deconditioning and an associated reduction in functional capacity. The importance of maintaining functional capacity is highlighted by the fact that ILD patients with the lowest physical activity levels have the lowest quality of life and the highest mortality. The effective management of dyspnea and exercise intolerance is therefore of critical importance when considering the management of patients with ILD. The pathophysiological mechanisms of dyspnea and exercise intolerance in ILD are complex, multifactorial, and poorly understood. Indeed, relatively few studies that have adequately investigated the mechanistic basis of dyspnea and exercise intolerance in patients with ILD. It is generally agreed upon that exercise limitation in ILD is related to the combination of altered respiratory mechanics, gas exchange impairment, and circulatory limitation. However, it is assumed that dyspnea and exercise intolerance are exclusively related to the respiratory and circulatory impairment associated with the pathogenesis of ILD. While this assumption is reasonable, it ignores the potentially crucial role of skeletal muscle dysfunction as a source of dyspnea and exercise intolerance. Recent experimental evidence indicates that skeletal muscle dysfunction contributes to both dyspnea and exercise intolerance in COPD. A growing body of literature supports the notion that skeletal muscle dysfunction is common in ILD. While the precise mechanisms remain unclear, several well-established skeletal muscle dysfunction-promoting factors are present in many ILD patients, including: chronic hypoxaemia, oxidative stress, pulmonary and systemic inflammation, physical deconditioning, malnutrition, and corticosteroid use. These factors may act individually or synergistically to impair skeletal muscle function by causing muscle atrophy, mitochondrial dysfunction, a reduction in type I muscle fibre proportion, and increases in intramuscular fat. To our knowledge, there is limited imaging data of skeletal muscle morphology in ILD, and assessments of skeletal muscle oxidative capacity, and contractile function have not been concurrently obtained. If present, skeletal muscle dysfunction likely reduces locomotor muscle oxidative capacity, leading to premature fatigue, increased dyspnea, and diminished exercise tolerance. Most importantly, there is no data on the physiological effects of skeletal muscle fatigue and dysfunction on dyspnea and exercise capacity nor whether targeted treatment options such as supplemental oxygen (O2) delivery can attenuate muscle fatigue. Accordingly, the aims of the proposed research are threefold: i) to characterize skeletal muscle function in patients with ILD compared to healthy controls, ii) to determine the influence of skeletal muscle dysfunction on dyspnea, fatigue, and exercise intolerance in patients with ILD compared to healthy controls, and iii) to determine if improving exercise tolerance using supplemental oxygen relieves exercise-induce skeletal muscle fatigue in ILD patients. RESEARCH DESIGN: Experimental hypotheses tested using combination of research designs. To test the hypotheses i) and ii), the investigators will use a cross sectional design. To test hypothesis iii), the investigators will use a single-blind placebo-controlled study design. METHODS Participants will report to the laboratory on four separate occasions separated by a minimum of 48 hours, and each visit will last ~2-3 hours. Visit 1: Participants will complete medical history screening, complete a series of questionnaires concerning chronic activity-related dyspnea, quality of life, and physical activity. Participants will then have their height and weight measured and perform pulmonary function testing. Finally, participants will perform a symptom limited incremental cycle exercise test. Detailed physiological and sensory measurements will be obtained immediately before and throughout the incremental cycle exercise test. Visit 1 will be intended to characterize participant's pulmonary function and exercise capacity. Visit 2: Participants will undergo a magnetic resonance imaging scan to assess the volume and the fat percentage of their quadriceps muscles They will then perform a series of tests aimed at evaluating their quadriceps muscle function, including: i) assessment of maximum voluntary quadriceps muscles strength, and ii) the non-invasive assessment of the oxidative capacity of their quadriceps muscle using near-infrared spectroscopy. Data from visit 2 will be used to address hypothesis 1 by characterizing participant's quadriceps muscle function. Visits 3: Participants will perform a constant-load exercise test to exhaustion while breathing ambient air (i.e., 20.93% oxygen). The work load will be set at 75% of the highest work rate achieved during the incremental exercise test performed during visit 1. Data from visits 3 and 4 will be used to address hypothesis 2 by characterizing the effect of exercise on skeletal muscle fatigue in patients with ILD and healthy controls. Visit 4: Participants will perform a constant-load exercise test while breathing supplemental oxygen (i.e., 60% oxygen). The work load will be set at 75% of the highest work rate achieved during the incremental exercise test performed during visit 1 and the test will be terminated once participants reach the same time that they achieved during the constant-load exercise test on Day 3. Data from visit 4 will be used to address hypothesis 3 by determining if supplemental oxygen can be used to alleviate exercise-induced skeletal muscle fatigue in patients with ILD and healthy controls. |
Conditions
Sequence: | 52507098 | Sequence: | 52507099 | Sequence: | 52507100 | Sequence: | 52507101 | Sequence: | 52507102 |
Name | Interstitial Lung Disease | Name | Idiopathic Pulmonary Fibrosis | Name | Hypersensitivity Pneumonitis | Name | Scleroderma | Name | Nonspecific Interstitial Pneumonia |
Downcase Name | interstitial lung disease | Downcase Name | idiopathic pulmonary fibrosis | Downcase Name | hypersensitivity pneumonitis | Downcase Name | scleroderma | Downcase Name | nonspecific interstitial pneumonia |
Id Information
Sequence: | 40398855 |
Id Source | org_study_id |
Id Value | H18-02059 |
Design Groups
Sequence: | 55963465 | Sequence: | 55963466 |
Group Type | Experimental | Group Type | Placebo Comparator |
Title | Hyperoxia | Title | Healthy Controls |
Description | During exercise on visit 4, participants in both groups (i.e., ILD patients and controls) will breathe supplemental oxygen (i.e., 60% oxygen) during constant-load exercise. | Description | During exercise on visit 3, participants in both groups (i.e., ILD patients and controls) will breathe ambient air (i.e., 20.93% oxygen) during constant-load exercise. |
Interventions
Sequence: | 52814977 |
Intervention Type | Biological |
Name | Hyperoxia |
Description | Participants breathe 60% oxygen during exercise |
Design Outcomes
Sequence: | 178629817 | Sequence: | 178629818 | Sequence: | 178629819 | Sequence: | 178629820 | Sequence: | 178629821 | Sequence: | 178629822 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Change in standardized dyspnea score during the constant load exercise test (visit 3) | Measure | Change in standardized dyspnea score during the constant load exercise test (visit 4) | Measure | Change in leg muscle strength measured following the constant load exercise test (visit 3) | Measure | Change in leg muscle strength measured following the constant load exercise test (visit 4) | Measure | Quadriceps muscle oxidative capacity measured using near-infrared spectroscopy | Measure | Quadriceps muscle volume measured using magnetic resonance imaging |
Time Frame | Dyspnea will be measured once every minute during exercise on visit 3 (up to 7 weeks after baseline) until participants reach volitional exhaustion (assessed for up to 30 minutes) | Time Frame | Dyspnea will be measured once every minute during exercise on visit 4 (up to 8 weeks after baseline) until participants reach volitional exhaustion (assessed for up to 30 minutes) | Time Frame | Leg muscle strength will be measured before and after exercise (assessed for up to 40 minutes) on visit 3 (up to 8 weeks after baseline) | Time Frame | Leg muscle strength will be measured before and after exercise (assessed for up to 40 minutes) on visit 4 (up to 8 weeks after baseline) | Time Frame | On visit 2, approximately 3 weeks post-baseline (visit 1) | Time Frame | On visit 2, approximately 3 weeks post-baseline (visit 1) |
Description | Dyspnea rating, measured using the Borg 0-10 category ratio scale, will be assessed every 1 minute during the constant-load exercise test on visit 3. | Description | Dyspnea rating, measured using the Borg 0-10 category ratio scale, will be assessed every 1 minute during the constant-load exercise test on visit 4. | Description | Leg muscle strength will be measured before (at rest) and 3 min after the constant-load exercise test on visit 3 using the femoral magnetic stimulation technique. | Description | Leg muscle strength will be measured before (at rest) and 3 min after the constant-load exercise test on visit 4 using the femoral magnetic stimulation technique. | Description | Quadriceps muscle oxidative capacity will measured using near-infrared spectroscopy. Parameters will be measured over 5 minutes once on visit 2 | Description | Quadriceps muscle volume will be measured using magnetic resonance imaging. Parameters will be measured over 15 minutes once on visit 2 |
Browse Conditions
Sequence: | 194767876 | Sequence: | 194767877 | Sequence: | 194767878 | Sequence: | 194767879 | Sequence: | 194767880 | Sequence: | 194767881 | Sequence: | 194767882 | Sequence: | 194767883 | Sequence: | 194767884 | Sequence: | 194767885 | Sequence: | 194767886 | Sequence: | 194767887 | Sequence: | 194767888 | Sequence: | 194767889 | Sequence: | 194767890 |
Mesh Term | Pneumonia | Mesh Term | Lung Diseases | Mesh Term | Pulmonary Fibrosis | Mesh Term | Idiopathic Pulmonary Fibrosis | Mesh Term | Lung Diseases, Interstitial | Mesh Term | Alveolitis, Extrinsic Allergic | Mesh Term | Hypersensitivity | Mesh Term | Fibrosis | Mesh Term | Pathologic Processes | Mesh Term | Respiratory Tract Infections | Mesh Term | Infections | Mesh Term | Respiratory Tract Diseases | Mesh Term | Immune System Diseases | Mesh Term | Respiratory Hypersensitivity | Mesh Term | Hypersensitivity, Immediate |
Downcase Mesh Term | pneumonia | Downcase Mesh Term | lung diseases | Downcase Mesh Term | pulmonary fibrosis | Downcase Mesh Term | idiopathic pulmonary fibrosis | Downcase Mesh Term | lung diseases, interstitial | Downcase Mesh Term | alveolitis, extrinsic allergic | Downcase Mesh Term | hypersensitivity | Downcase Mesh Term | fibrosis | Downcase Mesh Term | pathologic processes | Downcase Mesh Term | respiratory tract infections | Downcase Mesh Term | infections | Downcase Mesh Term | respiratory tract diseases | Downcase Mesh Term | immune system diseases | Downcase Mesh Term | respiratory hypersensitivity | Downcase Mesh Term | hypersensitivity, immediate |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48630120 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | University of British Columbia |
Overall Officials
Sequence: | 29460589 |
Role | Principal Investigator |
Name | Jordan A Guenette, PhD |
Affiliation | University of British Columbia |
Central Contacts
Sequence: | 12095056 | Sequence: | 12095057 |
Contact Type | primary | Contact Type | backup |
Name | Yannick Molgat-seon, PhD | Name | Satvir S Dhillon, MSc |
Phone | 1-604-682-2344 | Phone | 1-604-806-8835 |
yannick.molgat-seon@hli.ubc.ca | Satvir.Dhillon@hli.ubc.ca | ||
Phone Extension | 63258 | ||
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 68606541 | Sequence: | 68606542 |
Design Group Id | 55963466 | Design Group Id | 55963465 |
Intervention Id | 52814977 | Intervention Id | 52814977 |
Eligibilities
Sequence: | 30956773 |
Gender | All |
Minimum Age | 40 Years |
Maximum Age | 80 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria for ILD Patients:
Age 40-80 years (inclusive) Inclusion Criteria for Healthy Controls: Age 40-80 (inclusive) Exclusion Criteria for the ILD patients: Contraindication to exercise testing (e.g. significant cardiovascular, musculoskeletal, neurological disease) Exclusion Criteria for Healthy Controls: Currently smoking or previously smoked more than 10 pack-years |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253953517 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Single Facility | False |
Minimum Age Num | 40 |
Maximum Age Num | 80 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 4 |
Number Of Secondary Outcomes To Measure | 2 |
Designs
Sequence: | 30702349 |
Allocation | Non-Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Basic Science |
Time Perspective | |
Masking | Single |
Subject Masked | True |
Responsible Parties
Sequence: | 29069116 |
Responsible Party Type | Principal Investigator |
Name | Jordan Guenette |
Title | Associate Professor |
Affiliation | University of British Columbia |
]]>
https://zephyrnet.com/NCT03800004
2018-07-30
https://zephyrnet.com/?p=NCT03800004
NCT03800004https://www.clinicaltrials.gov/study/NCT03800004?tab=tableKatrina PiercePierce.Katrina@mayo.edu507-266-1078This study examines the bone health in children with atopic dermatitis
<![CDATA[
Studies
Study First Submitted Date | 2019-01-08 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2023-03-01 |
Start Month Year | July 30, 2018 |
Primary Completion Month Year | December 2024 |
Verification Month Year | February 2023 |
Verification Date | 2023-02-28 |
Last Update Posted Date | 2023-03-01 |
Detailed Descriptions
Sequence: | 20574452 |
Description | The goal of this study is to objectively evaluate bone health and contributing factors in children with AD. This will be compared with existing normative data. Such an objective prospective study, directly looking at bone health in children has not yet been done. This will be done using bone densitometry (DXA) and high-resolution peripheral quantitative computed tomography (HR-pQCT) for the accurate and precise measurement of bone health status. HR-pQCT is a cutting-edge technology available at only at a few academic centers in the United States that is used to measure bone strength with minimal doses of radiation. In addition, blood and urine metabolic parameters related to bone health will be analyzed, and data will be correlated with eczema severity. The results from this study will allow us to design large-scale, multi-institutional studies on bone health in this population and ultimately to guide decision making in children who may be at risk specifically regarding treatment recommendations and supportive care.
The specific aims of this project are: To determine bone mineral density (BMD) and cortical and trabecular bone strength in children with atopic dermatitis, using DXA and to compare this with normative data. |
Facilities
Sequence: | 198634213 |
Status | Recruiting |
Name | Mayo Clinic |
City | Rochester |
State | Minnesota |
Zip | 55906 |
Country | United States |
Facility Contacts
Sequence: | 27942023 | Sequence: | 27942024 |
Facility Id | 198634213 | Facility Id | 198634213 |
Contact Type | primary | Contact Type | backup |
Name | Henry Nguyen, MD | Name | Katrina Pierce |
Nguyen.Henry@mayo.edu | pierce.katrina@mayo.edu | ||
Phone | 507-284-4673 | Phone | 507-266-1078 |
Facility Investigators
Sequence: | 18227991 |
Facility Id | 198634213 |
Role | Principal Investigator |
Name | Megha M Tollefson, MD |
Conditions
Sequence: | 51791193 | Sequence: | 51791192 |
Name | Eczema | Name | Atopic Dermatitis |
Downcase Name | eczema | Downcase Name | atopic dermatitis |
Id Information
Sequence: | 39856314 |
Id Source | org_study_id |
Id Value | 17-007112 |
Countries
Sequence: | 42254742 |
Name | United States |
Removed | False |
Keywords
Sequence: | 79244741 |
Name | Bone Health |
Downcase Name | bone health |
Design Outcomes
Sequence: | 176155987 | Sequence: | 176155988 | Sequence: | 176155989 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary |
Measure | Correlate bone mineral density to normative data | Measure | Correlate bone age with the Eczema area and severity index and the Scoring atopic dermatitis score | Measure | Correlate bone age with serum markers |
Time Frame | 2 years | Time Frame | 2 years | Time Frame | 2 years |
Description | To determine bone mineral density (BMD) and cortical and trabecular bone strength in children with atopic dermatitis, using dual energy x-ray absorptiometry (DXA) and High-resolution peripheral quantitative computed tomography (HR-pQCT) and to compare this with normative data. | Description | To correlate bone mineral density with eczema severity using Eczema area and severity index (EASI) and Scoring atopic dermatitis (SCORAD) scores | Description | To determine if bone mineral density in children with atopic dermatitis correlates with bone age and bone-health specific serum markers |
Browse Conditions
Sequence: | 191956395 | Sequence: | 191956401 | Sequence: | 191956394 | Sequence: | 191956396 | Sequence: | 191956397 | Sequence: | 191956398 | Sequence: | 191956399 | Sequence: | 191956400 | Sequence: | 191956402 | Sequence: | 191956403 |
Mesh Term | Dermatitis | Mesh Term | Hypersensitivity, Immediate | Mesh Term | Dermatitis, Atopic | Mesh Term | Eczema | Mesh Term | Skin Diseases | Mesh Term | Skin Diseases, Genetic | Mesh Term | Genetic Diseases, Inborn | Mesh Term | Skin Diseases, Eczematous | Mesh Term | Hypersensitivity | Mesh Term | Immune System Diseases |
Downcase Mesh Term | dermatitis | Downcase Mesh Term | hypersensitivity, immediate | Downcase Mesh Term | dermatitis, atopic | Downcase Mesh Term | eczema | Downcase Mesh Term | skin diseases | Downcase Mesh Term | skin diseases, genetic | Downcase Mesh Term | genetic diseases, inborn | Downcase Mesh Term | skin diseases, eczematous | Downcase Mesh Term | hypersensitivity | Downcase Mesh Term | immune system diseases |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 47964981 | Sequence: | 47964982 |
Agency Class | OTHER | Agency Class | UNKNOWN |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | Mayo Clinic | Name | Pediatric Dermatology Research Alliance |
Overall Officials
Sequence: | 29061061 | Sequence: | 29061062 |
Role | Principal Investigator | Role | Study Director |
Name | Megha M Tollefson, MD | Name | Henry Nguyen, MD |
Affiliation | Mayo Clinic | Affiliation | Mayo Clinic |
Central Contacts
Sequence: | 11932090 | Sequence: | 11932091 |
Contact Type | primary | Contact Type | backup |
Name | Henry Nguyen, MD | Name | Katrina Pierce |
Phone | 507-284-4673 | Phone | 507-266-1078 |
Nguyen.Henry@mayo.edu | Pierce.Katrina@mayo.edu | ||
Role | Contact | Role | Contact |
Eligibilities
Sequence: | 30542319 |
Sampling Method | Probability Sample |
Gender | All |
Minimum Age | 5 Years |
Maximum Age | 17 Years |
Healthy Volunteers | No |
Population | Children with a diagnosis of moderate to severe atopic dermatitis as made by a dermatologist |
Criteria | Inclusion Criteria:
Children 5 to 17 years of age with a diagnosis of moderate to severe atopic dermatitis as made by a dermatologist Exclusion Criteria: Those without a confirmed diagnosis of moderate to severe atopic dermatitis |
Adult | False |
Child | True |
Older Adult | False |
Calculated Values
Sequence: | 254209554 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 5 |
Maximum Age Num | 17 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 3 |
Designs
Sequence: | 30290829 |
Observational Model | Cohort |
Time Perspective | Prospective |
Links
Sequence: | 4355635 |
Url | https://www.mayo.edu/research/clinical-trials |
Description | Mayo Clinic Clinical Trials |
Responsible Parties
Sequence: | 28669626 |
Responsible Party Type | Principal Investigator |
Name | Megha M. Tollefson, M.D. |
Title | Principal Investigator |
Affiliation | Mayo Clinic |
Study References
Sequence: | 51686565 | Sequence: | 51686566 | Sequence: | 51686567 | Sequence: | 51686568 |
Pmid | 25353616 | Pmid | 19673879 | Pmid | 20850893 | Pmid | 28207767 |
Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background |
Citation | Garg N, Silverberg JI. Association between eczema and increased fracture and bone or joint injury in adults: a US population-based study. JAMA Dermatol. 2015 Jan;151(1):33-41. doi: 10.1001/jamadermatol.2014.2098. | Citation | Haeck IM, Hamdy NA, Timmer-de Mik L, Lentjes EG, Verhaar HJ, Knol MJ, de Bruin-Weller MS, Bruijnzeel-Koomen CA. Low bone mineral density in adult patients with moderate to severe atopic dermatitis. Br J Dermatol. 2009 Dec;161(6):1248-54. doi: 10.1111/j.1365-2133.2009.09327.x. Epub 2009 Jun 4. | Citation | van Velsen SG, Knol MJ, van Eijk RL, de Vroede MA, de Wit TC, Lam MG, Haeck IM, de Bruin-Weller MS, Bruijnzeel-Koomen CA, Pasmans SG. Bone mineral density in children with moderate to severe atopic dermatitis. J Am Acad Dermatol. 2010 Nov;63(5):824-31. doi: 10.1016/j.jaad.2009.12.015. Epub 2010 Sep 17. | Citation | Wu CY, Lu YY, Lu CC, Su YF, Tsai TH, Wu CH. Osteoporosis in adult patients with atopic dermatitis: A nationwide population-based study. PLoS One. 2017 Feb 16;12(2):e0171667. doi: 10.1371/journal.pone.0171667. eCollection 2017. |
]]>
https://zephyrnet.com/NCT03799991
2021-03-01
https://zephyrnet.com/?p=NCT03799991
NCT03799991https://www.clinicaltrials.gov/study/NCT03799991?tab=tableYuri Agrawal, MDyagrawa1@jhmi.edu4105023107Nearly 2 out of 3 patients with Alzheimer’s disease (AD) experience problems with balance and mobility, which places such patients at increased risk of falling. The vestibular (inner ear balance) system plays an important role in balance stability, and vestibular therapy (VT) is well-known to improve balance function in healthy older adults. In this study, the investigators will conduct a first-in-kind randomized clinical trial to evaluate whether vestibular therapy improves reduces falls in patients with AD, in whom this treatment has never been studied.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-08 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2022-12-14 |
Start Month Year | March 1, 2021 |
Primary Completion Month Year | June 30, 2024 |
Verification Month Year | December 2022 |
Verification Date | 2022-12-31 |
Last Update Posted Date | 2022-12-14 |
Facilities
Sequence: | 200962641 |
Status | Recruiting |
Name | Johns Hopkins University School of Medicine |
City | Baltimore |
State | Maryland |
Zip | 21287 |
Country | United States |
Facility Contacts
Sequence: | 28246642 |
Facility Id | 200962641 |
Contact Type | primary |
Name | Yuri Agrawal |
Facility Investigators
Sequence: | 18419491 |
Facility Id | 200962641 |
Role | Principal Investigator |
Name | John Carey, MD |
Conditions
Sequence: | 52421116 | Sequence: | 52421117 | Sequence: | 52421118 |
Name | Vestibular Diseases | Name | Vestibular Disorder | Name | Alzheimer Disease |
Downcase Name | vestibular diseases | Downcase Name | vestibular disorder | Downcase Name | alzheimer disease |
Id Information
Sequence: | 40335745 |
Id Source | org_study_id |
Id Value | IRB00273752 |
Countries
Sequence: | 42763393 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55870259 | Sequence: | 55870260 |
Group Type | Experimental | Group Type | Active Comparator |
Title | Vestibular therapy | Title | Active control |
Description | Vestibular therapy (Vestibular physical therapy) entails an 8-week course of exercises delivered by a physical therapist designed to improve vestibular function. | Description | The active control regimen consists of eye movement exercises (e.g. smooth pursuit eye movements) and also general conditioning exercises (e.g. range of motion exercises, lifting light weights with the arms and legs). This regimen is "vestibular neutral" in that head movements which specifically challenge the vestibular system are avoided. |
Interventions
Sequence: | 52729826 | Sequence: | 52729827 |
Intervention Type | Behavioral | Intervention Type | Behavioral |
Name | Vestibular physical therapy | Name | Active control |
Description | Vestibular therapy is a set of exercises delivered by a physical therapist involving head movements. The therapy is delivered over a course of 8 weeks. | Description | Strength and flexibility exercises that do not involve head movements. |
Design Outcomes
Sequence: | 178312633 |
Outcome Type | primary |
Measure | Number of participant falls |
Time Frame | 1 year |
Description | Incidence of falls over a 1-year follow-up period |
Browse Conditions
Sequence: | 194435913 | Sequence: | 194435914 | Sequence: | 194435915 | Sequence: | 194435916 | Sequence: | 194435917 | Sequence: | 194435918 | Sequence: | 194435919 | Sequence: | 194435920 | Sequence: | 194435921 | Sequence: | 194435922 | Sequence: | 194435923 | Sequence: | 194435924 | Sequence: | 194435925 |
Mesh Term | Vestibular Diseases | Mesh Term | Alzheimer Disease | Mesh Term | Dementia | Mesh Term | Brain Diseases | Mesh Term | Central Nervous System Diseases | Mesh Term | Nervous System Diseases | Mesh Term | Tauopathies | Mesh Term | Neurodegenerative Diseases | Mesh Term | Neurocognitive Disorders | Mesh Term | Mental Disorders | Mesh Term | Labyrinth Diseases | Mesh Term | Ear Diseases | Mesh Term | Otorhinolaryngologic Diseases |
Downcase Mesh Term | vestibular diseases | Downcase Mesh Term | alzheimer disease | Downcase Mesh Term | dementia | Downcase Mesh Term | brain diseases | Downcase Mesh Term | central nervous system diseases | Downcase Mesh Term | nervous system diseases | Downcase Mesh Term | tauopathies | Downcase Mesh Term | neurodegenerative diseases | Downcase Mesh Term | neurocognitive disorders | Downcase Mesh Term | mental disorders | Downcase Mesh Term | labyrinth diseases | Downcase Mesh Term | ear diseases | Downcase Mesh Term | otorhinolaryngologic diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48551044 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Johns Hopkins University |
Overall Officials
Sequence: | 29414995 |
Role | Principal Investigator |
Name | Yuri Agrawal, MD |
Affiliation | Johns Hopkins University |
Central Contacts
Sequence: | 12074544 |
Contact Type | primary |
Name | Yuri Agrawal, MD |
Phone | 4105023107 |
yagrawa1@jhmi.edu | |
Role | Contact |
Design Group Interventions
Sequence: | 68489214 | Sequence: | 68489215 |
Design Group Id | 55870259 | Design Group Id | 55870260 |
Intervention Id | 52729826 | Intervention Id | 52729827 |
Eligibilities
Sequence: | 30908871 |
Gender | All |
Minimum Age | 60 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Diagnosis of AD based on the National Institute on Aging-Alzheimer Association 2011 criteria that is mild-moderate (CDR=0.5-2). Exclusion Criteria: Diagnosis of severe AD (CDR≥3). |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254168668 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 60 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Designs
Sequence: | 30654582 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Triple |
Subject Masked | True |
Investigator Masked | True |
Outcomes Assessor Masked | True |
Responsible Parties
Sequence: | 29021238 |
Responsible Party Type | Sponsor |
Study References
Sequence: | 52331765 |
Pmid | 35918757 |
Reference Type | derived |
Citation | Yesantharao LV, Rosenberg P, Oh E, Leoutsakos J, Munro CA, Agrawal Y. Vestibular therapy to reduce falls in people with Alzheimer's disease: study protocol for a pilot randomized controlled trial. Pilot Feasibility Stud. 2022 Aug 2;8(1):167. doi: 10.1186/s40814-022-01133-w. |
]]>
https://zephyrnet.com/NCT03799978
2019-03-09
https://zephyrnet.com/?p=NCT03799978
NCT03799978https://www.clinicaltrials.gov/study/NCT03799978?tab=tableNANANAThis is a single-center, open-label, randomized, two way crossover study to investigate the food effect on the pharmacokinetics of ACT-541468 in healthy male subjects.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-08 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2019-04-12 |
Start Month Year | March 9, 2019 |
Primary Completion Month Year | March 18, 2019 |
Verification Month Year | April 2019 |
Verification Date | 2019-04-30 |
Last Update Posted Date | 2019-04-12 |
Facilities
Sequence: | 199964474 |
Name | CEPHA s.r.o. |
City | Pilsen |
Zip | 323 00 |
Country | Czechia |
Conditions
Sequence: | 52138949 |
Name | Healthy |
Downcase Name | healthy |
Id Information
Sequence: | 40135017 |
Id Source | org_study_id |
Id Value | ID-078-113 |
Countries
Sequence: | 42542638 |
Name | Czechia |
Removed | False |
Design Groups
Sequence: | 55559285 | Sequence: | 55559286 |
Group Type | Experimental | Group Type | Experimental |
Title | Treatment A: ACT-541468 50 mg under fasted conditions | Title | Treatment B: ACT-541468 50 mg under fed conditions |
Description | Single oral dose administered on Day 1 under fasted conditions. | Description | Single oral dose administered on Day 1 administered after food intake. |
Interventions
Sequence: | 52454849 |
Intervention Type | Drug |
Name | ACT-541468 |
Description | ACT-541468 50 mg film-coated tablets |
Design Outcomes
Sequence: | 177263386 | Sequence: | 177263385 | Sequence: | 177263387 | Sequence: | 177263388 | Sequence: | 177263389 | Sequence: | 177263390 | Sequence: | 177263391 |
Outcome Type | other | Outcome Type | primary | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other |
Measure | Pharmacokinetic endpoint: AUC0-inf | Measure | Pharmacokinetic endpoint: AUC0-24 | Measure | Pharmacokinetic endpoint: Cmax | Measure | Pharmacokinetic endpoint: tmax | Measure | Pharmacokinetic endpoint: t½ | Measure | Treatment-emergent adverse events | Measure | Serious treatment-emergent adverse events |
Time Frame | Multiple timepoints; duration: up to 48 hours in each treatment period | Time Frame | Multiple timepoints; duration: up to 48 hours in each treatment period | Time Frame | Multiple timepoints; duration: up to 48 hours in each treatment period | Time Frame | Multiple timepoints; duration: up to 48 hours in each treatment period | Time Frame | Multiple timepoints; duration: up to 48 hours in each treatment period | Time Frame | From study treatment administration up to EOT; duration: up to 48 hours in each treatment period | Time Frame | From study treatment administration up to EOT; duration: up to 48 hours in each treatment period |
Description | AUC from time zero to infinity | Description | Area under the plasma concentration-time curve (AUC) from time zero to 24 h | Description | Maximum plasma concentration | Description | Time to reach maximum plasma concentration | Description | Terminal elimination half-life |
Sponsors
Sequence: | 48290664 |
Agency Class | INDUSTRY |
Lead Or Collaborator | lead |
Name | Idorsia Pharmaceuticals Ltd. |
Overall Officials
Sequence: | 29268505 |
Role | Study Director |
Name | Clinical Trials |
Affiliation | Idorsia Pharmaceuticals Ltd. |
Design Group Interventions
Sequence: | 68107376 | Sequence: | 68107377 |
Design Group Id | 55559285 | Design Group Id | 55559286 |
Intervention Id | 52454849 | Intervention Id | 52454849 |
Eligibilities
Sequence: | 30747691 |
Gender | Male |
Minimum Age | 18 Years |
Maximum Age | 45 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
Signed informed consent prior to any study-mandated procedure Exclusion Criteria: History of major medical or surgical disorders, which, in the opinion of the investigator, are likely to interfere with the absorption, distribution, metabolism, or excretion of the study treatments (appendectomy and herniotomy allowed, cholecystectomy not allowed) |
Adult | True |
Child | False |
Older Adult | False |
Calculated Values
Sequence: | 254121761 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 0 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 45 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Other Outcomes To Measure | 6 |
Designs
Sequence: | 30493974 |
Allocation | Randomized |
Intervention Model | Crossover Assignment |
Observational Model | |
Primary Purpose | Other |
Time Perspective | |
Masking | None (Open Label) |
Intervention Model Description | Two way crossover |
Responsible Parties
Sequence: | 28860254 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03799965
2017-12-01
https://zephyrnet.com/?p=NCT03799965
NCT03799965https://www.clinicaltrials.gov/study/NCT03799965?tab=tableemine yurt, doctordremine@gmail.com+905054782609Investigation of the effect of Enhanced Recovery After Surgery (ERAS) program on postoperative results of patients operated for open heart surgery.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-30 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2019-01-31 |
Start Month Year | December 1, 2017 |
Primary Completion Month Year | January 1, 2019 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-31 |
Detailed Descriptions
Sequence: | 20727159 |
Description | The ERAS protocol, also known as evidence based "fast-track surgery" (FTS), is an evidence based combination of findings regarding suggestions for patient care on various levels of the perioperative period, which work in synergy for accelerating the postoperative recovery period. It has been used sucessfully for many surgical disciplines, primarily colorectal surgery, since it was first reported in 1997. However, there is a significant insufficiency of this patient oriented rehabilitation program regarding cardiovascular surgeries. This study is to compare the postoperative follow up periods of patients with ERAS protocol and patients with standard protocol who were both operated for cardiac surgery.
Following approval of the local ethics committee, 210 patients who are operated for elective cardiac surgery are enrolled in this prospective randomized clinical trial. The patients who are not applied the ERAS protocol are evaluated in the control group (n=51). The findings regarding the patients under ERAS protocol are evaluated based on evidence. Our primary is to compare the durations of stay in the intensive care unit and in hospital; our secondary is to compare the incidences of complications of the groups. The demographic data, operative measurements, complication rates, the amounts of perioperative bleeding and drainage and the duration of stay in the intensive care unit and hospital are recorded. |
Facilities
Sequence: | 200159267 |
Status | Recruiting |
Name | Emine yurt |
City | Kocaeli |
State | Derince |
Zip | 41400 |
Country | Turkey |
Facility Contacts
Sequence: | 28113717 | Sequence: | 28113718 |
Facility Id | 200159267 | Facility Id | 200159267 |
Contact Type | primary | Contact Type | backup |
Name | ipek y duzyol, doctor | Name | emine yurt, doctor |
ipekyd@hotmail.com | dremine@gmail.com | ||
Phone | +905067922217 | Phone | +905054782609 |
Conditions
Sequence: | 52185435 | Sequence: | 52185436 |
Name | Enhanced Recovery After Surgery | Name | Open Heart Surgery |
Downcase Name | enhanced recovery after surgery | Downcase Name | open heart surgery |
Id Information
Sequence: | 40169040 |
Id Source | org_study_id |
Id Value | KUGOKAEK 2017/369 |
Countries
Sequence: | 42580633 |
Name | Turkey |
Removed | False |
Design Groups
Sequence: | 55609067 | Sequence: | 55609068 |
Group Type | Active Comparator | Group Type | Active Comparator |
Title | ERAS protocol are evaluated | Title | ERAS protocol are not evaluated |
Description | It is to compare the durations of stay in the intensive care unit and in hospital It is to compare the incidences of complications of the groups |
Description | It is to compare the durations of stay in the intensive care unit and in hospital It is to compare the incidences of complications of the groups |
Interventions
Sequence: | 52499380 | Sequence: | 52499381 |
Intervention Type | Other | Intervention Type | Other |
Name | ERAS (Enhanced Recovery After Surgery ) are evaluated | Name | ERAS are not evaluated |
Description | In this arm ERAS( Enhanced Recovery After Surgery) protocol will be inserted.The findings regarding the patients under ERAS protocol are evaluated based on evidence. | Description | In this arm ERAS( Enhanced Recovery After Surgery) protocol will not be inserted.The findings regarding the patients under ERAS protocol are evaluated based on evidence. |
Design Outcomes
Sequence: | 177431890 | Sequence: | 177431891 |
Outcome Type | primary | Outcome Type | primary |
Measure | durations of stay | Measure | complications |
Time Frame | 24 hours | Time Frame | 24 hours |
Description | compare the durations of stay in the intensive care unit and in hospital | Description | compare the incidences of complications |
Sponsors
Sequence: | 48332280 | Sequence: | 48332281 |
Agency Class | OTHER | Agency Class | OTHER |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | Kocaeli Derince Education and Research Hospital | Name | Kocaeli University |
Central Contacts
Sequence: | 12012290 | Sequence: | 12012291 |
Contact Type | primary | Contact Type | backup |
Name | Ipek Y duzyol, doctor | Name | emine yurt, doctor |
Phone | +905067922217 | Phone | +905054782609 |
ipekyd@hotmail.com | dremine@gmail.com | ||
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 68168115 | Sequence: | 68168116 |
Design Group Id | 55609067 | Design Group Id | 55609068 |
Intervention Id | 52499380 | Intervention Id | 52499381 |
Eligibilities
Sequence: | 30773549 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
over 18 years old; Exclusion Criteria: Patients who refuse to participate in the study; |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253952598 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 13 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 2 |
Designs
Sequence: | 30519680 |
Allocation | Randomized |
Intervention Model | Crossover Assignment |
Observational Model | |
Primary Purpose | Other |
Time Perspective | |
Masking | Double |
Subject Masked | True |
Investigator Masked | True |
Responsible Parties
Sequence: | 28885981 |
Responsible Party Type | Principal Investigator |
Name | Ipek Yakin Duzyol |
Title | specialist doctor |
Affiliation | Kocaeli Derince Education and Research Hospital |
]]>
https://zephyrnet.com/NCT03799952
2019-02-07
https://zephyrnet.com/?p=NCT03799952
NCT03799952https://www.clinicaltrials.gov/study/NCT03799952?tab=tableNANANAThe objective of this study is to recruit a group of older adults and study a broad set of physical health, mental health, and social outcomes when participants exercise with an older adult, peer-led exercise program.
The program to be evaluated is called Zoomers on the Go. It is a 12-week program which involves two 60-minute sessions per week and educates participants about falls, along with aerobic and resistance exercise, flexibility, and balance activities. The program is offered to older adults (age 50+) and it is delivered in their community by an older adult who is trained as a certified Zoomers group exercise leader.
Participants will be recruited, then randomized so that half of them can participate in a Zoomers class in the spring (intervention group) while half will have to wait until the fall of 2019 (control group). Pre-testing for both groups will begin around March 2019. The intervention group will participate in the program for 12 weeks, then there will be post-testing following this 12-weeks for both groups. Outcomes will be compared for the intervention and control groups, to determine if there are changes in the data pre- to post-measurements that are evident solely for the intervention group.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-20 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2021-07-14 |
Start Month Year | February 7, 2019 |
Primary Completion Month Year | November 28, 2019 |
Verification Month Year | July 2021 |
Verification Date | 2021-07-31 |
Last Update Posted Date | 2021-07-14 |
Results First Posted Date | 2021-07-14 |
Detailed Descriptions
Sequence: | 20713083 |
Description | This study is a randomized control trial where subjects will be randomly assigned to a control or an intervention group. Participants will be recruited through general advertisements (e.g. radio, newspaper, posters), in Fredericton and surrounding areas. These participants will be volunteers, and no compensation will be provided besides having access to a free exercise program in their community. Eligibility will be determined by the research staff prior to the baseline assessment day.Eligible participants will be evaluated at an initial day of testing at either a Horizon CommunityHealth Centre or at the University of New Brunswick in the Cardiometabolic Exercise and Lifestyle Laboratory (CELLab). This first visit will involve the confirmation of eligibility, reading and signing a consent form, and the administration of the measurements discussed previously. All research staff will have received the appropriate training to deliver these fitness assessments, finger pricks, and interviews.
At the end of the baseline visit, research staff will randomly assign participants to the intervention or control group. The participant will wear a pedometer for seven consecutive days following this initial visit. The paper form for any information collected (e.g. consent form) will be stored in the CELLab at UNB in a locked cabinet. The CELLab has limited access; only staff has access through a password to the lab. All information will be linked to a participant number for which the only linkable personal information (e.g., name, age, sex) will be kept in a password protected computer and only the Principal Investigator, Co-Investigators, and Research Coordinator will have access to this information. Information will be stored for a maximum of 7 years. Following this baseline assessment, participants in the intervention group will be assigned to an exercise program most convenient to them. This is a 12-week exercise program, offered twice a week. Full attendance is not mandatory for being a participant. This is a peer-led exercise program, meaning it is instructed by a leader of similar age. This leader has received extensive Fitness New Brunswick training to deliver a program aimed to reduce the risk of falls and help older adults safely increase their physical activity levels. This 60-minute exercise program involves aerobic and resistance exercise, as well as flexibility and balance activities. The program is currently designed to help individuals meet the physical activity guidelines. Participants' numbers will be used to register attendance from the leaders. Following this 12-week intervention or control period, participants will repeat all the baseline assessments (including questionnaires and interviews), with an exception that they will not have to wear the pedometer in the follow up visit. The primary objective will be to determine whether participants' experiences with the program were positive or negative, and specifically identifying participants' attributions of why/how the exercise intervention positively impacted their physical and/or mental health. |
Facilities
Sequence: | 200013871 |
Name | Kinesiology Building |
City | Fredericton |
State | New Brunswick |
Zip | E3B 5A3 |
Country | Canada |
Conditions
Sequence: | 52147766 | Sequence: | 52147767 |
Name | Aging | Name | Fall |
Downcase Name | aging | Downcase Name | fall |
Id Information
Sequence: | 40141580 |
Id Source | org_study_id |
Id Value | 2019-01Zoom |
Countries
Sequence: | 42550768 |
Name | Canada |
Removed | False |
Design Groups
Sequence: | 55568470 | Sequence: | 55568471 |
Group Type | Experimental | Group Type | No Intervention |
Title | Intervention | Title | Control |
Description | Participants are offered to attend a 12-week exercise program, classes offered twice a week, each class 60 minutes in length. | Description | Participants are instructed to continue with their daily activities and their "normal" physical activity levels for 12-weeks. |
Interventions
Sequence: | 52463575 |
Intervention Type | Behavioral |
Name | Zoomers on the Go Exercise Program |
Description | 60 minute exercise class involving resistance and aerobic training activities, as well as flexibility and balance activities. An educational handout is offered at the end of every class, relating to health behaviour. |
Keywords
Sequence: | 79834602 | Sequence: | 79834603 | Sequence: | 79834604 |
Name | Older adult | Name | Peer-led exercise program | Name | Risk of falling |
Downcase Name | older adult | Downcase Name | peer-led exercise program | Downcase Name | risk of falling |
Design Outcomes
Sequence: | 177297610 | Sequence: | 177297611 | Sequence: | 177297612 | Sequence: | 177297613 | Sequence: | 177297614 | Sequence: | 177297615 | Sequence: | 177297616 | Sequence: | 177297617 | Sequence: | 177297618 | Sequence: | 177297619 | Sequence: | 177297620 | Sequence: | 177297621 | Sequence: | 177297622 | Sequence: | 177297623 | Sequence: | 177297624 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other |
Measure | Balance | Measure | Walking Speed | Measure | Flexibility | Measure | Strength, Arm Curl Test | Measure | Strength, Chair Stand Test | Measure | Depression, Anxiety, Stress | Measure | Perceived Quality of Life | Measure | Researcher-generated Measure of Exercise Self-efficacy Based on Bandura's Concept of Self-efficacy | Measure | Connectedness, Sense of Belonging, and Friendships | Measure | The Amount of Bodily Sway When Performing Tasks and Balancing. | Measure | Blood Draw Via Finger Prick and Analyzed With a Cardiochek Machine | Measure | Measured on a Portable Biomechanical Board. | Measure | Systolic Blood Pressure | Measure | Resting Heart Rate | Measure | Blood Draw Via Finger Prick and Analyzed With a Cardiochek Machine for Cholesterol Levels |
Time Frame | Change pre and post (after the 12 weeks) | Time Frame | Change pre and post (after the 12 weeks) | Time Frame | Change pre and post (after the 12 weeks) | Time Frame | Change pre and post (after the 12 weeks) | Time Frame | Change pre and post (after the 12 weeks) | Time Frame | Pre and post (before and after the 12 week exercise program) | Time Frame | Pre and post (before and after the 12 week exercise program) | Time Frame | Pre and post (before and after the 12 week exercise program) | Time Frame | Following the 12 week program | Time Frame | Pre and post (before and after the 12 week exercise program) | Time Frame | Pre and post (before and after the 12 week exercise program) | Time Frame | Pre and post (after the 12 weeks) | Time Frame | Pre and post (after the 12 weeks) | Time Frame | Pre and post (after the 12 weeks) | Time Frame | Pre and post (before and after the 12 week exercise program) |
Description | One leg stand test (seconds) | Description | 6-minute test (meters walked) | Description | Back scratch test (cm). The Back Scratch Test is a measure of flexibility of your upper body. Place your right hand behind your back with your palm out and your fingers extended up. Reach up as far as possible and attempt to touch the fingers of your two hands together. Some people are not able to touch at all, while others' fingers may overlap. Position fingers so that they are pointing toward each other. The distance between the fingertips of one hand and the other is measured to the nearest half-inch. If fingers overlap, the amount of the overlap will be measured. Fingertips just touching receive a score of "0". If fingers do not touch, it is a negative score of the distance between the fingers, measured to the nearest .5 or half inch. It is a positive score if fingers overlap, measuring the overlap to the nearest .5 or half inch. | Description | Number of bicep curls with light weight | Description | Chair stand test, number of chair stand in 30 seconds | Description | Depression Anxiety Stress Scales – 21 item (DASS-21) was used to measure past week depression, anxiety, and stress. Low is better. (Lovibond & Lovibond, 1995). | Description | The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). | Description | The outcome measure on exercise self-efficacy (based on Bandura's concept of self-efficacy) is measured on a 1-4 scale. A higher score is more desirable than a lower score | Description | All collected information via interviews with participants | Description | Measured by a portable biomechanical board. Can detect sway through sensors. | Description | Blood draw via finger prick and analyzed with a Cardiochek machine
An individual's glucose levels in capillary blood, taken by a finger prick and assessed with a Cardiochek machine |
Description | An individual's centre of mass as determined by sensors on a biomechanical board. | Description | Blood pressure cuff (mmHg) | Description | Radial pulse palpation (bpm) | Description | An individual's cholesterol levels in capillary blood, taken by a finger prick and assessed with a Cardiochek machine |
Sponsors
Sequence: | 48298227 | Sequence: | 48298228 | Sequence: | 48298229 | Sequence: | 48298230 | Sequence: | 48298231 |
Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER | Agency Class | UNKNOWN |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator |
Name | University of New Brunswick | Name | New Brunswick Health Research Foundation | Name | Horizon Health Network | Name | Universite de Moncton | Name | Fitness New Brunswick |
Design Group Interventions
Sequence: | 68119628 |
Design Group Id | 55568470 |
Intervention Id | 52463575 |
Eligibilities
Sequence: | 30752360 |
Gender | All |
Minimum Age | 50 Years |
Maximum Age | N/A |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
50 years of age or older Exclusion Criteria: Under 50 years of age |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254174930 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 9 |
Were Results Reported | True |
Months To Report Results | 12 |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 50 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 5 |
Number Of Secondary Outcomes To Measure | 2 |
Number Of Other Outcomes To Measure | 8 |
Designs
Sequence: | 30498628 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Prevention |
Time Perspective | |
Masking | Single |
Intervention Model Description | Randomized to a control or intervention group. The intervention group will have pre- and post-testing following 12-weeks of exercise, while the control group will have pre- and post-testing following 12-weeks of "normal" activity. |
Subject Masked | True |
Drop Withdrawals
Sequence: | 28975585 | Sequence: | 28975586 | Sequence: | 28975587 | Sequence: | 28975588 |
Result Group Id | 56079277 | Result Group Id | 56079278 | Result Group Id | 56079277 | Result Group Id | 56079278 |
Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 |
Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study |
Reason | Program was too easy, discontinued | Reason | Program was too easy, discontinued | Reason | Lost to Follow-up | Reason | Lost to Follow-up |
Count | 1 | Count | 0 | Count | 0 | Count | 2 |
Milestones
Sequence: | 40992015 | Sequence: | 40992016 | Sequence: | 40992017 | Sequence: | 40992018 | Sequence: | 40992019 | Sequence: | 40992020 |
Result Group Id | 56079277 | Result Group Id | 56079278 | Result Group Id | 56079277 | Result Group Id | 56079278 | Result Group Id | 56079277 | Result Group Id | 56079278 |
Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 |
Title | STARTED | Title | STARTED | Title | COMPLETED | Title | COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED |
Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study |
Count | 31 | Count | 31 | Count | 30 | Count | 29 | Count | 1 | Count | 2 |
Participant Flows
Sequence: | 3920076 |
Recruitment Details | Recruitment occurred between January and March 2019. Participants were recruited through radio advertisements, newspapers, posters, and social media. Per the participants availability they were allocated to the randomization or preferred arm. |
Pre Assignment Details | Participants were excluded if they were not cleared by the Get Active Questionnaire and did not receive clearance from their primary physician to participate |
Outcome Counts
Sequence: | 73972381 | Sequence: | 73972382 | Sequence: | 73972383 | Sequence: | 73972384 | Sequence: | 73972385 | Sequence: | 73972386 | Sequence: | 73972387 | Sequence: | 73972388 | Sequence: | 73972389 | Sequence: | 73972390 | Sequence: | 73972391 | Sequence: | 73972392 | Sequence: | 73972393 | Sequence: | 73972394 | Sequence: | 73972395 | Sequence: | 73972396 | Sequence: | 73972397 | Sequence: | 73972398 | Sequence: | 73972399 | Sequence: | 73972400 |
Outcome Id | 30793035 | Outcome Id | 30793035 | Outcome Id | 30793036 | Outcome Id | 30793036 | Outcome Id | 30793037 | Outcome Id | 30793037 | Outcome Id | 30793038 | Outcome Id | 30793038 | Outcome Id | 30793039 | Outcome Id | 30793039 | Outcome Id | 30793040 | Outcome Id | 30793040 | Outcome Id | 30793041 | Outcome Id | 30793041 | Outcome Id | 30793045 | Outcome Id | 30793045 | Outcome Id | 30793047 | Outcome Id | 30793047 | Outcome Id | 30793048 | Outcome Id | 30793048 |
Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 |
Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure |
Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants |
Count | 30 | Count | 29 | Count | 30 | Count | 29 | Count | 30 | Count | 29 | Count | 30 | Count | 29 | Count | 30 | Count | 29 | Count | 30 | Count | 29 | Count | 30 | Count | 29 | Count | 30 | Count | 29 | Count | 30 | Count | 29 | Count | 30 | Count | 29 |
Provided Documents
Sequence: | 2577769 |
Document Type | Study Protocol and Statistical Analysis Plan |
Has Protocol | True |
Has Icf | False |
Has Sap | True |
Document Date | 2018-11-23 |
Url | https://ClinicalTrials.gov/ProvidedDocs/52/NCT03799952/Prot_SAP_000.pdf |
Reported Event Totals
Sequence: | 27934075 | Sequence: | 27934076 | Sequence: | 27934077 | Sequence: | 27934078 | Sequence: | 27934079 | Sequence: | 27934080 |
Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG001 | Ctgov Group Code | EG001 |
Event Type | serious | Event Type | other | Event Type | deaths | Event Type | serious | Event Type | other | Event Type | deaths |
Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality | Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality |
Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 |
Subjects At Risk | 30 | Subjects At Risk | 30 | Subjects At Risk | 30 | Subjects At Risk | 29 | Subjects At Risk | 29 | Subjects At Risk | 29 |
Created At | 2023-08-08 21:34:49.899586 | Created At | 2023-08-08 21:34:49.899586 | Created At | 2023-08-08 21:34:49.899586 | Created At | 2023-08-08 21:34:49.899586 | Created At | 2023-08-08 21:34:49.899586 | Created At | 2023-08-08 21:34:49.899586 |
Updated At | 2023-08-08 21:34:49.899586 | Updated At | 2023-08-08 21:34:49.899586 | Updated At | 2023-08-08 21:34:49.899586 | Updated At | 2023-08-08 21:34:49.899586 | Updated At | 2023-08-08 21:34:49.899586 | Updated At | 2023-08-08 21:34:49.899586 |
Responsible Parties
Sequence: | 28864902 |
Responsible Party Type | Principal Investigator |
Name | Danielle Bouchard |
Title | Associate Professor |
Affiliation | University of New Brunswick |
Result Agreements
Sequence: | 3850820 |
Pi Employee | No |
Result Contacts
Sequence: | 3850785 |
Organization | University of New Brunswick |
Name | Dr. Danielle Bouchard |
Phone | 1 (506) 443-3908 |
danielle.bouchard@unb.ca | |
Outcomes
Sequence: | 30793035 | Sequence: | 30793036 | Sequence: | 30793037 | Sequence: | 30793038 | Sequence: | 30793039 | Sequence: | 30793040 | Sequence: | 30793041 | Sequence: | 30793042 | Sequence: | 30793043 | Sequence: | 30793044 | Sequence: | 30793045 | Sequence: | 30793046 | Sequence: | 30793047 | Sequence: | 30793048 | Sequence: | 30793049 |
Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Other Pre-specified | Outcome Type | Other Pre-specified | Outcome Type | Other Pre-specified | Outcome Type | Other Pre-specified | Outcome Type | Other Pre-specified | Outcome Type | Other Pre-specified | Outcome Type | Other Pre-specified | Outcome Type | Other Pre-specified |
Title | Balance | Title | Walking Speed | Title | Flexibility | Title | Strength, Arm Curl Test | Title | Strength, Chair Stand Test | Title | Depression, Anxiety, Stress | Title | Perceived Quality of Life | Title | Researcher-generated Measure of Exercise Self-efficacy Based on Bandura's Concept of Self-efficacy | Title | Connectedness, Sense of Belonging, and Friendships | Title | The Amount of Bodily Sway When Performing Tasks and Balancing. | Title | Blood Draw Via Finger Prick and Analyzed With a Cardiochek Machine | Title | Measured on a Portable Biomechanical Board. | Title | Systolic Blood Pressure | Title | Resting Heart Rate | Title | Blood Draw Via Finger Prick and Analyzed With a Cardiochek Machine for Cholesterol Levels |
Description | One leg stand test (seconds) | Description | 6-minute test (meters walked) | Description | Back scratch test (cm). The Back Scratch Test is a measure of flexibility of your upper body. Place your right hand behind your back with your palm out and your fingers extended up. Reach up as far as possible and attempt to touch the fingers of your two hands together. Some people are not able to touch at all, while others' fingers may overlap. Position fingers so that they are pointing toward each other. The distance between the fingertips of one hand and the other is measured to the nearest half-inch. If fingers overlap, the amount of the overlap will be measured. Fingertips just touching receive a score of "0". If fingers do not touch, it is a negative score of the distance between the fingers, measured to the nearest .5 or half inch. It is a positive score if fingers overlap, measuring the overlap to the nearest .5 or half inch. | Description | Number of bicep curls with light weight | Description | Chair stand test, number of chair stand in 30 seconds | Description | Depression Anxiety Stress Scales – 21 item (DASS-21) was used to measure past week depression, anxiety, and stress. Low is better. (Lovibond & Lovibond, 1995). | Description | The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). | Description | The outcome measure on exercise self-efficacy (based on Bandura's concept of self-efficacy) is measured on a 1-4 scale. A higher score is more desirable than a lower score | Description | All collected information via interviews with participants | Description | Measured by a portable biomechanical board. Can detect sway through sensors. | Description | Blood draw via finger prick and analyzed with a Cardiochek machine
An individual's glucose levels in capillary blood, taken by a finger prick and assessed with a Cardiochek machine |
Description | An individual's centre of mass as determined by sensors on a biomechanical board. | Description | Blood pressure cuff (mmHg) | Description | Radial pulse palpation (bpm) | Description | An individual's cholesterol levels in capillary blood, taken by a finger prick and assessed with a Cardiochek machine |
Time Frame | Change pre and post (after the 12 weeks) | Time Frame | Change pre and post (after the 12 weeks) | Time Frame | Change pre and post (after the 12 weeks) | Time Frame | Change pre and post (after the 12 weeks) | Time Frame | Change pre and post (after the 12 weeks) | Time Frame | Pre and post (before and after the 12 week exercise program) | Time Frame | Pre and post (before and after the 12 week exercise program) | Time Frame | Pre and post (before and after the 12 week exercise program) | Time Frame | Following the 12 week program | Time Frame | Pre and post (before and after the 12 week exercise program) | Time Frame | Pre and post (before and after the 12 week exercise program) | Time Frame | Pre and post (after the 12 weeks) | Time Frame | Pre and post (after the 12 weeks) | Time Frame | Pre and post (after the 12 weeks) | Time Frame | Pre and post (before and after the 12 week exercise program) |
Units | score on a scale | Units | meters | Units | centimeters | Units | reps/30 seconds | Units | reps/30 seconds | Units | score on a scale | Units | score on a scale | Units | mmol/L | Units | mmHg | Units | beats per minute | ||||||||||
Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | ||||||||||
Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean |
Outcome Measurements
Sequence: | 235564785 | Sequence: | 235564786 | Sequence: | 235564787 | Sequence: | 235564766 | Sequence: | 235564767 | Sequence: | 235564768 | Sequence: | 235564769 | Sequence: | 235564770 | Sequence: | 235564771 | Sequence: | 235564772 | Sequence: | 235564773 | Sequence: | 235564774 | Sequence: | 235564775 | Sequence: | 235564776 | Sequence: | 235564777 | Sequence: | 235564778 | Sequence: | 235564779 | Sequence: | 235564780 | Sequence: | 235564781 | Sequence: | 235564782 | Sequence: | 235564783 | Sequence: | 235564784 | Sequence: | 235564788 | Sequence: | 235564789 | Sequence: | 235564790 | Sequence: | 235564791 | Sequence: | 235564792 | Sequence: | 235564793 | Sequence: | 235564794 | Sequence: | 235564795 | Sequence: | 235564796 | Sequence: | 235564797 | Sequence: | 235564798 | Sequence: | 235564799 | Sequence: | 235564800 | Sequence: | 235564801 | Sequence: | 235564802 | Sequence: | 235564803 | Sequence: | 235564804 | Sequence: | 235564805 | Sequence: | 235564806 | Sequence: | 235564807 | Sequence: | 235564808 | Sequence: | 235564809 | Sequence: | 235564810 | Sequence: | 235564811 | Sequence: | 235564812 | Sequence: | 235564813 | Sequence: | 235564814 | Sequence: | 235564815 | Sequence: | 235564816 | Sequence: | 235564817 | Sequence: | 235564818 | Sequence: | 235564819 | Sequence: | 235564820 | Sequence: | 235564821 | Sequence: | 235564822 | Sequence: | 235564823 | Sequence: | 235564824 | Sequence: | 235564825 | Sequence: | 235564826 | Sequence: | 235564827 | Sequence: | 235564828 | Sequence: | 235564829 | Sequence: | 235564830 | Sequence: | 235564831 | Sequence: | 235564832 | Sequence: | 235564833 | Sequence: | 235564834 | Sequence: | 235564835 | Sequence: | 235564836 | Sequence: | 235564837 | Sequence: | 235564838 | Sequence: | 235564839 | Sequence: | 235564840 | Sequence: | 235564841 | Sequence: | 235564842 | Sequence: | 235564843 | Sequence: | 235564844 | Sequence: | 235564845 |
Outcome Id | 30793038 | Outcome Id | 30793039 | Outcome Id | 30793039 | Outcome Id | 30793035 | Outcome Id | 30793035 | Outcome Id | 30793035 | Outcome Id | 30793035 | Outcome Id | 30793035 | Outcome Id | 30793035 | Outcome Id | 30793035 | Outcome Id | 30793035 | Outcome Id | 30793036 | Outcome Id | 30793036 | Outcome Id | 30793036 | Outcome Id | 30793036 | Outcome Id | 30793037 | Outcome Id | 30793037 | Outcome Id | 30793037 | Outcome Id | 30793037 | Outcome Id | 30793038 | Outcome Id | 30793038 | Outcome Id | 30793038 | Outcome Id | 30793039 | Outcome Id | 30793039 | Outcome Id | 30793040 | Outcome Id | 30793040 | Outcome Id | 30793040 | Outcome Id | 30793040 | Outcome Id | 30793040 | Outcome Id | 30793040 | Outcome Id | 30793040 | Outcome Id | 30793040 | Outcome Id | 30793040 | Outcome Id | 30793040 | Outcome Id | 30793040 | Outcome Id | 30793040 | Outcome Id | 30793041 | Outcome Id | 30793041 | Outcome Id | 30793041 | Outcome Id | 30793041 | Outcome Id | 30793041 | Outcome Id | 30793041 | Outcome Id | 30793041 | Outcome Id | 30793041 | Outcome Id | 30793041 | Outcome Id | 30793041 | Outcome Id | 30793041 | Outcome Id | 30793041 | Outcome Id | 30793041 | Outcome Id | 30793041 | Outcome Id | 30793041 | Outcome Id | 30793041 | Outcome Id | 30793041 | Outcome Id | 30793041 | Outcome Id | 30793041 | Outcome Id | 30793041 | Outcome Id | 30793041 | Outcome Id | 30793041 | Outcome Id | 30793041 | Outcome Id | 30793041 | Outcome Id | 30793041 | Outcome Id | 30793041 | Outcome Id | 30793041 | Outcome Id | 30793041 | Outcome Id | 30793041 | Outcome Id | 30793041 | Outcome Id | 30793041 | Outcome Id | 30793041 | Outcome Id | 30793045 | Outcome Id | 30793045 | Outcome Id | 30793045 | Outcome Id | 30793045 | Outcome Id | 30793047 | Outcome Id | 30793047 | Outcome Id | 30793047 | Outcome Id | 30793047 | Outcome Id | 30793048 | Outcome Id | 30793048 | Outcome Id | 30793048 | Outcome Id | 30793048 |
Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 |
Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 |
Classification | Post | Classification | Pre | Classification | Pre | Classification | Pre (eyes open) | Classification | Pre (eyes open) | Classification | Post (eyes open) | Classification | Post (eyes open) | Classification | Pre (eyes closed) | Classification | Pre (eyes closed) | Classification | Post (eyes closed) | Classification | Post (eyes closed) | Classification | Pre | Classification | Pre | Classification | Post | Classification | Post | Classification | Pre | Classification | Pre | Classification | Post | Classification | Post | Classification | Pre | Classification | Pre | Classification | Post | Classification | Post | Classification | Post | Classification | Pre Stress (0-28) | Classification | Pre Stress (0-28) | Classification | Post Stress (0-28) | Classification | Post Stress (0-28) | Classification | Pre Anxiety (0-20) | Classification | Pre Anxiety (0-20) | Classification | Post Anxiety (0-20) | Classification | Post Anxiety (0-20) | Classification | Pre Depression (0-34) | Classification | Pre Depression (0-34) | Classification | Post Depression (0-34) | Classification | Post Depression (0-34) | Classification | Pre Physical Functioning | Classification | Pre Physical Functioning | Classification | Post Physical Functioning | Classification | Post Physical Functioning | Classification | Pre Limitations due to Physical Health | Classification | Pre Limitations due to Physical Health | Classification | Post Limitations due to Physical Health | Classification | Post Limitations due to Physical Health | Classification | Pre Pain | Classification | Pre Pain | Classification | Post Pain | Classification | Post Pain | Classification | Pre General Health | Classification | Pre General Health | Classification | Post General Health | Classification | Post General Health | Classification | Pre Energy/Fatigue | Classification | Pre Energy/Fatigue | Classification | Post Energy/Fatigue | Classification | Post Energy/Fatigue | Classification | Pre Social Functioning | Classification | Pre Social Functioning | Classification | Post Social Functioning | Classification | Post Social Functioning | Classification | Pre Limitations Emotional Problems | Classification | Pre Limitations Emotional Problems | Classification | Post Limitations Emotional Problems | Classification | Post Limitations Emotional Problems | Classification | Pre Emotional Well-Being | Classification | Pre Emotional Well-Being | Classification | Post Emotional Well-Being | Classification | Post Emotional Well-Being | Classification | Pre | Classification | Pre | Classification | Post | Classification | Post | Classification | Pre | Classification | Pre | Classification | Post | Classification | Post | Classification | Pre | Classification | Pre | Classification | Post | Classification | Post |
Title | Strength, Arm Curl Test | Title | Strength, Chair Stand Test | Title | Strength, Chair Stand Test | Title | Balance | Title | Balance | Title | Balance | Title | Balance | Title | Balance | Title | Balance | Title | Balance | Title | Balance | Title | Walking Speed | Title | Walking Speed | Title | Walking Speed | Title | Walking Speed | Title | Flexibility | Title | Flexibility | Title | Flexibility | Title | Flexibility | Title | Strength, Arm Curl Test | Title | Strength, Arm Curl Test | Title | Strength, Arm Curl Test | Title | Strength, Chair Stand Test | Title | Strength, Chair Stand Test | Title | Depression, Anxiety, Stress | Title | Depression, Anxiety, Stress | Title | Depression, Anxiety, Stress | Title | Depression, Anxiety, Stress | Title | Depression, Anxiety, Stress | Title | Depression, Anxiety, Stress | Title | Depression, Anxiety, Stress | Title | Depression, Anxiety, Stress | Title | Depression, Anxiety, Stress | Title | Depression, Anxiety, Stress | Title | Depression, Anxiety, Stress | Title | Depression, Anxiety, Stress | Title | Perceived Quality of Life | Title | Perceived Quality of Life | Title | Perceived Quality of Life | Title | Perceived Quality of Life | Title | Perceived Quality of Life | Title | Perceived Quality of Life | Title | Perceived Quality of Life | Title | Perceived Quality of Life | Title | Perceived Quality of Life | Title | Perceived Quality of Life | Title | Perceived Quality of Life | Title | Perceived Quality of Life | Title | Perceived Quality of Life | Title | Perceived Quality of Life | Title | Perceived Quality of Life | Title | Perceived Quality of Life | Title | Perceived Quality of Life | Title | Perceived Quality of Life | Title | Perceived Quality of Life | Title | Perceived Quality of Life | Title | Perceived Quality of Life | Title | Perceived Quality of Life | Title | Perceived Quality of Life | Title | Perceived Quality of Life | Title | Perceived Quality of Life | Title | Perceived Quality of Life | Title | Perceived Quality of Life | Title | Perceived Quality of Life | Title | Perceived Quality of Life | Title | Perceived Quality of Life | Title | Perceived Quality of Life | Title | Perceived Quality of Life | Title | Blood Draw Via Finger Prick and Analyzed With a Cardiochek Machine | Title | Blood Draw Via Finger Prick and Analyzed With a Cardiochek Machine | Title | Blood Draw Via Finger Prick and Analyzed With a Cardiochek Machine | Title | Blood Draw Via Finger Prick and Analyzed With a Cardiochek Machine | Title | Systolic Blood Pressure | Title | Systolic Blood Pressure | Title | Systolic Blood Pressure | Title | Systolic Blood Pressure | Title | Resting Heart Rate | Title | Resting Heart Rate | Title | Resting Heart Rate | Title | Resting Heart Rate |
Description | Number of bicep curls with light weight | Description | Chair stand test, number of chair stand in 30 seconds | Description | Chair stand test, number of chair stand in 30 seconds | Description | One leg stand test (seconds) | Description | One leg stand test (seconds) | Description | One leg stand test (seconds) | Description | One leg stand test (seconds) | Description | One leg stand test (seconds) | Description | One leg stand test (seconds) | Description | One leg stand test (seconds) | Description | One leg stand test (seconds) | Description | 6-minute test (meters walked) | Description | 6-minute test (meters walked) | Description | 6-minute test (meters walked) | Description | 6-minute test (meters walked) | Description | Back scratch test (cm). The Back Scratch Test is a measure of flexibility of your upper body. Place your right hand behind your back with your palm out and your fingers extended up. Reach up as far as possible and attempt to touch the fingers of your two hands together. Some people are not able to touch at all, while others' fingers may overlap. Position fingers so that they are pointing toward each other. The distance between the fingertips of one hand and the other is measured to the nearest half-inch. If fingers overlap, the amount of the overlap will be measured. Fingertips just touching receive a score of "0". If fingers do not touch, it is a negative score of the distance between the fingers, measured to the nearest .5 or half inch. It is a positive score if fingers overlap, measuring the overlap to the nearest .5 or half inch. | Description | Back scratch test (cm). The Back Scratch Test is a measure of flexibility of your upper body. Place your right hand behind your back with your palm out and your fingers extended up. Reach up as far as possible and attempt to touch the fingers of your two hands together. Some people are not able to touch at all, while others' fingers may overlap. Position fingers so that they are pointing toward each other. The distance between the fingertips of one hand and the other is measured to the nearest half-inch. If fingers overlap, the amount of the overlap will be measured. Fingertips just touching receive a score of "0". If fingers do not touch, it is a negative score of the distance between the fingers, measured to the nearest .5 or half inch. It is a positive score if fingers overlap, measuring the overlap to the nearest .5 or half inch. | Description | Back scratch test (cm). The Back Scratch Test is a measure of flexibility of your upper body. Place your right hand behind your back with your palm out and your fingers extended up. Reach up as far as possible and attempt to touch the fingers of your two hands together. Some people are not able to touch at all, while others' fingers may overlap. Position fingers so that they are pointing toward each other. The distance between the fingertips of one hand and the other is measured to the nearest half-inch. If fingers overlap, the amount of the overlap will be measured. Fingertips just touching receive a score of "0". If fingers do not touch, it is a negative score of the distance between the fingers, measured to the nearest .5 or half inch. It is a positive score if fingers overlap, measuring the overlap to the nearest .5 or half inch. | Description | Back scratch test (cm). The Back Scratch Test is a measure of flexibility of your upper body. Place your right hand behind your back with your palm out and your fingers extended up. Reach up as far as possible and attempt to touch the fingers of your two hands together. Some people are not able to touch at all, while others' fingers may overlap. Position fingers so that they are pointing toward each other. The distance between the fingertips of one hand and the other is measured to the nearest half-inch. If fingers overlap, the amount of the overlap will be measured. Fingertips just touching receive a score of "0". If fingers do not touch, it is a negative score of the distance between the fingers, measured to the nearest .5 or half inch. It is a positive score if fingers overlap, measuring the overlap to the nearest .5 or half inch. | Description | Number of bicep curls with light weight | Description | Number of bicep curls with light weight | Description | Number of bicep curls with light weight | Description | Chair stand test, number of chair stand in 30 seconds | Description | Chair stand test, number of chair stand in 30 seconds | Description | Depression Anxiety Stress Scales – 21 item (DASS-21) was used to measure past week depression, anxiety, and stress. Low is better. (Lovibond & Lovibond, 1995). | Description | Depression Anxiety Stress Scales – 21 item (DASS-21) was used to measure past week depression, anxiety, and stress. Low is better. (Lovibond & Lovibond, 1995). | Description | Depression Anxiety Stress Scales – 21 item (DASS-21) was used to measure past week depression, anxiety, and stress. Low is better. (Lovibond & Lovibond, 1995). | Description | Depression Anxiety Stress Scales – 21 item (DASS-21) was used to measure past week depression, anxiety, and stress. Low is better. (Lovibond & Lovibond, 1995). | Description | Depression Anxiety Stress Scales – 21 item (DASS-21) was used to measure past week depression, anxiety, and stress. Low is better. (Lovibond & Lovibond, 1995). | Description | Depression Anxiety Stress Scales – 21 item (DASS-21) was used to measure past week depression, anxiety, and stress. Low is better. (Lovibond & Lovibond, 1995). | Description | Depression Anxiety Stress Scales – 21 item (DASS-21) was used to measure past week depression, anxiety, and stress. Low is better. (Lovibond & Lovibond, 1995). | Description | Depression Anxiety Stress Scales – 21 item (DASS-21) was used to measure past week depression, anxiety, and stress. Low is better. (Lovibond & Lovibond, 1995). | Description | Depression Anxiety Stress Scales – 21 item (DASS-21) was used to measure past week depression, anxiety, and stress. Low is better. (Lovibond & Lovibond, 1995). | Description | Depression Anxiety Stress Scales – 21 item (DASS-21) was used to measure past week depression, anxiety, and stress. Low is better. (Lovibond & Lovibond, 1995). | Description | Depression Anxiety Stress Scales – 21 item (DASS-21) was used to measure past week depression, anxiety, and stress. Low is better. (Lovibond & Lovibond, 1995). | Description | Depression Anxiety Stress Scales – 21 item (DASS-21) was used to measure past week depression, anxiety, and stress. Low is better. (Lovibond & Lovibond, 1995). | Description | The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). | Description | The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). | Description | The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). | Description | The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). | Description | The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). | Description | The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). | Description | The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). | Description | The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). | Description | The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). | Description | The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). | Description | The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). | Description | The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). | Description | The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). | Description | The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). | Description | The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). | Description | The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). | Description | The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). | Description | The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). | Description | The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). | Description | The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). | Description | The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). | Description | The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). | Description | The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). | Description | The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). | Description | The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). | Description | The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). | Description | The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). | Description | The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). | Description | The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). | Description | The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). | Description | The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). | Description | The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). | Description | Blood draw via finger prick and analyzed with a Cardiochek machine
An individual's glucose levels in capillary blood, taken by a finger prick and assessed with a Cardiochek machine |
Description | Blood draw via finger prick and analyzed with a Cardiochek machine
An individual's glucose levels in capillary blood, taken by a finger prick and assessed with a Cardiochek machine |
Description | Blood draw via finger prick and analyzed with a Cardiochek machine
An individual's glucose levels in capillary blood, taken by a finger prick and assessed with a Cardiochek machine |
Description | Blood draw via finger prick and analyzed with a Cardiochek machine
An individual's glucose levels in capillary blood, taken by a finger prick and assessed with a Cardiochek machine |
Description | Blood pressure cuff (mmHg) | Description | Blood pressure cuff (mmHg) | Description | Blood pressure cuff (mmHg) | Description | Blood pressure cuff (mmHg) | Description | Radial pulse palpation (bpm) | Description | Radial pulse palpation (bpm) | Description | Radial pulse palpation (bpm) | Description | Radial pulse palpation (bpm) |
Units | reps/30 seconds | Units | reps/30 seconds | Units | reps/30 seconds | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | meters | Units | meters | Units | meters | Units | meters | Units | centimeters | Units | centimeters | Units | centimeters | Units | centimeters | Units | reps/30 seconds | Units | reps/30 seconds | Units | reps/30 seconds | Units | reps/30 seconds | Units | reps/30 seconds | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | mmol/L | Units | mmol/L | Units | mmol/L | Units | mmol/L | Units | mmHg | Units | mmHg | Units | mmHg | Units | mmHg | Units | beats per minute | Units | beats per minute | Units | beats per minute | Units | beats per minute |
Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean |
Param Value | 17.4 | Param Value | 14.1 | Param Value | 13.6 | Param Value | 26.7 | Param Value | 27.9 | Param Value | 34.7 | Param Value | 29.7 | Param Value | 5.0 | Param Value | 4.9 | Param Value | 5.3 | Param Value | 4.4 | Param Value | 476 | Param Value | 507 | Param Value | 539 | Param Value | 504 | Param Value | -7.5 | Param Value | -5.2 | Param Value | -5.7 | Param Value | -4.7 | Param Value | 20.1 | Param Value | 17.3 | Param Value | 23.9 | Param Value | 17.9 | Param Value | 14.1 | Param Value | 6.0 | Param Value | 5.7 | Param Value | 4.1 | Param Value | 8.2 | Param Value | 3.5 | Param Value | 2.6 | Param Value | 3.2 | Param Value | 5.0 | Param Value | 4.8 | Param Value | 3.2 | Param Value | 3.2 | Param Value | 5.5 | Param Value | 78.0 | Param Value | 80.9 | Param Value | 81.2 | Param Value | 80.4 | Param Value | 78.3 | Param Value | 81.7 | Param Value | 90.8 | Param Value | 79.0 | Param Value | 73.5 | Param Value | 79.1 | Param Value | 71.9 | Param Value | 71.0 | Param Value | 71.2 | Param Value | 72.4 | Param Value | 75.5 | Param Value | 69.8 | Param Value | 63.5 | Param Value | 67.4 | Param Value | 68.7 | Param Value | 65.4 | Param Value | 90.2 | Param Value | 88.9 | Param Value | 92.1 | Param Value | 86.4 | Param Value | 84.6 | Param Value | 78.8 | Param Value | 88.9 | Param Value | 84.0 | Param Value | 80.4 | Param Value | 82.5 | Param Value | 84.7 | Param Value | 78.7 | Param Value | 5.34 | Param Value | 5.61 | Param Value | 4.70 | Param Value | 5.11 | Param Value | 123.8 | Param Value | 127.5 | Param Value | 125.7 | Param Value | 124.5 | Param Value | 68.1 | Param Value | 70.5 | Param Value | 63.0 | Param Value | 67.2 |
Param Value Num | 17.4 | Param Value Num | 14.1 | Param Value Num | 13.6 | Param Value Num | 26.7 | Param Value Num | 27.9 | Param Value Num | 34.7 | Param Value Num | 29.7 | Param Value Num | 5.0 | Param Value Num | 4.9 | Param Value Num | 5.3 | Param Value Num | 4.4 | Param Value Num | 476.0 | Param Value Num | 507.0 | Param Value Num | 539.0 | Param Value Num | 504.0 | Param Value Num | -7.5 | Param Value Num | -5.2 | Param Value Num | -5.7 | Param Value Num | -4.7 | Param Value Num | 20.1 | Param Value Num | 17.3 | Param Value Num | 23.9 | Param Value Num | 17.9 | Param Value Num | 14.1 | Param Value Num | 6.0 | Param Value Num | 5.7 | Param Value Num | 4.1 | Param Value Num | 8.2 | Param Value Num | 3.5 | Param Value Num | 2.6 | Param Value Num | 3.2 | Param Value Num | 5.0 | Param Value Num | 4.8 | Param Value Num | 3.2 | Param Value Num | 3.2 | Param Value Num | 5.5 | Param Value Num | 78.0 | Param Value Num | 80.9 | Param Value Num | 81.2 | Param Value Num | 80.4 | Param Value Num | 78.3 | Param Value Num | 81.7 | Param Value Num | 90.8 | Param Value Num | 79.0 | Param Value Num | 73.5 | Param Value Num | 79.1 | Param Value Num | 71.9 | Param Value Num | 71.0 | Param Value Num | 71.2 | Param Value Num | 72.4 | Param Value Num | 75.5 | Param Value Num | 69.8 | Param Value Num | 63.5 | Param Value Num | 67.4 | Param Value Num | 68.7 | Param Value Num | 65.4 | Param Value Num | 90.2 | Param Value Num | 88.9 | Param Value Num | 92.1 | Param Value Num | 86.4 | Param Value Num | 84.6 | Param Value Num | 78.8 | Param Value Num | 88.9 | Param Value Num | 84.0 | Param Value Num | 80.4 | Param Value Num | 82.5 | Param Value Num | 84.7 | Param Value Num | 78.7 | Param Value Num | 5.34 | Param Value Num | 5.61 | Param Value Num | 4.7 | Param Value Num | 5.11 | Param Value Num | 123.8 | Param Value Num | 127.5 | Param Value Num | 125.7 | Param Value Num | 124.5 | Param Value Num | 68.1 | Param Value Num | 70.5 | Param Value Num | 63.0 | Param Value Num | 67.2 |
Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation |
Dispersion Value | 3.5 | Dispersion Value | 2.6 | Dispersion Value | 2.7 | Dispersion Value | 14.4 | Dispersion Value | 16.4 | Dispersion Value | 13.4 | Dispersion Value | 15.6 | Dispersion Value | 3.4 | Dispersion Value | 3.2 | Dispersion Value | 3.5 | Dispersion Value | 2.9 | Dispersion Value | 94.3 | Dispersion Value | 90.3 | Dispersion Value | 82.5 | Dispersion Value | 79.7 | Dispersion Value | 9.9 | Dispersion Value | 9.7 | Dispersion Value | 9.9 | Dispersion Value | 9.9 | Dispersion Value | 5.1 | Dispersion Value | 4.1 | Dispersion Value | 4.9 | Dispersion Value | 4.4 | Dispersion Value | 3.5 | Dispersion Value | 5.6 | Dispersion Value | 6.2 | Dispersion Value | 3.9 | Dispersion Value | 7.7 | Dispersion Value | 3.8 | Dispersion Value | 4.7 | Dispersion Value | 3.3 | Dispersion Value | 7.5 | Dispersion Value | 6.3 | Dispersion Value | 3.8 | Dispersion Value | 5.6 | Dispersion Value | 9.1 | Dispersion Value | 21.2 | Dispersion Value | 20.1 | Dispersion Value | 20.2 | Dispersion Value | 18.8 | Dispersion Value | 33.9 | Dispersion Value | 28.8 | Dispersion Value | 24.1 | Dispersion Value | 32.8 | Dispersion Value | 22.3 | Dispersion Value | 17.6 | Dispersion Value | 20.8 | Dispersion Value | 23.0 | Dispersion Value | 19.1 | Dispersion Value | 11.8 | Dispersion Value | 15.6 | Dispersion Value | 16.4 | Dispersion Value | 19.1 | Dispersion Value | 18.0 | Dispersion Value | 16.3 | Dispersion Value | 17.6 | Dispersion Value | 14.9 | Dispersion Value | 16.3 | Dispersion Value | 13.7 | Dispersion Value | 19.1 | Dispersion Value | 28.3 | Dispersion Value | 33.8 | Dispersion Value | 25.3 | Dispersion Value | 32.1 | Dispersion Value | 13.5 | Dispersion Value | 12.4 | Dispersion Value | 10.2 | Dispersion Value | 13.2 | Dispersion Value | 0.69 | Dispersion Value | 1.05 | Dispersion Value | 0.52 | Dispersion Value | 0.65 | Dispersion Value | 12.6 | Dispersion Value | 11.1 | Dispersion Value | 14.9 | Dispersion Value | 9.5 | Dispersion Value | 9.4 | Dispersion Value | 6.7 | Dispersion Value | 7.0 | Dispersion Value | 7.6 |
Dispersion Value Num | 3.5 | Dispersion Value Num | 2.6 | Dispersion Value Num | 2.7 | Dispersion Value Num | 14.4 | Dispersion Value Num | 16.4 | Dispersion Value Num | 13.4 | Dispersion Value Num | 15.6 | Dispersion Value Num | 3.4 | Dispersion Value Num | 3.2 | Dispersion Value Num | 3.5 | Dispersion Value Num | 2.9 | Dispersion Value Num | 94.3 | Dispersion Value Num | 90.3 | Dispersion Value Num | 82.5 | Dispersion Value Num | 79.7 | Dispersion Value Num | 9.9 | Dispersion Value Num | 9.7 | Dispersion Value Num | 9.9 | Dispersion Value Num | 9.9 | Dispersion Value Num | 5.1 | Dispersion Value Num | 4.1 | Dispersion Value Num | 4.9 | Dispersion Value Num | 4.4 | Dispersion Value Num | 3.5 | Dispersion Value Num | 5.6 | Dispersion Value Num | 6.2 | Dispersion Value Num | 3.9 | Dispersion Value Num | 7.7 | Dispersion Value Num | 3.8 | Dispersion Value Num | 4.7 | Dispersion Value Num | 3.3 | Dispersion Value Num | 7.5 | Dispersion Value Num | 6.3 | Dispersion Value Num | 3.8 | Dispersion Value Num | 5.6 | Dispersion Value Num | 9.1 | Dispersion Value Num | 21.2 | Dispersion Value Num | 20.1 | Dispersion Value Num | 20.2 | Dispersion Value Num | 18.8 | Dispersion Value Num | 33.9 | Dispersion Value Num | 28.8 | Dispersion Value Num | 24.1 | Dispersion Value Num | 32.8 | Dispersion Value Num | 22.3 | Dispersion Value Num | 17.6 | Dispersion Value Num | 20.8 | Dispersion Value Num | 23.0 | Dispersion Value Num | 19.1 | Dispersion Value Num | 11.8 | Dispersion Value Num | 15.6 | Dispersion Value Num | 16.4 | Dispersion Value Num | 19.1 | Dispersion Value Num | 18.0 | Dispersion Value Num | 16.3 | Dispersion Value Num | 17.6 | Dispersion Value Num | 14.9 | Dispersion Value Num | 16.3 | Dispersion Value Num | 13.7 | Dispersion Value Num | 19.1 | Dispersion Value Num | 28.3 | Dispersion Value Num | 33.8 | Dispersion Value Num | 25.3 | Dispersion Value Num | 32.1 | Dispersion Value Num | 13.5 | Dispersion Value Num | 12.4 | Dispersion Value Num | 10.2 | Dispersion Value Num | 13.2 | Dispersion Value Num | 0.69 | Dispersion Value Num | 1.05 | Dispersion Value Num | 0.52 | Dispersion Value Num | 0.65 | Dispersion Value Num | 12.6 | Dispersion Value Num | 11.1 | Dispersion Value Num | 14.9 | Dispersion Value Num | 9.5 | Dispersion Value Num | 9.4 | Dispersion Value Num | 6.7 | Dispersion Value Num | 7.0 | Dispersion Value Num | 7.6 |
Study References
Sequence: | 52040799 |
Pmid | 33573594 |
Reference Type | derived |
Citation | Bouchard DR, Olthuis JV, Bouffard-Levasseur V, Shannon C, McDonald T, Senechal M. Peer-led exercise program for ageing adults to improve physical functions – a randomized trial. Eur Rev Aging Phys Act. 2021 Feb 11;18(1):2. doi: 10.1186/s11556-021-00257-x. |
Baseline Counts
Sequence: | 11379728 | Sequence: | 11379729 | Sequence: | 11379730 |
Result Group Id | 56079274 | Result Group Id | 56079275 | Result Group Id | 56079276 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 |
Units | Participants | Units | Participants | Units | Participants |
Scope | overall | Scope | overall | Scope | overall |
Count | 30 | Count | 29 | Count | 59 |
Result Groups
Sequence: | 56079274 | Sequence: | 56079275 | Sequence: | 56079276 | Sequence: | 56079277 | Sequence: | 56079278 | Sequence: | 56079279 | Sequence: | 56079280 | Sequence: | 56079281 | Sequence: | 56079282 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 |
Result Type | Baseline | Result Type | Baseline | Result Type | Baseline | Result Type | Participant Flow | Result Type | Participant Flow | Result Type | Outcome | Result Type | Outcome | Result Type | Reported Event | Result Type | Reported Event |
Title | Intervention | Title | Control | Title | Total | Title | Intervention | Title | Control | Title | Intervention | Title | Control | Title | Intervention | Title | Control |
Description | Participants are offered to attend a 12-week exercise program, classes offered twice a week, each class 60 minutes in length.
Zoomers on the Go Exercise Program: 60 minute exercise class involving resistance and aerobic training activities, as well as flexibility and balance activities. An educational handout is offered at the end of every class, relating to health behaviour. |
Description | Participants are instructed to continue with their daily activities and their "normal" physical activity levels for 12-weeks. | Description | Total of all reporting groups | Description | Participants are offered to attend a 12-week exercise program, classes offered twice a week, each class 60 minutes in length.
Zoomers on the Go Exercise Program: 60 minute exercise class involving resistance and aerobic training activities, as well as flexibility and balance activities. An educational handout is offered at the end of every class, relating to health behaviour. |
Description | Participants are instructed to continue with their daily activities and their "normal" physical activity levels for 12-weeks. | Description | Participants are offered to attend a 12-week exercise program, classes offered twice a week, each class 60 minutes in length.
Zoomers on the Go Exercise Program: 60 minute exercise class involving resistance and aerobic training activities, as well as flexibility and balance activities. An educational handout is offered at the end of every class, relating to health behaviour. |
Description | Participants are instructed to continue with their daily activities and their "normal" physical activity levels for 12-weeks. | Description | Participants are offered to attend a 12-week exercise program, classes offered twice a week, each class 60 minutes in length.
Zoomers on the Go Exercise Program: 60 minute exercise class involving resistance and aerobic training activities, as well as flexibility and balance activities. An educational handout is offered at the end of every class, relating to health behaviour. |
Description | Participants are instructed to continue with their daily activities and their "normal" physical activity levels for 12-weeks. |
Baseline Measurements
Sequence: | 125539998 | Sequence: | 125539999 | Sequence: | 125539989 | Sequence: | 125539990 | Sequence: | 125539991 | Sequence: | 125539992 | Sequence: | 125539993 | Sequence: | 125539994 | Sequence: | 125539995 | Sequence: | 125539996 | Sequence: | 125539997 | Sequence: | 125540000 | Sequence: | 125540001 | Sequence: | 125540002 | Sequence: | 125540003 | Sequence: | 125540004 | Sequence: | 125540005 | Sequence: | 125540006 | Sequence: | 125540007 | Sequence: | 125540008 | Sequence: | 125540009 | Sequence: | 125540010 | Sequence: | 125540011 | Sequence: | 125540012 | Sequence: | 125540013 | Sequence: | 125540014 | Sequence: | 125540015 | Sequence: | 125540016 | Sequence: | 125540017 | Sequence: | 125540018 | Sequence: | 125540019 | Sequence: | 125540020 | Sequence: | 125540021 |
Result Group Id | 56079274 | Result Group Id | 56079275 | Result Group Id | 56079274 | Result Group Id | 56079275 | Result Group Id | 56079276 | Result Group Id | 56079274 | Result Group Id | 56079275 | Result Group Id | 56079276 | Result Group Id | 56079274 | Result Group Id | 56079275 | Result Group Id | 56079276 | Result Group Id | 56079276 | Result Group Id | 56079274 | Result Group Id | 56079275 | Result Group Id | 56079276 | Result Group Id | 56079274 | Result Group Id | 56079275 | Result Group Id | 56079276 | Result Group Id | 56079274 | Result Group Id | 56079275 | Result Group Id | 56079276 | Result Group Id | 56079274 | Result Group Id | 56079275 | Result Group Id | 56079276 | Result Group Id | 56079274 | Result Group Id | 56079275 | Result Group Id | 56079276 | Result Group Id | 56079274 | Result Group Id | 56079275 | Result Group Id | 56079276 | Result Group Id | 56079274 | Result Group Id | 56079275 | Result Group Id | 56079276 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 |
Classification | Canada | Classification | Canada | Classification | Canada | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Category | Female | Category | Female | Category | Female | Category | Male | Category | Male | Category | Male | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Age, Continuous | Title | Age, Continuous | Title | Age, Continuous | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Race/Ethnicity, Customized | Title | Region of Enrollment | Title | Region of Enrollment | Title | Region of Enrollment | Title | Body Mass Index (BMI) | Title | Body Mass Index (BMI) | Title | Body Mass Index (BMI) | Title | Occupation (Retired) | Title | Occupation (Retired) | Title | Occupation (Retired) | Title | Marital Status (Married) | Title | Marital Status (Married) | Title | Marital Status (Married) | Title | Household Income (>$100,000/year) | Title | Household Income (>$100,000/year) | Title | Household Income (>$100,000/year) | Title | Physical Activity Level (Steps/day) | Title | Physical Activity Level (Steps/day) | Title | Physical Activity Level (Steps/day) | Title | Physical Activity Level (MVPA/week) | Title | Physical Activity Level (MVPA/week) | Title | Physical Activity Level (MVPA/week) |
Description | Race/Ethnicity not collected | Description | Race/Ethnicity not collected | Description | Race/Ethnicity not collected | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Units | Participants | Units | Participants | Units | years | Units | years | Units | years | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | participants | Units | participants | Units | participants | Units | kg/m^2 | Units | kg/m^2 | Units | kg/m^2 | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Steps/day | Units | Steps/day | Units | Steps/day | Units | Minutes of MVPA per week | Units | Minutes of MVPA per week | Units | Minutes of MVPA per week |
Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean |
Param Value | 0 | Param Value | 0 | Param Value | 66.6 | Param Value | 66.1 | Param Value | 66.4 | Param Value | 28 | Param Value | 23 | Param Value | 51 | Param Value | 2 | Param Value | 6 | Param Value | 8 | Param Value | 0 | Param Value | 30 | Param Value | 29 | Param Value | 59 | Param Value | 28.9 | Param Value | 25.8 | Param Value | 27.4 | Param Value | 19 | Param Value | 14 | Param Value | 33 | Param Value | 14 | Param Value | 20 | Param Value | 34 | Param Value | 6.0 | Param Value | 6.0 | Param Value | 12 | Param Value | 6349 | Param Value | 7221 | Param Value | 6762 | Param Value | 68 | Param Value | 48 | Param Value | 58 |
Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 66.6 | Param Value Num | 66.1 | Param Value Num | 66.4 | Param Value Num | 28.0 | Param Value Num | 23.0 | Param Value Num | 51.0 | Param Value Num | 2.0 | Param Value Num | 6.0 | Param Value Num | 8.0 | Param Value Num | 0.0 | Param Value Num | 30.0 | Param Value Num | 29.0 | Param Value Num | 59.0 | Param Value Num | 28.9 | Param Value Num | 25.8 | Param Value Num | 27.4 | Param Value Num | 19.0 | Param Value Num | 14.0 | Param Value Num | 33.0 | Param Value Num | 14.0 | Param Value Num | 20.0 | Param Value Num | 34.0 | Param Value Num | 6.0 | Param Value Num | 6.0 | Param Value Num | 12.0 | Param Value Num | 6349.0 | Param Value Num | 7221.0 | Param Value Num | 6762.0 | Param Value Num | 68.0 | Param Value Num | 48.0 | Param Value Num | 58.0 |
Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | ||||||||||||||||||||||||||||||||||||||||||
Dispersion Value | 7.2 | Dispersion Value | 7.0 | Dispersion Value | 7.2 | Dispersion Value | 4.5 | Dispersion Value | 4.8 | Dispersion Value | 4.9 | Dispersion Value | 2903 | Dispersion Value | 2964 | Dispersion Value | 2939 | Dispersion Value | 68 | Dispersion Value | 81 | Dispersion Value | 74 | ||||||||||||||||||||||||||||||||||||||||||
Dispersion Value Num | 7.2 | Dispersion Value Num | 7.0 | Dispersion Value Num | 7.2 | Dispersion Value Num | 4.5 | Dispersion Value Num | 4.8 | Dispersion Value Num | 4.9 | Dispersion Value Num | 2903.0 | Dispersion Value Num | 2964.0 | Dispersion Value Num | 2939.0 | Dispersion Value Num | 68.0 | Dispersion Value Num | 81.0 | Dispersion Value Num | 74.0 | ||||||||||||||||||||||||||||||||||||||||||
Number Analyzed | 30 | Number Analyzed | 29 | Number Analyzed | 30 | Number Analyzed | 29 | Number Analyzed | 59 | Number Analyzed | 30 | Number Analyzed | 29 | Number Analyzed | 59 | Number Analyzed | 30 | Number Analyzed | 29 | Number Analyzed | 59 | Number Analyzed | 59 | Number Analyzed | 30 | Number Analyzed | 29 | Number Analyzed | 59 | Number Analyzed | 30 | Number Analyzed | 29 | Number Analyzed | 59 | Number Analyzed | 30 | Number Analyzed | 29 | Number Analyzed | 59 | Number Analyzed | 30 | Number Analyzed | 29 | Number Analyzed | 59 | Number Analyzed | 30 | Number Analyzed | 29 | Number Analyzed | 59 | Number Analyzed | 30 | Number Analyzed | 29 | Number Analyzed | 59 | Number Analyzed | 30 | Number Analyzed | 29 | Number Analyzed | 59 |
Population Description | Not collected | Population Description | Not collected | Population Description | Not collected | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Calculate Percentage | No | Calculate Percentage | No | Calculate Percentage | No |
]]>
https://zephyrnet.com/NCT03799939
2019-02-05
https://zephyrnet.com/?p=NCT03799939
NCT03799939https://www.clinicaltrials.gov/study/NCT03799939?tab=tableNANANAChimney trial is designed to compare the effectiveness and safety of specifically designated polyvinylidene fluoride mesh (PVDF, Dynamesh IPST) to controls in a multi center, randomized setting.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-06 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2021-08-17 |
Start Month Year | February 5, 2019 |
Primary Completion Month Year | July 2022 |
Verification Month Year | August 2021 |
Verification Date | 2021-08-31 |
Last Update Posted Date | 2021-08-17 |
Detailed Descriptions
Sequence: | 20735867 |
Description | The European Hernia Society recommends the use of prophylactic mesh when permanent colostomy is made. The results of previous trials using keyhole technique are partially unsatisfactory. Specifically designed PVDF mesh used in this trial showed promising results in previous small trial.
Chimney trial is designed to compare the effectiveness and safety of mesh group to controls operated with no preventive mesh in parastomal hernia prevention after laparoscopic or robotic-assisted abdominoperineal resection or low Haartman's procedure for rectal adenocarcinoma. |
Facilities
Sequence: | 200244762 | Sequence: | 200244763 | Sequence: | 200244764 | Sequence: | 200244765 | Sequence: | 200244766 | Sequence: | 200244767 | Sequence: | 200244768 |
Name | Helsinki University Hospital | Name | Keski-Suomi Central Hospital | Name | Oulu University Hospital | Name | Seinäjoki Central Hospital | Name | Tampere University Hospital | Name | Turku University Hospital | Name | Maziar Nikberg |
City | Helsinki | City | Jyväskylä | City | Oulu | City | Seinäjoki | City | Tampere | City | Turku | City | Västerås |
Country | Finland | Country | Finland | Country | Finland | Country | Finland | Country | Finland | Country | Finland | Country | Sweden |
Conditions
Sequence: | 52208319 | Sequence: | 52208320 | Sequence: | 52208321 |
Name | Parastomal Hernia | Name | Rectal Adenocarcinoma | Name | Abdominoperineal Resection |
Downcase Name | parastomal hernia | Downcase Name | rectal adenocarcinoma | Downcase Name | abdominoperineal resection |
Id Information
Sequence: | 40186303 |
Id Source | org_study_id |
Id Value | 305/2018 |
Countries
Sequence: | 42599797 | Sequence: | 42599798 |
Name | Finland | Name | Sweden |
Removed | False | Removed | False |
Design Groups
Sequence: | 55634925 | Sequence: | 55634926 |
Group Type | Active Comparator | Group Type | No Intervention |
Title | Intervention group | Title | Control group |
Description | Polyvinylidene fluoride mesh used in this trial (Dynamesh IPST) is synthetic mesh with central tube to accommodate bowel tightly and designed to prevent and treat parastomal hernia. | Description | Participants in control group are operated with no preventive mesh. |
Interventions
Sequence: | 52522285 |
Intervention Type | Device |
Name | Intervention group |
Description | Polyvinylidene fluoride mesh (Dynamesh IPST) is used on intraperitoneal onlay position to prevent parastomal hernia. |
Design Outcomes
Sequence: | 177512082 | Sequence: | 177512083 | Sequence: | 177512084 | Sequence: | 177512085 | Sequence: | 177512086 | Sequence: | 177512087 | Sequence: | 177512088 | Sequence: | 177512089 | Sequence: | 177512090 | Sequence: | 177512091 | Sequence: | 177512092 | Sequence: | 177512093 | Sequence: | 177512094 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Incidence of parastomal hernia | Measure | Incidence of parastomal hernia at long term follow up | Measure | Surgical site infection rate | Measure | Complications | Measure | Stoma related complications | Measure | Reoperation rate | Measure | Operative time | Measure | Length of stay | Measure | Rand 36 quality of life | Measure | Quality of life measured by Colostomy impact score | Measure | Medico-economic substudy | Measure | Radiological substudy of stoma distance | Measure | Radiological substudy of adipose tissue thickness |
Time Frame | 12 months | Time Frame | 5 years | Time Frame | 30 days | Time Frame | 30 days | Time Frame | 5 years | Time Frame | 5 years | Time Frame | 1 day | Time Frame | 30 days | Time Frame | 5 years | Time Frame | 5 years | Time Frame | 5 years | Time Frame | 3 years | Time Frame | 3 years |
Description | Incidence of parastomal hernia at 12 months follow up | Description | Incidence of parastomal hernia during 5 years of follow up | Description | Surgical site infections measured by Clavien-Dindo Classification | Description | Complications measured by Clavien-Dindo Classification | Description | Stoma related complications measured by Clavien-Dindo Classification | Description | Need for reoperations | Description | Operative time | Description | Length of stay at the hospital | Description | Quality of life measured by Rand-36 quality of life questionnaire | Description | Quality of life measured by Colostomy impact score | Description | Medico-economic substudy including both short and long term costs included in both groups | Description | Distance of stoma from midline defined by umbilicus | Description | Thickness of adipose tissue on computer tomography scan on contralateral site of stoma |
Browse Conditions
Sequence: | 193627771 | Sequence: | 193627770 |
Mesh Term | Pathological Conditions, Anatomical | Mesh Term | Hernia |
Downcase Mesh Term | pathological conditions, anatomical | Downcase Mesh Term | hernia |
Mesh Type | mesh-ancestor | Mesh Type | mesh-list |
Sponsors
Sequence: | 48353890 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | University of Oulu |
Overall Officials
Sequence: | 29306099 |
Role | Principal Investigator |
Name | Elisa Mäkäräinen-Uhlbäck, M.D. |
Affiliation | Oulu University Hospital |
Design Group Interventions
Sequence: | 68199471 |
Design Group Id | 55634925 |
Intervention Id | 52522285 |
Eligibilities
Sequence: | 30787000 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
18 years or older Exclusion Criteria: Abdominoperineal resection or Hartmann's operation by laparotomy or conversion to laparotomy |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253989876 |
Number Of Facilities | 7 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | False |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 12 |
Designs
Sequence: | 30533070 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Prevention |
Time Perspective | |
Masking | Single |
Masking Description | Participants are unaware of the randomization group. |
Intervention Model Description | Chimney trial is a prospective randomized controlled multicenter trial. |
Subject Masked | True |
Responsible Parties
Sequence: | 28899364 |
Responsible Party Type | Principal Investigator |
Name | Elisa Makarainen-Uhlback |
Title | Principal Investigator |
Affiliation | University of Oulu |
Study References
Sequence: | 52103276 |
Pmid | 31779699 |
Reference Type | derived |
Citation | Makarainen-Uhlback E, Wiik H, Kossi J, Nikberg M, Ohtonen P, Rautio T. Chimney Trial: study protocol for a randomized controlled trial. Trials. 2019 Nov 28;20(1):652. doi: 10.1186/s13063-019-3764-y. |
]]>
https://zephyrnet.com/NCT03799926
2019-02-18
https://zephyrnet.com/?p=NCT03799926
NCT03799926https://www.clinicaltrials.gov/study/NCT03799926?tab=tableNANANATo investigate the efficacy of each ZG-801 starting dose and the titration algorithm of ZG-801 for the treatment of hyperkalemia in Japanese patients.
To evaluate the safety of ZG-801 for the chronic use (total over 52 weeks). In addition, to confirm the safety after the discontinuation of ZG-801 treatment on 1 week follow-up.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-08 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2021-03-25 |
Start Month Year | February 18, 2019 |
Primary Completion Month Year | November 6, 2019 |
Verification Month Year | March 2021 |
Verification Date | 2021-03-31 |
Last Update Posted Date | 2021-03-25 |
Facilities
Sequence: | 200108504 |
Name | Zeria Investigative Sites |
City | Kanagawa |
Country | Japan |
Conditions
Sequence: | 52171317 |
Name | Hyperkalemia |
Downcase Name | hyperkalemia |
Id Information
Sequence: | 40158677 |
Id Source | org_study_id |
Id Value | ZG-801-01 |
Countries
Sequence: | 42568976 |
Name | Japan |
Removed | False |
Design Groups
Sequence: | 55593234 | Sequence: | 55593235 | Sequence: | 55593236 | Sequence: | 55593237 | Sequence: | 55593238 | Sequence: | 55593239 | Sequence: | 55593240 | Sequence: | 55593241 |
Group Type | Experimental | Group Type | Experimental | Group Type | Experimental | Group Type | Experimental | Group Type | Experimental | Group Type | Experimental | Group Type | Experimental | Group Type | Experimental |
Title | Stratum 1: 8.4 g patiromer | Title | Stratum 1: 16.8 g patiromer | Title | Stratum 1: placebo of 8.4 g patiromer | Title | Stratum 1: placebo of 16.8 g patiromer | Title | Stratum 2: 8.4 g patiromer | Title | Stratum 2: 16.8 g patiromer | Title | Stratum 3: 8.4 g patiromer | Title | Stratum 3: 16.8 g patiromer |
Description | Non-dialysis subjects with serum potassium 5.1 to < 6.0 mEq/L range at baseline | Description | Non-dialysis subjects with serum potassium 5.1 to < 6.0 mEq/L range at baseline | Description | Non-dialysis subjects with serum potassium 5.1 to < 6.0 mEq/L range at baseline | Description | Non-dialysis subjects with serum potassium 5.1 to < 6.0 mEq/L range at baseline | Description | Non-dialysis subjects with serum potassium 6.0 to < 6.5 mEq/L range at baseline | Description | Non-dialysis subjects with serum potassium 6.0 to < 6.5 mEq/L range at baseline | Description | Dialysis subjects with serum potassium 5.5 to < 6.5 mEq/L range at baseline | Description | Dialysis subjects with serum potassium 5.5 to < 6.5 mEq/L range at baseline |
Interventions
Sequence: | 52485544 | Sequence: | 52485545 | Sequence: | 52485546 | Sequence: | 52485547 | Sequence: | 52485548 | Sequence: | 52485549 | Sequence: | 52485550 | Sequence: | 52485551 |
Intervention Type | Drug | Intervention Type | Drug | Intervention Type | Drug | Intervention Type | Drug | Intervention Type | Drug | Intervention Type | Drug | Intervention Type | Drug | Intervention Type | Drug |
Name | patiromer | Name | patiromer | Name | placebo | Name | placebo | Name | patiromer | Name | patiromer | Name | patiromer | Name | patiromer |
Description | Patiromer starting dose: 1 packet/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 1) | Description | Patiromer starting dose: 2 packets/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 1) | Description | Placebo starting dose: 1 packet/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 1) | Description | Placebo starting dose: 2 packets/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 1) | Description | Patiromer starting dose: 1 packet/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 2) | Description | Patiromer starting dose: 2 packets/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 2) | Description | Patiromer starting dose: 1 packet/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 3) | Description | Patiromer starting dose: 2 packets/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 3) |
Design Outcomes
Sequence: | 177379077 | Sequence: | 177379078 | Sequence: | 177379079 | Sequence: | 177379080 | Sequence: | 177379081 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Change in serum potassium from baseline to 1 week after the start of administration in each group of starting dose | Measure | Change in serum potassium 4 weeks after the start of administration in each group of starting dose | Measure | Proportion of subjects with a normalized serum potassium level at 4 weeks after the start of administration in each group of starting dose | Measure | Incidence of adverse events | Measure | Incidence of adverse drug reactions |
Time Frame | Baseline to week 1 | Time Frame | Baseline to week 4 | Time Frame | Week 4 | Time Frame | Over 52-week study period | Time Frame | Over 52-week study period |
Browse Conditions
Sequence: | 193486993 | Sequence: | 193486994 | Sequence: | 193486995 |
Mesh Term | Hyperkalemia | Mesh Term | Water-Electrolyte Imbalance | Mesh Term | Metabolic Diseases |
Downcase Mesh Term | hyperkalemia | Downcase Mesh Term | water-electrolyte imbalance | Downcase Mesh Term | metabolic diseases |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48319342 |
Agency Class | INDUSTRY |
Lead Or Collaborator | lead |
Name | Zeria Pharmaceutical |
Design Group Interventions
Sequence: | 68149209 | Sequence: | 68149210 | Sequence: | 68149211 | Sequence: | 68149212 | Sequence: | 68149213 | Sequence: | 68149214 | Sequence: | 68149215 | Sequence: | 68149216 |
Design Group Id | 55593234 | Design Group Id | 55593235 | Design Group Id | 55593236 | Design Group Id | 55593237 | Design Group Id | 55593238 | Design Group Id | 55593239 | Design Group Id | 55593240 | Design Group Id | 55593241 |
Intervention Id | 52485544 | Intervention Id | 52485545 | Intervention Id | 52485546 | Intervention Id | 52485547 | Intervention Id | 52485548 | Intervention Id | 52485549 | Intervention Id | 52485550 | Intervention Id | 52485551 |
Eligibilities
Sequence: | 30765388 |
Gender | All |
Minimum Age | 20 Years |
Maximum Age | 80 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Males and females ages 18 – 80 Exclusion Criteria: Subjects with hospitalization for hyper- or hypoglycemia with Type 2 diabetes or for acute exacerbations of heart failure within the previous 3 months |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253885881 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 8 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 20 |
Maximum Age Num | 80 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 4 |
Designs
Sequence: | 30511554 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Quadruple |
Subject Masked | True |
Caregiver Masked | True |
Investigator Masked | True |
Outcomes Assessor Masked | True |
Responsible Parties
Sequence: | 28877849 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03799913
2019-04-10
https://zephyrnet.com/?p=NCT03799913
NCT03799913https://www.clinicaltrials.gov/study/NCT03799913?tab=tableZhigang Zhang, M.D.zzg2011@zju.edu.cn86+057189713631The goal of this clinical trial is to study the feasibility and efficacy of anti-MESO antigen receptors (CARs) T cell therapy for relapsed and refractory ovarian cancer.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-08 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2019-04-10 |
Start Month Year | April 10, 2019 |
Primary Completion Month Year | October 2021 |
Verification Month Year | April 2019 |
Verification Date | 2019-04-30 |
Last Update Posted Date | 2019-04-10 |
Detailed Descriptions
Sequence: | 20741242 |
Description | Primary Objectives
1.To determine the feasibility ad safety of anti-MESO CAR-T cells in treating patients with MESO-positive ovarian cancer. Secondary Objectives To access the efficacy of anti-MESO CAR-T cells in patients with ovarian cancer. |
Facilities
Sequence: | 200280791 |
Status | Recruiting |
Name | The Second Affiliated hospital of Zhejiang University School of Medicine |
City | Hangzhou |
State | Zhejiang |
Zip | 310009 |
Country | China |
Facility Contacts
Sequence: | 28132913 |
Facility Id | 200280791 |
Contact Type | primary |
Name | Jianwei Zhou, M.D. |
jianwei-zhou@163.com | |
Phone | 0571-89713634 |
Browse Interventions
Sequence: | 96133392 | Sequence: | 96133393 | Sequence: | 96133394 | Sequence: | 96133395 | Sequence: | 96133396 | Sequence: | 96133397 | Sequence: | 96133398 | Sequence: | 96133399 | Sequence: | 96133400 | Sequence: | 96133401 | Sequence: | 96133402 |
Mesh Term | Cyclophosphamide | Mesh Term | Fludarabine | Mesh Term | Immunosuppressive Agents | Mesh Term | Immunologic Factors | Mesh Term | Physiological Effects of Drugs | Mesh Term | Antirheumatic Agents | Mesh Term | Antineoplastic Agents, Alkylating | Mesh Term | Alkylating Agents | Mesh Term | Molecular Mechanisms of Pharmacological Action | Mesh Term | Antineoplastic Agents | Mesh Term | Myeloablative Agonists |
Downcase Mesh Term | cyclophosphamide | Downcase Mesh Term | fludarabine | Downcase Mesh Term | immunosuppressive agents | Downcase Mesh Term | immunologic factors | Downcase Mesh Term | physiological effects of drugs | Downcase Mesh Term | antirheumatic agents | Downcase Mesh Term | antineoplastic agents, alkylating | Downcase Mesh Term | alkylating agents | Downcase Mesh Term | molecular mechanisms of pharmacological action | Downcase Mesh Term | antineoplastic agents | Downcase Mesh Term | myeloablative agonists |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52221705 |
Name | Ovarian Cancer |
Downcase Name | ovarian cancer |
Id Information
Sequence: | 40195753 |
Id Source | org_study_id |
Id Value | MESO |
Countries
Sequence: | 42609743 |
Name | China |
Removed | False |
Design Groups
Sequence: | 55650003 |
Group Type | Experimental |
Title | anti-MESO CAR-T cells |
Description | Administration with anti-MESO CAR-T cells in the MESO-positive ovarian cancer patients |
Interventions
Sequence: | 52535510 | Sequence: | 52535511 | Sequence: | 52535512 |
Intervention Type | Biological | Intervention Type | Drug | Intervention Type | Drug |
Name | anti-MESO CAR-T cells | Name | Fludarabine | Name | Cyclophosphamide |
Description | Retroviral vector-transduced autologous T cells to express anti-MESO CARs | Description | 30mg/m2/d | Description | 300mg/m2/d |
Keywords
Sequence: | 79942018 | Sequence: | 79942019 | Sequence: | 79942020 | Sequence: | 79942021 |
Name | CAR-T | Name | MESO | Name | Ovarian Cancer | Name | Relapsed and Refractory |
Downcase Name | car-t | Downcase Name | meso | Downcase Name | ovarian cancer | Downcase Name | relapsed and refractory |
Design Outcomes
Sequence: | 177562099 | Sequence: | 177562100 | Sequence: | 177562101 | Sequence: | 177562102 | Sequence: | 177562103 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0 | Measure | Overall complete remission rate defined by the standard response criteria for malignant lymphoma for each arm | Measure | Progress Free Survival (PFS) after administration | Measure | Duration of CAR-positive T cells in circulation | Measure | Detection of PD1 antibody in serum |
Time Frame | 1 years post infusion | Time Frame | 12 months post infusion | Time Frame | 12 months post infusion | Time Frame | 12 months post infusion | Time Frame | 12 months post infusion |
Browse Conditions
Sequence: | 193679156 | Sequence: | 193679157 | Sequence: | 193679158 | Sequence: | 193679159 | Sequence: | 193679160 | Sequence: | 193679161 | Sequence: | 193679162 | Sequence: | 193679163 | Sequence: | 193679164 | Sequence: | 193679165 | Sequence: | 193679166 | Sequence: | 193679167 | Sequence: | 193679168 | Sequence: | 193679169 | Sequence: | 193679170 | Sequence: | 193679171 | Sequence: | 193679172 | Sequence: | 193679173 | Sequence: | 193679174 |
Mesh Term | Ovarian Neoplasms | Mesh Term | Carcinoma, Ovarian Epithelial | Mesh Term | Endocrine Gland Neoplasms | Mesh Term | Neoplasms by Site | Mesh Term | Neoplasms | Mesh Term | Ovarian Diseases | Mesh Term | Adnexal Diseases | Mesh Term | Genital Diseases, Female | Mesh Term | Female Urogenital Diseases | Mesh Term | Female Urogenital Diseases and Pregnancy Complications | Mesh Term | Urogenital Diseases | Mesh Term | Genital Neoplasms, Female | Mesh Term | Urogenital Neoplasms | Mesh Term | Genital Diseases | Mesh Term | Endocrine System Diseases | Mesh Term | Gonadal Disorders | Mesh Term | Carcinoma | Mesh Term | Neoplasms, Glandular and Epithelial | Mesh Term | Neoplasms by Histologic Type |
Downcase Mesh Term | ovarian neoplasms | Downcase Mesh Term | carcinoma, ovarian epithelial | Downcase Mesh Term | endocrine gland neoplasms | Downcase Mesh Term | neoplasms by site | Downcase Mesh Term | neoplasms | Downcase Mesh Term | ovarian diseases | Downcase Mesh Term | adnexal diseases | Downcase Mesh Term | genital diseases, female | Downcase Mesh Term | female urogenital diseases | Downcase Mesh Term | female urogenital diseases and pregnancy complications | Downcase Mesh Term | urogenital diseases | Downcase Mesh Term | genital neoplasms, female | Downcase Mesh Term | urogenital neoplasms | Downcase Mesh Term | genital diseases | Downcase Mesh Term | endocrine system diseases | Downcase Mesh Term | gonadal disorders | Downcase Mesh Term | carcinoma | Downcase Mesh Term | neoplasms, glandular and epithelial | Downcase Mesh Term | neoplasms by histologic type |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48366590 | Sequence: | 48366591 | Sequence: | 48366592 |
Agency Class | OTHER | Agency Class | OTHER | Agency Class | INDUSTRY |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator |
Name | Zhejiang University | Name | Second Affiliated Hospital, School of Medicine, Zhejiang University | Name | Hrain Biotechnology Co., Ltd. |
Overall Officials
Sequence: | 29312998 |
Role | Study Chair |
Name | Jianwei Zhou, M.D. |
Affiliation | Zhejiang University |
Central Contacts
Sequence: | 12020629 |
Contact Type | primary |
Name | Zhigang Zhang, M.D. |
Phone | 86+057189713631 |
zzg2011@zju.edu.cn | |
Role | Contact |
Design Group Interventions
Sequence: | 68217624 | Sequence: | 68217625 | Sequence: | 68217626 |
Design Group Id | 55650003 | Design Group Id | 55650003 | Design Group Id | 55650003 |
Intervention Id | 52535510 | Intervention Id | 52535511 | Intervention Id | 52535512 |
Eligibilities
Sequence: | 30794811 |
Gender | Female |
Minimum Age | 18 Years |
Maximum Age | 70 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
18 to 70 Years Old, female; Exclusion Criteria: Accompanied by other uncontrolled malignant tumors; |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254004483 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 70 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 4 |
Designs
Sequence: | 30540851 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Responsible Parties
Sequence: | 28907171 |
Responsible Party Type | Principal Investigator |
Name | Zhigang Zhang |
Title | Dr |
Affiliation | Zhejiang University |
]]>
https://zephyrnet.com/NCT03799900
2018-11-01
https://zephyrnet.com/?p=NCT03799900
NCT03799900https://www.clinicaltrials.gov/study/NCT03799900?tab=tableNANANABased on the pharmacological class of rapastinel, this study will be conducted to evaluate the abuse potential of single doses of rapastinel as compared with ketamine, a NMDAR antagonist that is a Schedule III dissociative anesthetic, and placebo in recreational polydrug users.
<![CDATA[
Studies
Study First Submitted Date | 2018-11-15 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2019-05-16 |
Start Month Year | November 1, 2018 |
Primary Completion Month Year | March 24, 2019 |
Verification Month Year | May 2019 |
Verification Date | 2019-05-31 |
Last Update Posted Date | 2019-05-16 |
Facilities
Sequence: | 199965077 |
Name | Vince and Associates Clinical Research Inc |
City | Overland Park |
State | Kansas |
Zip | 66212 |
Country | United States |
Browse Interventions
Sequence: | 95996913 | Sequence: | 95996914 | Sequence: | 95996915 | Sequence: | 95996916 | Sequence: | 95996917 | Sequence: | 95996918 | Sequence: | 95996919 | Sequence: | 95996920 | Sequence: | 95996921 | Sequence: | 95996922 | Sequence: | 95996923 | Sequence: | 95996924 | Sequence: | 95996925 | Sequence: | 95996926 |
Mesh Term | Ketamine | Mesh Term | Analgesics | Mesh Term | Sensory System Agents | Mesh Term | Peripheral Nervous System Agents | Mesh Term | Physiological Effects of Drugs | Mesh Term | Anesthetics, Dissociative | Mesh Term | Anesthetics, Intravenous | Mesh Term | Anesthetics, General | Mesh Term | Anesthetics | Mesh Term | Central Nervous System Depressants | Mesh Term | Excitatory Amino Acid Antagonists | Mesh Term | Excitatory Amino Acid Agents | Mesh Term | Neurotransmitter Agents | Mesh Term | Molecular Mechanisms of Pharmacological Action |
Downcase Mesh Term | ketamine | Downcase Mesh Term | analgesics | Downcase Mesh Term | sensory system agents | Downcase Mesh Term | peripheral nervous system agents | Downcase Mesh Term | physiological effects of drugs | Downcase Mesh Term | anesthetics, dissociative | Downcase Mesh Term | anesthetics, intravenous | Downcase Mesh Term | anesthetics, general | Downcase Mesh Term | anesthetics | Downcase Mesh Term | central nervous system depressants | Downcase Mesh Term | excitatory amino acid antagonists | Downcase Mesh Term | excitatory amino acid agents | Downcase Mesh Term | neurotransmitter agents | Downcase Mesh Term | molecular mechanisms of pharmacological action |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52139008 |
Name | Human Abuse Potential |
Downcase Name | human abuse potential |
Id Information
Sequence: | 40135065 |
Id Source | org_study_id |
Id Value | RAP-PK-12 |
Countries
Sequence: | 42542690 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55559347 | Sequence: | 55559348 | Sequence: | 55559349 | Sequence: | 55559350 | Sequence: | 55559351 | Sequence: | 55559352 | Sequence: | 55559353 | Sequence: | 55559354 | Sequence: | 55559355 | Sequence: | 55559356 | Sequence: | 55559357 | Sequence: | 55559358 | Sequence: | 55559359 |
Group Type | Experimental | Group Type | Placebo Comparator | Group Type | Experimental | Group Type | Placebo Comparator | Group Type | Experimental | Group Type | Placebo Comparator | Group Type | Experimental | Group Type | Placebo Comparator | Group Type | Experimental | Group Type | Experimental | Group Type | Experimental | Group Type | Active Comparator | Group Type | Placebo Comparator |
Title | Part 1, Cohort 1: Ketamine Low Dose | Title | Part 1, Cohort 1: Placebo | Title | Part 1, Cohort 2: Ketamine Medium Dose | Title | Part 1, Cohort 2: Placebo | Title | Part 1, Cohort 3 (Optional): Ketamine High Dose | Title | Part 1, Cohort 3 (Optional): Placebo | Title | Part 2, Qualification Phase: Ketamine | Title | Part 2, Qualification Phase: Placebo | Title | Part 2, Treatment Phase: Rapastinel Low Dose | Title | Part 2, Treatment Phase: Rapastinel Medium Dose | Title | Part 2, Treatment Phase: Rapastinel High Dose | Title | Part 2, Treatment Phase: Ketamine | Title | Part 2, Treatment Phase: Placebo |
Description | Some participants will be administered a single IV dose of ketamine on Day 1. | Description | Some participants will be administered a single IV dose of placebo on Day 1. | Description | Some participants will be administered a single IV dose of ketamine on Day 1. | Description | Some participants will be administered a single IV dose of placebo on Day 1. | Description | Optional: some participants will be administered a single IV dose of ketamine on Day 1. | Description | Optional: some participants will be administered a single IV dose of placebo on Day 1. | Description | Participants will receive IV ketamine on Day 1 and placebo on Day 2 in a randomized crossover manner. | Description | Participants will receive IV ketamine on Day 2 and placebo on Day 1 in a randomized crossover manner. | Description | Participants will be administered single IV doses of rapastinel, ketamine, and placebo in a randomized crossover manner. | Description | Participants will be administered single IV doses of rapastinel, ketamine, and placebo in a randomized crossover manner. | Description | Participants will be administered single IV doses of rapastinel, ketamine, and placebo in a randomized crossover manner. | Description | Participants will be administered single IV doses of rapastinel, ketamine, and placebo in a randomized crossover manner. | Description | Participants will be administered single IV doses of rapastinel, ketamine, and placebo in a randomized crossover manner. |
Interventions
Sequence: | 52454912 | Sequence: | 52454913 | Sequence: | 52454914 |
Intervention Type | Drug | Intervention Type | Drug | Intervention Type | Drug |
Name | Rapastinel | Name | Ketamine | Name | Placebo |
Description | During the Treatment Phase in Part 2, participants will be administered single IV doses of rapastinel, ketamine, and placebo in a randomized crossover manner. | Description | Part 1
Part 2, Qualification Phase: Participants will be administered single IV doses of ketamine and placebo in a randomized crossover manner Part 2, Treatment Phase: Participants will be administered single IV doses of rapastinel, ketamine, and placebo in a randomized crossover manner. |
Description | Part 1
Part 2, Qualification Phase: Participants will be administered single IV doses of ketamine and placebo in a randomized crossover manner Part 2, Treatment Phase: Participants will be administered single IV doses of rapastinel, ketamine, and placebo in a randomized crossover manner. |
Design Outcomes
Sequence: | 177263647 | Sequence: | 177263648 | Sequence: | 177263649 | Sequence: | 177263650 | Sequence: | 177263651 | Sequence: | 177263652 | Sequence: | 177263653 | Sequence: | 177263654 | Sequence: | 177263655 | Sequence: | 177263656 | Sequence: | 177263657 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Maximum effect (Emax) for "At this Moment" Drug Liking visual analog scale (VAS). | Measure | Maximum effect (Emax) | Measure | Minimum effect (Emin) | Measure | Time to Emax (TEmax) | Measure | Time to Emin (TEmin) | Measure | Time averaged area under the effect curve (TA_AUE) | Measure | Maximum plasma drug concentration (Cmax) | Measure | Area under the plasma concentration versus time curve from time 0 to the last quantifiable concentration (AUClast) | Measure | Adverse events | Measure | Proportion of abnormal electrocardiograms | Measure | Columbia-Suicide Severity Rating Scale |
Time Frame | Treatment Phase: Pre-dose and up to 24 hours post-dose | Time Frame | Treatment Phase: Pre-dose and up to 24 hours post-dose | Time Frame | Treatment Phase: Pre-dose and up to 24 hours post-dose | Time Frame | Treatment Phase: Pre-dose and up to 24 hours post-dose | Time Frame | Treatment Phase: Pre-dose and up to 24 hours post-dose | Time Frame | Treatment Phase: Hour 0 and up to 24 Hours post-dose | Time Frame | Treatment Phase: Pre-dose and up to 24 hours post-dose | Time Frame | Treatment Phase: Pre-dose and up to 24 hours post-dose | Time Frame | Part 1: 6 weeks, Part 2: 9 weeks | Time Frame | Part 1: 6 weeks, Part 2: 9 weeks | Time Frame | Part 1: 6 weeks, Part 2: 9 weeks |
Description | The drug liking VAS measures the participant's liking for the drug and is scored from 0 to 100, with 0 reflecting "Strong disliking" and 100 reflecting "Strong liking". | Description | The C-SSRS is a clinician-rated instrument that reports the severity of both suicidal ideation and behavior. Suicidal ideation is classified on a 5-item scale: 1 (least severe) to 5 (most severe). |
Sponsors
Sequence: | 48290711 |
Agency Class | INDUSTRY |
Lead Or Collaborator | lead |
Name | Naurex, Inc, an affiliate of Allergan plc |
Overall Officials
Sequence: | 29268533 |
Role | Study Director |
Name | Sheng Fang Su |
Affiliation | Allergan |
Design Group Interventions
Sequence: | 68107457 | Sequence: | 68107458 | Sequence: | 68107459 | Sequence: | 68107460 | Sequence: | 68107461 | Sequence: | 68107462 | Sequence: | 68107463 | Sequence: | 68107464 | Sequence: | 68107465 | Sequence: | 68107466 | Sequence: | 68107467 | Sequence: | 68107468 | Sequence: | 68107469 |
Design Group Id | 55559357 | Design Group Id | 55559355 | Design Group Id | 55559356 | Design Group Id | 55559347 | Design Group Id | 55559349 | Design Group Id | 55559351 | Design Group Id | 55559353 | Design Group Id | 55559358 | Design Group Id | 55559348 | Design Group Id | 55559350 | Design Group Id | 55559352 | Design Group Id | 55559354 | Design Group Id | 55559359 |
Intervention Id | 52454912 | Intervention Id | 52454912 | Intervention Id | 52454912 | Intervention Id | 52454913 | Intervention Id | 52454913 | Intervention Id | 52454913 | Intervention Id | 52454913 | Intervention Id | 52454913 | Intervention Id | 52454914 | Intervention Id | 52454914 | Intervention Id | 52454914 | Intervention Id | 52454914 | Intervention Id | 52454914 |
Eligibilities
Sequence: | 30747725 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 55 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
Participant must be a current recreational polydrug user Exclusion Criteria: Evidence of drug or alcohol dependence (excluding nicotine and caffeine) within the past 2 years |
Adult | True |
Child | False |
Older Adult | False |
Calculated Values
Sequence: | 254121861 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 4 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 55 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 10 |
Designs
Sequence: | 30494008 |
Allocation | Randomized |
Intervention Model | Crossover Assignment |
Observational Model | |
Primary Purpose | Other |
Time Perspective | |
Masking | Double |
Subject Masked | True |
Investigator Masked | True |
Responsible Parties
Sequence: | 28860288 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03799887
2010-10-20
https://zephyrnet.com/?p=NCT03799887
NCT03799887https://www.clinicaltrials.gov/study/NCT03799887?tab=tableNANANABody weight supported treadmill training (BWSTT) is an important rehabilitative choice for neurologically impaired subjects such as Parkinson’s disease (PD). The aim of the study is to evaluate the effectiveness of different percentages BWSTT on gait, balance, quality of life and fatigue in moderate to advanced PD.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-08 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2019-01-10 |
Start Month Year | October 20, 2010 |
Primary Completion Month Year | October 20, 2010 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-10 |
Detailed Descriptions
Sequence: | 20727169 |
Description | Body weight supported treadmill training (BWSTT) is an important rehabilitative choice for neurologically impaired subjects such as Parkinson's disease (PD). The aim of the study is to evaluate the effectiveness of different percentages BWSTT on gait, balance, quality of life and fatigue in moderate to advanced PD. Thirty five patients were randomly assigned to one of the three groups according to the percentage unweighed: 0% BWSTT, 10% BWSTT and 20% BWSTT. All patients participated 30 minutes BWSTT sessions 5 days a week, for 6 weeks. Primary outcomes were 6 minute walk test (6MWT), Berg balance scale (BBS), Unified Parkinson's Disease Rating Scale (UPDRS); and secondary outcomes were Nottingham health profile (NHP), Fatigue Impact Scale (FIS) and Fatigue Severity Scale (FSS) which were performed at the beginning and end of the rehabilitation. |
Facilities
Sequence: | 200159378 |
Name | Tuğba Atan |
City | Çorum |
Zip | 19100 |
Country | Turkey |
Conditions
Sequence: | 52185460 |
Name | Parkinson Disease |
Downcase Name | parkinson disease |
Id Information
Sequence: | 40169059 |
Id Source | org_study_id |
Id Value | 2010-171 |
Countries
Sequence: | 42580650 |
Name | Turkey |
Removed | False |
Design Groups
Sequence: | 55609094 | Sequence: | 55609095 | Sequence: | 55609096 |
Group Type | Active Comparator | Group Type | Experimental | Group Type | Experimental |
Title | 0% unweighed BWSTT | Title | 10% unweighed BWSTT | Title | 20% unweighed BWSTT |
Description | 0% unweighed Body Weight Supported Treadmill Training | Description | 0% unweighed Body Weight Supported Treadmill Training | Description | 20% unweighed Body Weight Supported Treadmill Training |
Interventions
Sequence: | 52499406 | Sequence: | 52499407 | Sequence: | 52499408 |
Intervention Type | Behavioral | Intervention Type | Behavioral | Intervention Type | Behavioral |
Name | 0% unweighed BWSTT | Name | 10% unweighed BWSTT | Name | 20% unweighed BWSTT |
Description | 30 minutes conventional rehabilitation program (CRP) including range of motion, stretching and strengthening exercises for upper and lower extremities, balance and mobility exercises.
After CRP, participants were provided 30 minutes 0% unweighed BWSTT sessions including a 5 minutes warm – up and cool – down period for each session, 5 days a week, for 6 weeks (totally, 30 sessions). |
Description | 30 minutes conventional rehabilitation program (CRP) including range of motion, stretching and strengthening exercises for upper and lower extremities, balance and mobility exercises.
After CRP, participants were provided 30 minutes 10% unweighed BWSTT sessions including a 5 minutes warm – up and cool – down period for each session, 5 days a week, for 6 weeks (totally, 30 sessions). |
Description | 30 minutes conventional rehabilitation program (CRP) including range of motion, stretching and strengthening exercises for upper and lower extremities, balance and mobility exercises.
After CRP, participants were provided 30 minutes 20% unweighed BWSTT sessions including a 5 minutes warm – up and cool – down period for each session, 5 days a week, for 6 weeks (totally, 30 sessions). |
Keywords
Sequence: | 79888706 | Sequence: | 79888707 | Sequence: | 79888708 | Sequence: | 79888709 | Sequence: | 79888710 |
Name | Parkinson's disease | Name | gait | Name | balance | Name | treadmill training | Name | fatigue |
Downcase Name | parkinson's disease | Downcase Name | gait | Downcase Name | balance | Downcase Name | treadmill training | Downcase Name | fatigue |
Design Outcomes
Sequence: | 177431970 | Sequence: | 177431971 | Sequence: | 177431972 | Sequence: | 177431973 | Sequence: | 177431974 | Sequence: | 177431975 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | 6 Minute Walk Test (6MWT) | Measure | Berg Balance Scale (BBS): | Measure | Unified Parkinson's Disease Rating Scale (UPDRS): | Measure | Nottingham Health Profile (NHP): | Measure | Fatigue Impact Scale (FIS): | Measure | Fatigue Severity Scale (FSS): |
Time Frame | 6 weeks | Time Frame | 6 weeks | Time Frame | 6 weeks | Time Frame | 6 weeks | Time Frame | 6 weeks | Time Frame | 6 weeks |
Description | Functional exercise capacity was assessed by distance walked in 6 minutes (6MWT). The patient was asked to walk as long as possible for 6 minutes on a 30 meters of marked and flat ground, at a self selected speed. 6MWT is a submaximal exercise test and can be used to assess treatment response . | Description | It contains 14 instructions and 0 – 4 points is given for each instruction according to the performance of the patients. 0 points are given when the patient totally could not do the activity while 4 points are given when the patient completes the activity independently. | Description | It is used to follow the clinical status of PD. It consists of four main parts (totally 183 points): mentation, behavior and mood (UPDRS I: 16 points), activities of daily living (UPDRS II: 52 points), motor examination (UPDRS III: 92 points), treatment complications (UPDRS IV: 23 points). | Description | It contains 38 items that address pain, physical mobility, emotional reactions, energy, social isolation, and sleep dimensions. Higher scores indicate worse quality of life. | Description | This scale assesses the cognitive, physical and social effects of fatigue during the last one week in a total of 40 – item questionnaire (0 = no problem, 4 = maximum problem). | Description | This scale assesses the severity of fatigue during the last one week in a total of 9 – item questionnaire (1 = strongly disagree, 7 = strongly agree). The total score ranges from 9 – 63, in which higher score means higher severity of fatigue . |
Browse Conditions
Sequence: | 193540034 | Sequence: | 193540035 | Sequence: | 193540036 | Sequence: | 193540037 | Sequence: | 193540038 | Sequence: | 193540039 | Sequence: | 193540040 | Sequence: | 193540041 | Sequence: | 193540042 | Sequence: | 193540043 | Sequence: | 193540044 |
Mesh Term | Parkinson Disease | Mesh Term | Fatigue | Mesh Term | Body Weight | Mesh Term | Parkinsonian Disorders | Mesh Term | Basal Ganglia Diseases | Mesh Term | Brain Diseases | Mesh Term | Central Nervous System Diseases | Mesh Term | Nervous System Diseases | Mesh Term | Movement Disorders | Mesh Term | Synucleinopathies | Mesh Term | Neurodegenerative Diseases |
Downcase Mesh Term | parkinson disease | Downcase Mesh Term | fatigue | Downcase Mesh Term | body weight | Downcase Mesh Term | parkinsonian disorders | Downcase Mesh Term | basal ganglia diseases | Downcase Mesh Term | brain diseases | Downcase Mesh Term | central nervous system diseases | Downcase Mesh Term | nervous system diseases | Downcase Mesh Term | movement disorders | Downcase Mesh Term | synucleinopathies | Downcase Mesh Term | neurodegenerative diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48332315 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Hitit University |
Design Group Interventions
Sequence: | 68168151 | Sequence: | 68168152 | Sequence: | 68168153 |
Design Group Id | 55609094 | Design Group Id | 55609095 | Design Group Id | 55609096 |
Intervention Id | 52499406 | Intervention Id | 52499407 | Intervention Id | 52499408 |
Eligibilities
Sequence: | 30773563 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 85 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Clinical diagnosis of Parkinson's disease according to the UK Brain Bank criteria. Exclusion Criteria: Subjects had cardiovascular, inflammatory or musculoskeletal problems that could prevent them to participate in an exercise program. |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253952660 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 0 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 85 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 3 |
Number Of Secondary Outcomes To Measure | 3 |
Designs
Sequence: | 30519694 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Double |
Subject Masked | True |
Investigator Masked | True |
Responsible Parties
Sequence: | 28885995 |
Responsible Party Type | Principal Investigator |
Name | Tuğba Atan |
Title | Assoc. Prof. |
Affiliation | Hitit University |
]]>
https://zephyrnet.com/NCT03799874
2019-07-01
https://zephyrnet.com/?p=NCT03799874
NCT03799874https://www.clinicaltrials.gov/study/NCT03799874?tab=tableNANANAThis study will be a multi-center, prospective, randomized, partially double-blind, placebo-controlled Phase II clinical trial of inhaled CO (iCO) for the treatment of ARDS. The trial will be conducted at 7 tertiary care medical centers including Weill Cornell Medicine/NewYork-Presbyterian Hospital, Brigham and Women’s Hospital (BWH), Massachusetts General Hospital (MGH), Duke University Hospital, Durham Veterans Administration Medical Center, New York-Presbyterian Brooklyn Methodist Hospital, and Duke Regional Hospital. The purpose of this study is to evaluate the safety, tolerability, and efficacy of inhaled carbon monoxide (iCO) for the treatment of ARDS and to examine the biologic readouts of low dose iCO therapy in patients with ARDS
<![CDATA[
Studies
Study First Submitted Date | 2018-12-06 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2022-08-23 |
Start Month Year | July 1, 2019 |
Primary Completion Month Year | December 2023 |
Verification Month Year | August 2022 |
Verification Date | 2022-08-31 |
Last Update Posted Date | 2022-08-23 |
Detailed Descriptions
Sequence: | 20850604 |
Description | Acute respiratory distress syndrome (ARDS) is a devastating disease affecting military, veteran, and civilian populations. ARDS is a syndrome of severe acute lung inflammation and hypoxemic respiratory failure with an incidence of 180,000 cases annually in the United States. Despite recent advances in critical care management and lung protective ventilation strategies, ARDS morbidity and mortality remain unacceptably high. The lack of specific effective therapies for ARDS indicates a need for new treatments that target novel pathways. Carbon monoxide (CO) represents a novel therapeutic modality in ARDS based on data obtained in experimental models of ARDS over the past decade.
CO has been shown to be protective in experimental models of acute lung injury (ALI) and sepsis. Furthermore, multiple human studies have demonstrated that experimental administration of several different concentrations of CO is well tolerated and that low dose inhaled CO can be safely administered to subjects in a controlled research environment. The investigators have previously conducted a Phase I trial of low dose iCO in ARDS which demonstrated that precise administration of low dose iCO (100 and 200 ppm) is feasible, well-tolerated, and safe in patients with sepsis-induced ARDS. The purpose of this study is to assess the safety and efficacy of low dose inhaled carbon monoxide (iCO) therapy in mechanically ventilated patients with ARDS. |
Facilities
Sequence: | 201277248 | Sequence: | 201277249 | Sequence: | 201277250 | Sequence: | 201277251 | Sequence: | 201277252 | Sequence: | 201277253 | Sequence: | 201277254 |
Name | Massachusetts General Hospital | Name | Brigham and Women's Hospital | Name | Washington University | Name | New York-Presbyterian Brooklyn Methodist Hospital | Name | Weill Cornell Medical College | Name | Duke Regional Hospital | Name | Duke University Hospital |
City | Boston | City | Boston | City | Saint Louis | City | Brooklyn | City | New York | City | Durham | City | Durham |
State | Massachusetts | State | Massachusetts | State | Missouri | State | New York | State | New York | State | North Carolina | State | North Carolina |
Zip | 02114 | Zip | 02115 | Zip | 63130 | Zip | 11215 | Zip | 10065 | Zip | 27704 | Zip | 27710 |
Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States |
Browse Interventions
Sequence: | 96590314 | Sequence: | 96590315 | Sequence: | 96590316 | Sequence: | 96590317 | Sequence: | 96590318 | Sequence: | 96590319 |
Mesh Term | Carbon Monoxide | Mesh Term | Antimetabolites | Mesh Term | Molecular Mechanisms of Pharmacological Action | Mesh Term | Gasotransmitters | Mesh Term | Neurotransmitter Agents | Mesh Term | Physiological Effects of Drugs |
Downcase Mesh Term | carbon monoxide | Downcase Mesh Term | antimetabolites | Downcase Mesh Term | molecular mechanisms of pharmacological action | Downcase Mesh Term | gasotransmitters | Downcase Mesh Term | neurotransmitter agents | Downcase Mesh Term | physiological effects of drugs |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52503085 |
Name | Acute Respiratory Distress Syndrome |
Downcase Name | acute respiratory distress syndrome |
Id Information
Sequence: | 40395925 | Sequence: | 40395926 |
Id Source | org_study_id | Id Source | secondary_id |
Id Value | 2018P002051 | Id Value | CDMRP-PR171025, W81XWH1810667 |
Id Type | Other Grant/Funding Number | ||
Id Type Description | United States Army Medical Research Acquisition Activity | ||
Countries
Sequence: | 42832464 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55959192 | Sequence: | 55959193 |
Group Type | Experimental | Group Type | Placebo Comparator |
Title | Inhaled Carbon Monoxide | Title | Medical air |
Description | Inhaled Carbon Monoxide at 200 ppm for up to 90 minutes daily for 3 days. | Description | Inhaled Medical Air for up to 90 minutes daily for 3 days. |
Interventions
Sequence: | 52811074 | Sequence: | 52811075 |
Intervention Type | Drug | Intervention Type | Other |
Name | Inhaled Carbon Monoxide at 200 ppm | Name | Inhaled Medical air |
Description | Inhaled Carbon Monoxide at 200 ppm for 90 minutes daily for 3 days. | Description | Inhaled Medical Air for up to 90 minutes daily for 3 days. |
Design Outcomes
Sequence: | 178616982 | Sequence: | 178616983 | Sequence: | 178616984 | Sequence: | 178616985 | Sequence: | 178616986 | Sequence: | 178616987 | Sequence: | 178616988 | Sequence: | 178616989 | Sequence: | 178616990 | Sequence: | 178616991 | Sequence: | 178616992 | Sequence: | 178616993 | Sequence: | 178616994 | Sequence: | 178616995 | Sequence: | 178616996 | Sequence: | 178616997 | Sequence: | 178616998 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other |
Measure | Primary Safety Outcome: Number of pre-specified administration-related adverse events. | Measure | Primary Efficacy Outcome: Change in Mitochondrial DNA (mtDNA) level from day 1 to day 5 | Measure | Lung injury score (LIS) on days 1-5, and on day 7 | Measure | PaO2/FiO2 ratio on days 1-5, and on day 7 | Measure | Oxygenation Index (OI) on days 1-5, and day 7 | Measure | Dead Space Fraction (Vd/Vt) on days 1-3, and day 7 | Measure | Sequential Organ Failure Assessment (SOFA) score on days 1-5, 7, 14, 28 | Measure | Change in biomarkers of autophagy | Measure | Change in biomarkers of inflammation and inflammasome activation | Measure | Change in lipid mediators | Measure | Change in biomarkers of mitochondrial quality control | Measure | Ventilator-free days at day 28 | Measure | ICU-free days at day 28 | Measure | Hospital-free days at day 60 | Measure | Hospital mortality to day 28 and 60 | Measure | Montreal Cognitive Assessment- MoCA-Blind | Measure | Hayling Sentence Completion Test |
Time Frame | 7 days | Time Frame | 5 days | Time Frame | 7 days | Time Frame | 7 days | Time Frame | 7 days | Time Frame | 7 days | Time Frame | 28 days | Time Frame | 5 days | Time Frame | 5 days | Time Frame | 5 days | Time Frame | 5 days | Time Frame | 28 days | Time Frame | 28 days | Time Frame | 60 days | Time Frame | 60 days | Time Frame | 6 months | Time Frame | 6 months |
Description | Safety of inhaled CO, defined by the incidence of pre-specified administration-related AEs (as defined below) and spontaneously reported AEs through study day 7.
Acute MI within 48 hours of study drug administration |
Description | Mitochondrial DNA (mtDNA) plasma levels will be measured by quantitative PCR of human NADH dehydrogenase 1. | Description | The Lung Injury Score (LIS) is a composite 4-point scoring system including the PaO2/FiO2, PEEP, quasi-static respiratory compliance, and the extent of infiltrates on the chest X-ray. Each of the four components is categorized from 0 to 4, where a higher number is worse. The total Lung Injury Score is obtained by dividing the aggregate sum by the number of components used. Previous randomized clinical trials in ARDS have shown that a decreased LIS correlates with improvement in lung physiology as well as important clinical outcomes including mortality and ventilator-free days (VFDs). | Description | PaO2/FiO2 will be measured daily on days 1-5 and on day 7 in ventilated subjects. | Description | The oxygenation index will be measured daily on days 1-5 and on day 7 in ventilated subjects. Oxygenation index is calculated as (FiO2 X mean airway pressure)/PaO2. | Description | The dead space fraction will be measured daily on days 1-3 and on day 7 in ventilated subjects. | Description | Organ failure will be assessed using the SOFA score. SOFA scores will be assessed daily on days 1-5, and thereafter on days 7, 14, and 28, as the SOFA score has been shown to be a reliable prognostic indicator of outcomes in critically ill patients. To calculate the Sequential Organ Failure Assessment (SOFA) score, each of the six components (Respiratory, Coagulation, Liver, Cardiovascular, Central Nervous System, Renal) is categorized from 0-4, where a higher number is worse. The SOFA score (0-24) will be calculated by summing all six components. | Description | Autophagy markers (eg. LC3B) will be measured in plasma daily on days 1-3 and on day 5. | Description | Cytokine plasma levels (eg. IL-18) will be measured by ELISA daily on days 1-3 and on day 5. | Description | Lipid mediators (LM) and specialized pro-resolving mediators (SPMs) will be measured in plasma using liquid chromatography-tandem mass spectrometry (LC-MS-MS) based methods daily on days 1-3 and on day 5. | Description | Mitochondrial quality control biomarkers (eg. Pink1, Wipi1) will be measured in peripheral blood mononuclear cells (PBMCs) daily on days 1-3 and on day 5. | Description | Ventilator-free days to day 28 are defined as the number of days from the time of initiating unassisted breathing to day 28 after randomization, assuming survival for at least two consecutive calendar days after initiating unassisted breathing and continued unassisted breathing to day 28. If a subject returns to assisted breathing and subsequently achieves unassisted breathing to day 28, VFDs will be counted from the end of the last period of assisted breathing to day 28. Participants who do not survive to day 28 are assigned zero ventilator-free days. | Description | ICU-free days will be assessed on day 28. ICU-free days is defined as the number of days between randomization and day 28 in which the patient is in the ICU (for any part of a day). | Description | Hospital-free days will be assessed on day 60. Hospital-free days are days alive post hospital discharge through day 60. Patients who die on or prior to day 60 are assigned zero hospital-free days. | Description | Mortality will be assessed on day 28 and day 60 | Description | The MoCA-Blind will be administered at 6 months via telephone interview to assess 4 items examining attention, verbal learning and memory, executive functions/language, and orientation. The test is scored out of 22 with 18 and above considered normal. | Description | The Hayling Sentence Completion Test will be administered at 6 months via telephone interview. The Hayling Sentence Completion Test is a neuropsychological test consisting of two types of sentence completion. The first section is scored based on time taken to complete the sentence. The second section is scored based on time taken to complete a sentence as well as the quality of answer. These scores are combined and scaled according to age. |
Browse Conditions
Sequence: | 194752862 | Sequence: | 194752863 | Sequence: | 194752864 | Sequence: | 194752865 | Sequence: | 194752866 | Sequence: | 194752867 | Sequence: | 194752868 | Sequence: | 194752869 | Sequence: | 194752870 | Sequence: | 194752871 | Sequence: | 194752872 | Sequence: | 194752873 |
Mesh Term | Respiratory Distress Syndrome | Mesh Term | Respiratory Distress Syndrome, Newborn | Mesh Term | Acute Lung Injury | Mesh Term | Syndrome | Mesh Term | Disease | Mesh Term | Pathologic Processes | Mesh Term | Lung Diseases | Mesh Term | Respiratory Tract Diseases | Mesh Term | Respiration Disorders | Mesh Term | Infant, Premature, Diseases | Mesh Term | Infant, Newborn, Diseases | Mesh Term | Lung Injury |
Downcase Mesh Term | respiratory distress syndrome | Downcase Mesh Term | respiratory distress syndrome, newborn | Downcase Mesh Term | acute lung injury | Downcase Mesh Term | syndrome | Downcase Mesh Term | disease | Downcase Mesh Term | pathologic processes | Downcase Mesh Term | lung diseases | Downcase Mesh Term | respiratory tract diseases | Downcase Mesh Term | respiration disorders | Downcase Mesh Term | infant, premature, diseases | Downcase Mesh Term | infant, newborn, diseases | Downcase Mesh Term | lung injury |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48626627 | Sequence: | 48626628 | Sequence: | 48626629 | Sequence: | 48626630 | Sequence: | 48626631 | Sequence: | 48626632 | Sequence: | 48626633 | Sequence: | 48626634 | Sequence: | 48626635 |
Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER | Agency Class | FED | Agency Class | OTHER | Agency Class | UNKNOWN | Agency Class | FED | Agency Class | OTHER |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator |
Name | Brigham and Women's Hospital | Name | Massachusetts General Hospital | Name | Weill Medical College of Cornell University | Name | Duke University | Name | Durham VA Medical Center | Name | New York Presbyterian Brooklyn Methodist Hospital | Name | Duke Regional Hospital | Name | U.S. Army Medical Research Acquisition Activity | Name | Washington University School of Medicine |
Overall Officials
Sequence: | 29458470 |
Role | Principal Investigator |
Name | Rebecca Baron, MD |
Affiliation | Brigham and Women's Hospital |
Design Group Interventions
Sequence: | 68601127 | Sequence: | 68601128 |
Design Group Id | 55959192 | Design Group Id | 55959193 |
Intervention Id | 52811074 | Intervention Id | 52811075 |
Eligibilities
Sequence: | 30954616 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
All intubated patients ≥ 18 years old with ARDS ARDS is defined when all four of the following criteria are met: A PaO2/FiO2 ratio ≤ 300 with at least 5 cm H2O positive end-expiratory airway pressure (PEEP) Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in this study: Age less than 18 years |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253909900 |
Number Of Facilities | 7 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | False |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 2 |
Number Of Secondary Outcomes To Measure | 9 |
Number Of Other Outcomes To Measure | 6 |
Designs
Sequence: | 30700196 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Double |
Masking Description | The study drug will be blinded to the study staff using identical tanks containing either CO or placebo air. The administering respiratory therapist (RT) and a physician study staff member will be unblinded to the treatment assignments. |
Subject Masked | True |
Caregiver Masked | True |
Intervention Other Names
Sequence: | 26839054 |
Intervention Id | 52811074 |
Name | iCO |
Responsible Parties
Sequence: | 29066962 |
Responsible Party Type | Principal Investigator |
Name | Rebecca Baron |
Title | Associate Professor of Medicine |
Affiliation | Brigham and Women's Hospital |
Study References
Sequence: | 52410158 | Sequence: | 52410159 | Sequence: | 52410160 | Sequence: | 52410161 | Sequence: | 52410162 | Sequence: | 52410163 | Sequence: | 52410164 | Sequence: | 52410165 | Sequence: | 52410166 | Sequence: | 52410167 | Sequence: | 52410168 | Sequence: | 52410169 | Sequence: | 52410170 | Sequence: | 52410171 |
Pmid | 24391478 | Pmid | 12133657 | Pmid | 25770182 | Pmid | 19465554 | Pmid | 26320156 | Pmid | 9149675 | Pmid | 15557136 | Pmid | 1194155 | Pmid | 5430001 | Pmid | 11704374 | Pmid | 11247913 | Pmid | 26186946 | Pmid | 30518685 | Pmid | 29100885 |
Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background |
Citation | Nakahira K, Kyung SY, Rogers AJ, Gazourian L, Youn S, Massaro AF, Quintana C, Osorio JC, Wang Z, Zhao Y, Lawler LA, Christie JD, Meyer NJ, Mc Causland FR, Waikar SS, Waxman AB, Chung RT, Bueno R, Rosas IO, Fredenburgh LE, Baron RM, Christiani DC, Hunninghake GM, Choi AM. Circulating mitochondrial DNA in patients in the ICU as a marker of mortality: derivation and validation. PLoS Med. 2013 Dec;10(12):e1001577; discussion e1001577. doi: 10.1371/journal.pmed.1001577. Epub 2013 Dec 31. | Citation | Brealey D, Brand M, Hargreaves I, Heales S, Land J, Smolenski R, Davies NA, Cooper CE, Singer M. Association between mitochondrial dysfunction and severity and outcome of septic shock. Lancet. 2002 Jul 20;360(9328):219-23. doi: 10.1016/S0140-6736(02)09459-X. | Citation | Jung SS, Moon JS, Xu JF, Ifedigbo E, Ryter SW, Choi AM, Nakahira K. Carbon monoxide negatively regulates NLRP3 inflammasome activation in macrophages. Am J Physiol Lung Cell Mol Physiol. 2015 May 15;308(10):L1058-67. doi: 10.1152/ajplung.00400.2014. Epub 2015 Mar 13. | Citation | Rhodes MA, Carraway MS, Piantadosi CA, Reynolds CM, Cherry AD, Wester TE, Natoli MJ, Massey EW, Moon RE, Suliman HB. Carbon monoxide, skeletal muscle oxidative stress, and mitochondrial biogenesis in humans. Am J Physiol Heart Circ Physiol. 2009 Jul;297(1):H392-9. doi: 10.1152/ajpheart.00164.2009. Epub 2009 May 22. | Citation | Fredenburgh LE, Kraft BD, Hess DR, Harris RS, Wolf MA, Suliman HB, Roggli VL, Davies JD, Winkler T, Stenzler A, Baron RM, Thompson BT, Choi AM, Welty-Wolf KE, Piantadosi CA. Effects of inhaled CO administration on acute lung injury in baboons with pneumococcal pneumonia. Am J Physiol Lung Cell Mol Physiol. 2015 Oct 15;309(8):L834-46. doi: 10.1152/ajplung.00240.2015. Epub 2015 Aug 28. | Citation | Hausberg M, Somers VK. Neural circulatory responses to carbon monoxide in healthy humans. Hypertension. 1997 May;29(5):1114-8. doi: 10.1161/01.hyp.29.5.1114. | Citation | Mayr FB, Spiel A, Leitner J, Marsik C, Germann P, Ullrich R, Wagner O, Jilma B. Effects of carbon monoxide inhalation during experimental endotoxemia in humans. Am J Respir Crit Care Med. 2005 Feb 15;171(4):354-60. doi: 10.1164/rccm.200404-446OC. Epub 2004 Nov 19. | Citation | Peterson JE, Stewart RD. Predicting the carboxyhemoglobin levels resulting from carbon monoxide exposures. J Appl Physiol. 1975 Oct;39(4):633-8. doi: 10.1152/jappl.1975.39.4.633. | Citation | Stewart RD, Peterson JE, Baretta ED, Bachand RT, Hosko MJ, Herrmann AA. Experimental human exposure to carbon monoxide. Arch Environ Health. 1970 Aug;21(2):154-64. doi: 10.1080/00039896.1970.10667214. No abstract available. | Citation | Zevin S, Saunders S, Gourlay SG, Jacob P, Benowitz NL. Cardiovascular effects of carbon monoxide and cigarette smoking. J Am Coll Cardiol. 2001 Nov 15;38(6):1633-8. doi: 10.1016/s0735-1097(01)01616-3. | Citation | Ren X, Dorrington KL, Robbins PA. Respiratory control in humans after 8 h of lowered arterial PO2, hemodilution, or carboxyhemoglobinemia. J Appl Physiol (1985). 2001 Apr;90(4):1189-95. doi: 10.1152/jappl.2001.90.4.1189. | Citation | Pecorella SR, Potter JV, Cherry AD, Peacher DF, Welty-Wolf KE, Moon RE, Piantadosi CA, Suliman HB. The HO-1/CO system regulates mitochondrial-capillary density relationships in human skeletal muscle. Am J Physiol Lung Cell Mol Physiol. 2015 Oct 15;309(8):L857-71. doi: 10.1152/ajplung.00104.2015. Epub 2015 Jul 17. | Citation | Fredenburgh LE, Perrella MA, Barragan-Bradford D, Hess DR, Peters E, Welty-Wolf KE, Kraft BD, Harris RS, Maurer R, Nakahira K, Oromendia C, Davies JD, Higuera A, Schiffer KT, Englert JA, Dieffenbach PB, Berlin DA, Lagambina S, Bouthot M, Sullivan AI, Nuccio PF, Kone MT, Malik MJ, Porras MAP, Finkelsztein E, Winkler T, Hurwitz S, Serhan CN, Piantadosi CA, Baron RM, Thompson BT, Choi AM. A phase I trial of low-dose inhaled carbon monoxide in sepsis-induced ARDS. JCI Insight. 2018 Dec 6;3(23):e124039. doi: 10.1172/jci.insight.124039. | Citation | Rosas IO, Goldberg HJ, Collard HR, El-Chemaly S, Flaherty K, Hunninghake GM, Lasky JA, Lederer DJ, Machado R, Martinez FJ, Maurer R, Teller D, Noth I, Peters E, Raghu G, Garcia JGN, Choi AMK. A Phase II Clinical Trial of Low-Dose Inhaled Carbon Monoxide in Idiopathic Pulmonary Fibrosis. Chest. 2018 Jan;153(1):94-104. doi: 10.1016/j.chest.2017.09.052. Epub 2017 Oct 31. |
]]>
https://zephyrnet.com/NCT03799861
2018-07-05
https://zephyrnet.com/?p=NCT03799861
NCT03799861https://www.clinicaltrials.gov/study/NCT03799861?tab=tableNANANAHeart rate (HR) is not routinely assessed during newborn resuscitations in low- and lower-middle income countries (LMICs). Many non-breathing newborns classified as fresh stillbirths have a heartbeat and are live born. The effect of a low-cost monitor for measuring HR on the problem of misclassification of stillbirths in LMICs is unknown.
Knowledge of HR during newborn resuscitation might also result in timely administration of appropriate interventions, and improvement in outcomes. Helping Babies Breathe (HBB), a resuscitation algorithm developed by the American Academy of Pediatrics (AAP), is widely accepted as the standard of care for newborn resuscitation in low-resource settings. In keeping with the International Liaison Committee on Resuscitation (ILCOR) recommendations that HR be measured during newborn resuscitation, HBB calls for HR assessment after 1 minute of positive-pressure ventilation with good chest movement (or sooner if there is a helper who can palpate/auscultate heart rate). However, given the frequent reality of a single provider attending deliveries in LMICs, as well as the currently available methods for assessing HR (i.e. palpitation or auscultation), assessment of HR is challenging to perform without delaying or stopping the provision of other life-saving interventions such as bag and mask ventilation. The effect of low-cost, continuous HR monitoring to guide resuscitation in these settings is unknown.
NeoBeat is a low-cost, battery-operated device designed by Laerdal Global Health for the measurement of newborn HR. The device can be placed rapidly on a newborn by a single provider, and within 5 seconds, displays HR digitally. A preliminary trial of NeoBeat in 349 non-breathing newborns in Tanzania detected a HR in 67% of newborns classified as stillbirths, suggesting up to two thirds of fresh stillbirths may be misclassified in similar settings.
This trial will evaluate: 1) the effectiveness of HBB in combination with NeoBeat for vital status detection on reduction of reported stillbirths, and 2) the effectiveness of HR-guided HBB on effective breathing at 3 minutes.
The primary hypothesis is that implementation of HBB with measurement of HR using NeoBeat will decrease the reported total stillbirth rate by 15% compared to standard care. The secondary hypothesis is that implementation of HR-guided HBB will increase the proportion of newborns not breathing well at birth who are effectively breathing at 3 minutes by 50% compared to HBB with NeoBeat.
<![CDATA[
Studies
Study First Submitted Date | 2018-11-09 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2022-03-31 |
Start Month Year | July 5, 2018 |
Primary Completion Month Year | July 30, 2020 |
Verification Month Year | March 2022 |
Verification Date | 2022-03-31 |
Last Update Posted Date | 2022-03-31 |
Facilities
Sequence: | 200863498 | Sequence: | 200863499 | Sequence: | 200863500 |
Name | Binza-Delvaux Maternity Hospital | Name | Centre Hospital Kingasani | Name | Mother and Child Hospital Bumbu |
City | Kinshasa | City | Kinshasa | City | Kinshasa |
Country | Congo, The Democratic Republic of the | Country | Congo, The Democratic Republic of the | Country | Congo, The Democratic Republic of the |
Conditions
Sequence: | 52399526 | Sequence: | 52399524 | Sequence: | 52399525 | Sequence: | 52399527 |
Name | Neonatal Bradycardia | Name | Stillbirth | Name | Neonatal Respiratory Depression | Name | Neonatal Resuscitation |
Downcase Name | neonatal bradycardia | Downcase Name | stillbirth | Downcase Name | neonatal respiratory depression | Downcase Name | neonatal resuscitation |
Id Information
Sequence: | 40320674 |
Id Source | org_study_id |
Id Value | 7200AA18FA00010 |
Countries
Sequence: | 42743900 |
Name | Congo, The Democratic Republic of the |
Removed | False |
Design Groups
Sequence: | 55846561 | Sequence: | 55846562 | Sequence: | 55846563 |
Title | Epoch 1: Care prior to HBB training | Title | Epoch 2: HBB with NeoBeat | Title | Epoch 3: HR-guided HBB |
Description | A period of demographic and birth outcome data collection for a retrospective cohort of all infants born in the three study hospitals during the 18 months prior to the start of Epoch 2, reflecting care prior to HBB training. | Description | Implementation of Helping Babies Breathe training in combination with NeoBeat for detection of HR in non-breathing newborns, after which demographic and birth outcome data will be abstracted from the medical record along with observational data on resuscitation for prospective cohort of all infants born in the three study hospitals for a 9-month period. | Description | Implementation of HR-guided Helping Babies Breathe training with NeoBeat for measurement of HR throughout resuscitation of non-breathing newborns, after which demographic and birth outcome data will be abstracted from the medical record along with observational data on resuscitation for a prospective cohort of all infants born in the three study hospitals for a 9-month period. |
Interventions
Sequence: | 52708687 | Sequence: | 52708688 |
Intervention Type | Other | Intervention Type | Other |
Name | Epoch 2: HBB with NeoBeat | Name | Epoch 3: HR-guided HBB |
Description | At the beginning of Epoch 2, all birth attendants in each of the 3 maternity units will participate in a 2 day workshop in Kinshasa in French that will include instructions regarding use of NeoBeat and training in HBB 2.0. Participants will be introduced to NeoBeat, which will include practice with NeoBeat using the NeoNatalie newborn simulator. This training will be conducted in French using typical adapted training materials for this program that incorporate placement of NeoBeat at appropriate times in the algorithm, including a flipchart and NeoNatalie. Participants will complete the pre and post knowledge check questionnaire for the training as well as the Observed Standardized Clinical Exams (OSCEs) with the incorporation of use of NeoBeat into the OSCEs. | Description | At the beginning of Epoch 3, all birth attendants in each of the 3 maternity units will participate in a 1 day workshop in Kinshasa in French that will instruct them in an adapted, HR-guided HBB algorithm. This training will include simulation with NeoNatalie and NeoBeat. Participants will complete a pre and post knowledge check questionnaire for the training as well as the Observed Standardized Clinical Exams (OSCEs). |
Keywords
Sequence: | 80178385 | Sequence: | 80178386 | Sequence: | 80178387 | Sequence: | 80178388 |
Name | Neonatal Resuscitation | Name | Stillbirth | Name | Neonatal Respiratory Depression | Name | Neonatal Bradycardia |
Downcase Name | neonatal resuscitation | Downcase Name | stillbirth | Downcase Name | neonatal respiratory depression | Downcase Name | neonatal bradycardia |
Design Outcomes
Sequence: | 178223249 | Sequence: | 178223250 | Sequence: | 178223251 | Sequence: | 178223252 | Sequence: | 178223253 | Sequence: | 178223254 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other |
Measure | Reported Total Stillbirth Rate | Measure | Effective, Spontaneous Breathing at 3 Minutes | Measure | Fresh Stillbirth Rate | Measure | Macerated Stillbirth Rate | Measure | Neonatal Death Prior to Discharge | Measure | Number of Providers Adhering to Resuscitation Algorithm |
Time Frame | At delivery | Time Frame | At 3 minutes of life | Time Frame | At delivery | Time Frame | At delivery | Time Frame | Up to 28 days of life | Time Frame | At delivery |
Description | The total number of stillborn infants (both fresh and macerated) at the facility per 1,000 births, with stillbirth as classified by the delivery attendant. | Description | Breathing without the assistance of stimulation or bag and mask ventilation at a respiratory rate ≥ 40 breaths per minute with a HR ≥ 100 beats per minute at 32 minutes of life. | Description | Total number of non-breathing newborns without a HR at the time of birth, and without signs of maceration, as determined by the delivery attendant, per 1,000 births. | Description | Total number of non-breathing newborns without a HR at the time of birth, with signs of maceration, as determined by the delivery attendant, per 1,000 births. | Description | Death of a live born infant during the birth hospitalization, where death occurs prior to discharge or transfer from the facility of birth. | Description | any number of provider actions to promote resuscitation of the non-breathing newborn such as suctioning, stimulation, bag and mask ventilation and corrective measures to improve bag and mask ventilation in response to newborn respiratory condition or HR as defined in the resuscitation algorithm. |
Browse Conditions
Sequence: | 194354564 | Sequence: | 194354565 | Sequence: | 194354566 | Sequence: | 194354567 | Sequence: | 194354568 | Sequence: | 194354569 | Sequence: | 194354570 | Sequence: | 194354571 | Sequence: | 194354572 | Sequence: | 194354573 | Sequence: | 194354574 | Sequence: | 194354575 | Sequence: | 194354576 | Sequence: | 194354577 | Sequence: | 194354578 | Sequence: | 194354579 |
Mesh Term | Respiratory Insufficiency | Mesh Term | Stillbirth | Mesh Term | Bradycardia | Mesh Term | Depression | Mesh Term | Behavioral Symptoms | Mesh Term | Arrhythmias, Cardiac | Mesh Term | Heart Diseases | Mesh Term | Cardiovascular Diseases | Mesh Term | Pathologic Processes | Mesh Term | Fetal Death | Mesh Term | Pregnancy Complications | Mesh Term | Female Urogenital Diseases and Pregnancy Complications | Mesh Term | Urogenital Diseases | Mesh Term | Death | Mesh Term | Respiration Disorders | Mesh Term | Respiratory Tract Diseases |
Downcase Mesh Term | respiratory insufficiency | Downcase Mesh Term | stillbirth | Downcase Mesh Term | bradycardia | Downcase Mesh Term | depression | Downcase Mesh Term | behavioral symptoms | Downcase Mesh Term | arrhythmias, cardiac | Downcase Mesh Term | heart diseases | Downcase Mesh Term | cardiovascular diseases | Downcase Mesh Term | pathologic processes | Downcase Mesh Term | fetal death | Downcase Mesh Term | pregnancy complications | Downcase Mesh Term | female urogenital diseases and pregnancy complications | Downcase Mesh Term | urogenital diseases | Downcase Mesh Term | death | Downcase Mesh Term | respiration disorders | Downcase Mesh Term | respiratory tract diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48532042 | Sequence: | 48532043 | Sequence: | 48532044 | Sequence: | 48532045 | Sequence: | 48532046 | Sequence: | 48532047 | Sequence: | 48532048 |
Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER | Agency Class | UNKNOWN |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator |
Name | American Academy of Pediatrics | Name | Kinshasa School of Public Health | Name | Laerdal Global Health | Name | RTI International | Name | Thrasher Research Fund | Name | University of North Carolina, Chapel Hill | Name | Saving Lives at Birth |
Overall Officials
Sequence: | 29404540 | Sequence: | 29404541 | Sequence: | 29404542 | Sequence: | 29404543 |
Role | Study Director | Role | Principal Investigator | Role | Study Chair | Role | Study Chair |
Name | Carl Bose, MD | Name | Jackie Patterson, MD, MPH | Name | Sara Berkelhamer, MD | Name | Nalini Singhal, MD |
Affiliation | University of North Carolina, Chapel Hill | Affiliation | University of North Carolina, Chapel Hill | Affiliation | University at Buffalo | Affiliation | University of Calgary |
Design Group Interventions
Sequence: | 68459037 | Sequence: | 68459038 |
Design Group Id | 55846562 | Design Group Id | 55846563 |
Intervention Id | 52708687 | Intervention Id | 52708688 |
Eligibilities
Sequence: | 30896967 |
Sampling Method | Non-Probability Sample |
Gender | All |
Minimum Age | 28 Weeks |
Maximum Age | 45 Weeks |
Healthy Volunteers | Accepts Healthy Volunteers |
Population | All newborns delivered at any of the following 3 maternity units in Kinshasa, DRC over 3 years: Bumbu, Kingasani and Binza-Delvaux. The first 18 months of patients enrolled in the study will be retrospective, while the subsequent 18 months will be prospective. The entire study population will include non-observed and observed deliveries. Observed deliveries will be a convenience sample of non-breathing newborns based on availability of study nurses. |
Criteria | Inclusion Criteria: all newborns delivered via vaginal, assisted or operative delivery at any of 3 participating maternity units in Kinshasa, Democratic Republic of Congo (DRC), during the study period will be enrolled. All newborns will be included, regardless of:
intrauterine fetal demise Exclusion Criteria: Newborns transferred to the maternity unit following delivery at a referral hospital or in the community |
Adult | False |
Child | True |
Older Adult | False |
Calculated Values
Sequence: | 254144501 |
Number Of Facilities | 3 |
Registered In Calendar Year | 2018 |
Actual Duration | 25 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | False |
Minimum Age Num | 28 |
Maximum Age Num | 45 |
Minimum Age Unit | Weeks |
Maximum Age Unit | Weeks |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 1 |
Number Of Other Outcomes To Measure | 4 |
Designs
Sequence: | 30642701 |
Observational Model | Cohort |
Time Perspective | Prospective |
Responsible Parties
Sequence: | 29009316 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03799848
2018-06-12
https://zephyrnet.com/?p=NCT03799848
NCT03799848https://www.clinicaltrials.gov/study/NCT03799848?tab=tableNANANAThis is a Phase I open-label study to evaluate the pharmacokinetic (PK) profile of a single oral dose of vadadustat in subjects with hepatic impairment(HI) compared to healthy matched control subjects with normal hepatic function.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-27 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2019-03-22 |
Start Month Year | June 12, 2018 |
Primary Completion Month Year | October 18, 2018 |
Verification Month Year | March 2019 |
Verification Date | 2019-03-31 |
Last Update Posted Date | 2019-03-22 |
Detailed Descriptions
Sequence: | 20721591 |
Description | This is an open label, parallel-group, single dose, Phase 1 study to evaluate the PK profile, safety, and tolerability of a single oral 450 mg dose of vadadustat in subjects with hepatic impairment relative to control subjects with normal hepatic function. The study will enroll up to 24 subjects in 3 groups of 8 subjects at 2 study sites. Blood samples for vadadustat PK and its metabolites will be collected pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 18, 24, 36, 48, 60, and 72 hours post-dose. |
Facilities
Sequence: | 200107899 | Sequence: | 200107900 |
Name | Prism Clinical Research | Name | American Research Corporation at the University of Texas Liver Institute |
City | Saint Paul | City | San Antonio |
State | Minnesota | State | Texas |
Zip | 55114 | Zip | 78215 |
Country | United States | Country | United States |
Conditions
Sequence: | 52171116 |
Name | Hepatic Impairment |
Downcase Name | hepatic impairment |
Id Information
Sequence: | 40158558 |
Id Source | org_study_id |
Id Value | AKB-6548-CI-0024 |
Countries
Sequence: | 42568862 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55593065 |
Group Type | Experimental |
Title | Vadadustat |
Description | Group 1: Subjects with moderately impaired hepatic function (Child-Pugh Class B) Group 2: Normal healthy volunteers Group 3: Subjects with mildly impaired hepatic function (Child-Pugh Class A) |
Interventions
Sequence: | 52485364 |
Intervention Type | Drug |
Name | Vadadustat |
Description | Oral tablet |
Keywords
Sequence: | 79868355 | Sequence: | 79868356 | Sequence: | 79868357 | Sequence: | 79868358 |
Name | Hepatic impairment | Name | Healthy subjects | Name | Child-pugh | Name | Vadadustat |
Downcase Name | hepatic impairment | Downcase Name | healthy subjects | Downcase Name | child-pugh | Downcase Name | vadadustat |
Design Outcomes
Sequence: | 177378459 | Sequence: | 177378460 | Sequence: | 177378461 | Sequence: | 177378462 | Sequence: | 177378463 | Sequence: | 177378464 | Sequence: | 177378465 | Sequence: | 177378466 | Sequence: | 177378467 | Sequence: | 177378468 | Sequence: | 177378469 | Sequence: | 177378470 | Sequence: | 177378471 | Sequence: | 177378472 | Sequence: | 177378473 | Sequence: | 177378474 | Sequence: | 177378475 | Sequence: | 177378476 | Sequence: | 177378477 | Sequence: | 177378478 | Sequence: | 177378479 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Area under the concentration-time curve from dosing to last measurable concentration (AUClast) | Measure | Area under the concentration-time curve from dosing to infinity (AUCinf) | Measure | Observed maximum concentration (Cmax). | Measure | Time to reach Cmax of vadadustat | Measure | Apparent total body clearance (CL/F) of vadadustat | Measure | Apparent volume of distribution (Vd/F) of vadadustat | Measure | Terminal half-life (t1/2) of vadadustat | Measure | Time to reach Tmax of vadadustat | Measure | Assessment of Treatment-Emergent Adverse Events (TEAEs) as reported by study subjects | Measure | Cmax related to free drug (Cmax, free) of Vadadustat Unbound | Measure | AUClast related to free drug (AUClast, free) of Vadadustat Unbound | Measure | AUCinf related to free drug (AUCinf, free) of Vadadustat Unbound | Measure | CL/F related to free drug (CL/Ffree) of Vadadustat Unbound | Measure | Terminal half-life (t1/2) of Vadadustat Unbound | Measure | The area under the concentration-time curve from dosing to last measurable concentration (AUClast) of Vadadustat metabolites | Measure | The area under the concentration-time curve from dosing to infinity (AUCinf) of Vadadustat metabolite | Measure | Time to reach Cmax of vadadustat metabolites | Measure | Terminal half-life (t1/2) of Vadadustat metabolites | Measure | Renal clearance (CLr) of Vadadustat/metabolite(s) Urine | Measure | Cumulative amount of drug excreted (Ae) of Vadadustat/metabolite(s) Urine | Measure | Cumulative fraction of drug excreted (Fe) of Vadadustat/metabolite(s) Urine |
Time Frame | Day 1, Day 4 | Time Frame | Day 1, Day 4 | Time Frame | Day 1, Day 4 | Time Frame | Day 1, Day 4 | Time Frame | Day 1, Day 4 | Time Frame | Day 1, Day 4 | Time Frame | Day 1, Day 4 | Time Frame | Day 1, Day 4 | Time Frame | Up to 9 Weeks | Time Frame | Day 1, Day 4 | Time Frame | Day 1, Day 4 | Time Frame | Day 1, Day 4 | Time Frame | Day 1, Day 4 | Time Frame | Day 1, Day 4 | Time Frame | Day 1, Day 4 | Time Frame | Day 1, Day 4 | Time Frame | Day 1, Day 4 | Time Frame | Day 1, Day 4 | Time Frame | Day 1, Day 4 | Time Frame | Day 1, Day 4 | Time Frame | Day 1, Day 4 |
Browse Conditions
Sequence: | 193486247 | Sequence: | 193486248 |
Mesh Term | Liver Diseases | Mesh Term | Digestive System Diseases |
Downcase Mesh Term | liver diseases | Downcase Mesh Term | digestive system diseases |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48319190 |
Agency Class | INDUSTRY |
Lead Or Collaborator | lead |
Name | Akebia Therapeutics |
Overall Officials
Sequence: | 29285298 |
Role | Study Director |
Name | Akebia Therapeutics |
Affiliation | Akebia Therapeutics |
Design Group Interventions
Sequence: | 68148995 |
Design Group Id | 55593065 |
Intervention Id | 52485364 |
Eligibilities
Sequence: | 30765285 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 70 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria (All groups):
Male or female subjects between ≥18 years and ≤70 years of age Additional Group-Specific Inclusion Criteria: Group 1 (Moderate Hepatic Impairment Subjects): Presence of Moderate hepatic impairment (Child-Pugh Class B) Group 2 (Normal Hepatic Function Subjects): Normal hepatic function Group 3 (Mild Hepatic Impairment Subjects): Presence of mild hepatic impairment ( Child-Pugh Class A) Exclusion Criteria (all groups): Renal impairment ≥ Stage 3 (estimated glomerular filtration rate [eGFR] <60 mL/min/1.73m2 using the Modification of Diet in Renal Disease (MDRD) study equation) |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253878068 |
Number Of Facilities | 2 |
Registered In Calendar Year | 2018 |
Actual Duration | 4 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | False |
Minimum Age Num | 18 |
Maximum Age Num | 70 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 3 |
Number Of Secondary Outcomes To Measure | 18 |
Designs
Sequence: | 30511452 |
Intervention Model | Sequential Assignment |
Observational Model | |
Primary Purpose | Basic Science |
Time Perspective | |
Masking | None (Open Label) |
Intervention Other Names
Sequence: | 26673676 |
Intervention Id | 52485364 |
Name | AKB-6548 |
Responsible Parties
Sequence: | 28877746 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03799835
2019-01-17
https://zephyrnet.com/?p=NCT03799835
NCT03799835https://www.clinicaltrials.gov/study/NCT03799835?tab=tableMaggy Chaussonm-chausson@unicancer.fr+33185343112This is an open-label, randomized, multicentric study in patients with high-risk non-muscle invasive bladder cancer who had never received BCG for this disease.
The objective is to evaluate the efficacy of atezolizumab as measured by recurrence-free survival.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-08 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2022-05-31 |
Start Month Year | January 17, 2019 |
Primary Completion Month Year | April 1, 2024 |
Verification Month Year | May 2022 |
Verification Date | 2022-05-31 |
Last Update Posted Date | 2022-05-31 |
Detailed Descriptions
Sequence: | 20795631 |
Description | ALBAN study will randomize 516 patients in 45 centers in Europe (France, Belgium and Spain), according to a ratio 1:1 in the following arms of treatment:
Arm A (control arm): BCG only The are two factors of stratifications (center and CIS). |
Facilities
Sequence: | 200760783 | Sequence: | 200760784 | Sequence: | 200760785 | Sequence: | 200760786 | Sequence: | 200760787 | Sequence: | 200760788 | Sequence: | 200760789 | Sequence: | 200760790 | Sequence: | 200760791 | Sequence: | 200760792 | Sequence: | 200760793 | Sequence: | 200760794 | Sequence: | 200760795 | Sequence: | 200760796 | Sequence: | 200760797 | Sequence: | 200760798 | Sequence: | 200760799 | Sequence: | 200760800 | Sequence: | 200760801 | Sequence: | 200760802 | Sequence: | 200760803 | Sequence: | 200760804 | Sequence: | 200760805 | Sequence: | 200760806 | Sequence: | 200760807 | Sequence: | 200760808 | Sequence: | 200760809 | Sequence: | 200760810 | Sequence: | 200760811 | Sequence: | 200760812 | Sequence: | 200760813 | Sequence: | 200760814 | Sequence: | 200760815 | Sequence: | 200760816 | Sequence: | 200760817 | Sequence: | 200760818 | Sequence: | 200760819 | Sequence: | 200760820 |
Status | Active, not recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Active, not recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Not yet recruiting | Status | Recruiting | Status | Recruiting | Status | Not yet recruiting | Status | Not yet recruiting | Status | Not yet recruiting |
Name | Groupe Jolimont – Hôpital de Jolimont | Name | AZ Delta – Campus Rumbeke | Name | Centre Hospitalier Universitaire Angers | Name | Centre Hospitalier Universitaire Bordeaux | Name | Hôpital G. Montpied | Name | Clinique Claude Bernard | Name | CHU Grenoble | Name | Hôpital privé Toulon – Sainte Marguerite | Name | Hôpital du Kremlin-Bicêtre | Name | Hôpital Saint Vincent | Name | Hôpital privé de la Louvière | Name | Hôpital Saint Philibert | Name | Insitut Paoli Calmette | Name | Centre Hospitalier Universitaire Marseille | Name | Centre Hospitalier Universitaire Nîmes | Name | Hôpital européen Georges Pompidou | Name | Hôpital Saint Louis | Name | Groupe Hospitalier Paris Saint Joseph | Name | Hôpital Cochin | Name | Institut Mutualiste Montsouris | Name | Centre Hospitalier Universitaire Tenon | Name | Hôpital Diaconesses- Croix Saint Simon | Name | Hôpital La Pitié Salpétrière | Name | Centre Hospitalier Universitaire Lyon Sud | Name | Centre CARIO-HPCA | Name | Centre Hospitalier Universitaire Rennes | Name | Hôpitaux d'instruction des armées Begin | Name | Hôpital Foch | Name | Hôpitaux Leman | Name | Institut Claudius Regaud | Name | Centre Hospitalier Universitaire Tours | Name | Institut Gustave Roussy | Name | Hospital Universitario A Coruña | Name | Hospital Universitario de Jerez de la Frontera | Name | Hospital Universitario Ramon y Cajal | Name | Hospital Universitario La Paz | Name | Hospital General Universitario Morales Meseguer | Name | Hospital Universitario de Canarias |
City | Haine Saint Paul | City | Roeselare | City | Angers | City | Bordeaux | City | Clermont-Ferrand | City | Ermont | City | Grenoble | City | Hyères | City | Le Kremlin-Bicêtre | City | Lille | City | Lille | City | Lomme | City | Marseille | City | Marseille | City | Nîmes | City | Paris | City | Paris | City | Paris | City | Paris | City | Paris | City | Paris | City | Paris | City | Paris | City | Pierre-Bénite | City | Plérin | City | Rennes | City | Saint-Mandé | City | Suresnes | City | Thonon-les-Bains | City | Toulouse | City | Tours | City | Villejuif | City | A Coruña | City | Cadiz | City | Madrid | City | Madrid | City | Murcia | City | Santa Cruz De Tenerife |
Zip | 7100 | Zip | 8800 | Zip | 49933 | Zip | 33000 | Zip | 63003 | Zip | 95120 | Zip | 38043 | Zip | 83400 | Zip | 94270 | Zip | 59020 | Zip | 59800 | Zip | 59462 | Zip | 13009 | Zip | 13354 | Zip | 30900 | Zip | 75010 | Zip | 75010 | Zip | 75014 | Zip | 75014 | Zip | 75014 | Zip | 75020 | Zip | 75020 | Zip | 75651 | Zip | 69130 | Zip | 22198 | Zip | 35033 | Zip | 94160 | Zip | 92150 | Zip | 74200 | Zip | 31059 | Zip | 3700 | Zip | 94805 | Zip | 15006 | Zip | 11009 | Zip | 28034 | Zip | 28046 | Zip | 30008 | Zip | 38320 |
Country | Belgium | Country | Belgium | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain |
Facility Contacts
Sequence: | 28213718 | Sequence: | 28213719 | Sequence: | 28213720 | Sequence: | 28213721 | Sequence: | 28213722 | Sequence: | 28213723 | Sequence: | 28213724 | Sequence: | 28213725 | Sequence: | 28213726 | Sequence: | 28213727 | Sequence: | 28213728 | Sequence: | 28213729 | Sequence: | 28213730 | Sequence: | 28213731 | Sequence: | 28213732 | Sequence: | 28213733 | Sequence: | 28213734 | Sequence: | 28213735 | Sequence: | 28213736 | Sequence: | 28213737 | Sequence: | 28213738 | Sequence: | 28213739 | Sequence: | 28213740 | Sequence: | 28213741 | Sequence: | 28213742 | Sequence: | 28213743 | Sequence: | 28213744 | Sequence: | 28213745 | Sequence: | 28213746 | Sequence: | 28213747 | Sequence: | 28213748 | Sequence: | 28213749 | Sequence: | 28213750 | Sequence: | 28213751 | Sequence: | 28213752 | Sequence: | 28213753 | Sequence: | 28213754 | Sequence: | 28213755 | Sequence: | 28213756 | Sequence: | 28213757 | Sequence: | 28213758 | Sequence: | 28213759 | Sequence: | 28213760 | Sequence: | 28213761 | Sequence: | 28213762 | Sequence: | 28213763 | Sequence: | 28213764 | Sequence: | 28213765 | Sequence: | 28213766 | Sequence: | 28213767 | Sequence: | 28213768 | Sequence: | 28213769 | Sequence: | 28213770 | Sequence: | 28213771 | Sequence: | 28213772 | Sequence: | 28213773 | Sequence: | 28213774 | Sequence: | 28213775 | Sequence: | 28213776 | Sequence: | 28213777 |
Facility Id | 200760784 | Facility Id | 200760785 | Facility Id | 200760785 | Facility Id | 200760786 | Facility Id | 200760786 | Facility Id | 200760787 | Facility Id | 200760787 | Facility Id | 200760788 | Facility Id | 200760788 | Facility Id | 200760789 | Facility Id | 200760789 | Facility Id | 200760790 | Facility Id | 200760790 | Facility Id | 200760791 | Facility Id | 200760792 | Facility Id | 200760792 | Facility Id | 200760793 | Facility Id | 200760793 | Facility Id | 200760794 | Facility Id | 200760794 | Facility Id | 200760795 | Facility Id | 200760795 | Facility Id | 200760796 | Facility Id | 200760796 | Facility Id | 200760797 | Facility Id | 200760797 | Facility Id | 200760798 | Facility Id | 200760798 | Facility Id | 200760799 | Facility Id | 200760799 | Facility Id | 200760800 | Facility Id | 200760801 | Facility Id | 200760801 | Facility Id | 200760802 | Facility Id | 200760802 | Facility Id | 200760803 | Facility Id | 200760803 | Facility Id | 200760804 | Facility Id | 200760804 | Facility Id | 200760805 | Facility Id | 200760805 | Facility Id | 200760806 | Facility Id | 200760806 | Facility Id | 200760807 | Facility Id | 200760807 | Facility Id | 200760808 | Facility Id | 200760809 | Facility Id | 200760809 | Facility Id | 200760810 | Facility Id | 200760812 | Facility Id | 200760813 | Facility Id | 200760813 | Facility Id | 200760814 | Facility Id | 200760815 | Facility Id | 200760816 | Facility Id | 200760817 | Facility Id | 200760818 | Facility Id | 200760819 | Facility Id | 200760819 | Facility Id | 200760820 |
Contact Type | primary | Contact Type | primary | Contact Type | backup | Contact Type | primary | Contact Type | backup | Contact Type | primary | Contact Type | backup | Contact Type | primary | Contact Type | backup | Contact Type | primary | Contact Type | backup | Contact Type | primary | Contact Type | backup | Contact Type | primary | Contact Type | primary | Contact Type | backup | Contact Type | primary | Contact Type | backup | Contact Type | primary | Contact Type | backup | Contact Type | primary | Contact Type | backup | Contact Type | primary | Contact Type | backup | Contact Type | primary | Contact Type | backup | Contact Type | primary | Contact Type | backup | Contact Type | primary | Contact Type | backup | Contact Type | primary | Contact Type | primary | Contact Type | backup | Contact Type | primary | Contact Type | backup | Contact Type | primary | Contact Type | backup | Contact Type | primary | Contact Type | backup | Contact Type | primary | Contact Type | backup | Contact Type | primary | Contact Type | backup | Contact Type | primary | Contact Type | backup | Contact Type | primary | Contact Type | primary | Contact Type | backup | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | backup | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | backup | Contact Type | primary |
Name | Lieven Goeman, MD | Name | Souhil Lebdai, MD | Name | MD | Name | Grégoire Robert, MD | Name | Marine Gross-Goupil, MD | Name | Laurent Guy, MD | Name | MD | Name | Laurent Thomas, MD | Name | Julie Giroud, MD | Name | Jean-Luc Descotes, MD-PHD | Name | Mathieu Laramas, MD | Name | Mael Martin, MD | Name | Philippe Bernard, MD | Name | Jacques Irani, MD | Name | Jean-Louis Bonnal | Name | Sylvie Berger | Name | Pierre Colin, MD | Name | Olvier Romano, MD | Name | Jean-Louis Bonnal | Name | Sylvie Berger | Name | Géraldine Pignot, MD | Name | Gwenaelle Gravis, MD | Name | Eric LECHEVALLIER, MD | Name | Jean-Laurent DEVILLE, MD | Name | Stéphane Droupy, MD | Name | Nadine Houédé, MD | Name | Marc-Olivier Timsit, MD | Name | Constance Thibault, MD | Name | Alexandra Masson-Lecomte, MD | Name | Hélène Gautier, MD | Name | Xavier Durand | Name | Nicolas Barry Delongchamps, MD | Name | Olivier Huillard | Name | Rafael Sanchez-Salas, MD | Name | Mostefa Bennamoun, MD | Name | Olivier Traxer, MD | Name | Ahmed Khalil, MD | Name | Philippe Sebe, MD | Name | Camille Serrate, MD | Name | Morgan Roupret, MD-PHD | Name | Baptiste Abbar, MD | Name | Alain Ruffion, MD | Name | Denis Maillet, MD | Name | Luc Corbel | Name | Dominique Besson | Name | Romain Mathieu, MD | Name | Hugo Picchi, MD | Name | Marie Dusaud, MD-PHD | Name | Yann Neuzillet, MD-PHD | Name | Damien Pouessel, MD | Name | Franck Bruyère, MD | Name | Claude Linassier, MD | Name | Yohann Loriot, MD | Name | Sara Martinez Breijo, MD | Name | Álvaro Juárez Soto, MD | Name | Álvaro Sánchez González, MD | Name | Mario Álvarez Maestro, MD | Name | Tomás Fernández Aparicio, MD | Name | Marta Zafra Poves, MD | Name | Ana Cristina Plata Bello, MD |
Browse Interventions
Sequence: | 96350077 | Sequence: | 96350076 | Sequence: | 96350078 | Sequence: | 96350079 | Sequence: | 96350080 | Sequence: | 96350081 | Sequence: | 96350082 | Sequence: | 96350083 | Sequence: | 96350084 |
Mesh Term | BCG Vaccine | Mesh Term | Atezolizumab | Mesh Term | Immune Checkpoint Inhibitors | Mesh Term | Molecular Mechanisms of Pharmacological Action | Mesh Term | Antineoplastic Agents, Immunological | Mesh Term | Antineoplastic Agents | Mesh Term | Adjuvants, Immunologic | Mesh Term | Immunologic Factors | Mesh Term | Physiological Effects of Drugs |
Downcase Mesh Term | bcg vaccine | Downcase Mesh Term | atezolizumab | Downcase Mesh Term | immune checkpoint inhibitors | Downcase Mesh Term | molecular mechanisms of pharmacological action | Downcase Mesh Term | antineoplastic agents, immunological | Downcase Mesh Term | antineoplastic agents | Downcase Mesh Term | adjuvants, immunologic | Downcase Mesh Term | immunologic factors | Downcase Mesh Term | physiological effects of drugs |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52361123 |
Name | Bladder Cancer |
Downcase Name | bladder cancer |
Id Information
Sequence: | 40294592 | Sequence: | 40294593 |
Id Source | org_study_id | Id Source | secondary_id |
Id Value | UC-0160/1717 | Id Value | 2017-004512-19 |
Id Type | EudraCT Number | ||
Countries
Sequence: | 42717658 | Sequence: | 42717659 | Sequence: | 42717660 |
Name | Belgium | Name | France | Name | Spain |
Removed | False | Removed | False | Removed | False |
Design Groups
Sequence: | 55804330 | Sequence: | 55804331 |
Group Type | Active Comparator | Group Type | Experimental |
Title | Arm A : control arm | Title | Arm B: experimental arm |
Description | BCG therapy only
BCG therapy will be administered in two phases: induction phase: weekly administration of full dose of BCG intravesically up to 6 weeks, starting on the day of the first induction instillation (D1) |
Description | BCG therapy + administration of atezolizumab
BCG therapy will be administered in two phases: induction phase: weekly administration of full dose of BCG intravesically up to 6 weeks, starting on the day of the first induction instillation (D1) |
Interventions
Sequence: | 52671928 | Sequence: | 52671929 |
Intervention Type | Drug | Intervention Type | Drug |
Name | BCG | Name | Atezolizumab |
Description | Intravesical administration OncoTice wil be used only under two conditions : BCG Medac® unavailable and the patient has received at minimum one instillation of BCG Medac® | Description | IV perfusion |
Design Outcomes
Sequence: | 178080901 | Sequence: | 178080902 | Sequence: | 178080903 | Sequence: | 178080904 | Sequence: | 178080905 | Sequence: | 178080906 | Sequence: | 178080907 | Sequence: | 178080908 | Sequence: | 178080909 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Recurrence-free survival | Measure | Progression-free survival | Measure | Disease-specific survival | Measure | Overall Survival | Measure | Disease worsening in each arm | Measure | Complete response in each arm | Measure | Complete response among patients with CIS | Measure | National Cancer Institute – Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 | Measure | Quality of life questionnaire (QLQ): QLQ-C30 questionnaire (EORTC) |
Time Frame | 2 years | Time Frame | From randomization to the date of progression, assessed up to 5 years | Time Frame | From randomization to the date of death, assessed up to 5 years | Time Frame | From randomization to the date of death, assessed up to 5 years | Time Frame | From randomization to the date of death, assessed up to 5 years | Time Frame | 6 weeks and 2 years after randomization | Time Frame | 6 weeks and 2 years after randomization | Time Frame | Throughout study completion, assessed up to 5 years | Time Frame | At randomization, every 12 weeks for years 1 and 2 after randomization, then every 24 weeks for years 3 to 5 after randomization |
Description | Recurrence is defined as reappearance of disease (local recurrence or occurrence of any metastasis) after the start of therapy. | Description | Progression- free survival defined as the time from randomization to the date of disease progression defined as increase of stage from Ta to T1 or from CIS to T1; progression to Muscle Invasive Bladder Cancer (T≥ 2) or to lymph node N+ or to distant disease M+; the date of progression being determined by the endoscopic resection (TURBT) for a local relapse or by CT scan in case of non-local relapse. | Description | Disease-specific survival defined as the time from randomization to the date of death from bladder cancer. | Description | Overall Survival defined as the time from randomization to the date of death from any cause. | Description | Disease worsening, defined as cystectomy or change in therapy indicative, including systemic chemotherapy or radiation therapy. The date of diagnosis (cystoscopy or CT scan) leading to cystectomy or chemotherapy will be considered as the time of disease worsening. | Description | Complete response is assessed by cystoscopy and cytology. | Description | Complete response is assessed by cystoscopy and cytology. | Description | The frequency, nature, and severity of adverse events graded according to NCI CTCAE v5.0 and according to the immune-related adverse event (irAE). | Description | This self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials.
The questionnaire includes five functional scales (physical, everyday activity, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea and vomiting), a health/quality of life overall scale, and a number of additional elements assessing common symptoms (including dyspnea, loss of appetite, insomnia, constipation, and diarrhea), as well as, the perceived financial impact of the disease. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. |
Browse Conditions
Sequence: | 194209598 | Sequence: | 194209599 | Sequence: | 194209600 | Sequence: | 194209601 | Sequence: | 194209602 | Sequence: | 194209603 | Sequence: | 194209604 | Sequence: | 194209605 | Sequence: | 194209606 | Sequence: | 194209607 | Sequence: | 194209608 | Sequence: | 194209609 | Sequence: | 194209610 | Sequence: | 194209611 | Sequence: | 194209612 |
Mesh Term | Urinary Bladder Neoplasms | Mesh Term | Non-Muscle Invasive Bladder Neoplasms | Mesh Term | Urologic Neoplasms | Mesh Term | Urogenital Neoplasms | Mesh Term | Neoplasms by Site | Mesh Term | Neoplasms | Mesh Term | Female Urogenital Diseases | Mesh Term | Female Urogenital Diseases and Pregnancy Complications | Mesh Term | Urogenital Diseases | Mesh Term | Urinary Bladder Diseases | Mesh Term | Urologic Diseases | Mesh Term | Male Urogenital Diseases | Mesh Term | Carcinoma | Mesh Term | Neoplasms, Glandular and Epithelial | Mesh Term | Neoplasms by Histologic Type |
Downcase Mesh Term | urinary bladder neoplasms | Downcase Mesh Term | non-muscle invasive bladder neoplasms | Downcase Mesh Term | urologic neoplasms | Downcase Mesh Term | urogenital neoplasms | Downcase Mesh Term | neoplasms by site | Downcase Mesh Term | neoplasms | Downcase Mesh Term | female urogenital diseases | Downcase Mesh Term | female urogenital diseases and pregnancy complications | Downcase Mesh Term | urogenital diseases | Downcase Mesh Term | urinary bladder diseases | Downcase Mesh Term | urologic diseases | Downcase Mesh Term | male urogenital diseases | Downcase Mesh Term | carcinoma | Downcase Mesh Term | neoplasms, glandular and epithelial | Downcase Mesh Term | neoplasms by histologic type |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48496039 | Sequence: | 48496040 |
Agency Class | OTHER | Agency Class | INDUSTRY |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | UNICANCER | Name | Hoffmann-La Roche |
Overall Officials
Sequence: | 29385645 | Sequence: | 29385646 |
Role | Principal Investigator | Role | Principal Investigator |
Name | Morgan Roupret, MD-PHD | Name | Yohann Loriot, MD |
Affiliation | Hôpital Pitié-Salpétrière | Affiliation | Gustave Roussy, Cancer Campus, Grand Paris |
Central Contacts
Sequence: | 12056983 | Sequence: | 12056984 |
Contact Type | primary | Contact Type | backup |
Name | Soazig Nénan-Le Ficher | Name | Maggy Chausson |
Phone | +33185343113 | Phone | +33185343112 |
s-nenan@unicancer.fr | m-chausson@unicancer.fr | ||
Phone Extension | +33185343112 | ||
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 68408309 | Sequence: | 68408310 | Sequence: | 68408311 |
Design Group Id | 55804330 | Design Group Id | 55804331 | Design Group Id | 55804331 |
Intervention Id | 52671928 | Intervention Id | 52671928 | Intervention Id | 52671929 |
Eligibilities
Sequence: | 30874885 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Signed informed consent form after the last endoscopic surgery (TURBT) Any high risk non muscle invasive urothelial carcinoma histologically confirmed (mixed histology tumors allowed if urothelial carcinoma histology is predominant) defined on the TURBT as any of the following : T1 tumor and/or At least one additional (second) resection of the primary tumor has been performed in any of the following cases [without upstaging towards Muscle Invasive Bladder Cancer (EAU guidelines, 2017)] : T1 tumors at physician's discretion, Adequate hematologic and end-organ function, as defined by the following laboratory results obtained within 7 days prior to the first study treatment: absolute neutrophil count (ANC) ≥1500 cells/μL Exclusion Criteria: Patient having received previous BCG therapy for bladder cancer Malignancies other than urothelial cancer within 5 years prior to Day 1 of cycle 1 of treatment except the following: Patients with localized low risk prostate cancer (defined as Stage ≤T2b, Gleason score ≤7, and PSA at prostate cancer diagnosis ≤20 ng/mL [if measured]) treated with curative intent (radiotherapy and/or prostatectomy) and without prostate-specific antigen (PSA) recurrence are eligible. History of autoimmune disease or history of immunosuppression, or conditions associated with congenital or acquired immune deficiency , including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis (see Appendix 6 for a more comprehensive list of autoimmune diseases) Patients with a history of autoimmune-related hypothyroidism/hyperthyroidism on a stable dose of thyroid replacement hormone may be eligible for this study. Patients with active hepatitis B virus (HBV; chronic or acute; defined as having a positive hepatitis B surface antigen (HBsAg) test prior the randomisation) or hepatitis C. Patients with past HBV infection or resolved HBV infection (defined as the presence of hepatitis B core antibody (HBc Ab) and absence of HBsAg) are eligible. HBV DNA must be obtained in these patients prior to randomisation. Signs or symptoms of urinary infection and/or other signs and symptoms > grade 1 (NCI CTCAE v5.0) within 2 weeks prior to Cycle 1, Day 1 Patients receiving therapeutic oral or IV antibiotics within 2 weeks prior to Cycle 1, Day 1 are not eligible Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within the previous 3 months before Cycle1, Day 1, unstable arrhythmias, or unstable angina. – Patients with known coronary artery disease, congestive heart failure not meeting the above criteria, or left ventricular ejection fraction <50% must be on a stable medical regimen that is optimized in the opinion of the treating physician, in consultation with a cardiologist if appropriate. Major surgical procedure other than for diagnosis within 4 weeks prior to Cycle 1, Day 1 or anticipation of need for a major surgical procedure during the course of the study Administration of a live, attenuated vaccine within 4 weeks before Cycle 1, Day 1 or anticipation if such a live, attenuated vaccine will be required during the study – Influenza vaccination should be given during influenza season only (approximately October through May in the Northern Hemisphere and approximately April through September in the Southern Hemisphere). Patients must agree not to receive live, attenuated influenza vaccine (e.g., FluMist®) within 4 weeks prior to Cycle 1, Day 1, at randomization, during treatment or within 5 months following the last dose of atezolizumab (for patients randomized to atezolizumab). Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications Treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor (anti-TNF) agents) within 2 weeks prior to Cycle 1, Day 1, or anticipated requirement for systemic immunosuppressive medications during the trial Patients who have received acute, low-dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea, multiple doses for contrast allergy) may be enrolled in the study. |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254059340 |
Number Of Facilities | 38 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | False |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 8 |
Designs
Sequence: | 30620677 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Intervention Other Names
Sequence: | 26769339 | Sequence: | 26769340 | Sequence: | 26769341 | Sequence: | 26769342 |
Intervention Id | 52671928 | Intervention Id | 52671928 | Intervention Id | 52671929 | Intervention Id | 52671929 |
Name | Bacillus Calmette Guerin (BCG) Medac® | Name | OncoTice | Name | MPDL3280A | Name | Tecentriq® |
Responsible Parties
Sequence: | 28987208 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03799822
2017-05-01
https://zephyrnet.com/?p=NCT03799822
NCT03799822https://www.clinicaltrials.gov/study/NCT03799822?tab=tableNANANAThe investigators refer to the trial with clinicaltrials.gov indentifier NCT02610933 entitled Effect on Vascular Calcification of Replacing Warfarin by Rivaroxaban With or Without VitK2 in Hemodialysis Patients.
After termination of this trial, included patients will be asked to participate in the extension trial by continuing the treament of their respective allocation arm. No new intervention will be done.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-07 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2020-11-03 |
Start Month Year | May 1, 2017 |
Primary Completion Month Year | September 15, 2020 |
Verification Month Year | October 2020 |
Verification Date | 2020-10-31 |
Last Update Posted Date | 2020-11-03 |
Detailed Descriptions
Sequence: | 20709988 |
Description | The investigators refer to the trial with clinicaltrials.gov indentifier NCT02610933 entitled Effect on Vascular Calcification of Replacing Warfarin by Rivaroxaban With or Without VitK2 in Hemodialysis Patients.
After termination of this trial, included patients will be asked to participate in the extension trial by continuing the treament of their respective allocation arm. No new intervention will be done. Relevant endpoints like death, cardiovascular events and bleeding episodes will be registered. |
Facilities
Sequence: | 199965069 |
Name | OLV Hospital |
City | Aalst |
Zip | 9300 |
Country | Belgium |
Browse Interventions
Sequence: | 95996897 | Sequence: | 95996898 | Sequence: | 95996899 | Sequence: | 95996900 | Sequence: | 95996901 | Sequence: | 95996902 | Sequence: | 95996903 | Sequence: | 95996904 | Sequence: | 95996905 | Sequence: | 95996906 | Sequence: | 95996907 | Sequence: | 95996908 | Sequence: | 95996909 | Sequence: | 95996910 | Sequence: | 95996911 | Sequence: | 95996912 |
Mesh Term | Vitamin K | Mesh Term | Rivaroxaban | Mesh Term | Vitamins | Mesh Term | Micronutrients | Mesh Term | Physiological Effects of Drugs | Mesh Term | Factor Xa Inhibitors | Mesh Term | Antithrombins | Mesh Term | Serine Proteinase Inhibitors | Mesh Term | Protease Inhibitors | Mesh Term | Enzyme Inhibitors | Mesh Term | Molecular Mechanisms of Pharmacological Action | Mesh Term | Anticoagulants | Mesh Term | Antifibrinolytic Agents | Mesh Term | Fibrin Modulating Agents | Mesh Term | Hemostatics | Mesh Term | Coagulants |
Downcase Mesh Term | vitamin k | Downcase Mesh Term | rivaroxaban | Downcase Mesh Term | vitamins | Downcase Mesh Term | micronutrients | Downcase Mesh Term | physiological effects of drugs | Downcase Mesh Term | factor xa inhibitors | Downcase Mesh Term | antithrombins | Downcase Mesh Term | serine proteinase inhibitors | Downcase Mesh Term | protease inhibitors | Downcase Mesh Term | enzyme inhibitors | Downcase Mesh Term | molecular mechanisms of pharmacological action | Downcase Mesh Term | anticoagulants | Downcase Mesh Term | antifibrinolytic agents | Downcase Mesh Term | fibrin modulating agents | Downcase Mesh Term | hemostatics | Downcase Mesh Term | coagulants |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52139003 |
Name | Atrial Fibrillation |
Downcase Name | atrial fibrillation |
Id Information
Sequence: | 40135062 |
Id Source | org_study_id |
Id Value | OLV 2014/065 |
Countries
Sequence: | 42542686 |
Name | Belgium |
Removed | False |
Design Groups
Sequence: | 55559344 | Sequence: | 55559345 | Sequence: | 55559346 |
Group Type | Active Comparator | Group Type | Experimental | Group Type | Experimental |
Title | Control | Title | rivaroxaban | Title | rivaroxaban + K2 |
Description | Hemodialysis patients with non valvular atrial fibrillation receiving warfarin | Description | Hemodialysis patients with non valvular atrial fibrillation receiving rivaroxaban 10 mg od | Description | Hemodialysis patients with non valvular atrial fibrillation receiving rivaroxaban 10 mg od + vitamin K2 supplements |
Interventions
Sequence: | 52454908 | Sequence: | 52454909 | Sequence: | 52454910 |
Intervention Type | Drug | Intervention Type | Dietary Supplement | Intervention Type | Drug |
Name | Rivaroxaban 10 MG Oral Tablet | Name | MK-7 2000µg thrice weekly | Name | Vitamin K Antagonist – Drug |
Description | replacement of warfarin by rivaroxaban | Description | dietary supplement of vitamin K2 MK-7 2000µg thrice weekly | Description | treatment with a vitamin K antagonist |
Keywords
Sequence: | 79822817 | Sequence: | 79822818 | Sequence: | 79822819 |
Name | hemodialysis | Name | rivaroxaban | Name | vitamin K2 |
Downcase Name | hemodialysis | Downcase Name | rivaroxaban | Downcase Name | vitamin k2 |
Design Outcomes
Sequence: | 177263638 | Sequence: | 177263639 | Sequence: | 177263640 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary |
Measure | composite of fatal and non-fatal stroke and other cardiovascular events | Measure | death rate | Measure | safety: incidence of life-threatening, major and minor bleeding |
Time Frame | through study completion, on average 3 years | Time Frame | through study completion, on average 3 years | Time Frame | through study completion, on average 3 years |
Description | composite of fatal and non-fatal stroke and other cardiovascular events | Description | cause of death | Description | incidence of life-threatening, major and minor bleeding |
Browse Conditions
Sequence: | 193366519 | Sequence: | 193366520 | Sequence: | 193366521 | Sequence: | 193366522 | Sequence: | 193366523 |
Mesh Term | Atrial Fibrillation | Mesh Term | Arrhythmias, Cardiac | Mesh Term | Heart Diseases | Mesh Term | Cardiovascular Diseases | Mesh Term | Pathologic Processes |
Downcase Mesh Term | atrial fibrillation | Downcase Mesh Term | arrhythmias, cardiac | Downcase Mesh Term | heart diseases | Downcase Mesh Term | cardiovascular diseases | Downcase Mesh Term | pathologic processes |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48290708 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Onze Lieve Vrouw Hospital |
Overall Officials
Sequence: | 29268531 |
Role | Principal Investigator |
Name | Rogier Caluwe, MD |
Affiliation | OLV Hospital Aalst, Belgium |
Design Group Interventions
Sequence: | 68107453 | Sequence: | 68107454 | Sequence: | 68107455 | Sequence: | 68107456 |
Design Group Id | 55559345 | Design Group Id | 55559346 | Design Group Id | 55559346 | Design Group Id | 55559344 |
Intervention Id | 52454908 | Intervention Id | 52454908 | Intervention Id | 52454909 | Intervention Id | 52454910 |
Eligibilities
Sequence: | 30747722 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 100 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
inclusion in the trial with clinicaltrials.gov identifier NCT02610933 Exclusion Criteria: none |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254121851 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 41 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 100 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 2 |
Designs
Sequence: | 30494005 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Prevention |
Time Perspective | |
Masking | None (Open Label) |
Responsible Parties
Sequence: | 28860285 |
Responsible Party Type | Principal Investigator |
Name | Rogier Caluwe |
Title | Principal Investigator |
Affiliation | Onze Lieve Vrouw Hospital |
Study References
Sequence: | 52032730 |
Pmid | 33753537 |
Reference Type | derived |
Citation | De Vriese AS, Caluwe R, Van Der Meersch H, De Boeck K, De Bacquer D. Safety and Efficacy of Vitamin K Antagonists versus Rivaroxaban in Hemodialysis Patients with Atrial Fibrillation: A Multicenter Randomized Controlled Trial. J Am Soc Nephrol. 2021 Jun 1;32(6):1474-1483. doi: 10.1681/ASN.2020111566. Epub 2021 Mar 22. |
]]>
https://zephyrnet.com/NCT03799809
2016-12-01
https://zephyrnet.com/?p=NCT03799809
NCT03799809https://www.clinicaltrials.gov/study/NCT03799809?tab=tableSACHIN D, MDsachinmedico@gmail.com8129840208Pulmonary aspergillomas are a common cause of recurrent hemoptysis which may be moderate to severe in 2 to 50 % of cases and may be life threatening. Surgical resection, though curative, may not be feasible in significant number of patients and also associated significant post op complications. Bronchial artery embolisation (BAE) is effective for acute control of hemoptysis, however recurrences may occur in upto a quarter of subjects over a 1 year period.
Aspergilloma is caused by a fungus hence systemic antifungals seem appropriate choice. However the fungus only partially touch the walls of the cavities containing them and rarely come into contact with the bloodstream. This is the major reason why the systemic administration of antifungal agents is ineffective in eradicating the condition.
If surgical resection is not a treatment option to control recurrent hemoptysis, instillation of antifungal agents in an aspergilloma cavity could be considered(QoE II).The instillation of antifungal directly into the cavity (intra-cavitatory) containing aspergilloma brings the drug in contact with the fungus. Thus may lead to antifungal action and shrinkage or complete disappearance of aspergilloma. This can be achieved either by percutaneous route or bronchoscopically. Percutaneous approaches have been investigated however they can sometimes cause fungal spread in thoracic space resulting in fungal empyema which should be carefully avoided. Endobronchial instillation of antifungals have been investigated and found to be safe and effective in controlling hemoptysis, however published data comprise of case reports or small case series.
Recently we have published our experience of intrabronchial voriconazole in aspergilloma among 82 patients and found to be safe and effective in hemoptysis control, with transient post procedure cough as an adverse effect with no major serious adverse events. Multiple small studies and case reports have published the safety and efficacy of voriconazole. However, a quality data in the form of randomized controlled trial (RCT) is not there. Therefore, we planned this RCT to assess the efficacy of intrabronchial voriconazole in inoperable aspergilloma.
<![CDATA[
Studies
Study First Submitted Date | 2018-10-20 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2019-01-10 |
Start Month Year | December 1, 2016 |
Primary Completion Month Year | December 30, 2018 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-10 |
Detailed Descriptions
Sequence: | 20727129 |
Description | Primary Objective : To compare the percentage of patients achieving reduction in hemoptysis in intrabronchial voriconazole with standard medical therapy group vs standard medical therapy alone for inoperable symptomatic pulmonary aspergilloma.
Secondary Objectives: To compare the percentage of patients who have complete cessation of hemoptysis after 3 months. Number of Patients: 30 patients in each arm (Intrabronchial voriconazole with Standard medical therapy vs Standard medical therapy alone) Study Design : Prospective Randomized control study Dosages of drug – 400 mg iv preparation of Voriconazole every week for 4 sessions Duration of follow-up – 3-6 months Brief Methodology: Patients with aspergilloma who presented with hemoptysis will be screened for inclusion in the study. Diagnosis of aspergilloma will be based on characteristic computed tomography (CT) features with microbiological or serological evidence of Aspergillus (Aspergillus specific Ig G). The patients fulfilling the inclusion criteria will be taken informed consent and randomized into one of the two arms of intervention. Arm 1: Will receive 400 mg of Intrabronchial Voriconazole every week for 4 weeks along with standard medical therapy. Arm 2: Will receive standard medical therapy alone (hemostatics, anti-tussive and others as deemed appropriate by treating physician) All subjects in arm 1 will undergo fiberoptic bronchoscopy (FOB) following standard protocol under local anesthesia with supplemental oxygen and continuous hemodynamic monitoring. After identifying the segmental/sub-segmental bronchus of interest (as identified by CT) or cavity (if visible) the study drug voriconazole, will be instilled. The bronchoscope will be kept wedged for 60 seconds to prevent back leakage of the solution and then slowly withdrawn without applying suction. The patient will be kept in right or left lateral position (depending on the side of involvement) for the next 20 minutes. Following this patients will be observed for 48 hours for cessation of hemoptysis before discharge. The procedure will be done on day 1 of each week for 4 weeks in arm 1. All patients will receive standard medical treatment for hemoptysis including appropriate positioning, airway protection, blood product transfusions, antitussives, tranexamic acid, and antimicrobial therapy as clinically indicated. BAE shall be offered to all patients if indicated. Mild hemoptysis shall be defined as < 50 ml in 24 hrs, moderate hemoptysis as 50-200 ml in 24 hrs and massive hemoptysis as 200-600 ml in 24 hrs or any amount causing hemodynamic compromise/threatening ventilation. Records will be reviewed regarding demographics, primary etiology leading to fibrocavitary disease, duration and severity of hemoptysis/ other constitutional symptoms, extent of disease (unilateral, bilateral, associated pleural or parenchymal changes), simple vs complex aspergilloma. Size of index aspergilloma. The number of patients requiring emergency or hospital admission due to recurrent hemoptysis, and subsequent treatment details will be recorded. All patients will be followed up for 3-6 months. During follow up patients will be assessed for symptoms and severity, successful cessation of hemoptysis, requirement of BAE due to persistent or increased hemoptysis, number of sessions required for symptomatic improvement/cessation of hemoptysis, hemoptysis-free interval, recurrence of hemoptysis will be noted. Pre and post procedure CT scans (low dose limited CT through aspergilloma) will be compared by an independent radiologist blinded to the clinical outcome. Size of index aspergilloma shall be determined by addition of maximum diameter of largest length and width of the visible lesion. CTs shall be compared for documenting change in the size of index aspergilloma and decrease/disappearance of the cavity. On the basis of these parameters, aspergillomas will be described as no interval change, increased or decreased aspergilloma size, or disappearance and emptying of the cavity. Outcomes in the form of reduction/cessation of hemoptysis, decrease in size of aspergilloma, overall symptomatic improvement and mortality shall be recorded. |
Facilities
Sequence: | 200159067 |
Status | Recruiting |
Name | All India Institute of Medical Sciences |
City | New Delhi |
State | Delhi |
Zip | 110029 |
Country | India |
Facility Contacts
Sequence: | 28113704 |
Facility Id | 200159067 |
Contact Type | primary |
Name | Sachin D, MD |
sachinmedico@gmail.com | |
Phone | 8129840208 |
Browse Interventions
Sequence: | 96074006 | Sequence: | 96074007 | Sequence: | 96074008 | Sequence: | 96074009 | Sequence: | 96074010 | Sequence: | 96074011 | Sequence: | 96074012 | Sequence: | 96074013 | Sequence: | 96074014 | Sequence: | 96074015 | Sequence: | 96074016 | Sequence: | 96074017 |
Mesh Term | Voriconazole | Mesh Term | Antifungal Agents | Mesh Term | Anti-Infective Agents | Mesh Term | 14-alpha Demethylase Inhibitors | Mesh Term | Cytochrome P-450 Enzyme Inhibitors | Mesh Term | Enzyme Inhibitors | Mesh Term | Molecular Mechanisms of Pharmacological Action | Mesh Term | Steroid Synthesis Inhibitors | Mesh Term | Hormone Antagonists | Mesh Term | Hormones, Hormone Substitutes, and Hormone Antagonists | Mesh Term | Physiological Effects of Drugs | Mesh Term | Cytochrome P-450 CYP3A Inhibitors |
Downcase Mesh Term | voriconazole | Downcase Mesh Term | antifungal agents | Downcase Mesh Term | anti-infective agents | Downcase Mesh Term | 14-alpha demethylase inhibitors | Downcase Mesh Term | cytochrome p-450 enzyme inhibitors | Downcase Mesh Term | enzyme inhibitors | Downcase Mesh Term | molecular mechanisms of pharmacological action | Downcase Mesh Term | steroid synthesis inhibitors | Downcase Mesh Term | hormone antagonists | Downcase Mesh Term | hormones, hormone substitutes, and hormone antagonists | Downcase Mesh Term | physiological effects of drugs | Downcase Mesh Term | cytochrome p-450 cyp3a inhibitors |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52185349 |
Name | Aspergilloma |
Downcase Name | aspergilloma |
Id Information
Sequence: | 40168982 |
Id Source | org_study_id |
Id Value | AIIMS SACHIN |
Countries
Sequence: | 42580592 |
Name | India |
Removed | False |
Design Groups
Sequence: | 55608992 | Sequence: | 55608993 |
Group Type | Active Comparator | Group Type | No Intervention |
Title | Voriconazole | Title | Control |
Description | Will receive 400 mg of Intrabronchial Voriconazole every week for 4 weeks along with standard medical therapy. | Description | Will receive standard medical therapy alone (hemostatics, anti-tussive and others as deemed appropriate by treating physician) |
Interventions
Sequence: | 52499315 |
Intervention Type | Drug |
Name | Intrabronchial Voriconazole instillation |
Description | Efficacy of intrabronchial voriconazole instillation for inoperable pulmonary aspergilloma |
Design Outcomes
Sequence: | 177431653 | Sequence: | 177431654 | Sequence: | 177431655 | Sequence: | 177431656 | Sequence: | 177431657 | Sequence: | 177431658 | Sequence: | 177431659 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | To compare the percentage of patients achieving reduction in hemoptysis in intrabronchial voriconazole with standard medical therapy group vs standard medical therapy alone for inoperable pulmonary aspergilloma at 3 months. | Measure | To compare the percentage of patients who have complete cessation of hemoptysis after 3 months. | Measure | To compare the percentage of patients having recurrence of hemoptysis during 3 months follow up. | Measure | To compare the severity of hemoptysis during recurrence in both groups. | Measure | To compare the change in size of aspergilloma after 3 months following last intrabronchial voriconazole instillation. | Measure | To compare the percentage of patients who need BAE during anytime till 3 months. | Measure | To compare the percentage of patients with symptomatic improvement in Dyspnea On Exertion, Cough and hemoptysis. |
Time Frame | 3 months follow up | Time Frame | 3 months follow up | Time Frame | 3 months follow up | Time Frame | 3 months follow up | Time Frame | 3 months follow up | Time Frame | 3 months follow up | Time Frame | 3 months follow up |
Description | Percentage of patients achieving reduction in hemoptysis in intrabronchial voriconazole with standard medical therapy group vs standard medical therapy alone for inoperable pulmonary aspergilloma at 3 months. | Description | percentage of patients who have complete cessation of hemoptysis after 3 months. | Description | percentage of patients having recurrence of hemoptysis during 3 months follow up. | Description | severity of hemoptysis during recurrence in both groups shall be compared with visual analogue scale. | Description | change in size of aspergilloma after 3 months following last intrabronchial voriconazole instillation. | Description | percentage of patients who need BAE during anytime till 3 months. | Description | percentage of patients with symptomatic improvement in Dyspnea On Exertion, Cough and hemoptysis. |
Sponsors
Sequence: | 48332215 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | All India Institute of Medical Sciences, New Delhi |
Central Contacts
Sequence: | 12012276 |
Contact Type | primary |
Name | SACHIN D, MD |
Phone | 8129840208 |
sachinmedico@gmail.com | |
Role | Contact |
Design Group Interventions
Sequence: | 68168032 |
Design Group Id | 55608992 |
Intervention Id | 52499315 |
Eligibilities
Sequence: | 30773509 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Patients with mild to moderate hemoptysis AND inoperable aspergilloma/ those unwilling for surgery. Exclusion Criteria: Patient who are not fit for FOB (e.g. hemodynamic instability) |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253952452 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 6 |
Designs
Sequence: | 30519640 |
Allocation | Randomized |
Intervention Model | Crossover Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Responsible Parties
Sequence: | 28885941 |
Responsible Party Type | Principal Investigator |
Name | DR SACHIN D |
Title | senior resident |
Affiliation | All India Institute of Medical Sciences, New Delhi |
]]>
https://zephyrnet.com/NCT03799796
2019-01-06
https://zephyrnet.com/?p=NCT03799796
NCT03799796https://www.clinicaltrials.gov/study/NCT03799796?tab=tableNANANACurrently, Hispanic Spanish-speaking individuals are not receiving culturally appropriate diabetes care. Lack of knowledge impacts several areas of type 2 diabetes (T2D) management, including healthy eating and being physically active in Hispanic Spanish-speaking individuals. Use of diabetes technology is on the rise, however, many technologies do not provide Spanish-language options. A flash glucose monitoring (FGM) system is now available in both English and Spanish. Research suggests that use of FGM results in improved clinical outcomes. Furthermore, increased number of FGM scans are associated with improved clinical outcomes such as decreased A1C and improvements in BG time in range. Our preliminary work indicates that Hispanics (1) are willing to use diabetes technology, such as FGM, if it supports Spanish language and (2) in English-speaking populations, but not specific to the Hispanic Spanish-speaking population, FGM supports biobehavioral change. Further, our work, and the work of others, indicate Hispanic individuals desire for peer interactions to relate and understand the variables that impact T2D. Interaction with online peer support communities is associated with increased knowledge, receipt of emotional support, and improved glycemic levels. These results suggest that education and support to increase use and understanding of FGM will lead to improved clinical and behavioral outcomes.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-09 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2020-10-22 |
Start Month Year | January 6, 2019 |
Primary Completion Month Year | July 27, 2020 |
Verification Month Year | October 2020 |
Verification Date | 2020-10-31 |
Last Update Posted Date | 2020-10-22 |
Detailed Descriptions
Sequence: | 20716258 |
Description | Currently, Hispanic Spanish-speaking individuals are not receiving culturally appropriate diabetes care. Lack of knowledge impacts several areas of type 2 diabetes (T2D) management, including healthy eating and being physically active in Hispanic Spanish-speaking individuals. Use of diabetes technology is on the rise, however, many technologies do not provide Spanish-language options. A flash glucose monitoring (FGM) system is now available in both English and Spanish. FGM involves wearing an interstitial glucose sensor that is placed on the upper arm and a reader. When an individual wants to check their glucose level, they waive or scan the reader over their sensor and a glucose history, current glucose level, and projected glucose trend is displayed. Research suggests that use of FGM results in improved clinical outcomes. Furthermore, increased number of FGM scans are associated with improved clinical outcomes such as decreased A1C and improvements in BG time in range. Our preliminary work indicates that Hispanics (1) are willing to use diabetes technology, such as FGM, if it supports Spanish language and (2) in English-speaking populations, but not specific to the Hispanic Spanish-speaking population, FGM supports biobehavioral change. Further, our work, and the work of others, indicate Hispanic individuals desire for peer interactions to relate and understand the variables that impact T2D. Interaction with online peer support communities is associated with increased knowledge, receipt of emotional support, and improved glycemic levels. These results suggest that education and support to increase use and understanding of FGM will lead to improved clinical and behavioral outcomes.
Little is known about the uses, benefits, and limitations of online peer support in the context of learning how to use diabetes technology, such as FGM. Hispanic, Spanish speaking individuals are at high risk for T2D and associated morbidity and mortality. Hispanics are more likely to die from diabetes compared to Caucasian counterparts. The investigators propose to address gaps in diabetes care for Hispanic individuals by conducting a pilot trial of an online peer support intervention using an online peer facilitator to augment the use of FGM. The online peer facilitator will be Hispanic and bilingual in English and Spanish with substantial knowledge of diabetes and FGM. Our intervention is culturally appropriate to address the biobehavioral and biopsychosocial needs of Hispanic individuals. The investigators anticipate the additional support provided by the online peer facilitator will encourage healthy eating habits and physical activity behaviors in Hispanic individuals with T2D. Our research team is experienced with community-based participatory research in both diabetes online peer support communities and Hispanic populations using technology to support T2D. Examining online peer support communities to augment diabetes care in Hispanic Spanish speaking individuals is a promising, exciting, and innovative area of research that has not yet been explored. This proposed study contains several novel components. First, using online peer support communities is low-cost and easily accessible, making this intervention more translatable in the clinical setting while adding to the toolkit that already exists for diabetes care. Second, using FGM in a population not using insulin is forward thinking. Empowering people with their own glucose data, early in the course of their diabetes, may change the trajectory of diabetes management. The research team received PCORI pipeline-to-proposal funding (tiers I-III) to develop a research question via a community advisory board (CAB) in partnership with the diabetes online peer support community. The CAB included researchers, clinicians, and people with diabetes, both English and Spanish speaking. This study will address important questions identified by people affected by diabetes. Aim 1 Explore the relationship between engagement in an online peer support intervention with clinical and behavioral outcomes in Hispanic, Spanish speaking individuals with T2D using flash glucose monitoring for 12 weeks Method. A one group, pre-post evaluation of Hispanic, Spanish speaking individuals (N=43) recruited from a health center in Utah. Primary outcome: Time-in-range (average glucose level and number of minutes in 70mg/dl-180mg/dl in last 10 days of the study minus average glucose level and number of minutes in 70mg/dl-180mg/dl for 10 days baseline) between baseline and 12 weeks. Secondary outcomes: Change in A1C from baseline to 12 weeks. Online peer support engagement (measured by survey and Facebook activity), Frequency of FGM scans. Change in self-reported self-management behaviors, self-efficacy and quality of life between baseline and 12 weeks. Hypothesis. Increased engagement in the online peer support intervention will be associated with improved clinical, behavioral and psychosocial outcomes after 12 weeks of FGM. Aim 2. Evaluate the acceptability and feasibility of an online peer support intervention for Hispanic Spanish speaking individuals with T2D to learn how to use flash glucose monitoring to make changes to meal and activity choices. Method. Qualitative and quantitative analysis for measures of use of and satisfaction with flash glucose sensors, eligible participant acceptance of flash glucose sensors, and dropout rates, including causes for drop out, and online peer support engagement through platform analytics. A semi-structured interview will be conducted with participants at the end of the intervention explore their experiences during engagement with the online peer support community. Hypothesis. Online peer support engagement will be associated with satisfaction with FGM and number of daily scans. |
Facilities
Sequence: | 200053118 |
Name | University of Utah College of Nursing |
City | Salt Lake City |
State | Utah |
Zip | 841112 |
Country | United States |
Conditions
Sequence: | 52156372 |
Name | Diabetes Mellitus, Type 2 |
Downcase Name | diabetes mellitus, type 2 |
Id Information
Sequence: | 40148147 |
Id Source | org_study_id |
Id Value | ADC-SRR-IIS-18-23 |
Countries
Sequence: | 42557673 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55577805 |
Group Type | Experimental |
Title | Flash Glucose Monitoring with Online Peer Support |
Description | Pre-Test-Post-Test |
Interventions
Sequence: | 52471915 |
Intervention Type | Behavioral |
Name | Flash Glucose Monitoring with Online Peer Support |
Description | Hispanic Adults who are Spanish-Speaking with type 2 diabetes who are not using insulin will be asked to use flash glucose monitoring and to sign up for an moderated online peer support group where they can ask questions and share progress. |
Keywords
Sequence: | 79847961 | Sequence: | 79847962 | Sequence: | 79847963 | Sequence: | 79847964 |
Name | flash glucose monitoring | Name | online peer support | Name | Hispanic | Name | Spanish-Speaking |
Downcase Name | flash glucose monitoring | Downcase Name | online peer support | Downcase Name | hispanic | Downcase Name | spanish-speaking |
Design Outcomes
Sequence: | 177327598 | Sequence: | 177327599 | Sequence: | 177327600 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Time-in-Range | Measure | A1C | Measure | Online peer support engagement |
Time Frame | 12 weeks | Time Frame | 12 weeks | Time Frame | 12 weeks |
Description | Average glucose level and number of minutes spent between 70-180 mg/dL | Description | Glycosylated hemoglobin | Description | Survey, Activity in online peer support group |
Browse Conditions
Sequence: | 193431739 | Sequence: | 193431740 | Sequence: | 193431741 | Sequence: | 193431742 | Sequence: | 193431743 |
Mesh Term | Diabetes Mellitus | Mesh Term | Diabetes Mellitus, Type 2 | Mesh Term | Glucose Metabolism Disorders | Mesh Term | Metabolic Diseases | Mesh Term | Endocrine System Diseases |
Downcase Mesh Term | diabetes mellitus | Downcase Mesh Term | diabetes mellitus, type 2 | Downcase Mesh Term | glucose metabolism disorders | Downcase Mesh Term | metabolic diseases | Downcase Mesh Term | endocrine system diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48305973 | Sequence: | 48305974 |
Agency Class | OTHER | Agency Class | OTHER |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | University of Utah | Name | La Trobe University |
Overall Officials
Sequence: | 29277883 |
Role | Principal Investigator |
Name | Michelle L Litchman, PhD, FNP-BC |
Affiliation | University of Utah College of Nursing |
Design Group Interventions
Sequence: | 68130750 |
Design Group Id | 55577805 |
Intervention Id | 52471915 |
Eligibilities
Sequence: | 30757299 |
Gender | All |
Minimum Age | 21 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Age ≥21 years Exclusion Criteria: Non-Spanish speaking |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254225709 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 18 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 21 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 2 |
Designs
Sequence: | 30503524 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Other |
Time Perspective | |
Masking | None (Open Label) |
Intervention Other Names
Sequence: | 26665857 |
Intervention Id | 52471915 |
Name | Abbott Freestyle Libre |
Responsible Parties
Sequence: | 28869802 |
Responsible Party Type | Principal Investigator |
Name | Michelle Litchman |
Title | Assistant Professor |
Affiliation | University of Utah |
Study References
Sequence: | 52049347 |
Pmid | 35200153 |
Reference Type | derived |
Citation | Ng AH, Greenwood DA, Iacob E, Allen NA, Ferrer M, Rodriguez B, Litchman ML. Examining a Continuous Glucose Monitoring Plus Online Peer Support Community Intervention to Support Hispanic Adults With Type 2 Diabetes: Protocol for a Mixed Methods Feasibility Study. JMIR Res Protoc. 2022 Feb 24;11(2):e31595. doi: 10.2196/31595. |
]]>
https://zephyrnet.com/NCT03799783
2018-03-01
https://zephyrnet.com/?p=NCT03799783
NCT03799783https://www.clinicaltrials.gov/study/NCT03799783?tab=tableNANANAChildren’s compliance during diagnostic or therapeutic procedures is a challenge, often requiring the use of sedative and/or analgesic drugs.
Electroencephalogram (EEG) needs stillness for a medium-long period but, at the same time, the use of any drug for sedation may affect the exam through an interference with EEG waves. Dexmedetomidine is a selective ∝2-adrenergic agonist with sedative and anxiolytic properties, with a long effect and which does not alter EEG pattern.
The aim of this interventional study is to evaluate the effectiveness, safety and feasibility of dexmedetomidine for sedation during EEG in children who are not cooperative.
Children affected by behavioral disorders and requiring sedation to perform EEG were considered. The protocol establishes to administer IV dexmedetomidine (loading dose and continued infusion) to reach a targeted level of sedation (Pediatric Sedation State Scale = 2). Vital signs (SatO2, RR, EtCO2, HR, BP) and level of sedation are recorded before, during and after procedure until the offset.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-03 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2021-02-02 |
Start Month Year | March 1, 2018 |
Primary Completion Month Year | February 28, 2019 |
Verification Month Year | January 2021 |
Verification Date | 2021-01-31 |
Last Update Posted Date | 2021-02-02 |
Results First Posted Date | 2021-01-15 |
Detailed Descriptions
Sequence: | 20563345 |
Description | Compliance during diagnostic or therapeutic procedures is a very frequent challenge in children. Procedural sedation and analgesia represents an effective answer to this problem. Electroencephalogram (EEG) is a procedure which needs stillness for a medium-long period. Whereas the majority of children carry out this procedure without sedation, patients with behavioral problems, who frequently need to rule out the presence of seizures as associated symptoms or different disease, often show an insufficient compliance. Sedative drugs usually interfere with EEG cerebral waves pattern, so they can not be used. Dexmedetomidine is a selective ∝2-adrenergic agonist with prevalent sedative and anxiolytic properties, with a long effect and which does not alter EEG pattern.
The aim of this interventional study is to evaluate effectiveness, safety and feasibility of dexmedetomidine for sedation during EEG in children who are not cooperative. Children referred to the Pediatric Neurology Department of the Pediatric Hospital of Padova and required sedation to perform EEG were considered in the study. The protocol establishes to administer dexmedetomidine IV 2 μg/kg in 10 minutes (loading dose) followed by continuous infusion at a rate of 1 μg/kg/h until procedure was complete. The loading dose can be repeated up to two times, if needed, to achieve the targeted level of Pediatric Sedation State Scale (PSSS) of 2 (quiet, asleep or awake, not moving during procedure, and no frown or brow furrow indicating pain or anxiety, no verbalization of any complaint). Vital signs (SatO2, RR, EtCO2, HR, BP) and level of sedation are recorded before, during and after procedure until the complete awake of the patient. The quality of the EEG pattern was also evaluated. Occurrence and type of adverse events are registered during this period. Finally, the caregivers' opinion about the quality of the sedation and the presence of any sleep disturbance at home during the next 12 hours after the procedure were considered. |
Facilities
Sequence: | 198529678 |
Name | Pediatric Intensive Care Unit – Department of Woman's and Child's Health – Azienda Ospedaliera di Padova |
City | Padova |
State | PD |
Country | Italy |
Browse Interventions
Sequence: | 95247284 | Sequence: | 95247285 | Sequence: | 95247286 | Sequence: | 95247287 | Sequence: | 95247288 | Sequence: | 95247289 | Sequence: | 95247290 | Sequence: | 95247291 | Sequence: | 95247292 | Sequence: | 95247293 | Sequence: | 95247294 | Sequence: | 95247295 | Sequence: | 95247296 | Sequence: | 95247297 |
Mesh Term | Dexmedetomidine | Mesh Term | Hypnotics and Sedatives | Mesh Term | Central Nervous System Depressants | Mesh Term | Physiological Effects of Drugs | Mesh Term | Analgesics, Non-Narcotic | Mesh Term | Analgesics | Mesh Term | Sensory System Agents | Mesh Term | Peripheral Nervous System Agents | Mesh Term | Adrenergic alpha-2 Receptor Agonists | Mesh Term | Adrenergic alpha-Agonists | Mesh Term | Adrenergic Agonists | Mesh Term | Adrenergic Agents | Mesh Term | Neurotransmitter Agents | Mesh Term | Molecular Mechanisms of Pharmacological Action |
Downcase Mesh Term | dexmedetomidine | Downcase Mesh Term | hypnotics and sedatives | Downcase Mesh Term | central nervous system depressants | Downcase Mesh Term | physiological effects of drugs | Downcase Mesh Term | analgesics, non-narcotic | Downcase Mesh Term | analgesics | Downcase Mesh Term | sensory system agents | Downcase Mesh Term | peripheral nervous system agents | Downcase Mesh Term | adrenergic alpha-2 receptor agonists | Downcase Mesh Term | adrenergic alpha-agonists | Downcase Mesh Term | adrenergic agonists | Downcase Mesh Term | adrenergic agents | Downcase Mesh Term | neurotransmitter agents | Downcase Mesh Term | molecular mechanisms of pharmacological action |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 51763891 | Sequence: | 51763892 |
Name | Procedural Sedation | Name | Behavior Disorders |
Downcase Name | procedural sedation | Downcase Name | behavior disorders |
Id Information
Sequence: | 39832893 |
Id Source | org_study_id |
Id Value | 4422/AO/18 |
Countries
Sequence: | 42232503 |
Name | Italy |
Removed | False |
Design Groups
Sequence: | 55184878 |
Group Type | Experimental |
Title | Dexmedetomidine |
Description | 2 mcg/Kg iv dexmedetomidine (this dose may be repeated up to 2 times) followed by 1-2 mcg/Kg/hour iv continuous infusion |
Interventions
Sequence: | 52085223 |
Intervention Type | Drug |
Name | dexmedetomidine |
Description | To administer dexmedetomidine IV 2 μg/kg in 10 minutes (loading dose) followed by continuous infusion at a rate of 1 μg/kg/h until procedure was complete |
Keywords
Sequence: | 79197219 | Sequence: | 79197220 |
Name | dexmedetomidine | Name | sedation |
Downcase Name | dexmedetomidine | Downcase Name | sedation |
Design Outcomes
Sequence: | 176067587 | Sequence: | 176067588 |
Outcome Type | primary | Outcome Type | secondary |
Measure | Number of Patients That Reach a Score Equal or Lower Than 2 Ten Minutes After the Infusion of Dexmedetomidine (Assessed With the PSSS Pediatric Sedation State Scale) | Measure | Number of Patients With Adverse Events |
Time Frame | 10 minutes | Time Frame | during and immediately after DEX infusion, up to 150 minutes after DEX infusion (time to first awakening) |
Description | the PSSS is a validated scale for assessing the level of procedural sedation. It is a 6 items scale , from 0 to 5, where 5 is an alert patient and 0 is a deep sedation with abnormal vital signs. We evaluate patients 10 minutes after the infusion of dexmedetomidine. | Description | any adverse event potentially related with DEX-administration |
Browse Conditions
Sequence: | 191843053 |
Mesh Term | Mental Disorders |
Downcase Mesh Term | mental disorders |
Mesh Type | mesh-list |
Sponsors
Sequence: | 47940409 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Azienda Ospedaliera di Padova |
Overall Officials
Sequence: | 29046343 |
Role | Principal Investigator |
Name | angela amigoni, MD |
Affiliation | azienda Ospedaliera di Padova-Pediatric Intensive Care Unit |
Design Group Interventions
Sequence: | 67655734 |
Design Group Id | 55184878 |
Intervention Id | 52085223 |
Eligibilities
Sequence: | 30527023 |
Gender | All |
Minimum Age | 1 Month |
Maximum Age | 18 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
children affected by behavior disorders who underwent EEG procedure with sedation Exclusion Criteria: ASA > 2 |
Adult | True |
Child | True |
Older Adult | False |
Calculated Values
Sequence: | 254094507 |
Number Of Facilities | 1 |
Number Of Nsae Subjects | 10 |
Registered In Calendar Year | 2019 |
Actual Duration | 12 |
Were Results Reported | True |
Months To Report Results | 21 |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 1 |
Maximum Age Num | 18 |
Minimum Age Unit | Month |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 1 |
Designs
Sequence: | 30275912 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Intervention Model Description | Drug administration by a loading dose followed by continuous infusion during a procedure |
Intervention Other Names
Sequence: | 26476415 |
Intervention Id | 52085223 |
Name | dexdor |
Milestones
Sequence: | 40755998 | Sequence: | 40755999 | Sequence: | 40756000 |
Result Group Id | 55828807 | Result Group Id | 55828807 | Result Group Id | 55828807 |
Ctgov Group Code | FG000 | Ctgov Group Code | FG000 | Ctgov Group Code | FG000 |
Title | STARTED | Title | COMPLETED | Title | NOT COMPLETED |
Period | Overall Study | Period | Overall Study | Period | Overall Study |
Count | 19 | Count | 19 | Count | 0 |
Participant Flows
Sequence: | 3898056 |
Outcome Counts
Sequence: | 73518951 | Sequence: | 73518952 |
Outcome Id | 30605227 | Outcome Id | 30605228 |
Result Group Id | 55828808 | Result Group Id | 55828808 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG000 |
Scope | Measure | Scope | Measure |
Units | Participants | Units | Participants |
Count | 19 | Count | 19 |
Provided Documents
Sequence: | 2566077 |
Document Type | Study Protocol and Statistical Analysis Plan |
Has Protocol | True |
Has Icf | False |
Has Sap | True |
Document Date | 2020-02-20 |
Url | https://ClinicalTrials.gov/ProvidedDocs/83/NCT03799783/Prot_SAP_000.pdf |
Reported Event Totals
Sequence: | 27772330 | Sequence: | 27772331 | Sequence: | 27772332 |
Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG000 |
Event Type | serious | Event Type | other | Event Type | deaths |
Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality |
Subjects Affected | 0 | Subjects Affected | 10 | Subjects Affected | 0 |
Subjects At Risk | 19 | Subjects At Risk | 19 | Subjects At Risk | 19 |
Created At | 2023-08-06 14:32:18.993223 | Created At | 2023-08-06 14:32:18.993223 | Created At | 2023-08-06 14:32:18.993223 |
Updated At | 2023-08-06 14:32:18.993223 | Updated At | 2023-08-06 14:32:18.993223 | Updated At | 2023-08-06 14:32:18.993223 |
Reported Events
Sequence: | 524310152 | Sequence: | 524310153 |
Result Group Id | 55828809 | Result Group Id | 55828809 |
Ctgov Group Code | EG000 | Ctgov Group Code | EG000 |
Time Frame | 90 minutes | Time Frame | 90 minutes |
Event Type | other | Event Type | other |
Subjects Affected | 6 | Subjects Affected | 4 |
Subjects At Risk | 19 | Subjects At Risk | 19 |
Description | Other (not including serious) adverse events | Description | Other (not including serious) adverse events |
Event Count | 6 | Event Count | 4 |
Organ System | Cardiac disorders | Organ System | Cardiac disorders |
Adverse Event Term | hypotension | Adverse Event Term | bradycardia |
Frequency Threshold | 0 | Frequency Threshold | 0 |
Assessment | Systematic Assessment | Assessment | Systematic Assessment |
Responsible Parties
Sequence: | 28655773 |
Responsible Party Type | Principal Investigator |
Name | angela amigoni |
Title | Principal Investigator |
Affiliation | Azienda Ospedaliera di Padova |
Result Agreements
Sequence: | 3828800 |
Pi Employee | Yes |
Result Contacts
Sequence: | 3828765 |
Organization | University Hospital Padova |
Name | Angela Amigoni, MD |
Phone | 339 8333765 |
Angela.amigoni@aopd.veneto.it | |
Extension | ++39 |
Outcomes
Sequence: | 30605227 | Sequence: | 30605228 |
Outcome Type | Primary | Outcome Type | Secondary |
Title | Number of Patients That Reach a Score Equal or Lower Than 2 Ten Minutes After the Infusion of Dexmedetomidine (Assessed With the PSSS Pediatric Sedation State Scale) | Title | Number of Patients With Adverse Events |
Description | the PSSS is a validated scale for assessing the level of procedural sedation. It is a 6 items scale , from 0 to 5, where 5 is an alert patient and 0 is a deep sedation with abnormal vital signs. We evaluate patients 10 minutes after the infusion of dexmedetomidine. | Description | any adverse event potentially related with DEX-administration |
Time Frame | 10 minutes | Time Frame | during and immediately after DEX infusion, up to 150 minutes after DEX infusion (time to first awakening) |
Units | Participants | Units | Participants |
Param Type | Count of Participants | Param Type | Count of Participants |
Outcome Measurements
Sequence: | 234052032 | Sequence: | 234052033 |
Outcome Id | 30605227 | Outcome Id | 30605228 |
Result Group Id | 55828808 | Result Group Id | 55828808 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG000 |
Title | Number of Patients That Reach a Score Equal or Lower Than 2 Ten Minutes After the Infusion of Dexmedetomidine (Assessed With the PSSS Pediatric Sedation State Scale) | Title | Number of Patients With Adverse Events |
Description | the PSSS is a validated scale for assessing the level of procedural sedation. It is a 6 items scale , from 0 to 5, where 5 is an alert patient and 0 is a deep sedation with abnormal vital signs. We evaluate patients 10 minutes after the infusion of dexmedetomidine. | Description | any adverse event potentially related with DEX-administration |
Units | Participants | Units | Participants |
Param Type | Count of Participants | Param Type | Count of Participants |
Param Value | 13 | Param Value | 10 |
Param Value Num | 13.0 | Param Value Num | 10.0 |
Study References
Sequence: | 51656827 | Sequence: | 51656828 | Sequence: | 51656829 | Sequence: | 51656830 | Sequence: | 51656831 | Sequence: | 51656832 | Sequence: | 51656833 | Sequence: | 51656834 |
Pmid | 20017865 | Pmid | 28557732 | Pmid | 22536619 | Pmid | 27354454 | Pmid | 27516413 | Pmid | 25145661 | Pmid | 19589455 | Pmid | 16238552 |
Reference Type | background | Reference Type | result | Reference Type | result | Reference Type | result | Reference Type | result | Reference Type | result | Reference Type | result | Reference Type | result |
Citation | Mason KP, O'Mahony E, Zurakowski D, Libenson MH. Effects of dexmedetomidine sedation on the EEG in children. Paediatr Anaesth. 2009 Dec;19(12):1175-83. doi: 10.1111/j.1460-9592.2009.03160.x. | Citation | Cravero JP, Askins N, Sriswasdi P, Tsze DS, Zurakowski D, Sinnott S. Validation of the Pediatric Sedation State Scale. Pediatrics. 2017 May;139(5):e20162897. doi: 10.1542/peds.2016-2897. | Citation | National Clinical Guideline Centre (UK). Sedation in Children and Young People: Sedation for Diagnostic and Therapeutic Procedures in Children and Young People [Internet]. London: Royal College of Physicians (UK); 2010 Dec. Available from http://www.ncbi.nlm.nih.gov/books/NBK82237/ | Citation | Cote CJ, Wilson S; AMERICAN ACADEMY OF PEDIATRICS; AMERICAN ACADEMY OF PEDIATRIC DENTISTRY. Guidelines for Monitoring and Management of Pediatric Patients Before, During, and After Sedation for Diagnostic and Therapeutic Procedures: Update 2016. Pediatrics. 2016 Jul;138(1):e20161212. doi: 10.1542/peds.2016-1212. | Citation | Sulton C, McCracken C, Simon HK, Hebbar K, Reynolds J, Cravero J, Mallory M, Kamat P. Pediatric Procedural Sedation Using Dexmedetomidine: A Report From the Pediatric Sedation Research Consortium. Hosp Pediatr. 2016 Sep;6(9):536-44. doi: 10.1542/hpeds.2015-0280. Epub 2016 Aug 11. | Citation | Keidan I, Ben-Menachem E, Tzadok M, Ben-Zeev B, Berkenstadt H. Electroencephalography for children with autistic spectrum disorder: a sedation protocol. Paediatr Anaesth. 2015 Feb;25(2):200-5. doi: 10.1111/pan.12510. Epub 2014 Aug 22. | Citation | Lubisch N, Roskos R, Berkenbosch JW. Dexmedetomidine for procedural sedation in children with autism and other behavior disorders. Pediatr Neurol. 2009 Aug;41(2):88-94. doi: 10.1016/j.pediatrneurol.2009.02.006. | Citation | Zub D, Berkenbosch JW, Tobias JD. Preliminary experience with oral dexmedetomidine for procedural and anesthetic premedication. Paediatr Anaesth. 2005 Nov;15(11):932-8. doi: 10.1111/j.1460-9592.2005.01623.x. |
Baseline Counts
Sequence: | 11315437 |
Result Group Id | 55828806 |
Ctgov Group Code | BG000 |
Units | Participants |
Scope | overall |
Count | 19 |
Result Groups
Sequence: | 55828806 | Sequence: | 55828807 | Sequence: | 55828808 | Sequence: | 55828809 |
Ctgov Group Code | BG000 | Ctgov Group Code | FG000 | Ctgov Group Code | OG000 | Ctgov Group Code | EG000 |
Result Type | Baseline | Result Type | Participant Flow | Result Type | Outcome | Result Type | Reported Event |
Title | Dexmedetomidine | Title | Dexmedetomidine | Title | Dexmedetomidine | Title | Dexmedetomidine |
Description | 2 mcg/Kg iv dexmedetomidine (this dose may be repeated up to 2 times) followed by 1-2 mcg/Kg/hour iv continuous infusion
dexmedetomidine: To administrater dexmedetomidine IV 2 μg/kg in 10 minutes (loading dose) followed by continuous infusion at a rate of 1 μg/kg/h until procedure was complete |
Description | 2 mcg/Kg iv dexmedetomidine (this dose may be repeated up to 2 times) followed by 1-2 mcg/Kg/hour iv continuous infusion
dexmedetomidine: To administrater dexmedetomidine IV 2 μg/kg in 10 minutes (loading dose) followed by continuous infusion at a rate of 1 μg/kg/h until procedure was complete |
Description | 2 mcg/Kg iv dexmedetomidine (this dose may be repeated up to 2 times) followed by 1-2 mcg/Kg/hour iv continuous infusion
dexmedetomidine: To administrater dexmedetomidine IV 2 μg/kg in 10 minutes (loading dose) followed by continuous infusion at a rate of 1 μg/kg/h until procedure was complete |
Description | 2 mcg/Kg iv dexmedetomidine (this dose may be repeated up to 2 times) followed by 1-2 mcg/Kg/hour iv continuous infusion
dexmedetomidine: To administrater dexmedetomidine IV 2 μg/kg in 10 minutes (loading dose) followed by continuous infusion at a rate of 1 μg/kg/h until procedure was complete |
Baseline Measurements
Sequence: | 124860130 | Sequence: | 124860131 | Sequence: | 124860132 |
Result Group Id | 55828806 | Result Group Id | 55828806 | Result Group Id | 55828806 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 |
Category | Female | Category | Male | ||
Title | Age, Continuous | Title | Sex: Female, Male | Title | Sex: Female, Male |
Units | years | Units | Participants | Units | Participants |
Param Type | Mean | Param Type | Count of Participants | Param Type | Count of Participants |
Param Value | 7.3 | Param Value | 10 | Param Value | 9 |
Param Value Num | 7.3 | Param Value Num | 10.0 | Param Value Num | 9.0 |
Dispersion Type | Standard Deviation | ||||
Dispersion Value | 4 | ||||
Dispersion Value Num | 4.0 | ||||
Number Analyzed | 19 | Number Analyzed | 19 | Number Analyzed | 19 |
]]>
https://zephyrnet.com/NCT03799770
2019-01-01
https://zephyrnet.com/?p=NCT03799770
NCT03799770https://www.clinicaltrials.gov/study/NCT03799770?tab=tableNANANAThis is a diagnostic test accuracy study. The investigators measure optic nerve sheath diameter (ONSD) by ultrasound on the eye during living donor liver transplantation operation at 5 minutes after reperfusion to predict the occurrence of early tacrolimus neurotoxicity after liver transplantation.
We measured the ONSD at 4 timings: (T1) Post induction and before surgical incision, (T2) Portal vein clamping, (T3) 5 minutes after reperfusion, and (T4) 30 min after reperfusion.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-06 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2022-04-12 |
Start Month Year | January 1, 2019 |
Primary Completion Month Year | March 23, 2021 |
Verification Month Year | April 2022 |
Verification Date | 2022-04-30 |
Last Update Posted Date | 2022-04-12 |
Detailed Descriptions
Sequence: | 20675309 |
Description | Neurotoxicity is mainly associated with tacrolimus and cyclosporin, amounting to 10 – 30% for CS and up to 32% for tacrolimus.(2) . Sirolimus, everolimus, and mycophenolate mofetil lack the neurotoxicity of calcineurin inhibitors (3-4).
Neurotoxicity mostly occurs in the early postoperative period increasing morbidity, mortality and hospital and intensive care stay. Neurotoxicity has variable manifestations and mainly affects the CNS. They are usually divided into minor manifestations as tremor, headache, insomnia and paraesthesia or major encephalopathy, akinetic mutism, seizures, speech disorders, polyneuropathy, myopathy, pseudobulbar palsy and even stroke. (2) The main pathogenesis of calcinurin inhibitors neurotoxicity appears to be fluid extravasation (vasogenic edema) due to disruption of blood brain barrier, not cell destruction (cytotoxic edema).(5) During liver transplant operation there are changes in the intracranial pressure and cerebral perfusion pressure especially during reperfusion that may affect the integrity of blood brain barrier. (6) There are multiple methods for monitoring of intracranial pressure invasive or non -invasive. The invasive method remains the gold standard for monitoring of intracranial pressure but there is a controversy about its use in liver transplantation as it may be complicated by bleeding and infections (7). Also there are a multiple non-invasive methods for monitoring of ICP. Ultrasonographic measurement of the optic nerve sheath diameter (ONSD) was introduced recently as a useful noninvasive method for evaluating ICP. ONSD demonstrated a good correlation with the ICP level in many previously published studies. (8,9) Rajajee et al. found that the optimal cutoff of ONSD for the detection of an acutely increased ICP > 20 mm Hg was greater than 4.8 mm. (10) We hypothesize that the absolute value or the changes of ONSD during different stages of living donor liver transplantation operation may predict occurrence of early calcinurin inhibitor neurotoxicity (CNIN).We will investigate whether the absolute value or changes of ONSD during different stages of living donor liver transplantation operation may be a predictor of early calcinurin inhibitor neurotoxicity in the first month post liver transplantation. This is a prospective observational cohort study that will be conducted to all adult patients of both sex undergoing living donor liver transplantation operation at Gastro-Intestinal Surgical Centre (GISC), Mansoura university Hospitals, Mansoura, Egypt over the period covering more than 100 consecutive cases. After Institutional review board approval, we will secure informed consents from all included patients during the preoperative visits. Anesthesia and surgery techniques will be done according to our center's protocol.(11) Reperfusion: On portal vein declamping, we will start rapid 500 ml 4% albumin infusion or packed RBCs (according to the anhepatic hemoglobin level 5 min before declamping) through 14 Gauge peripheral venous cannula in all patients. For hypotension we will give norepinephrine and for resistant hypotension we will use adrenaline as rescue. Technique of ONSD: Sonographic measurement of ONSD was performed with the same manner of previous studies. Patients were placed in the supine position with their eyes closed, and a thick gel layer was applied to the closed upper eyelid. The 7.5-MHz linear probe was placed on the gel without excessive pressure and adjusted to the proper angle for displaying the entry of the optic nerve into the globe. The intensity of the ultrasound was adjusted to display optimal contrast between the retrobulbar echogenic fat tissue and the vertical hypoechoic band. An ultrasound beam was focused on the retrobulbar area using the lowest possible acoustic power that could measure ONSD. The ONSD was measured 3 mm behind the optic disc. Measurements were performed in the transverse and sagittal planes of both eyes, and the final ONSD value was calculated by averaging 4 measured values. (8) Immunosuppression: All patients will receive intravenous 0.5 gm methylprednisolone at the start of the warm ischemia. After hepatic artery anastomosis and declamping, we will administer 500 mg mycophenolate mofetil through the nasogastric tube and i.v. 20 mg basiliximab. In the ICU, patients will receive oral tacrolimus starting the day after the operation (adjusting the dose targeting serum level of 5-10 ng/ml) , mycophenolate mofetil 500 mg twice per day and basiliximab 20 mg iv 4 days after. |
Facilities
Sequence: | 199573623 |
Name | Gastroenerology Surgical Center – Liver transplantation program |
City | Mansourah |
State | Dakahlia |
Zip | 35516 |
Country | Egypt |
Conditions
Sequence: | 52049682 |
Name | Liver Transplant; Complications |
Downcase Name | liver transplant; complications |
Id Information
Sequence: | 40062482 |
Id Source | org_study_id |
Id Value | R.18.12.369 – 2018/12/16 |
Countries
Sequence: | 42460614 |
Name | Egypt |
Removed | False |
Interventions
Sequence: | 52361446 |
Intervention Type | Diagnostic Test |
Name | Optic nerve sheath diameter by ultrasound at 5 minutes post-reperfucion |
Description | Patients were placed in the supine position with their eyes closed, and a thick gel layer was applied to the closed upper eyelid. The 7.5-MHz linear probe was placed on the gel without excessive pressure and adjusted to the proper angle for displaying the entry of the optic nerve into the globe. The intensity of the ultrasound was adjusted to display optimal contrast between the retrobulbar echogenic fat tissue and the vertical hypoechoic band. An ultrasound beam was focused on the retrobulbar area using the lowest possible acoustic power that could measure ONSD. The ONSD was measured 3 mm behind the optic disc. Measurements were performed in the transverse and sagittal planes of both eyes, and the final ONSD value was calculated by average 4 measured values.
We measured the ONSD at 4 timings: (T1) Post induction and before surgical incision, (T2) Portal vein clamping, (T3) 5 minutes after reperfusion, and (T4) 30 min after reperfusion. |
Design Outcomes
Sequence: | 176959503 | Sequence: | 176959504 | Sequence: | 176959505 | Sequence: | 176959506 | Sequence: | 176959507 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Early tacrolimus neurotoxicity | Measure | Time and presentation of neurotoxicity | Measure | Intensive Care Unit stay | Measure | Hospital Length of stay | Measure | Mortality |
Time Frame | 28 days after transplantation | Time Frame | 28 days after transplantation | Time Frame | until discharge from ICU for 1 year | Time Frame | until discharge from the hospital for 1 year | Time Frame | three months after transplant |
Description | definition that will be considered when neurological events (visual disturbance, altered level of consciousness, confusion, psychosis, seizure, encephalopathy, tremors and/or coma or change in the pattern of the preexisting cirrhotic neurological changes ) appeared in the absence of central pontine myelinolysis, central nervous system infection, stroke, or hemorrhage within the first 4 weeks after LT and symptoms improved after dose modification of CNI therapy | Description | according to the 1ry outcome definition, the time (day) and presentation (clinically) reported | Description | reported in days | Description | Measured in days | Description | three-month all-cause mortality |
Browse Conditions
Sequence: | 193001016 | Sequence: | 193001017 | Sequence: | 193001018 | Sequence: | 193001019 |
Mesh Term | Neurotoxicity Syndromes | Mesh Term | Nervous System Diseases | Mesh Term | Poisoning | Mesh Term | Chemically-Induced Disorders |
Downcase Mesh Term | neurotoxicity syndromes | Downcase Mesh Term | nervous system diseases | Downcase Mesh Term | poisoning | Downcase Mesh Term | chemically-induced disorders |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48205598 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Mansoura University |
Overall Officials
Sequence: | 29214169 | Sequence: | 29214170 |
Role | Principal Investigator | Role | Study Director |
Name | Mahmoud M. Elsedeiq, MD | Name | Amr M. Yassin, MD |
Affiliation | Lecturer of anaesthesia and intensive care | Affiliation | professor of anaesthesia and surgical intensive care |
Eligibilities
Sequence: | 30693802 |
Sampling Method | Probability Sample |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 70 Years |
Healthy Volunteers | No |
Population | Adult (>= 18 years) recipients undergoing living donor liver transplantation |
Criteria | Inclusion Criteria:
All adult patients of both sex undergoing living donor liver transplantation operation Exclusion Criteria: History of optic neuritis |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253904316 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 27 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 70 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 4 |
Designs
Sequence: | 30440476 |
Observational Model | Cohort |
Time Perspective | Prospective |
Responsible Parties
Sequence: | 28806990 |
Responsible Party Type | Principal Investigator |
Name | Amr M. Yassen |
Title | professor of anaesthesia and surgical intensive care |
Affiliation | Mansoura University |
]]>
https://zephyrnet.com/NCT03799757
2016-01-31
https://zephyrnet.com/?p=NCT03799757
NCT03799757https://www.clinicaltrials.gov/study/NCT03799757?tab=tableNANANAin this study we are investigating the role of instillation of Bupivacaine through surgical drains at the end of mastectomy surgeries in controlling post operative pain and decreasing their pain killers requirement in the early postoperative period
<![CDATA[
Studies
Study First Submitted Date | 2019-01-06 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2019-01-10 |
Start Month Year | January 2016 |
Primary Completion Month Year | November 2018 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-10 |
Detailed Descriptions
Sequence: | 20741227 |
Description | patients were enrolled into 2 groups. in one group the wound was installed by 40ml of 0.25% bupivacaine through axillary and chest wall drains (20ml in each drain). Then, the drains were clamped for 20 minutes.
in the other group the wound was installed by 40ml of 0.9% normal saline through axillary and chest wall drains (20ml in each drain). Then, the drains were clamped for 20 minutes. (placebo group) patients and health care providers were blinded as regard the study group patients enrolled in. Visual Analog Pain Scale which is a score for detection of how much the patient is annoyed from the pain- was assessed two and four hours post-operative then every four hours thereafter. |
Facilities
Sequence: | 200280706 |
Name | Faculty of Medicine, Main Univeristy Hospital |
City | Alexandria |
Country | Egypt |
Browse Interventions
Sequence: | 96133373 | Sequence: | 96133374 | Sequence: | 96133375 | Sequence: | 96133376 | Sequence: | 96133377 | Sequence: | 96133378 | Sequence: | 96133379 |
Mesh Term | Bupivacaine | Mesh Term | Anesthetics, Local | Mesh Term | Anesthetics | Mesh Term | Central Nervous System Depressants | Mesh Term | Physiological Effects of Drugs | Mesh Term | Sensory System Agents | Mesh Term | Peripheral Nervous System Agents |
Downcase Mesh Term | bupivacaine | Downcase Mesh Term | anesthetics, local | Downcase Mesh Term | anesthetics | Downcase Mesh Term | central nervous system depressants | Downcase Mesh Term | physiological effects of drugs | Downcase Mesh Term | sensory system agents | Downcase Mesh Term | peripheral nervous system agents |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52221670 | Sequence: | 52221671 |
Name | Pain, Postoperative | Name | Breast Cancer |
Downcase Name | pain, postoperative | Downcase Name | breast cancer |
Id Information
Sequence: | 40195726 |
Id Source | org_study_id |
Id Value | malhussini001 |
Countries
Sequence: | 42609723 |
Name | Egypt |
Removed | False |
Design Groups
Sequence: | 55649952 | Sequence: | 55649953 |
Group Type | Active Comparator | Group Type | Placebo Comparator |
Title | Bupivacaine | Title | Placebo |
Description | The wound was installed by 40ml of 0.25% bupivacaine through axillary and chest wall drains (20ml in each drain). Then, the drains were clamped for 20 minutes. | Description | The wound was installed by 40ml of 0.9% normal saline through axillary and chest wall drains (20ml in each drain). Then, the drains were clamped for 20 minutes. (placebo group) |
Interventions
Sequence: | 52535481 | Sequence: | 52535482 |
Intervention Type | Drug | Intervention Type | Drug |
Name | 40ml of 0.25% bupivacaine | Name | 40ml of 0.9% normal saline |
Keywords
Sequence: | 79941965 | Sequence: | 79941966 | Sequence: | 79941967 |
Name | bupivacaine | Name | Post-mastectomy acute pain | Name | Wound instillation |
Downcase Name | bupivacaine | Downcase Name | post-mastectomy acute pain | Downcase Name | wound instillation |
Design Outcomes
Sequence: | 177561975 | Sequence: | 177561976 | Sequence: | 177561977 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary |
Measure | Visual analogue pain score | Measure | Number of demands for analgesic | Measure | Timing of first demand for analgesic |
Time Frame | first 24 hours | Time Frame | First 24 hours | Time Frame | First 24 hours |
Description | The intensity of pain will be assessed by the VAS score | Description | How many times the patient will require analgesics | Description | Time lapse between recovery from surgery and first demand for analgesic |
Browse Conditions
Sequence: | 193679043 | Sequence: | 193679041 | Sequence: | 193679042 | Sequence: | 193679044 | Sequence: | 193679045 |
Mesh Term | Pathologic Processes | Mesh Term | Pain, Postoperative | Mesh Term | Postoperative Complications | Mesh Term | Pain | Mesh Term | Neurologic Manifestations |
Downcase Mesh Term | pathologic processes | Downcase Mesh Term | pain, postoperative | Downcase Mesh Term | postoperative complications | Downcase Mesh Term | pain | Downcase Mesh Term | neurologic manifestations |
Mesh Type | mesh-ancestor | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48366555 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Alexandria University |
Overall Officials
Sequence: | 29312982 |
Role | Principal Investigator |
Name | Mahmoud A Alhussini, md |
Affiliation | faculty of medicine , univeristy of alexandria |
Design Group Interventions
Sequence: | 68217579 | Sequence: | 68217580 |
Design Group Id | 55649952 | Design Group Id | 55649953 |
Intervention Id | 52535481 | Intervention Id | 52535482 |
Eligibilities
Sequence: | 30794789 |
Gender | Female |
Minimum Age | 30 Years |
Maximum Age | 65 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
female patients with unilateral breast cancer candidates for total mastectomy and axillary dissection Exclusion Criteria: Male patients |
Gender Description | only females with breast cancer who were subjected to mastectomy with axillary nodal dissection were enrolled |
Gender Based | True |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254004454 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 34 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 30 |
Maximum Age Num | 65 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 3 |
Designs
Sequence: | 30540829 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Supportive Care |
Time Perspective | |
Masking | Triple |
Subject Masked | True |
Caregiver Masked | True |
Investigator Masked | True |
Responsible Parties
Sequence: | 28907149 |
Responsible Party Type | Principal Investigator |
Name | Mahmoud A. Alhussini |
Title | lecturer surgical oncology |
Affiliation | Alexandria University |
]]>
https://zephyrnet.com/NCT03799744
2019-03-20
https://zephyrnet.com/?p=NCT03799744
NCT03799744https://www.clinicaltrials.gov/study/NCT03799744?tab=tableNANANAThis is a Phase I Study to Evaluate the Safety, Tolerability, and Efficacy of VCN-01 in Combination With Durvalumab (MEDI4736) in Subjects With Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck.
VCN-01 is a genetically modified oncolytic adenovirus characterized by the presence of four independent genetic modifications on the backbone of the wild-type HAd5 adenovirus genome, encoding human PH20, that confer tumor selectivity and anti-tumor activity.
Durvalumab is a human monoclonal antibody (mAb) of the immunoglobulin G (IgG) 1 kappa subclass that inhibits binding of PD-L1.
The proposed mechanism of action (MOA) for durvalumab is interference in the interaction of PD-L1 with PD-1 and CD80 (B7.1). Blockade of PD-L1/PD-1 and PD-L1/CD80 interactions releases the inhibition of immune responses, including those that may result in tumor elimination.
<![CDATA[
Studies
Study First Submitted Date | 2018-11-09 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2022-03-28 |
Start Month Year | March 20, 2019 |
Primary Completion Month Year | January 31, 2023 |
Verification Month Year | March 2022 |
Verification Date | 2022-03-31 |
Last Update Posted Date | 2022-03-28 |
Detailed Descriptions
Sequence: | 20690211 |
Description | Research Hypothesis The presence of VCN-01 into the tumor after systemic administration will help to overcome the observed resistance to durvalumab and other PD1/PD-L1 checkpoint inhibitors. Primary objectives To evaluate the safety and tolerability of a single intravenous injection of VCN-01 combined with durvalumab in two administration regimens (concomitant or durvalumab starting two weeks later "sequential schedule"), and to determine the recommended phase II dose (RP2D) of the combination. Study design This is a phase I trial, multicenter, open label, and dose escalation study. Patients will be entered at each dose level, according to a planned dose escalation schedule. Absence of unacceptable toxicity at the previous dose is required for entering a patient in the subsequent level. Number of Centers: up to 3 Number of Patients: 15-20 patients Study Population: Patients with metastatic squamous cell carcinoma of the head and neck who have progressed during or after treatment with immune-checkpoint inhibitors. |
Facilities
Sequence: | 199706505 | Sequence: | 199706506 |
Name | Institut Català D'Oncologia | Name | Hospital Universitari Vall D'Hebron |
City | Hospitalet de Llobregat | City | Barcelona |
State | Barcelona | ||
Zip | 08908 | Zip | 08035 |
Country | Spain | Country | Spain |
Browse Interventions
Sequence: | 95880969 | Sequence: | 95880970 | Sequence: | 95880971 |
Mesh Term | Durvalumab | Mesh Term | Antineoplastic Agents, Immunological | Mesh Term | Antineoplastic Agents |
Downcase Mesh Term | durvalumab | Downcase Mesh Term | antineoplastic agents, immunological | Downcase Mesh Term | antineoplastic agents |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52087309 | Sequence: | 52087310 | Sequence: | 52087311 | Sequence: | 52087312 |
Name | Head and Neck Neoplasms | Name | Carcinoma, Squamous Cell of Head and Neck | Name | Metastasis | Name | Recurrence |
Downcase Name | head and neck neoplasms | Downcase Name | carcinoma, squamous cell of head and neck | Downcase Name | metastasis | Downcase Name | recurrence |
Id Information
Sequence: | 40091806 | Sequence: | 40091807 |
Id Source | org_study_id | Id Source | secondary_id |
Id Value | ICO-VCN-H&N-2018 | Id Value | 2018-001095-38 |
Id Type | EudraCT Number | ||
Countries
Sequence: | 42491726 |
Name | Spain |
Removed | False |
Design Groups
Sequence: | 55501347 | Sequence: | 55501348 |
Group Type | Experimental | Group Type | Experimental |
Title | VCN-01 and Durvalumab; concomitant. | Title | VCN-01 and Durvalumab; sequential |
Description | Combination VCN-01 (single iv dose) with Durvalumab, Concomitant schedule; Dose Escalation of VCN-01 | Description | Combination VCN-01 (single iv dose) with Durvalumab, Delayed schedule (14 days); Dose Escalation of VCN-01 |
Interventions
Sequence: | 52400334 | Sequence: | 52400335 |
Intervention Type | Genetic | Intervention Type | Biological |
Name | VCN-01 | Name | Durvalumab |
Description | Dose level 1: 3.3×10^12 viral particles/patient and Dose level 2: 1×10^13 viral particles/patient | Description | Dose: 1500 mg Q4W |
Design Outcomes
Sequence: | 177091026 | Sequence: | 177091027 | Sequence: | 177091028 | Sequence: | 177091029 | Sequence: | 177091030 | Sequence: | 177091031 | Sequence: | 177091032 | Sequence: | 177091033 | Sequence: | 177091034 | Sequence: | 177091035 | Sequence: | 177091036 | Sequence: | 177091037 | Sequence: | 177091038 | Sequence: | 177091039 | Sequence: | 177091040 | Sequence: | 177091041 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Safety by means of Adverse Events (AEs) | Measure | Objective response rate (ORR) | Measure | Progression Free Survival (PFS) | Measure | Maximum Plasma Concentration (Cmax ) of VCN-01 | Measure | Tmax of VCN-01 | Measure | AUC of VCN-01 | Measure | Apparent Half-Life (t1/2) of VCN-01 | Measure | Elimination rate constant of VCN-01 | Measure | VCN-01 viral shedding in blood | Measure | anti-VCN-01 antibodies | Measure | VCN-01 viral shedding in stool and sputum | Measure | Immunological changes induced by the combination of VCN-01 and durvalumab. | Measure | Changes in Microbiome in stool (VCN-01 and Durvalumab concomitant arm) | Measure | Changes in Microbiome in stool (VCN-01 and Durvalumab sequential) | Measure | Circulating free DNA (cfDNA) in plasma analysis (VCN-01 and Durvalumab concomitant arm) | Measure | Circulating free DNA (cfDNA) in plasma analysis (VCN-01 and Durvalumab sequential) |
Time Frame | through study completion, an average of 2 years | Time Frame | On Cycle 3 (+/- 3 days, each cycle is 28 days), and then every 2 cycles (± 7 days) until disease progression or withdrawal (an average of 2 years) | Time Frame | On Cycle 3 (+/- 3 days, each cycle is 28 days), and then every 2 cycles (± 7 days) until disease progression or withdrawal (an average of 2 years) | Time Frame | For both arms: On day 1 pre-dose (within 15 minutes prior to VCN-01 infusion) and then 30 minutes, 1, 2, 4, 6, 24 and 48 hours post VCN-01 administration. | Time Frame | VCN-01 and Durvalumab concomitant arm: On day 1 pre-dose (within 15 minutes prior to VCN-01 infusion) and then 30 minutes, 1 hours, 2 hours, 4 hours, 6 hours, 24 hours and 48 hours post VCN-01 administration. VCN-01 and Durvalumab sequential: On day 1 | Time Frame | VCN-01 and Durvalumab concomitant arm: On day 1 pre-dose (within 15 minutes prior to VCN-01 infusion) and then 30 minutes, 1 hours, 2 hours, 4 hours, 6 hours, 24 hours and 48 hours post VCN-01 administration. VCN-01 and Durvalumab sequential: On day 1 | Time Frame | VCN-01 and Durvalumab concomitant arm: On day 1 pre-dose (within 15 minutes prior to VCN-01 infusion) and then 30 minutes, 1 hours, 2 hours, 4 hours, 6 hours, 24 hours and 48 hours post VCN-01 administration. VCN-01 and Durvalumab sequential: On day 1 | Time Frame | VCN-01 and Durvalumab concomitant arm: On day 1 pre-dose (within 15 minutes prior to VCN-01 infusion) and then 30 minutes, 1 hours, 2 hours, 4 hours, 6 hours, 24 hours and 48 hours post VCN-01 administration. VCN-01 and Durvalumab sequential: On day 1 | Time Frame | VCN-01 and Durvalumab concomitant arm: On day 1: pre-dose and then, 4 hours, 24 hours and 48 hours post dose, on day 8, day 15, day 22 of cycle 1 (each cycle is 28 days), then on day1 of subsequent durvalumab cycles and at the final visit. Arm II: On day | Time Frame | At screening, on day 1 pre-dose (within 15 minutes prior to VCN-01 ) in both arms. In concomitant arm: at day1 of subsequent durvalumab cycles (each cycle is 28 days), and at the final visit. In sequential arm: at day15 on cycle 1, at day1 of subsequent | Time Frame | VCN-01 and Durvalumab concomitant arm: at day 1, 8, 15 and 22 on cycle 1 (each cycle is 28 days) And at day1 of subsequent durvalumab cycles. VCN-01 and Durvalumab sequential: at day -14, -7, 1, 8, 15 on cycle 1 and at day 1 of subsequent durvalumab | Time Frame | VCN-01 and Durvalumab concomitant arm: On day 1: pre-dose, at 30 minutes, 6 hours, 24 hours, 48 hours, at day 8 on cycle 1 (each cycle is 28 days), at day 1of cycle 2 and at the final visit. VCN-01 and Durvalumab sequential: On day 1, 15 minutes before | Time Frame | On day 1: pre-dose and 1st deposition after-dose (the first deposition occurred from day 1 to day 7), day 8, day 15, day 22 on cycle 1 (each cycle is 28 days). | Time Frame | On day -14 (pre-dose and 1st deposition after-dose), day -7, Day 1, day 8 and day15 on cycle 1 (each cycle is 28 days). | Time Frame | Pre-dose on day 1 (within 15min prior to VCN-01 infusion) and at day 8 on cycle 1, at day 1 on cycle 2, at day 1 on cycle 3 and at day 1 on cycle 4 (within 15min prior durvalumab administration) (each cycle is 28 days). | Time Frame | On day -14 pre-dose and 1st deposition after-dose(the first deposition occurred from day -14 to day -8), day -7, day 1, day 8 and day15 on cycle 1 (each cycle is 28 days). |
Description | Incidence of Adverse Events as assessed by CTCAE v4.0 | Description | Proportion of patients with reduction in tumor burden of a predefined amount assessed by CT or MRI | Description | Time from study enrollment until disease progression or death assessed by CT or MRI | Description | The maximum (or peak) concentration that VCN-01 achieves in plasma after its administration. | Description | Time to Maximum Plasma Concentration of VCN-01 | Description | The definite integral in a plot of drug concentration in blood plasma vs. time. | Description | The time it takes for half to be removed | Description | The rate at which VCN-01 is removed from the body. | Description | Determination of VCN-01 levels in peripheral blood samples | Description | Assessment of Blood levels of neutralizing anti-VCN-01 antibodies | Description | Determination of VCN-01 levels in stool and sputum | Description | Study of the Immunological changes induced by the combination of VCN-01 and durvalumab by assessment of blood levels of circulating Interleukin 6 and Interleukin 10 | Description | Analyse the microbiome in stool, prior and after VCN-01 administration | Description | Analyse the microbiome in stool, prior and after VCN-01 administration | Description | To analyse the circulating free DNA (cfDNA) in plasma obtained from samples collected prior and post VCN-01 treatment. | Description | To analyse the circulating free DNA (cfDNA) in plasma obtained from samples collected prior and post VCN-01 treatment. |
Browse Conditions
Sequence: | 193153204 | Sequence: | 193153194 | Sequence: | 193153195 | Sequence: | 193153196 | Sequence: | 193153197 | Sequence: | 193153198 | Sequence: | 193153199 | Sequence: | 193153200 | Sequence: | 193153201 | Sequence: | 193153202 | Sequence: | 193153203 | Sequence: | 193153205 |
Mesh Term | Disease Attributes | Mesh Term | Carcinoma | Mesh Term | Carcinoma, Squamous Cell | Mesh Term | Head and Neck Neoplasms | Mesh Term | Squamous Cell Carcinoma of Head and Neck | Mesh Term | Recurrence | Mesh Term | Neoplasms, Glandular and Epithelial | Mesh Term | Neoplasms by Histologic Type | Mesh Term | Neoplasms | Mesh Term | Neoplasms, Squamous Cell | Mesh Term | Pathologic Processes | Mesh Term | Neoplasms by Site |
Downcase Mesh Term | disease attributes | Downcase Mesh Term | carcinoma | Downcase Mesh Term | carcinoma, squamous cell | Downcase Mesh Term | head and neck neoplasms | Downcase Mesh Term | squamous cell carcinoma of head and neck | Downcase Mesh Term | recurrence | Downcase Mesh Term | neoplasms, glandular and epithelial | Downcase Mesh Term | neoplasms by histologic type | Downcase Mesh Term | neoplasms | Downcase Mesh Term | neoplasms, squamous cell | Downcase Mesh Term | pathologic processes | Downcase Mesh Term | neoplasms by site |
Mesh Type | mesh-ancestor | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48241675 | Sequence: | 48241676 | Sequence: | 48241677 | Sequence: | 48241678 |
Agency Class | OTHER | Agency Class | INDUSTRY | Agency Class | OTHER | Agency Class | INDUSTRY |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator |
Name | Institut Català d'Oncologia | Name | Theriva Biologics SL | Name | BioClever 2005 S.L. | Name | AstraZeneca |
Design Group Interventions
Sequence: | 68037155 | Sequence: | 68037156 | Sequence: | 68037157 | Sequence: | 68037158 |
Design Group Id | 55501347 | Design Group Id | 55501348 | Design Group Id | 55501347 | Design Group Id | 55501348 |
Intervention Id | 52400334 | Intervention Id | 52400334 | Intervention Id | 52400335 | Intervention Id | 52400335 |
Eligibilities
Sequence: | 30716696 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Written informed consent and any locally-required authorization (e.g., Data Privacy Directive in the EU) obtained from the patient prior to performing any protocol-related procedures; including screening evaluations must be obtained. Adequate normal organ and marrow function as defined below (transfusions intended to elevate any parameters below solely for the intent of meeting study eligibility are not permitted): Leukocytes ≥3000 mcL Exclusion Criteria: Receipt of the last dose of anticancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumour embolization, monoclonal antibodies) within 4 weeks (28 days) prior to the first dose of study treatment. Enrolment with a shorter period of time might be allowed upon discussion with the Study Physician/Medical Monitor according data of sufficient washout time form PK properties of the agent. Previous treatment PD1/PD-L1 inhibition (including Durvalumab) is a specific entry criterion, but patients:Must not have experienced a toxicity that led to permanent discontinuation of prior immunotherapy. All AEs while receiving prior immunotherapy must have completely resolved or resolved to baseline prior to screening for this study. o Exception: Patients with endocrine AE of ≤Grade 2 are permitted to enroll if they are stably maintained on appropriate replacement therapy and are asymptomatic. Must not have experienced a ≥Grade 3 immune related AE or an immune related neurologic or ocular AE of any grade while receiving prior immunotherapy. Presently has a second malignancy other than SCCHN, or history of treatment for invasive cancer other that SCCHN in the past 3 years except for: Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease. Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable. Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug. |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253951307 |
Number Of Facilities | 2 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | False |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 15 |
Designs
Sequence: | 30463233 |
Allocation | Non-Randomized |
Intervention Model | Sequential Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Intervention Model Description | This is a phase I trial, multicenter, open label, and dose escalation study. Patients will be entered at each dose level, according to a planned dose escalation schedule. Absence of unacceptable toxicity at the previous dose is required for entering a patient in the subsequent level.
The investigational treatment will be a single i.v. VCN-01 dose combined with concomitant i.v. durvalumab (MEDI4736) 1500 mg Q4W (Arm I) or durvalumab starting two weeks after VCN-01 administration, "sequential schedule" (Arm II). Patient recruitment in Arm I and Arm II will be performed in parallel based on slot availability. Only one single dose of VCN-01 will be administered to each patient during the trial. Durvalumab will be administered Q4W until disease progression, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion. |
Responsible Parties
Sequence: | 28829693 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03799731
2018-07-11
https://zephyrnet.com/?p=NCT03799731
NCT03799731https://www.clinicaltrials.gov/study/NCT03799731?tab=tableNANANAPhase 2A study, assessing the antitumor activity and the safety profile of GM102, a new compound (monoclonal antibody), administered alone or in combination with chemotherapy in patients with locally advanced or metastatic colorectal cancer. The primary objective of the study is to evaluate the antitumor activity of GM102 single agent and in combination with trifluridine/tipiracil.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-08 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2022-04-14 |
Start Month Year | July 11, 2018 |
Primary Completion Month Year | January 19, 2021 |
Verification Month Year | April 2022 |
Verification Date | 2022-04-30 |
Last Update Posted Date | 2022-04-14 |
Detailed Descriptions
Sequence: | 20848268 |
Description | GM102 is a humanized low fucose monoclonal antibody with a high affinity to AMHRII receptor (fetal receptor mediating the activity of AMH, reexpressed in a variety of solid tumors). GM102 acts through engagement of immune cells (macrophages, natural killer (NK) cells) to trigger ADCC (antibody dependent cellular cytotoxicity) and phagocytosis of tumor cells.
AMRHII expression was found in 73% of primary colorectal tumors tested. Advanced/metastatic colorectal cancer (CRC) remains an unmet need disease, with few therapeutic options beyond two or three lines of therapy. CRC is characterized by a tumor microenvironment (TME) particularly rich in macrophages and more specifically macrophages capable of tumor phagocytosis. The pattern of the TME remains a major prognostic factor in the metastatic setting. C201 consists in two parallel cohorts and an expansion of cohort II for patients with advanced or metastatic colorectal cancer in two different settings of the disease: Cohort I (GM102 as a single agent) in refractory patients, having exhausted all therapeutic options. Patients will receive GM102 alone at the dose of 7 mg/kg administered by intravenous infusion at Day 1, Day 8, Day 15 and Day 22 of each 28-day cycle Patients will be treated with GM102 (Cohort I) or GM102 and trifluridine/tipiracil (Cohort II and Cohort II expansion) until confirmed progression or toxicity. A Trial Steering Committee (TSC) will analyze and qualify GM102 activity and toxicities and will provide recommendations on the Investigational Medicinal Product (IMP) continuation. |
Facilities
Sequence: | 201251996 | Sequence: | 201251997 | Sequence: | 201251998 | Sequence: | 201251999 | Sequence: | 201252000 |
Name | Cliniques Universitaires Saint-Luc | Name | UZ Gasthuisberg | Name | UZ Leuven | Name | University Hopistal Olomouc | Name | University Hospital Motol |
City | Brussels | City | Gent | City | Leuven | City | Olomouc | City | Praha |
Country | Belgium | Country | Belgium | Country | Belgium | Country | Czechia | Country | Czechia |
Browse Interventions
Sequence: | 96578074 | Sequence: | 96578075 | Sequence: | 96578076 | Sequence: | 96578077 | Sequence: | 96578078 |
Mesh Term | Trifluridine | Mesh Term | Antimetabolites | Mesh Term | Molecular Mechanisms of Pharmacological Action | Mesh Term | Antiviral Agents | Mesh Term | Anti-Infective Agents |
Downcase Mesh Term | trifluridine | Downcase Mesh Term | antimetabolites | Downcase Mesh Term | molecular mechanisms of pharmacological action | Downcase Mesh Term | antiviral agents | Downcase Mesh Term | anti-infective agents |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52496656 |
Name | Colorectal Cancer |
Downcase Name | colorectal cancer |
Id Information
Sequence: | 40391235 |
Id Source | org_study_id |
Id Value | C201 |
Countries
Sequence: | 42826780 | Sequence: | 42826781 |
Name | Belgium | Name | Czechia |
Removed | False | Removed | False |
Design Groups
Sequence: | 55952552 | Sequence: | 55952553 | Sequence: | 55952554 |
Group Type | Experimental | Group Type | Experimental | Group Type | Experimental |
Title | Cohort I: GM102 single agent | Title | Cohort II: GM102 + trifluridine/tipiracil | Title | Cohort II expansion: GM102 + trifluridine/tipiracil |
Description | GM102 will be intravenously administered at the dose of 7 mg/kg on Days 1, 8, 15 and 22 of each 28-day cycle | Description | GM102 will be intravenously administered at the dose of 7 mg/kg on Days 1, 8, 15 and 22, and trifluridine/tipiracil will be orally administered at the dose of 35 mg/m² twice daily on Days 1 to 5 and days 8 to 12 of each 28-day cycle | Description | GM102 will be intravenously administered at the dose of 7 mg/kg on Days 1, 8, 15 and 22, after a loading dose of 10 mg/kg q1w during 28-day cycle 1, and trifluridine/tipiracil will be orally administered at the dose of 35 mg/m² twice daily on Days 1 to 5 and days 8 to 12 of each 28-day cycle |
Interventions
Sequence: | 52804814 | Sequence: | 52804815 | Sequence: | 52804816 |
Intervention Type | Drug | Intervention Type | Drug | Intervention Type | Drug |
Name | GM102 | Name | Trifluridine/Tipiracil | Name | GM102 expansion |
Description | GM102 7 mg/kg weekly | Description | Lonsurf 35 mg/m² twice daily during 10 days per cycle | Description | GM102 7 mg/kg weekly after a loading dose of 10 mg/kg q1w during 28-day cycle 1 |
Design Outcomes
Sequence: | 178594437 | Sequence: | 178594438 | Sequence: | 178594439 | Sequence: | 178594440 | Sequence: | 178594441 | Sequence: | 178594442 | Sequence: | 178594443 | Sequence: | 178594444 | Sequence: | 178594445 | Sequence: | 178594446 | Sequence: | 178594447 | Sequence: | 178594448 | Sequence: | 178594449 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Overall Response Rate (ORR) | Measure | Progression Free Survival (PFS) at 6 months | Measure | Immune Overall Response Rate (iORR) | Measure | Clinical Benefit Rate (CBR) | Measure | Tumor Growth Rate (TGR) before and under treatment | Measure | Progression Free Survival (PFS) | Measure | Overall Survival (OS) | Measure | Incidence of Serious Adverse Event (SAE) and Treatment Emergent Adverse Event (TEAE) | Measure | Pharmacodynamics evaluation | Measure | Exposure to murlentamab | Measure | Exposure to trifluridine | Measure | Evidence of anti-murlentamab antibodies (ADA) | Measure | AMHRII (Anti-Mullerian Hormone type II receptor) expression |
Time Frame | Through study completion, an average 1 year | Time Frame | 6 months after the first infusion | Time Frame | Through study completion, an average 1 year | Time Frame | up to 4 months | Time Frame | up to 2 months | Time Frame | Through study completion, an average 1 year | Time Frame | Through study completion, an average 1 year | Time Frame | Through study completion, an average 1 year | Time Frame | Up to 2 months | Time Frame | At days 1 and 15 of cycles 1, 2 (each cycle is 28 days) and End of Treatment for cohort I and II, an average of one year; days 1, 8,15 and 22 of cycles 1, 2 (each cycle is 28 days) and End of Treatment for cohort II expansion, an average of one year | Time Frame | At days 1 and 15 of cycles 1, 2 (each cycle is 28 days) and End of Treatment, an average of one year | Time Frame | Baseline, beginning of every even cycle in pre-dose (each cycle is 28 days) and at the End of Treatment, an average of one year | Time Frame | Up to 2 months |
Description | ORR from the end of cycle 2 and subsequently confirmed at least 4 weeks later using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 | Description | Proportion of patients without documented progression at 6 months | Description | ORR using immune Response Evaluation Criteria In Solid Tumors (iRECIST) | Description | CBR at 8 and 16 weeks defined as the number of non-progressors using RECIST 1.1 and iRECIST criteria | Description | Percentage of variation in TGR | Description | Time elapsed from the date of first infusion to the date of documented progression or death | Description | Time elapsed from the date of first infusion to the date of death | Description | Number of events | Description | Tumor Immune MicroEnvironment analysis and evolution changes: quantity/density and quality of immune cells | Description | PK parameters analysis | Description | Trifluridine plasma concentrations only for cohort II | Description | Presence of ADA | Description | AMHRII membrane expression in percentage |
Browse Conditions
Sequence: | 194727905 | Sequence: | 194727906 | Sequence: | 194727907 | Sequence: | 194727908 | Sequence: | 194727909 | Sequence: | 194727910 | Sequence: | 194727911 | Sequence: | 194727912 | Sequence: | 194727913 | Sequence: | 194727914 | Sequence: | 194727915 |
Mesh Term | Colorectal Neoplasms | Mesh Term | Intestinal Neoplasms | Mesh Term | Gastrointestinal Neoplasms | Mesh Term | Digestive System Neoplasms | Mesh Term | Neoplasms by Site | Mesh Term | Neoplasms | Mesh Term | Digestive System Diseases | Mesh Term | Gastrointestinal Diseases | Mesh Term | Colonic Diseases | Mesh Term | Intestinal Diseases | Mesh Term | Rectal Diseases |
Downcase Mesh Term | colorectal neoplasms | Downcase Mesh Term | intestinal neoplasms | Downcase Mesh Term | gastrointestinal neoplasms | Downcase Mesh Term | digestive system neoplasms | Downcase Mesh Term | neoplasms by site | Downcase Mesh Term | neoplasms | Downcase Mesh Term | digestive system diseases | Downcase Mesh Term | gastrointestinal diseases | Downcase Mesh Term | colonic diseases | Downcase Mesh Term | intestinal diseases | Downcase Mesh Term | rectal diseases |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48621046 |
Agency Class | INDUSTRY |
Lead Or Collaborator | lead |
Name | GamaMabs Pharma |
Overall Officials
Sequence: | 29455255 |
Role | Principal Investigator |
Name | Eric Van Cutsem, MD |
Affiliation | UZ Leuven, Belgium |
Design Group Interventions
Sequence: | 68592500 | Sequence: | 68592501 | Sequence: | 68592502 | Sequence: | 68592503 | Sequence: | 68592504 |
Design Group Id | 55952552 | Design Group Id | 55952553 | Design Group Id | 55952554 | Design Group Id | 55952553 | Design Group Id | 55952554 |
Intervention Id | 52804814 | Intervention Id | 52804814 | Intervention Id | 52804815 | Intervention Id | 52804815 | Intervention Id | 52804816 |
Eligibilities
Sequence: | 30951203 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Histologically confirmed metastatic or locally advanced colorectal adenocarcinoma. Exclusion Criteria: Age < 18 years old. |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253858422 |
Number Of Facilities | 5 |
Registered In Calendar Year | 2019 |
Actual Duration | 30 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | False |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 2 |
Number Of Secondary Outcomes To Measure | 11 |
Designs
Sequence: | 30696791 |
Allocation | Non-Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Intervention Other Names
Sequence: | 26835264 |
Intervention Id | 52804815 |
Name | Lonsurf |
Responsible Parties
Sequence: | 29063548 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03799718
2019-03-13
https://zephyrnet.com/?p=NCT03799718
NCT03799718https://www.clinicaltrials.gov/study/NCT03799718?tab=tableNANANAA multidose open-label study with autologous Mesenchymal Stromal Stem Cells Secreting Neurotrophic Factors (MSC-NTF cells) involving 20 participants with progressive MS at multiple investigational study sites.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-07 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2022-11-14 |
Start Month Year | March 13, 2019 |
Primary Completion Month Year | March 11, 2021 |
Verification Month Year | August 2021 |
Verification Date | 2021-08-31 |
Last Update Posted Date | 2022-11-14 |
Results First Posted Date | 2022-11-14 |
Detailed Descriptions
Sequence: | 20713085 |
Description | An open-label study with a single treatment arm involving 20 participants with progressive MS at multiple investigational study sites. After providing informed consent, participants meeting the inclusion and exclusion criteria will be randomized and approximately 4 weeks later will undergo a bone-marrow aspiration (BMA). Each participants will receive three Intrathecal cell transplantations within 16 weeks and will be followed for 12 weeks for safety and efficacy. |
Facilities
Sequence: | 200013922 | Sequence: | 200013923 | Sequence: | 200013924 | Sequence: | 200013925 |
Name | University of Southern California | Name | Stanford University School of Medicine | Name | The Mount Sinai Hospital | Name | Cleveland Clinic |
City | Los Angeles | City | Redwood City | City | New York | City | Cleveland |
State | California | State | California | State | New York | State | Ohio |
Zip | 90033 | Zip | 94305 | Zip | 10029 | Zip | 44195 |
Country | United States | Country | United States | Country | United States | Country | United States |
Conditions
Sequence: | 52147770 |
Name | Multiple Sclerosis, Chronic Progressive |
Downcase Name | multiple sclerosis, chronic progressive |
Id Information
Sequence: | 40141583 |
Id Source | org_study_id |
Id Value | BCT-101-US |
Countries
Sequence: | 42550783 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55568475 |
Group Type | Experimental |
Title | NurOwn (MSC-NTF cells) |
Description | Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors |
Interventions
Sequence: | 52463579 |
Intervention Type | Biological |
Name | NurOwn (MSC-NTF cells) |
Description | Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors |
Design Outcomes
Sequence: | 177297640 | Sequence: | 177297641 | Sequence: | 177297642 | Sequence: | 177297643 | Sequence: | 177297644 | Sequence: | 177297645 | Sequence: | 177297646 | Sequence: | 177297647 | Sequence: | 177297648 | Sequence: | 177297649 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Number of Participants With Treatment-emergent Adverse Events | Measure | Number of Participants With 25% or Greater Improvement From Baseline in Time 25 Foot Walk (T25FW) Speed or Nine-Hole Peg Test (9-HPT) | Measure | Number of Participants With 25% or Greater Improvement From Baseline to Week 28 in Timed 25 Foot Walk (T25FW) Speed | Measure | Number of Participants With 25% or Greater Improvement From Baseline to Week 28 in 9-HPT | Measure | Number of Participants Who Had >5.5 in Expanded Disability Status Scale (EDSS) at Baseline, With ≥0.5 Points Improvement From Baseline to Week 28 | Measure | Number of Participants With ≥10 Points Improvement From Baseline to Week 28 in Multiple Sclerosis Walking Scale (MSWS-12) | Measure | Number of Participants With ≥8 Letter Improvement From Baseline to Week 28 in LCLA Binocular 2.5% Contrast Level | Measure | Number of Participants With ≥ 3 Points Improvement From Baseline to Week 28 in Symbol Digit Modalities Test (SDMT) Score | Measure | Change in Concentration of Vascular Endothelial Growth Factor (VEGF) Neuroprotective Biomarker From Baseline in the Cerebrospinal Fluid (CSF) 16 Weeks Following First NurOwn® Treatment | Measure | Change in Concentration of Hepatocyte Growth Factor (HGF) Neuroprotective Biomarker From Baseline in the Cerebrospinal Fluid (CSF) 16 Weeks Following NurOwn® Treatment |
Time Frame | Up to 28 weeks post-first treatment | Time Frame | From Baseline (pre-first treatment) to 28 weeks post-first treatment | Time Frame | From Baseline (pre-first treatment) to 28 weeks post-first treatment | Time Frame | From Baseline (pre-first treatment) to 28 weeks post-first treatment | Time Frame | From Baseline (pre-first treatment) to 28 weeks post-first treatment | Time Frame | From Baseline (pre-first treatment) to 28 weeks post-first treatment | Time Frame | From Baseline (pre-first treatment) to 28 weeks post-first treatment | Time Frame | From Baseline (pre-first treatment) to 28 weeks post-first treatment | Time Frame | From Baseline (pre-first treatment) to 16 weeks post first treatment | Time Frame | From Baseline (pre-first treatment) to 16 weeks post first treatment |
Description | Combined safety of all 3 intrathecal doses of NurOwn® (MSC-NTF cells) Number of participants who experienced Treatment-emergent Adverse Events during the study.
Treatment-emergent Adverse Event is an adverse event that occurs for the first time after initiation of first treatment or if it had occurred prior to initiation first treatment, it worsens in severity after initiation of first treatment. |
Description | 25% or greater improvement at 28 weeks from Baseline in Time 25 Foot Walk (T25FW) speed or 9 Hole Peg Test (9-HPT).
The T25FW is a quantitative mobility and leg function performance test based on a timed 25-feet walk. The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. T25FW is the average of the two successive trials. Higher values represent better outcomes. The 9HPT is used to measure upper extremity function in patients with various neurological diagnoses. The participant is asked to pick up the nine pegs, puts them in the nine holes, and, once completed, removes them again as quickly as possible, replacing them into the container. The total time to complete the task is recorded. Higher values represent worse outcomes. |
Description | ≥25% improvement in T25FW speed over 28 weeks The T25FW is a quantitative mobility and leg function performance test based on a timed 25-feet walk.
The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The task is immediately administered again by having the patient walk back the same distance Baseline T25FW is the average of the two successive trials. Higher values represent better outcomes |
Description | The Nine-Hole Peg Test (9HPT) is used to measure upper extremity function in patients with various neurological diagnoses.
The participant is seated at a table with a small, shallow container holding nine pegs and a wood or plastic block containing nine empty holes. On a start command when a stopwatch is started, the participant picks up the nine pegs one at a time as quickly as possible, puts them in the nine holes, and, once they are in the holes, removes them again as quickly as possible one at a time, replacing them into the shallow container. The total time to complete the task is recorded. Two consecutive trials with the dominant hand are immediately followed by two consecutive trials with the non-dominant hand. Baseline 9HPT is the average of 2 trials of dominant hand and nondominant hand. The higher values represent a worse outcome. |
Description | Expanded Disability Status Scale (EDSS) provides a total score on a scale that ranges from 0 (no disability) through 1 to 10 (death due to MS), in 0.5-point steps. The first levels 1.0 to 4.5 refer to people with a high degree of ambulatory ability and the sequent levels 5.0 to 9.5 refer to the loss of ambulatory ability. The higher score represents the worse outcome. | Description | The Multiple Sclerosis Walking Scale (MSWS)-12 is a patient-reported outcome measure of the walking limitations due to MS during the past 2 weeks.
It contains 12 questions that assess the impact of MS on different aspects of walking function and quality. Total administration time should be approximately 5 minutes. Activities are rated by participant from min. 1 (not at all) to max. 5 (extremely) and summed to calculate a total score using a scale from 0 to 60 (ranging from low to high impact on walking). This score is then divided by 60 and multiplied by 100 to get a score between 0 and 100 A higher score represents a worse outcome. |
Description | The Low contrast letter acuity (LCLA) is a leading outcome measure to assess visual disability in multiple sclerosis (MS) research Total administration time, for a typical MS patient, is approximately 10-15 minutes to complete, when testing each eye individually and binocular vision for two different contrast levels.
The score for each chart is quantified as the number of letters identified correctly with a minimum scrore of 0 letter and a maximum score of 70 letters. The higher score represents the better outcome. |
Description | Symbol Digit Modalities test (SDMT) is a commonly used test to assess psychomotor speed, which measures processing speed as well as motor speed.
It is a paper-pencil measure which requires an individual to substitute digits for abstract symbols using a reference key Scoring involves summing the number of correct substitutions within the 90 second interval (max = 110) Minimum score is 0 and maximum score 110. The higher score represents the better outcome. |
Description | Change from baseline (pre-first treatment) in the concentration of Vascular endothelial growth factor (VEGF) neuroprotective biomarker in the Cerebrospinal fluid (CSF) at 16 weeks following first NurOwn® treatment The concentration of the biomarker is measured as Picogram per milliliter (pg/ml). A higher concentration of neuroprotective biomarkers suggests a better outcome | Description | Change from baseline in the concentration of Hepatocyte growth factor (HGF) neuroprotective biomarker in the Cerebrospinal Fluid (CSF) at 16 weeks following the first NurOwn® treatment The concentration of the biomarker is measured as Picogram per milliliter (pg/ml). A higher concentration of neuroprotective biomarkers suggests a better outcome |
Browse Conditions
Sequence: | 193399231 | Sequence: | 193399232 | Sequence: | 193399233 | Sequence: | 193399234 | Sequence: | 193399235 | Sequence: | 193399236 | Sequence: | 193399237 | Sequence: | 193399238 | Sequence: | 193399239 | Sequence: | 193399240 | Sequence: | 193399241 |
Mesh Term | Multiple Sclerosis | Mesh Term | Multiple Sclerosis, Chronic Progressive | Mesh Term | Pathologic Processes | Mesh Term | Demyelinating Autoimmune Diseases, CNS | Mesh Term | Autoimmune Diseases of the Nervous System | Mesh Term | Nervous System Diseases | Mesh Term | Demyelinating Diseases | Mesh Term | Autoimmune Diseases | Mesh Term | Immune System Diseases | Mesh Term | Chronic Disease | Mesh Term | Disease Attributes |
Downcase Mesh Term | multiple sclerosis | Downcase Mesh Term | multiple sclerosis, chronic progressive | Downcase Mesh Term | pathologic processes | Downcase Mesh Term | demyelinating autoimmune diseases, cns | Downcase Mesh Term | autoimmune diseases of the nervous system | Downcase Mesh Term | nervous system diseases | Downcase Mesh Term | demyelinating diseases | Downcase Mesh Term | autoimmune diseases | Downcase Mesh Term | immune system diseases | Downcase Mesh Term | chronic disease | Downcase Mesh Term | disease attributes |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48298234 |
Agency Class | INDUSTRY |
Lead Or Collaborator | lead |
Name | Brainstorm-Cell Therapeutics |
Overall Officials
Sequence: | 29272860 |
Role | Principal Investigator |
Name | Jeffrey Cohen, MD |
Affiliation | The Cleveland Clinic |
Design Group Interventions
Sequence: | 68119632 |
Design Group Id | 55568475 |
Intervention Id | 52463579 |
Eligibilities
Sequence: | 30752363 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 65 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Males and females ages 18 to 65 years old, inclusive, at the Screening Visit. Exclusion Criteria: Prior stem cell therapy of any kind. |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254175113 |
Number Of Facilities | 4 |
Number Of Nsae Subjects | 68 |
Number Of Sae Subjects | 2 |
Registered In Calendar Year | 2019 |
Actual Duration | 24 |
Were Results Reported | True |
Months To Report Results | 18 |
Has Us Facility | True |
Has Single Facility | False |
Minimum Age Num | 18 |
Maximum Age Num | 65 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 9 |
Designs
Sequence: | 30498631 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Intervention Model Description | Open label |
Drop Withdrawals
Sequence: | 28975619 |
Result Group Id | 56079294 |
Ctgov Group Code | FG000 |
Period | Overall Study |
Reason | Adverse Event |
Count | 2 |
Milestones
Sequence: | 40992027 | Sequence: | 40992028 | Sequence: | 40992029 |
Result Group Id | 56079294 | Result Group Id | 56079294 | Result Group Id | 56079294 |
Ctgov Group Code | FG000 | Ctgov Group Code | FG000 | Ctgov Group Code | FG000 |
Title | STARTED | Title | COMPLETED | Title | NOT COMPLETED |
Period | Overall Study | Period | Overall Study | Period | Overall Study |
Description | 20 participants underwent bone marrow aspiration. In two participants, autologous bone marrow culture failed to meet specific MSC-NTF cell product release criteria and they did not receive treatment | Description | Of the 20 participants enrolled, 18 were treated, 17 received all three treatments and one received two treatments. | ||
Count | 20 | Count | 18 | Count | 2 |
Count Units | 54 | Count Units | 53 | Count Units | 1 |
Participant Flows
Sequence: | 3920078 |
Pre Assignment Details | Not meeting inclusion exclusion criteria |
Units Analyzed | Treatments |
Outcome Counts
Sequence: | 73972415 | Sequence: | 73972416 | Sequence: | 73972417 | Sequence: | 73972418 | Sequence: | 73972419 | Sequence: | 73972420 | Sequence: | 73972421 | Sequence: | 73972422 | Sequence: | 73972423 | Sequence: | 73972424 |
Outcome Id | 30793057 | Outcome Id | 30793058 | Outcome Id | 30793059 | Outcome Id | 30793060 | Outcome Id | 30793061 | Outcome Id | 30793062 | Outcome Id | 30793063 | Outcome Id | 30793064 | Outcome Id | 30793065 | Outcome Id | 30793066 |
Result Group Id | 56079295 | Result Group Id | 56079295 | Result Group Id | 56079295 | Result Group Id | 56079295 | Result Group Id | 56079295 | Result Group Id | 56079295 | Result Group Id | 56079295 | Result Group Id | 56079295 | Result Group Id | 56079295 | Result Group Id | 56079295 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 |
Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure |
Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants |
Count | 18 | Count | 18 | Count | 18 | Count | 18 | Count | 10 | Count | 18 | Count | 18 | Count | 18 | Count | 17 | Count | 17 |
Provided Documents
Sequence: | 2577770 | Sequence: | 2577771 |
Document Type | Study Protocol | Document Type | Statistical Analysis Plan |
Has Protocol | True | Has Protocol | False |
Has Icf | False | Has Icf | False |
Has Sap | False | Has Sap | True |
Document Date | 2019-06-01 | Document Date | 2019-04-12 |
Url | https://ClinicalTrials.gov/ProvidedDocs/18/NCT03799718/Prot_000.pdf | Url | https://ClinicalTrials.gov/ProvidedDocs/18/NCT03799718/SAP_001.pdf |
Reported Event Totals
Sequence: | 27934087 | Sequence: | 27934088 | Sequence: | 27934089 |
Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG000 |
Event Type | serious | Event Type | other | Event Type | deaths |
Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality |
Subjects Affected | 2 | Subjects Affected | 18 | Subjects Affected | 0 |
Subjects At Risk | 18 | Subjects At Risk | 18 | Subjects At Risk | 18 |
Created At | 2023-08-08 21:34:52.883141 | Created At | 2023-08-08 21:34:52.883141 | Created At | 2023-08-08 21:34:52.883141 |
Updated At | 2023-08-08 21:34:52.883141 | Updated At | 2023-08-08 21:34:52.883141 | Updated At | 2023-08-08 21:34:52.883141 |
Reported Events
Sequence: | 528025622 | Sequence: | 528025623 | Sequence: | 528025624 | Sequence: | 528025625 | Sequence: | 528025626 | Sequence: | 528025627 | Sequence: | 528025628 | Sequence: | 528025629 | Sequence: | 528025630 | Sequence: | 528025631 | Sequence: | 528025632 | Sequence: | 528025633 | Sequence: | 528025634 |
Result Group Id | 56079296 | Result Group Id | 56079296 | Result Group Id | 56079296 | Result Group Id | 56079296 | Result Group Id | 56079296 | Result Group Id | 56079296 | Result Group Id | 56079296 | Result Group Id | 56079296 | Result Group Id | 56079296 | Result Group Id | 56079296 | Result Group Id | 56079296 | Result Group Id | 56079296 | Result Group Id | 56079296 |
Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG000 |
Time Frame | 28 weeks | Time Frame | 28 weeks | Time Frame | 28 weeks | Time Frame | 28 weeks | Time Frame | 28 weeks | Time Frame | 28 weeks | Time Frame | 28 weeks | Time Frame | 28 weeks | Time Frame | 28 weeks | Time Frame | 28 weeks | Time Frame | 28 weeks | Time Frame | 28 weeks | Time Frame | 28 weeks |
Event Type | serious | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other |
Subjects Affected | 2 | Subjects Affected | 16 | Subjects Affected | 15 | Subjects Affected | 6 | Subjects Affected | 5 | Subjects Affected | 4 | Subjects Affected | 4 | Subjects Affected | 3 | Subjects Affected | 3 | Subjects Affected | 3 | Subjects Affected | 3 | Subjects Affected | 3 | Subjects Affected | 3 |
Subjects At Risk | 18 | Subjects At Risk | 18 | Subjects At Risk | 18 | Subjects At Risk | 18 | Subjects At Risk | 18 | Subjects At Risk | 18 | Subjects At Risk | 18 | Subjects At Risk | 18 | Subjects At Risk | 18 | Subjects At Risk | 18 | Subjects At Risk | 18 | Subjects At Risk | 18 | Subjects At Risk | 18 |
Description | Adverse Events (AE) were collected over a period of 38 weeks from the time of informed consent at the screening visit through the last study visit (Visit 7 or an Early Termination visit) Treatment Emergent Adverse Events (TEAE) were collected over a period of 28 weeks from the time of the first treatment through the last study visit (Visit 7 or an Early Termination visit) | Description | Adverse Events (AE) were collected over a period of 38 weeks from the time of informed consent at the screening visit through the last study visit (Visit 7 or an Early Termination visit) Treatment Emergent Adverse Events (TEAE) were collected over a period of 28 weeks from the time of the first treatment through the last study visit (Visit 7 or an Early Termination visit) | Description | Adverse Events (AE) were collected over a period of 38 weeks from the time of informed consent at the screening visit through the last study visit (Visit 7 or an Early Termination visit) Treatment Emergent Adverse Events (TEAE) were collected over a period of 28 weeks from the time of the first treatment through the last study visit (Visit 7 or an Early Termination visit) | Description | Adverse Events (AE) were collected over a period of 38 weeks from the time of informed consent at the screening visit through the last study visit (Visit 7 or an Early Termination visit) Treatment Emergent Adverse Events (TEAE) were collected over a period of 28 weeks from the time of the first treatment through the last study visit (Visit 7 or an Early Termination visit) | Description | Adverse Events (AE) were collected over a period of 38 weeks from the time of informed consent at the screening visit through the last study visit (Visit 7 or an Early Termination visit) Treatment Emergent Adverse Events (TEAE) were collected over a period of 28 weeks from the time of the first treatment through the last study visit (Visit 7 or an Early Termination visit) | Description | Adverse Events (AE) were collected over a period of 38 weeks from the time of informed consent at the screening visit through the last study visit (Visit 7 or an Early Termination visit) Treatment Emergent Adverse Events (TEAE) were collected over a period of 28 weeks from the time of the first treatment through the last study visit (Visit 7 or an Early Termination visit) | Description | Adverse Events (AE) were collected over a period of 38 weeks from the time of informed consent at the screening visit through the last study visit (Visit 7 or an Early Termination visit) Treatment Emergent Adverse Events (TEAE) were collected over a period of 28 weeks from the time of the first treatment through the last study visit (Visit 7 or an Early Termination visit) | Description | Adverse Events (AE) were collected over a period of 38 weeks from the time of informed consent at the screening visit through the last study visit (Visit 7 or an Early Termination visit) Treatment Emergent Adverse Events (TEAE) were collected over a period of 28 weeks from the time of the first treatment through the last study visit (Visit 7 or an Early Termination visit) | Description | Adverse Events (AE) were collected over a period of 38 weeks from the time of informed consent at the screening visit through the last study visit (Visit 7 or an Early Termination visit) Treatment Emergent Adverse Events (TEAE) were collected over a period of 28 weeks from the time of the first treatment through the last study visit (Visit 7 or an Early Termination visit) | Description | Adverse Events (AE) were collected over a period of 38 weeks from the time of informed consent at the screening visit through the last study visit (Visit 7 or an Early Termination visit) Treatment Emergent Adverse Events (TEAE) were collected over a period of 28 weeks from the time of the first treatment through the last study visit (Visit 7 or an Early Termination visit) | Description | Adverse Events (AE) were collected over a period of 38 weeks from the time of informed consent at the screening visit through the last study visit (Visit 7 or an Early Termination visit) Treatment Emergent Adverse Events (TEAE) were collected over a period of 28 weeks from the time of the first treatment through the last study visit (Visit 7 or an Early Termination visit) | Description | Adverse Events (AE) were collected over a period of 38 weeks from the time of informed consent at the screening visit through the last study visit (Visit 7 or an Early Termination visit) Treatment Emergent Adverse Events (TEAE) were collected over a period of 28 weeks from the time of the first treatment through the last study visit (Visit 7 or an Early Termination visit) | Description | Adverse Events (AE) were collected over a period of 38 weeks from the time of informed consent at the screening visit through the last study visit (Visit 7 or an Early Termination visit) Treatment Emergent Adverse Events (TEAE) were collected over a period of 28 weeks from the time of the first treatment through the last study visit (Visit 7 or an Early Termination visit) |
Event Count | 2 | Event Count | 35 | Event Count | 29 | Event Count | 8 | Event Count | 5 | Event Count | 4 | Event Count | 5 | Event Count | 3 | Event Count | 4 | Event Count | 3 | Event Count | 4 | Event Count | 3 | Event Count | 4 |
Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Infections and infestations | Organ System | Musculoskeletal and connective tissue disorders | Organ System | General disorders | Organ System | General disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Injury, poisoning and procedural complications | Organ System | General disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders |
Adverse Event Term | Arachnoiditis | Adverse Event Term | Headache | Adverse Event Term | Back pain | Adverse Event Term | Urinary tract infection | Adverse Event Term | Musculoskeletal pain | Adverse Event Term | Injection site pain | Adverse Event Term | Pyrexia | Adverse Event Term | Arthralgia | Adverse Event Term | Fall | Adverse Event Term | Fatigue | Adverse Event Term | Muscular weakness | Adverse Event Term | Musculoskeletal stiffness | Adverse Event Term | Pain in extremity |
Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 |
Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment |
Responsible Parties
Sequence: | 28864905 |
Responsible Party Type | Sponsor |
Result Agreements
Sequence: | 3850822 |
Pi Employee | No |
Restriction Type | GT60 |
Result Contacts
Sequence: | 3850787 |
Organization | Brainstorm Cell therapeutics |
Name | Ralph Kern, MD, Chief Medical Officer |
Phone | 201-488-0460 |
rkern@brainstorm-cell.com | |
Outcomes
Sequence: | 30793057 | Sequence: | 30793058 | Sequence: | 30793059 | Sequence: | 30793060 | Sequence: | 30793061 | Sequence: | 30793062 | Sequence: | 30793063 | Sequence: | 30793064 | Sequence: | 30793065 | Sequence: | 30793066 |
Outcome Type | Primary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary |
Title | Number of Participants With Treatment-emergent Adverse Events | Title | Number of Participants With 25% or Greater Improvement From Baseline in Time 25 Foot Walk (T25FW) Speed or Nine-Hole Peg Test (9-HPT) | Title | Number of Participants With 25% or Greater Improvement From Baseline to Week 28 in Timed 25 Foot Walk (T25FW) Speed | Title | Number of Participants With 25% or Greater Improvement From Baseline to Week 28 in 9-HPT | Title | Number of Participants Who Had >5.5 in Expanded Disability Status Scale (EDSS) at Baseline, With ≥0.5 Points Improvement From Baseline to Week 28 | Title | Number of Participants With ≥10 Points Improvement From Baseline to Week 28 in Multiple Sclerosis Walking Scale (MSWS-12) | Title | Number of Participants With ≥8 Letter Improvement From Baseline to Week 28 in LCLA Binocular 2.5% Contrast Level | Title | Number of Participants With ≥ 3 Points Improvement From Baseline to Week 28 in Symbol Digit Modalities Test (SDMT) Score | Title | Change in Concentration of Vascular Endothelial Growth Factor (VEGF) Neuroprotective Biomarker From Baseline in the Cerebrospinal Fluid (CSF) 16 Weeks Following First NurOwn® Treatment | Title | Change in Concentration of Hepatocyte Growth Factor (HGF) Neuroprotective Biomarker From Baseline in the Cerebrospinal Fluid (CSF) 16 Weeks Following NurOwn® Treatment |
Description | Combined safety of all 3 intrathecal doses of NurOwn® (MSC-NTF cells) Number of participants who experienced Treatment-emergent Adverse Events during the study.
Treatment-emergent Adverse Event is an adverse event that occurs for the first time after initiation of first treatment or if it had occurred prior to initiation first treatment, it worsens in severity after initiation of first treatment. |
Description | 25% or greater improvement at 28 weeks from Baseline in Time 25 Foot Walk (T25FW) speed or 9 Hole Peg Test (9-HPT).
The T25FW is a quantitative mobility and leg function performance test based on a timed 25-feet walk. The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. T25FW is the average of the two successive trials. Higher values represent better outcomes. The 9HPT is used to measure upper extremity function in patients with various neurological diagnoses. The participant is asked to pick up the nine pegs, puts them in the nine holes, and, once completed, removes them again as quickly as possible, replacing them into the container. The total time to complete the task is recorded. Higher values represent worse outcomes. |
Description | ≥25% improvement in T25FW speed over 28 weeks The T25FW is a quantitative mobility and leg function performance test based on a timed 25-feet walk.
The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The task is immediately administered again by having the patient walk back the same distance Baseline T25FW is the average of the two successive trials. Higher values represent better outcomes |
Description | The Nine-Hole Peg Test (9HPT) is used to measure upper extremity function in patients with various neurological diagnoses.
The participant is seated at a table with a small, shallow container holding nine pegs and a wood or plastic block containing nine empty holes. On a start command when a stopwatch is started, the participant picks up the nine pegs one at a time as quickly as possible, puts them in the nine holes, and, once they are in the holes, removes them again as quickly as possible one at a time, replacing them into the shallow container. The total time to complete the task is recorded. Two consecutive trials with the dominant hand are immediately followed by two consecutive trials with the non-dominant hand. Baseline 9HPT is the average of 2 trials of dominant hand and nondominant hand. The higher values represent a worse outcome. |
Description | Expanded Disability Status Scale (EDSS) provides a total score on a scale that ranges from 0 (no disability) through 1 to 10 (death due to MS), in 0.5-point steps. The first levels 1.0 to 4.5 refer to people with a high degree of ambulatory ability and the sequent levels 5.0 to 9.5 refer to the loss of ambulatory ability. The higher score represents the worse outcome. | Description | The Multiple Sclerosis Walking Scale (MSWS)-12 is a patient-reported outcome measure of the walking limitations due to MS during the past 2 weeks.
It contains 12 questions that assess the impact of MS on different aspects of walking function and quality. Total administration time should be approximately 5 minutes. Activities are rated by participant from min. 1 (not at all) to max. 5 (extremely) and summed to calculate a total score using a scale from 0 to 60 (ranging from low to high impact on walking). This score is then divided by 60 and multiplied by 100 to get a score between 0 and 100 A higher score represents a worse outcome. |
Description | The Low contrast letter acuity (LCLA) is a leading outcome measure to assess visual disability in multiple sclerosis (MS) research Total administration time, for a typical MS patient, is approximately 10-15 minutes to complete, when testing each eye individually and binocular vision for two different contrast levels.
The score for each chart is quantified as the number of letters identified correctly with a minimum scrore of 0 letter and a maximum score of 70 letters. The higher score represents the better outcome. |
Description | Symbol Digit Modalities test (SDMT) is a commonly used test to assess psychomotor speed, which measures processing speed as well as motor speed.
It is a paper-pencil measure which requires an individual to substitute digits for abstract symbols using a reference key Scoring involves summing the number of correct substitutions within the 90 second interval (max = 110) Minimum score is 0 and maximum score 110. The higher score represents the better outcome. |
Description | Change from baseline (pre-first treatment) in the concentration of Vascular endothelial growth factor (VEGF) neuroprotective biomarker in the Cerebrospinal fluid (CSF) at 16 weeks following first NurOwn® treatment The concentration of the biomarker is measured as Picogram per milliliter (pg/ml). A higher concentration of neuroprotective biomarkers suggests a better outcome | Description | Change from baseline in the concentration of Hepatocyte growth factor (HGF) neuroprotective biomarker in the Cerebrospinal Fluid (CSF) at 16 weeks following the first NurOwn® treatment The concentration of the biomarker is measured as Picogram per milliliter (pg/ml). A higher concentration of neuroprotective biomarkers suggests a better outcome |
Time Frame | Up to 28 weeks post-first treatment | Time Frame | From Baseline (pre-first treatment) to 28 weeks post-first treatment | Time Frame | From Baseline (pre-first treatment) to 28 weeks post-first treatment | Time Frame | From Baseline (pre-first treatment) to 28 weeks post-first treatment | Time Frame | From Baseline (pre-first treatment) to 28 weeks post-first treatment | Time Frame | From Baseline (pre-first treatment) to 28 weeks post-first treatment | Time Frame | From Baseline (pre-first treatment) to 28 weeks post-first treatment | Time Frame | From Baseline (pre-first treatment) to 28 weeks post-first treatment | Time Frame | From Baseline (pre-first treatment) to 16 weeks post first treatment | Time Frame | From Baseline (pre-first treatment) to 16 weeks post first treatment |
Population | The primary, secondary, and exploratory efficacy endpoints were analyzed using the modified intent to treat (mITT) and Efficacy Evaluable (EE) populations The mITT population was defined in this study as all participants who received at least 1 treatment and had at least 1 T25FW or 9-HPT assessment post baseline. Baseline was defined as the most recent assessment prior to receiving the first transplantation on Day 0, at Visit 3 | Population | The modified intent to treat (mITT) population was defined in this study as all participants who received at least 1 treatment and had at least 1 T25FW or 9-HPT assessment post baseline. Baseline was defined as the most recent assessment prior to receiving the first transplantation on Day 0, at Visit 3 | Population | mITT population | Population | The mITT population was defined in this study as all participants who received at least 1 treatment and had at least 1 T25FW or 9-HPT assessment post baseline. Baseline was defined as the most recent assessment prior to receiving the first transplantation on Day 0, at Visit 3. | Population | The mITT population was defined in this study as all participants who received at least 1 treatment and had at least 1 T25FW or 9-HPT assessment post baseline.
Baseline was defined as the most recent assessment prior to receiving the first transplantation on Day 0, at Visit 3. The participants in mITT population whose EDSS Score was >5.5 at Baseline was analyzed. |
Population | The mITT population was defined in this study as all participants who received at least 1 treatment and had at least 1 T25FW or 9-HPT assessment post baseline. Baseline was defined as the most recent assessment prior to receiving the first transplantation on Day 0, at Visit 3 | Population | The mITT population was defined in this study as all participants who received at least 1 treatment and had at least 1 T25FW or 9-HPT assessment post baseline. Baseline was defined as the most recent assessment prior to receiving the first transplantation on Day 0, at Visit 3 | Population | The mITT population was defined in this study as all participants who received at least 1 treatment and had at least 1 T25FW or 9-HPT assessment post baseline. Baseline was defined as the most recent assessment prior to receiving the first transplantation on Day 0, at Visit 3. | Population | mITT Population with data available at week 16 | Population | mITT population with data available at week 16 |
Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Picograms per milliliter | Units | picograms per milliliter |
Dispersion Type | Inter-Quartile Range | Dispersion Type | Inter-Quartile Range | ||||||||||||||||
Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Geometric Mean | Param Type | Geometric Mean |
Outcome Measurements
Sequence: | 235564904 | Sequence: | 235564905 | Sequence: | 235564906 | Sequence: | 235564907 | Sequence: | 235564908 | Sequence: | 235564909 | Sequence: | 235564910 | Sequence: | 235564911 | Sequence: | 235564912 | Sequence: | 235564913 | Sequence: | 235564914 | Sequence: | 235564915 | Sequence: | 235564916 | Sequence: | 235564917 | Sequence: | 235564918 | Sequence: | 235564919 | Sequence: | 235564920 | Sequence: | 235564921 | Sequence: | 235564922 | Sequence: | 235564923 | Sequence: | 235564924 | Sequence: | 235564925 | Sequence: | 235564926 |
Outcome Id | 30793057 | Outcome Id | 30793058 | Outcome Id | 30793058 | Outcome Id | 30793058 | Outcome Id | 30793059 | Outcome Id | 30793059 | Outcome Id | 30793059 | Outcome Id | 30793060 | Outcome Id | 30793060 | Outcome Id | 30793060 | Outcome Id | 30793061 | Outcome Id | 30793061 | Outcome Id | 30793062 | Outcome Id | 30793062 | Outcome Id | 30793062 | Outcome Id | 30793063 | Outcome Id | 30793063 | Outcome Id | 30793063 | Outcome Id | 30793064 | Outcome Id | 30793064 | Outcome Id | 30793064 | Outcome Id | 30793065 | Outcome Id | 30793066 |
Result Group Id | 56079295 | Result Group Id | 56079295 | Result Group Id | 56079295 | Result Group Id | 56079295 | Result Group Id | 56079295 | Result Group Id | 56079295 | Result Group Id | 56079295 | Result Group Id | 56079295 | Result Group Id | 56079295 | Result Group Id | 56079295 | Result Group Id | 56079295 | Result Group Id | 56079295 | Result Group Id | 56079295 | Result Group Id | 56079295 | Result Group Id | 56079295 | Result Group Id | 56079295 | Result Group Id | 56079295 | Result Group Id | 56079295 | Result Group Id | 56079295 | Result Group Id | 56079295 | Result Group Id | 56079295 | Result Group Id | 56079295 | Result Group Id | 56079295 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 |
Category | Number of Participants with 25% or greater improvement from Baseline inT25FW speed or 9-HPT | Category | Number of Participants with <25% improvement from Baseline inT25FW speed or 9-HPT | Category | Number of Participants with missing data at week 28 | Category | Number of participants with 25% or more improvement | Category | Number of participants without 25% or more improvement | Category | Number of participants with missing values at week 28 | Category | Number of Participants with 25% or greater improvement from Baseline to Week 28 in 9-HPT | Category | Number of Participants with less than 25% improvement from Baseline to Week 28 in 9-HPT | Category | Number of participants with missing values at week 28 | Category | No of Participants with >5.5 in EDSS at Baseline with ≥0.5 Points Improvement from Baseline to Wk 28 | Category | No of Participants with >5.5 in EDSS at Baseline with <0.5 Points Improvement from Baseline to Wk 28 | Category | Number of Participants with ≥10 Points Improvement from Baseline to Week 28 in MSWS-12 | Category | Number of Participants with <10 Points Improvement from Baseline to Week 28 in MSWS-12 | Category | Number of Participants with missing data at week 28 | Category | No. of participants with ≥8 Letter improvement at Week 28 in LCLA Binocular 2.5% Contrast Level | Category | No. of Participants with <8 Letter Improvement at week 28 in LCLA Binocular 2.5% Contrast Level | Category | Number of Participants with missing data at week 28 | Category | Number of Participants with ≥ 3 points Improvement from Baseline to Week 28 in SDMT Score | Category | Number of Participants with < 3 points Improvement from Baseline to Week 28 in SDMT Score | Category | Number of Participants with missing data at week 28 | ||||||
Title | Number of Participants With Treatment-emergent Adverse Events | Title | Number of Participants With 25% or Greater Improvement From Baseline in Time 25 Foot Walk (T25FW) Speed or Nine-Hole Peg Test (9-HPT) | Title | Number of Participants With 25% or Greater Improvement From Baseline in Time 25 Foot Walk (T25FW) Speed or Nine-Hole Peg Test (9-HPT) | Title | Number of Participants With 25% or Greater Improvement From Baseline in Time 25 Foot Walk (T25FW) Speed or Nine-Hole Peg Test (9-HPT) | Title | Number of Participants With 25% or Greater Improvement From Baseline to Week 28 in Timed 25 Foot Walk (T25FW) Speed | Title | Number of Participants With 25% or Greater Improvement From Baseline to Week 28 in Timed 25 Foot Walk (T25FW) Speed | Title | Number of Participants With 25% or Greater Improvement From Baseline to Week 28 in Timed 25 Foot Walk (T25FW) Speed | Title | Number of Participants With 25% or Greater Improvement From Baseline to Week 28 in 9-HPT | Title | Number of Participants With 25% or Greater Improvement From Baseline to Week 28 in 9-HPT | Title | Number of Participants With 25% or Greater Improvement From Baseline to Week 28 in 9-HPT | Title | Number of Participants Who Had >5.5 in Expanded Disability Status Scale (EDSS) at Baseline, With ≥0.5 Points Improvement From Baseline to Week 28 | Title | Number of Participants Who Had >5.5 in Expanded Disability Status Scale (EDSS) at Baseline, With ≥0.5 Points Improvement From Baseline to Week 28 | Title | Number of Participants With ≥10 Points Improvement From Baseline to Week 28 in Multiple Sclerosis Walking Scale (MSWS-12) | Title | Number of Participants With ≥10 Points Improvement From Baseline to Week 28 in Multiple Sclerosis Walking Scale (MSWS-12) | Title | Number of Participants With ≥10 Points Improvement From Baseline to Week 28 in Multiple Sclerosis Walking Scale (MSWS-12) | Title | Number of Participants With ≥8 Letter Improvement From Baseline to Week 28 in LCLA Binocular 2.5% Contrast Level | Title | Number of Participants With ≥8 Letter Improvement From Baseline to Week 28 in LCLA Binocular 2.5% Contrast Level | Title | Number of Participants With ≥8 Letter Improvement From Baseline to Week 28 in LCLA Binocular 2.5% Contrast Level | Title | Number of Participants With ≥ 3 Points Improvement From Baseline to Week 28 in Symbol Digit Modalities Test (SDMT) Score | Title | Number of Participants With ≥ 3 Points Improvement From Baseline to Week 28 in Symbol Digit Modalities Test (SDMT) Score | Title | Number of Participants With ≥ 3 Points Improvement From Baseline to Week 28 in Symbol Digit Modalities Test (SDMT) Score | Title | Change in Concentration of Vascular Endothelial Growth Factor (VEGF) Neuroprotective Biomarker From Baseline in the Cerebrospinal Fluid (CSF) 16 Weeks Following First NurOwn® Treatment | Title | Change in Concentration of Hepatocyte Growth Factor (HGF) Neuroprotective Biomarker From Baseline in the Cerebrospinal Fluid (CSF) 16 Weeks Following NurOwn® Treatment |
Description | Combined safety of all 3 intrathecal doses of NurOwn® (MSC-NTF cells) Number of participants who experienced Treatment-emergent Adverse Events during the study.
Treatment-emergent Adverse Event is an adverse event that occurs for the first time after initiation of first treatment or if it had occurred prior to initiation first treatment, it worsens in severity after initiation of first treatment. |
Description | 25% or greater improvement at 28 weeks from Baseline in Time 25 Foot Walk (T25FW) speed or 9 Hole Peg Test (9-HPT).
The T25FW is a quantitative mobility and leg function performance test based on a timed 25-feet walk. The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. T25FW is the average of the two successive trials. Higher values represent better outcomes. The 9HPT is used to measure upper extremity function in patients with various neurological diagnoses. The participant is asked to pick up the nine pegs, puts them in the nine holes, and, once completed, removes them again as quickly as possible, replacing them into the container. The total time to complete the task is recorded. Higher values represent worse outcomes. |
Description | 25% or greater improvement at 28 weeks from Baseline in Time 25 Foot Walk (T25FW) speed or 9 Hole Peg Test (9-HPT).
The T25FW is a quantitative mobility and leg function performance test based on a timed 25-feet walk. The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. T25FW is the average of the two successive trials. Higher values represent better outcomes. The 9HPT is used to measure upper extremity function in patients with various neurological diagnoses. The participant is asked to pick up the nine pegs, puts them in the nine holes, and, once completed, removes them again as quickly as possible, replacing them into the container. The total time to complete the task is recorded. Higher values represent worse outcomes. |
Description | 25% or greater improvement at 28 weeks from Baseline in Time 25 Foot Walk (T25FW) speed or 9 Hole Peg Test (9-HPT).
The T25FW is a quantitative mobility and leg function performance test based on a timed 25-feet walk. The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. T25FW is the average of the two successive trials. Higher values represent better outcomes. The 9HPT is used to measure upper extremity function in patients with various neurological diagnoses. The participant is asked to pick up the nine pegs, puts them in the nine holes, and, once completed, removes them again as quickly as possible, replacing them into the container. The total time to complete the task is recorded. Higher values represent worse outcomes. |
Description | ≥25% improvement in T25FW speed over 28 weeks The T25FW is a quantitative mobility and leg function performance test based on a timed 25-feet walk.
The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The task is immediately administered again by having the patient walk back the same distance Baseline T25FW is the average of the two successive trials. Higher values represent better outcomes |
Description | ≥25% improvement in T25FW speed over 28 weeks The T25FW is a quantitative mobility and leg function performance test based on a timed 25-feet walk.
The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The task is immediately administered again by having the patient walk back the same distance Baseline T25FW is the average of the two successive trials. Higher values represent better outcomes |
Description | ≥25% improvement in T25FW speed over 28 weeks The T25FW is a quantitative mobility and leg function performance test based on a timed 25-feet walk.
The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The task is immediately administered again by having the patient walk back the same distance Baseline T25FW is the average of the two successive trials. Higher values represent better outcomes |
Description | The Nine-Hole Peg Test (9HPT) is used to measure upper extremity function in patients with various neurological diagnoses.
The participant is seated at a table with a small, shallow container holding nine pegs and a wood or plastic block containing nine empty holes. On a start command when a stopwatch is started, the participant picks up the nine pegs one at a time as quickly as possible, puts them in the nine holes, and, once they are in the holes, removes them again as quickly as possible one at a time, replacing them into the shallow container. The total time to complete the task is recorded. Two consecutive trials with the dominant hand are immediately followed by two consecutive trials with the non-dominant hand. Baseline 9HPT is the average of 2 trials of dominant hand and nondominant hand. The higher values represent a worse outcome. |
Description | The Nine-Hole Peg Test (9HPT) is used to measure upper extremity function in patients with various neurological diagnoses.
The participant is seated at a table with a small, shallow container holding nine pegs and a wood or plastic block containing nine empty holes. On a start command when a stopwatch is started, the participant picks up the nine pegs one at a time as quickly as possible, puts them in the nine holes, and, once they are in the holes, removes them again as quickly as possible one at a time, replacing them into the shallow container. The total time to complete the task is recorded. Two consecutive trials with the dominant hand are immediately followed by two consecutive trials with the non-dominant hand. Baseline 9HPT is the average of 2 trials of dominant hand and nondominant hand. The higher values represent a worse outcome. |
Description | The Nine-Hole Peg Test (9HPT) is used to measure upper extremity function in patients with various neurological diagnoses.
The participant is seated at a table with a small, shallow container holding nine pegs and a wood or plastic block containing nine empty holes. On a start command when a stopwatch is started, the participant picks up the nine pegs one at a time as quickly as possible, puts them in the nine holes, and, once they are in the holes, removes them again as quickly as possible one at a time, replacing them into the shallow container. The total time to complete the task is recorded. Two consecutive trials with the dominant hand are immediately followed by two consecutive trials with the non-dominant hand. Baseline 9HPT is the average of 2 trials of dominant hand and nondominant hand. The higher values represent a worse outcome. |
Description | Expanded Disability Status Scale (EDSS) provides a total score on a scale that ranges from 0 (no disability) through 1 to 10 (death due to MS), in 0.5-point steps. The first levels 1.0 to 4.5 refer to people with a high degree of ambulatory ability and the sequent levels 5.0 to 9.5 refer to the loss of ambulatory ability. The higher score represents the worse outcome. | Description | Expanded Disability Status Scale (EDSS) provides a total score on a scale that ranges from 0 (no disability) through 1 to 10 (death due to MS), in 0.5-point steps. The first levels 1.0 to 4.5 refer to people with a high degree of ambulatory ability and the sequent levels 5.0 to 9.5 refer to the loss of ambulatory ability. The higher score represents the worse outcome. | Description | The Multiple Sclerosis Walking Scale (MSWS)-12 is a patient-reported outcome measure of the walking limitations due to MS during the past 2 weeks.
It contains 12 questions that assess the impact of MS on different aspects of walking function and quality. Total administration time should be approximately 5 minutes. Activities are rated by participant from min. 1 (not at all) to max. 5 (extremely) and summed to calculate a total score using a scale from 0 to 60 (ranging from low to high impact on walking). This score is then divided by 60 and multiplied by 100 to get a score between 0 and 100 A higher score represents a worse outcome. |
Description | The Multiple Sclerosis Walking Scale (MSWS)-12 is a patient-reported outcome measure of the walking limitations due to MS during the past 2 weeks.
It contains 12 questions that assess the impact of MS on different aspects of walking function and quality. Total administration time should be approximately 5 minutes. Activities are rated by participant from min. 1 (not at all) to max. 5 (extremely) and summed to calculate a total score using a scale from 0 to 60 (ranging from low to high impact on walking). This score is then divided by 60 and multiplied by 100 to get a score between 0 and 100 A higher score represents a worse outcome. |
Description | The Multiple Sclerosis Walking Scale (MSWS)-12 is a patient-reported outcome measure of the walking limitations due to MS during the past 2 weeks.
It contains 12 questions that assess the impact of MS on different aspects of walking function and quality. Total administration time should be approximately 5 minutes. Activities are rated by participant from min. 1 (not at all) to max. 5 (extremely) and summed to calculate a total score using a scale from 0 to 60 (ranging from low to high impact on walking). This score is then divided by 60 and multiplied by 100 to get a score between 0 and 100 A higher score represents a worse outcome. |
Description | The Low contrast letter acuity (LCLA) is a leading outcome measure to assess visual disability in multiple sclerosis (MS) research Total administration time, for a typical MS patient, is approximately 10-15 minutes to complete, when testing each eye individually and binocular vision for two different contrast levels.
The score for each chart is quantified as the number of letters identified correctly with a minimum scrore of 0 letter and a maximum score of 70 letters. The higher score represents the better outcome. |
Description | The Low contrast letter acuity (LCLA) is a leading outcome measure to assess visual disability in multiple sclerosis (MS) research Total administration time, for a typical MS patient, is approximately 10-15 minutes to complete, when testing each eye individually and binocular vision for two different contrast levels.
The score for each chart is quantified as the number of letters identified correctly with a minimum scrore of 0 letter and a maximum score of 70 letters. The higher score represents the better outcome. |
Description | The Low contrast letter acuity (LCLA) is a leading outcome measure to assess visual disability in multiple sclerosis (MS) research Total administration time, for a typical MS patient, is approximately 10-15 minutes to complete, when testing each eye individually and binocular vision for two different contrast levels.
The score for each chart is quantified as the number of letters identified correctly with a minimum scrore of 0 letter and a maximum score of 70 letters. The higher score represents the better outcome. |
Description | Symbol Digit Modalities test (SDMT) is a commonly used test to assess psychomotor speed, which measures processing speed as well as motor speed.
It is a paper-pencil measure which requires an individual to substitute digits for abstract symbols using a reference key Scoring involves summing the number of correct substitutions within the 90 second interval (max = 110) Minimum score is 0 and maximum score 110. The higher score represents the better outcome. |
Description | Symbol Digit Modalities test (SDMT) is a commonly used test to assess psychomotor speed, which measures processing speed as well as motor speed.
It is a paper-pencil measure which requires an individual to substitute digits for abstract symbols using a reference key Scoring involves summing the number of correct substitutions within the 90 second interval (max = 110) Minimum score is 0 and maximum score 110. The higher score represents the better outcome. |
Description | Symbol Digit Modalities test (SDMT) is a commonly used test to assess psychomotor speed, which measures processing speed as well as motor speed.
It is a paper-pencil measure which requires an individual to substitute digits for abstract symbols using a reference key Scoring involves summing the number of correct substitutions within the 90 second interval (max = 110) Minimum score is 0 and maximum score 110. The higher score represents the better outcome. |
Description | Change from baseline (pre-first treatment) in the concentration of Vascular endothelial growth factor (VEGF) neuroprotective biomarker in the Cerebrospinal fluid (CSF) at 16 weeks following first NurOwn® treatment The concentration of the biomarker is measured as Picogram per milliliter (pg/ml). A higher concentration of neuroprotective biomarkers suggests a better outcome | Description | Change from baseline in the concentration of Hepatocyte growth factor (HGF) neuroprotective biomarker in the Cerebrospinal Fluid (CSF) at 16 weeks following the first NurOwn® treatment The concentration of the biomarker is measured as Picogram per milliliter (pg/ml). A higher concentration of neuroprotective biomarkers suggests a better outcome |
Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Picograms per milliliter | Units | picograms per milliliter |
Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Geometric Mean | Param Type | Geometric Mean |
Param Value | 18 | Param Value | 3 | Param Value | 13 | Param Value | 2 | Param Value | 2 | Param Value | 12 | Param Value | 4 | Param Value | 2 | Param Value | 13 | Param Value | 3 | Param Value | 3 | Param Value | 7 | Param Value | 6 | Param Value | 10 | Param Value | 2 | Param Value | 4 | Param Value | 11 | Param Value | 3 | Param Value | 10 | Param Value | 5 | Param Value | 3 | Param Value | 90.17 | Param Value | 15.16 |
Param Value Num | 18.0 | Param Value Num | 3.0 | Param Value Num | 13.0 | Param Value Num | 2.0 | Param Value Num | 2.0 | Param Value Num | 12.0 | Param Value Num | 4.0 | Param Value Num | 2.0 | Param Value Num | 13.0 | Param Value Num | 3.0 | Param Value Num | 3.0 | Param Value Num | 7.0 | Param Value Num | 6.0 | Param Value Num | 10.0 | Param Value Num | 2.0 | Param Value Num | 4.0 | Param Value Num | 11.0 | Param Value Num | 3.0 | Param Value Num | 10.0 | Param Value Num | 5.0 | Param Value Num | 3.0 | Param Value Num | 90.17 | Param Value Num | 15.16 |
Dispersion Type | Inter-Quartile Range | Dispersion Type | Inter-Quartile Range | ||||||||||||||||||||||||||||||||||||||||||
Dispersion Lower Limit | -9.16 | Dispersion Lower Limit | 0.2 | ||||||||||||||||||||||||||||||||||||||||||
Dispersion Upper Limit | 124.8 | Dispersion Upper Limit | 19.44 | ||||||||||||||||||||||||||||||||||||||||||
Baseline Counts
Sequence: | 11379734 |
Result Group Id | 56079293 |
Ctgov Group Code | BG000 |
Units | Participants |
Scope | overall |
Count | 18 |
Result Groups
Sequence: | 56079293 | Sequence: | 56079294 | Sequence: | 56079295 | Sequence: | 56079296 |
Ctgov Group Code | BG000 | Ctgov Group Code | FG000 | Ctgov Group Code | OG000 | Ctgov Group Code | EG000 |
Result Type | Baseline | Result Type | Participant Flow | Result Type | Outcome | Result Type | Reported Event |
Title | NurOwn (MSC-NTF Cells) | Title | NurOwn (MSC-NTF Cells) | Title | NurOwn (MSC-NTF Cells) | Title | NurOwn (MSC-NTF Cells) |
Description | Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors
NurOwn (MSC-NTF cells): Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors |
Description | Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors NurOwn (MSC-NTF cells). Study drug was supplied in one 5 mL syringe containing 4 mL of NurOwn (MSC-NTF cells) suspension at a dose of 100-125 x106 cells for IT administration. 3 doses of NurOwn (MSC-NTF cells) were transplanted intrathecally at 8-week intervals (Day 0-1, week 8, and week 16) | Description | Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors
NurOwn (MSC-NTF cells): Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors |
Description | Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors
NurOwn (MSC-NTF cells): Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors |
Baseline Measurements
Sequence: | 125540031 | Sequence: | 125540032 | Sequence: | 125540033 | Sequence: | 125540034 | Sequence: | 125540035 | Sequence: | 125540036 | Sequence: | 125540037 | Sequence: | 125540038 | Sequence: | 125540039 | Sequence: | 125540040 | Sequence: | 125540041 | Sequence: | 125540042 | Sequence: | 125540043 | Sequence: | 125540044 | Sequence: | 125540045 | Sequence: | 125540046 |
Result Group Id | 56079293 | Result Group Id | 56079293 | Result Group Id | 56079293 | Result Group Id | 56079293 | Result Group Id | 56079293 | Result Group Id | 56079293 | Result Group Id | 56079293 | Result Group Id | 56079293 | Result Group Id | 56079293 | Result Group Id | 56079293 | Result Group Id | 56079293 | Result Group Id | 56079293 | Result Group Id | 56079293 | Result Group Id | 56079293 | Result Group Id | 56079293 | Result Group Id | 56079293 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 |
Classification | United States | ||||||||||||||||||||||||||||||
Category | Female | Category | Male | Category | Hispanic or Latino | Category | Not Hispanic or Latino | Category | Unknown or Not Reported | Category | American Indian or Alaska Native | Category | Asian | Category | Native Hawaiian or Other Pacific Islander | Category | Black or African American | Category | White | Category | More than one race | Category | Unknown or Not Reported | ||||||||
Title | Age, Continuous | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Ethnicity (NIH/OMB) | Title | Ethnicity (NIH/OMB) | Title | Ethnicity (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Region of Enrollment | Title | Timed 25-foot walk speed | Title | Nine-Hole Peg Test (9HPT) |
Description | The T25FW is a quantitative mobility and leg function performance test based on a timed 25-feet walk. The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The time is calculated from the initiation of the instruction to start and ends when the patient has reached the 25-foot mark. The task is immediately administered again by having the patient walk back the same distance. Baseline T25FW is the average of the two successive trials. Higher values represent better outcomes | Description | The Nine-Hole Peg Test (9HPT) is used to measure upper extremity function in patients with various neurological diagnoses The participant is seated at a table with a container holding nine pegs and a block with 9 empty holes. On a start command, the participant picks up the nine pegs, puts them in the nine holes, and, once completed, removes them again as quickly as possible, replacing them into the container. The total time to complete the task is recorded.
Baseline 9HPT is the average of 2 trials of dominant hand and nondominant hand. Higher values represent a worse outcome. |
||||||||||||||||||||||||||||
Units | years | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Feet/seconds | Units | Seconds |
Param Type | Mean | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Mean | Param Type | Mean |
Param Value | 47.4 | Param Value | 10 | Param Value | 8 | Param Value | 0 | Param Value | 18 | Param Value | 0 | Param Value | 0 | Param Value | 1 | Param Value | 0 | Param Value | 2 | Param Value | 15 | Param Value | 0 | Param Value | 0 | Param Value | 18 | Param Value | 2.4 | Param Value | 35.2 |
Param Value Num | 47.4 | Param Value Num | 10.0 | Param Value Num | 8.0 | Param Value Num | 0.0 | Param Value Num | 18.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 2.0 | Param Value Num | 15.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 18.0 | Param Value Num | 2.4 | Param Value Num | 35.2 |
Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | ||||||||||||||||||||||||||
Dispersion Value | 9.6 | Dispersion Value | 1.6 | Dispersion Value | 15.7 | ||||||||||||||||||||||||||
Dispersion Value Num | 9.6 | Dispersion Value Num | 1.6 | Dispersion Value Num | 15.7 | ||||||||||||||||||||||||||
Number Analyzed | 18 | Number Analyzed | 18 | Number Analyzed | 18 | Number Analyzed | 18 | Number Analyzed | 18 | Number Analyzed | 18 | Number Analyzed | 18 | Number Analyzed | 18 | Number Analyzed | 18 | Number Analyzed | 18 | Number Analyzed | 18 | Number Analyzed | 18 | Number Analyzed | 18 | Number Analyzed | 18 | Number Analyzed | 18 | Number Analyzed | 18 |
]]>
https://zephyrnet.com/NCT03799705
2019-12-01
https://zephyrnet.com/?p=NCT03799705
NCT03799705https://www.clinicaltrials.gov/study/NCT03799705?tab=tableNANANAResearchers are trying to identify versions of genes as well as factors in subjects blood associated with certain types of congenital malformations(CMs). This study will help the researchers to better understand family traits that contribute to CMs.
<![CDATA[
Studies
Study First Submitted Date | 2018-08-29 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2023-01-12 |
Start Month Year | December 1, 2019 |
Primary Completion Month Year | December 29, 2022 |
Verification Month Year | January 2023 |
Verification Date | 2023-01-31 |
Last Update Posted Date | 2023-01-12 |
Facilities
Sequence: | 200307683 |
Name | Mayo Clinic |
City | Rochester |
State | Minnesota |
Zip | 55905 |
Country | United States |
Conditions
Sequence: | 52232513 | Sequence: | 52232514 |
Name | Vacterl Association | Name | Congenital Malformation |
Downcase Name | vacterl association | Downcase Name | congenital malformation |
Id Information
Sequence: | 40203470 |
Id Source | org_study_id |
Id Value | 18-001135 |
Countries
Sequence: | 42617551 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55662294 |
Title | History of VACTERL or congenital malformations |
Description | 1) Adults with VACTERL association; 2) adults with a history of congenital malformations resembling VACTERL association; 3) gravid and non-gravid women with a history of recurrent miscarriage, their surviving offspring, and the biological father of offspring; 4) newly diagnosed VACTERL patients identified by healthcare providers. |
Design Outcomes
Sequence: | 177602129 | Sequence: | 177602130 |
Outcome Type | primary | Outcome Type | primary |
Measure | Genetic variants | Measure | Targeted metabolomics |
Time Frame | 2 years | Time Frame | 2 years |
Description | Identification of genetic variants which may be associated with VACTERL association or other congenital malformations. | Description | Identification of changes in metabolic pathways which may provide functional insight into the presence of genetic variants in patients with VACTERL association |
Browse Conditions
Sequence: | 193720423 |
Mesh Term | Congenital Abnormalities |
Downcase Mesh Term | congenital abnormalities |
Mesh Type | mesh-list |
Sponsors
Sequence: | 48376931 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Mayo Clinic |
Overall Officials
Sequence: | 29318892 |
Role | Principal Investigator |
Name | Myra Wick, MD PhD |
Affiliation | Mayo Clinic |
Eligibilities
Sequence: | 30801282 |
Sampling Method | Non-Probability Sample |
Gender | All |
Minimum Age | 0 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Population | A US population consisting of adults with VACTERL, adults and offspring with a family history of VACTERL, and women with a history of miscarriage and/or congenital malformations. |
Criteria | Inclusion Criteria:
Adults with confirmed or putative diagnosis of VACTERL association; Exclusion Criteria: 1) Parents of non-biological children 3) Children with congenital malformations associated with an identifiable environmental or lifestyle exposure 4) Children with congenital malformations associated with confirmed chromosomal disorders 5) Failure to abstain from red meat, meat products, chicken, peanuts, or brewer's yeast (including beer) at least 24 hours prior to blood and urine collection. |
Adult | True |
Child | True |
Older Adult | True |
Calculated Values
Sequence: | 254016371 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 37 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 0 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 2 |
Designs
Sequence: | 30547302 |
Observational Model | Family-Based |
Time Perspective | Other |
Links
Sequence: | 4392923 |
Url | https://www.mayo.edu/research/clinical-trials |
Description | Mayo Clinic Clinical Trials |
Responsible Parties
Sequence: | 28913638 |
Responsible Party Type | Principal Investigator |
Name | Myra J. Wick |
Title | Principal Investigator |
Affiliation | Mayo Clinic |
]]>
https://zephyrnet.com/NCT03799692
2018-11-19
https://zephyrnet.com/?p=NCT03799692
NCT03799692https://www.clinicaltrials.gov/study/NCT03799692?tab=tableYin Liuliuyinfudan@163.com13818051895This is an open-label, single arm, two-stage Simon Design study for women with LuminalB/HER-2 Negative Breast Cancer treated with Nanoparticle Albumin-Bound Paclitaxel and Carboplatin.
The primary objective of the trial is to evaluate of the efficacy and safety of Nanoparticle Albumin-Bound Paclitaxel Combined with Carboplatin as Neoadjuvant Chemotherapy in Luminal B/HER-2 Negative Breast Cancer.
The primary endpoint of the study is to assess Pathological complete response rate(pCR)using the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
The total number of patients to be included in this study is 78 patients.
The duration of the study, from first patient visit to last patient visit will be approximately 12 months.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-08 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2019-01-10 |
Start Month Year | November 19, 2018 |
Primary Completion Month Year | March 30, 2019 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-10 |
Facilities
Sequence: | 200107904 | Sequence: | 200107905 |
Status | Recruiting | Status | Recruiting |
Name | Fudan University Shanghai Cancer Center | Name | Department of Breast Surgery, Cancer Hospital, Fudan University |
City | Shanghai | City | Shanghai |
State | Shanghai | ||
Zip | 200032 | Zip | 200032 |
Country | China | Country | China |
Facility Contacts
Sequence: | 28106390 | Sequence: | 28106391 |
Facility Id | 200107904 | Facility Id | 200107905 |
Contact Type | primary | Contact Type | primary |
Name | Zhi-Min Shao, MD.PhD. | Name | Zhimin Shao |
zhimingshao@yahoo.com | zhimingshao@yahoo.com | ||
Phone | 13601637369 | Phone | 86(21)64175590 |
Phone Extension | 88807 |
Facility Investigators
Sequence: | 18332487 | Sequence: | 18332488 |
Facility Id | 200107904 | Facility Id | 200107905 |
Role | Principal Investigator | Role | Principal Investigator |
Name | Zhi-Min Shao, MD.PhD. | Name | Zhimin Shao |
Conditions
Sequence: | 52171119 |
Name | HER-2 Negative Breast Cancer |
Downcase Name | her-2 negative breast cancer |
Id Information
Sequence: | 40158561 |
Id Source | org_study_id |
Id Value | 1808189-8 |
Countries
Sequence: | 42568865 |
Name | China |
Removed | False |
Design Groups
Sequence: | 55593069 |
Group Type | Experimental |
Title | Chemotherapy |
Description | Nanoparticle Albumin-Bound Paclitaxel 125mg/m2, iv, Carboplatin AUC=2, iv, d1, 8, 15, 4 cycles (21 days per cycle). |
Interventions
Sequence: | 52485368 |
Intervention Type | Drug |
Name | Chemotherapy |
Description | Drug: Nanoparticle Albumin-Bound Paclitaxel Nanoparticle Albumin-Bound Paclitaxel 125mg/m2, iv, d1, 8, 15.
Drug: Carboplatin AUC=2 iv, d1, 8, 15. |
Keywords
Sequence: | 79868364 |
Name | Neoadjuvant Chemotherapy |
Downcase Name | neoadjuvant chemotherapy |
Design Outcomes
Sequence: | 177378485 | Sequence: | 177378486 | Sequence: | 177378487 | Sequence: | 177378488 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | The primary endpoint is pathological complete remission (pCR) | Measure | Objective response rate (ORR) | Measure | Breast conserving surgery (BCS) rate | Measure | Adverse events (AE) |
Time Frame | 3 months | Time Frame | 3 months | Time Frame | 3 months | Time Frame | 3 months |
Description | Histopathological examination of breast and axillary lymph node specimens without invasive cancer cell remnants. Complete pathological response is also considered to be achieved if only in situ cancer cell remnants are present in the surgical specimens. | Description | The second endpoint ORR composed of tumor response classifications of complete response (CR) and partial response (PR), refers to the number of cases with complete and partial response after treatment as a percentage of the total number of evaluable cases. | Description | Percentage of patients undergoing breast-conserving surgery after neoadjuvant therapy as a whole evaluable. | Description | Adverse events (AE) were monitored on an ongoing basis and classified according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.03. Patients were assessed for toxicities before each administration, and toxicity was graded accordingly. |
Browse Conditions
Sequence: | 193486256 | Sequence: | 193486257 | Sequence: | 193486258 | Sequence: | 193486259 | Sequence: | 193486260 |
Mesh Term | Breast Neoplasms | Mesh Term | Neoplasms by Site | Mesh Term | Neoplasms | Mesh Term | Breast Diseases | Mesh Term | Skin Diseases |
Downcase Mesh Term | breast neoplasms | Downcase Mesh Term | neoplasms by site | Downcase Mesh Term | neoplasms | Downcase Mesh Term | breast diseases | Downcase Mesh Term | skin diseases |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48319195 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Fudan University |
Overall Officials
Sequence: | 29285300 |
Role | Principal Investigator |
Name | Zhimin Shao |
Affiliation | Fudan University |
Central Contacts
Sequence: | 12008851 | Sequence: | 12008852 |
Contact Type | primary | Contact Type | backup |
Name | Zhimin Shao | Name | Yin Liu |
Phone | 18017312288 | Phone | 13818051895 |
szm@163.com | liuyinfudan@163.com | ||
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 68148999 |
Design Group Id | 55593069 |
Intervention Id | 52485368 |
Eligibilities
Sequence: | 30765288 |
Gender | Female |
Minimum Age | 18 Years |
Maximum Age | 70 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
1.Age: from 18 to 70 years old, female. Exclusion Criteria: 1.Any prior cytotoxic chemotherapy, endocrine therapy, biological therapy, or radiation therapy. |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253878248 |
Number Of Facilities | 2 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | False |
Minimum Age Num | 18 |
Maximum Age Num | 70 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 3 |
Designs
Sequence: | 30511455 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Responsible Parties
Sequence: | 28877749 |
Responsible Party Type | Principal Investigator |
Name | Zhimin Shao |
Title | professor |
Affiliation | Fudan University |
]]>
https://zephyrnet.com/NCT03799679
2018-11-26
https://zephyrnet.com/?p=NCT03799679
NCT03799679https://www.clinicaltrials.gov/study/NCT03799679?tab=tableYin LiuNA13818051895This is an open-label, single arm, two-stage Simon Design study for women with Triple Negative Breast Cancer treated with Nanoparticle Albumin-Bound Paclitaxel and Carboplatin.
The primary objective of the trial is to evaluate of the efficacy and safety of weekly Nanoparticle Albumin-Bound Paclitaxel(Nab-P) Followed by Dose-Intensive Epirubicin in Combination with Cyclophosphamide as Neoadjuvant Chemotherapy in Triple Negative Breast Cancer.
The primary endpoint of the study is to to assess Pathological complete response rate(pCR)using the Response Evaluation Criteria in Solid Tumors (RECIST 1.1)..
The total number of patients to be included in this study is 60 patients.
The duration of the study, from first patient visit to last patient visit will be approximately 19 months.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-08 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2019-01-10 |
Start Month Year | November 26, 2018 |
Primary Completion Month Year | November 30, 2019 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-10 |
Facilities
Sequence: | 200280207 |
Status | Recruiting |
Name | Cancer Hospital/ Institute, Fudan University |
City | Shanghai |
State | Shanghai |
Zip | 200032 |
Country | China |
Facility Contacts
Sequence: | 28132832 |
Facility Id | 200280207 |
Contact Type | primary |
Name | Zhimin Shao, M.D. |
zhimingshao@yahoo.com | |
Phone | 862164175590 |
Phone Extension | 8808 |
Browse Interventions
Sequence: | 96132746 |
Mesh Term | Antineoplastic Agents |
Downcase Mesh Term | antineoplastic agents |
Mesh Type | mesh-list |
Conditions
Sequence: | 52221385 |
Name | Triple Negative Breast Cancer |
Downcase Name | triple negative breast cancer |
Id Information
Sequence: | 40195538 |
Id Source | org_study_id |
Id Value | 1808189-7 |
Countries
Sequence: | 42609534 |
Name | China |
Removed | False |
Design Groups
Sequence: | 55649654 |
Group Type | Experimental |
Title | Chemotherapy |
Description | Nanoparticle Albumin-Bound Paclitaxel 125mg/m2, iv, d1* 12 cycles ( weekly), followed by epirubicin 90mg/m2, iv, d1 + cyclophosphamide 600mg/m2, iv, d1 * 4 cycles (14 days per cycle) |
Interventions
Sequence: | 52535179 |
Intervention Type | Drug |
Name | Chemotherapeutic Agent |
Description | Drug: Nanoparticle Albumin-Bound Paclitaxel Nanoparticle Albumin-Bound Paclitaxel 125mg/m2, iv, d1. Patients will receive this as a single-agent for the first twelve weeks, then followed by epirubicin in combination with cyclophosphamide.
Drug: Epirubicin 90 mg/m² given IV Drug: Cyclophosphamide 600 mg/m² given IV |
Keywords
Sequence: | 79941581 |
Name | Neoadjuvant Chemotherapy |
Downcase Name | neoadjuvant chemotherapy |
Design Outcomes
Sequence: | 177560887 | Sequence: | 177560888 | Sequence: | 177560889 | Sequence: | 177560890 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | The primary endpoint is pathological complete remission (pCR) | Measure | The second endpoint includes the objective response rate (ORR) | Measure | Breast conserving surgery(BCS) rate | Measure | Adverse events (AE) |
Time Frame | 2 months | Time Frame | 2 months | Time Frame | 2 months | Time Frame | 2 months |
Description | Histopathological examination of breast and axillary lymph node specimens without invasive cancer cell remnants. Complete pathological response is also considered to be achieved if only in situ cancer cell remnants are present in the surgical specimens. | Description | The second endpoint ORR composed of tumor response classifications of complete response (CR) and partial response (PR), refers to the number of cases with complete and partial response after treatment as a percentage of the total number of evaluable cases. | Description | Percentage of patients undergoing breast-conserving surgery after neoadjuvant therapy as a whole evaluable. | Description | Adverse events (AE) were monitored on an ongoing basis and classified according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.03. Patients were assessed for toxicities before each administration, and toxicity was graded accordingly. |
Browse Conditions
Sequence: | 193677956 | Sequence: | 193677957 | Sequence: | 193677958 | Sequence: | 193677959 | Sequence: | 193677960 | Sequence: | 193677961 |
Mesh Term | Breast Neoplasms | Mesh Term | Triple Negative Breast Neoplasms | Mesh Term | Neoplasms by Site | Mesh Term | Neoplasms | Mesh Term | Breast Diseases | Mesh Term | Skin Diseases |
Downcase Mesh Term | breast neoplasms | Downcase Mesh Term | triple negative breast neoplasms | Downcase Mesh Term | neoplasms by site | Downcase Mesh Term | neoplasms | Downcase Mesh Term | breast diseases | Downcase Mesh Term | skin diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48366296 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Fudan University |
Overall Officials
Sequence: | 29312849 |
Role | Principal Investigator |
Name | Zhimin Shao |
Affiliation | Fudan University |
Central Contacts
Sequence: | 12020554 | Sequence: | 12020555 |
Contact Type | primary | Contact Type | backup |
Name | Zhimin Shao | Name | Yin Liu |
Phone | 18017312288 | Phone | 13818051895 |
szm@163.com | |||
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 68217189 |
Design Group Id | 55649654 |
Intervention Id | 52535179 |
Eligibilities
Sequence: | 30794629 |
Gender | Female |
Minimum Age | 18 Years |
Maximum Age | 70 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Age: from 18 to 70 years old, female. Exclusion Criteria: Any prior cytotoxic chemotherapy, endocrine therapy, biological therapy, or radiation therapy. |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254004176 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 70 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 3 |
Designs
Sequence: | 30540669 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Intervention Model Description | This is an open-label, single arm, two-stage Simon Design study for women with Triple Negative Breast Cancer. Patients will treated by Nanoparticle Albumin-Bound Paclitaxel Followed by Dose-Intensive Epirubicin in Combination with Cyclophosphamide. |
Responsible Parties
Sequence: | 28906989 |
Responsible Party Type | Principal Investigator |
Name | Zhimin Shao |
Title | professor |
Affiliation | Fudan University |
]]>
https://zephyrnet.com/NCT03799666
2019-01-07
https://zephyrnet.com/?p=NCT03799666
NCT03799666https://www.clinicaltrials.gov/study/NCT03799666?tab=tableNANANA3R aims to increase the access of patients with chronic respiratory diseases (CRD) to pulmonary rehabilitation (PR) in Portugal. The main goals of 3R are: i) design and implement an innovative community-based PR programme; ii) assess the cost-benefit of the community-based PR programme; iii) disseminate and perform knowledge transfer about PR across the country.
PR is an evidence-based intervention for the management of CRD and offering PR has been defined as a priority by national/international organizations. However, in Portugal PR is practically inexistent (<1% of “candidate” patients have access). Currently, PR programmes are hospital-based and directed to patients with advanced disease. One of the recommendations to enhance the implementation of PR is the development on novel models of programme delivery. It is hypothesised that community-based programs, direct to patients at all grades of the disease, and involving all stakeholders (health professionals, patients, society, policy makers) may turn PR more accessible.
The plan is to implement community-based PR programs in 4 primary care centres of 2 ACES of the centre region of Portugal and assess the impact of such intervention in several domains using surrogate and patient-/family-centered outcomes. A cost-benefit analysis will be performed on acute exacerbations and healthcare utilization. Dissemination will include one conference, activities with the community, courses and an online PR toolkit. Four schools of 2 polytechnics, 2 city councils, the Health Regional Administration-Centre (ARS-Centro) and all respiratory professional and civic national associations are partners.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-14 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2020-07-08 |
Start Month Year | January 7, 2019 |
Primary Completion Month Year | December 30, 2019 |
Verification Month Year | July 2020 |
Verification Date | 2020-07-31 |
Last Update Posted Date | 2020-07-08 |
Detailed Descriptions
Sequence: | 20709994 |
Description | More than 1 billion people suffer from chronic respiratory diseases worldwide and, in Europe, the total annual cost of respiratory diseases amounts to more than €380 billion. In Portugal, respiratory diseases are the 3rd leading cause of death and direct costs related to hospitalizations (in 2013 – €213 millions). Management of chronic respiratory diseases are high priorities for the National Health Service, and particularly, for the Center Health Regional Administration.
Pulmonary rehabilitation (PR) is an evidence-based intervention for the management of patients with chronic respiratory diseases (grade A). Offering PR has long been defined as a priority by several national and international organizations. Despite this firm recommendation and the knowhow on the provision of PR, in Portugal, PR is practically inexistent, with <1% of "candidate" patients having access to this standard care. Therefore, the need for a National Network on PR has been acknowledged as a priority. It is hypothesised that community-based programmes, direct to patients at all grades of the disease, and involving all stakeholders (health professionals, patients/family, society, policy makers) may turn PR more accessible. Thus, the main goal of this project is to increase the access of patients with chronic respiratory diseases, namely COPD, to PR in the center region of Portugal and disseminate this intervention nationally. 3R aims to implement and disseminate community-based PR programs in Portugal. Specifically, it will: Implement 4 community-based PR programmes (Task 1); To bring PR from bench to Portuguese common practice, 3R brings together a strong consortium composed of 4 schools of 2 Polytechnic Institutions, 2 City Councils, Health Regional Administration – Centre and all respiratory national associations (Sociedade, Portuguesa do Pulmão – SPP, RESPIRA and Fundação Portuguesa do Pulmão – FPP). This consortium involves an experienced team with complementary backgrounds and integrates students from the several institutions during all activities. It is strongly believed that jointly this multidisciplinary team has the experience and complementary skills, as well as the means, to guarantee the success and outreach of the project. It is estimated that 73 patients will be required to detect significant differences in patients' health-related quality of life (HRQOL), based on a previous study. Stable patients with CRD and their family members will be recruited from Primary Care Centres (PCCs) of the ACES of Baixo Vouga and Baixo Mondego (ACES-BV & BM). Family doctors from PCCs will provide a list of eligible individuals. Individuals/families will be contacted and those interested will meet with researchers to receive further information about the study and sign the informed consents. Participants will be divided in two groups: experimental (EG) and control (CG). The EG will include participants/families wanting to participate in a 12-week community-based PR programme and the CG will include those willing to collaborate in data collection but not in the PR programmes (Task 1). The PR programme will include exercise training (endurance, strength and balance training) twice a week and psychoeducational sessions every two weeks performed by a multidisciplinary team. Data will be collected at baseline, at 12 weeks (i.e., immediately post-PR), 3 and 6 months post-PR. Data analysis will be undertaken using Statistical Package for the Social Sciences (SPSS) software and will include descriptive and inferential statistics. To analyse changes in outcome measures, data from baseline and after treatment assessments will be compared. Moreover, between groups comparisons will also be performed for baseline, after intervention and follow-ups assessments. Effect sizes for the interventions will also be calculated. |
Facilities
Sequence: | 199965088 |
Name | University of Aveiro |
City | Aveiro |
Zip | 3810-193 |
Country | Portugal |
Conditions
Sequence: | 52139020 |
Name | Chronic Respiratory Disease |
Downcase Name | chronic respiratory disease |
Id Information
Sequence: | 40135076 |
Id Source | org_study_id |
Id Value | SAICT-POL/23926/2016 |
Countries
Sequence: | 42542700 |
Name | Portugal |
Removed | False |
Design Groups
Sequence: | 55559374 | Sequence: | 55559375 |
Group Type | Experimental | Group Type | Active Comparator |
Title | Pulmonary Rehabilitation Group | Title | Standard Care Group |
Description | Patients will participate in a 12-week community-based pulmonary rehabilitation programme. | Description | Patients will continue to receive the standard care, which means the daily medication prescribed by the pshysician from the primary care centre team. |
Interventions
Sequence: | 52454925 | Sequence: | 52454926 |
Intervention Type | Other | Intervention Type | Other |
Name | Pulmonary Rehabilitation | Name | Daily medication |
Description | Patients will be treated with daily medication prescribed by the physician. Additionally patients will participate in a 12-w.eek community-based pulmonary rehabilitation programme, with two exercise training sessions per week and six psycho-education sessions, managed by a multidisciplinary team, once every two weeks. Patient's families will be invited to participate in the psychoeducational component | Description | Patients will be treated with daily medication prescribed by the physician and will continue to receive the standard care from the primary care centre team. |
Keywords
Sequence: | 79822843 | Sequence: | 79822844 | Sequence: | 79822845 | Sequence: | 79822846 |
Name | Pulmonary rehabilitation | Name | Community-based | Name | Chronic Respiratory Diseases | Name | Cost-benefit analysis |
Downcase Name | pulmonary rehabilitation | Downcase Name | community-based | Downcase Name | chronic respiratory diseases | Downcase Name | cost-benefit analysis |
Design Outcomes
Sequence: | 177263841 | Sequence: | 177263842 | Sequence: | 177263843 | Sequence: | 177263844 | Sequence: | 177263845 | Sequence: | 177263846 | Sequence: | 177263847 | Sequence: | 177263848 | Sequence: | 177263849 | Sequence: | 177263850 | Sequence: | 177263851 | Sequence: | 177263852 | Sequence: | 177263853 | Sequence: | 177263854 | Sequence: | 177263855 | Sequence: | 177263856 | Sequence: | 177263857 | Sequence: | 177263858 | Sequence: | 177263859 | Sequence: | 177263860 | Sequence: | 177263861 | Sequence: | 177263862 | Sequence: | 177263863 | Sequence: | 177263864 | Sequence: | 177263865 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | other |
Measure | Change in Health Related quality-of-life: St. George Respiratory Questionnaire | Measure | Change in airflow obstruction | Measure | Change in exercise capacity | Measure | Change in functionality | Measure | Change in quadriceps muscle strength | Measure | Change in biceps muscle strength | Measure | Change in muscle cross sectional area | Measure | Change in upper limb muscle strength | Measure | Change in respiratory muscle strength | Measure | Change in frequency of exacerbations | Measure | Change in Healthcare utilization | Measure | Change in family adaptability/cohesion | Measure | Change in balance | Measure | Change in Physical activity | Measure | Change in Physical activity | Measure | Change in Diaphragm excursion | Measure | Change in Dyspnoea | Measure | Change in symptom's impact in patients life | Measure | Change in Emotional state | Measure | Change in Fatigue symptoms | Measure | Change in Fatigue | Measure | Change in cough-related quality of life: Leicester Cough Questionnaire | Measure | Change in cough and sputum symptoms | Measure | Digital Technology access | Measure | Change in Body Mass Index |
Time Frame | Up to 9 months | Time Frame | Up to 9 months | Time Frame | Up to 9 months | Time Frame | Up to 9 months | Time Frame | Up to 9 months | Time Frame | Up to 3 months | Time Frame | Up to 3 months | Time Frame | Up to 9 months | Time Frame | Up to 3 months | Time Frame | Up to 9 months | Time Frame | Up to 9 months | Time Frame | Up to 3 months | Time Frame | Up to 3 months | Time Frame | Up to 3 months | Time Frame | Up to 9 months | Time Frame | Up to 3 months | Time Frame | Up to 9 months | Time Frame | Up to 9 months | Time Frame | Up to 9 months | Time Frame | Up to 3 months | Time Frame | Up to 3 months | Time Frame | Up to 3 months | Time Frame | Up to 3 months | Time Frame | At baseline | Time Frame | Up to 9 months |
Description | St. George Respiratory Questionnaire (SGRQ) will be used to assess Health Related quality-of-life. The SGRQ is a comprehensive well-established 50-item questionnaire to measure health status in patients with chronic respiratory diseases. Scores can be provided for each domain and as a total score, ranging from 0 (no impairment) to 100 (worst possible health status). | Description | Forced expiratory volume in one second and forced vital capacity will be measured with a portable spirometer to assess the degree of airflow obstruction. Results will be expressed in liters and percentage of predicted. We will calculate the ratio between the forced expiratory volume in one second and the forced vital capacity. | Description | Exercise capacity will be tested in a 6-minute walk test, since it allows exercise prescription. The test results will be presented as the walked distance (meters). | Description | Functionality will be tested with the 1-minute sit-to-stand, with the results presented as number of sit-to-stand repetitions. | Description | Quadriceps muscle strength will be measured using a handheld dynamometer (kilogram/force). | Description | Biceps muscle strength will be measured using a handheld dynamometer (kilogram/force). | Description | Cross-sectional will be measured with ultrasound of the lower (quadriceps) and upper (biceps) limb muscles. | Description | Upper limb strength will be measured with Handgrip (kg) | Description | Respiratory muscle strength will be measured through a respiratory pressure meter to assess inspiratory and expiratory muscle strength (cm/H20) | Description | Number of exacerbations in the previous year, healthcare utilization, such as emergency department visits or hospital admissions, in the previous year, which are related to COPD decline | Description | Healthcare utilization will be assessed through the number of participants that visit emergency department and the number of visits of each participant in the previous year. The number and duration of hospital admissions in the previous year will also be assessed. | Description | Family function was assessed with the family adaptability and cohesion evaluation scale (FACES-IV). The FACES-IV is a 62 items subdivided in: cohesion and flexibility dimensions, and family communication and family satisfaction scales. The cohesion and flexibility dimensions provide six family scales, two balanced scales (Balanced cohesion and balanced flexibility, with percentile scores ranging from 16 to 85) and four unbalanced scales (Disengaged, Enmeshed, Rigid and Chaotic, with percentile scores ranging from 10 to 99). The six family types (Balanced, Rigidly Cohesive, Midrange, Flexibly unbalanced, chaotically unbalanced and unbalanced) can be plotted onto the Circumplex Model. The family communications and Satisfaction scales are composed of 10 items each, with percentile scores ranging from 10 to 99. In all FACES-IV subscales higher scores indicate better family cohesion, flexibility, communication or satisfaction. | Description | Balance will be assessed with the Brief-Best tests. | Description | Accelerometry will be used to assess physical activity. | Description | The Brief Physical Activity questionnaire will be used to assess physical activity. It a 2 items questionnaire, with scores ranging from 0 to 8. If the sum of the two items score is above or equal 4 the subject will be considered physically active. | Description | Ultrasound will be used to assess the diaphragm excursion, only volunteer from patients who agree to come to ESSUA and will be seen previously by a physician | Description | Medical Research Council scale will be used to assess functional dyspnoea related to respiratory impairment. It is a 5-point scale, rated from 0 to 4, with higher scores denoting greater breathlessness severity. | Description | COPD Assessment Test (CAT) will be used to assess burdensome symptoms in patients' life with 8 items (cough, sputum, dyspnoea, chest tightness, capacity of exercise and home daily activities, confidence leaving home, sleep and energy levels).he scores range from 0-40, organised in 4 categories, namely <10 low impact, 10-20 medium, 21-30 high and >30 very high impact, with 5 representing the upper limit of normal in healthy non-smokers | Description | Hospital Anxiety and Depression Scale will be used to assess symptoms of anxiety and depression. It is a 14 item questionnaire that can be subdivided in two subscales: anxiety and depression. Scores are provided for each subscale and range from 0 to 21, with higher scores meaning more symptoms of anxiety and depression. | Description | The fatigue subscale of the Checklist of Individual Strength (CIS-20) will be used to assess fatigue.The subscale of subjective fatigue is a 8-item questionnaire, with higher scores indicating higher levels of fatigue. The total scores range from 8 to 56. | Description | The Functional Assessment of Cancer Therapy – Fatigue subscale (FACIT-F) will be used to assess fatigue levels. It is multi-dimensional 13-item questionnaire assessing tiredness, weakness and difficulty in handling daily activities due to fatigue. Scores range from 0 to 52, with higher scores indicating less fatigue. | Description | Cough-related quality of life will be assessed with the Leicester Cough Questionnaire, which is a 19 items scale organised in 3 domains (physical, psychological and social). Each domain has a score ranging from 1 to 7 and the LCQ total score varies from 3 to 21. Higher scores express a better quality of life and less impact of cough. | Description | The Cough and Sputum Assessment Questionnaire (CASA-Q) will be used to assess cough and sputum symptoms, based on their reported frequency and severity, and their impact on daily activities. t is a 20-item questionnaire containing 4 domains: cough symptoms, cough impact, sputum symptoms and sputum impact. All items are rescored and summed, achieving a score ranging from 0 to 100 for each domain, with higher scores indicating fewer symptoms or less cough and sputum impact. | Description | A survey asking about the use of internet and access to computers, smartphones (combination of mobile phone, web browser and computer capabilities)/tablets and cell phones (simple devices mainly for voice calls and text messages) will be used to assess digital technology access. Confidence in using these technologies will be assessed using a numerical scale from 0 (not at all confident) to 10 (completely confident). | Description | Patients' body mass index will be assessed in kg/m^2 based on patients' height and weight. |
Browse Conditions
Sequence: | 193366592 | Sequence: | 193366593 |
Mesh Term | Respiratory Tract Diseases | Mesh Term | Respiration Disorders |
Downcase Mesh Term | respiratory tract diseases | Downcase Mesh Term | respiration disorders |
Mesh Type | mesh-list | Mesh Type | mesh-list |
Sponsors
Sequence: | 48290727 | Sequence: | 48290728 |
Agency Class | OTHER | Agency Class | OTHER |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | Aveiro University | Name | Fundação para a Ciência e a Tecnologia |
Overall Officials
Sequence: | 29268537 |
Role | Principal Investigator |
Name | Alda S. Marques, PhD |
Affiliation | School of Health Sciences of the University of Aveiro (ESSUA) |
Design Group Interventions
Sequence: | 68107484 | Sequence: | 68107485 |
Design Group Id | 55559374 | Design Group Id | 55559375 |
Intervention Id | 52454925 | Intervention Id | 52454926 |
Eligibilities
Sequence: | 30747735 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
clinical diagnosis of a chronic respiratory disease Exclusion Criteria: cognitive impairments |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254121947 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 11 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 23 |
Number Of Other Outcomes To Measure | 1 |
Designs
Sequence: | 30494018 |
Allocation | Non-Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Responsible Parties
Sequence: | 28860298 |
Responsible Party Type | Principal Investigator |
Name | Alda Sofia Pires de Dias Marques |
Title | Senior Lecturer |
Affiliation | Aveiro University |
Study References
Sequence: | 52032743 | Sequence: | 52032744 | Sequence: | 52032745 |
Pmid | 34499161 | Pmid | 32184112 | Pmid | 31151409 |
Reference Type | derived | Reference Type | derived | Reference Type | derived |
Citation | Paixao C, Rebelo P, Oliveira A, Jacome C, Cruz J, Martins V, Simao P, Marques A. Responsiveness and Minimal Clinically Important Difference of the Brief-BESTest in People With COPD After Pulmonary Rehabilitation. Phys Ther. 2021 Nov 1;101(11):pzab209. doi: 10.1093/ptj/pzab209. | Citation | Rebelo P, Oliveira A, Andrade L, Valente C, Marques A. Minimal Clinically Important Differences for Patient-Reported Outcome Measures of Fatigue in Patients With COPD Following Pulmonary Rehabilitation. Chest. 2020 Aug;158(2):550-561. doi: 10.1016/j.chest.2020.02.045. Epub 2020 Mar 14. | Citation | Marques A, Jacome C, Rebelo P, Paixao C, Oliveira A, Cruz J, Freitas C, Rua M, Loureiro H, Peguinho C, Marques F, Simoes A, Santos M, Martins P, Andre A, De Francesco S, Martins V, Brooks D, Simao P. Improving access to community-based pulmonary rehabilitation: 3R protocol for real-world settings with cost-benefit analysis. BMC Public Health. 2019 May 31;19(1):676. doi: 10.1186/s12889-019-7045-1. |
]]>
https://zephyrnet.com/NCT03799653
2019-03-20
https://zephyrnet.com/?p=NCT03799653
NCT03799653https://www.clinicaltrials.gov/study/NCT03799653?tab=tableHaihua Zhu, MasterNA86592-2137278The Nurse Cohort Study Xiamen (NCSX) is an open-ended prospective cohort study with very broad research aims. The primary objectives of the NCSX is planned to examine genetic, epigenetic, biological, psychological, social, lifestyle and other environmental factors of nurses in relation to incidence and progression of the common chronic diseases, such as hypertension, ischemic heart disease, stroke, diabetes, chronic kidney disease and some cancers, which are emerging with economic development in Xiamen, China. Specifically, we intend to test whether empirically driven hypothesis and emerging risk factors mainly developed in response to observations in economically developed Western societies apply in a population living in a rapid changing lifestyle in China now.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-08 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2022-04-13 |
Start Month Year | March 20, 2019 |
Primary Completion Month Year | December 31, 2023 |
Verification Month Year | April 2022 |
Verification Date | 2022-04-30 |
Last Update Posted Date | 2022-04-13 |
Detailed Descriptions
Sequence: | 20695742 |
Description | Objectives: To establish a cohort of about 10,000 registered nurses (aged 20 or over) in Xiamen, China; to describe the baseline major risk factors; to analyze their interrelationships; and to examine the risks of incidence and progression of major chronic diseases, such as hypertension, stroke, CKD and cancers, and all-cause and cause-specific mortality by different levels of the risk factors after about 5 years follow-up.
Design: A prospective cohort study. Setting: 7 public hospitals in Xiamen, China. Participants: About 10,000 registered nurses (aged 20 or over) who work in public hospitals in Xiamen, China. Main outcome: Incidences of common chronic diseases, such as CVD, diabetes, chronic kidney disease, and cancers; progression of these diseases; all cause and specific-cause mortality. Hypothesis: Relative risks of major risk factors. Results of the study should have strong impact on prevention and control of these diseases and promoting nurses'health in the local population. |
Facilities
Sequence: | 199774612 |
Status | Recruiting |
Name | The First Affiliated Hospital of Xiamen University |
City | Xiamen |
State | Fujian |
Zip | 361003 |
Country | China |
Facility Contacts
Sequence: | 28074247 |
Facility Id | 199774612 |
Contact Type | primary |
Name | Zhibin Li, Ph.D. |
zhibinli33@hotmail.com | |
Phone | 86592-2137364 |
Conditions
Sequence: | 52101405 |
Name | Hypertension |
Downcase Name | hypertension |
Id Information
Sequence: | 40103879 |
Id Source | org_study_id |
Id Value | KYH2019-002 |
Countries
Sequence: | 42506278 |
Name | China |
Removed | False |
Design Groups
Sequence: | 55517395 |
Title | Nurses |
Description | All subjects are registered nurses in Xiamen, China |
Interventions
Sequence: | 52415405 |
Intervention Type | Other |
Name | No intervention |
Description | This is a prospective observational study, and there is no intervention. |
Design Outcomes
Sequence: | 177137644 | Sequence: | 177137645 |
Outcome Type | primary | Outcome Type | secondary |
Measure | Incidence rate | Measure | Mortality |
Time Frame | 2019.1.21-2024.12.31 | Time Frame | 2019.1.21-2024.12.31 |
Description | The incidence rates of common chronic diseases, such as hypertension, The stroke, CKD and cancers | Description | All-cause and cause-specific mortality |
Browse Conditions
Sequence: | 193212086 | Sequence: | 193212087 | Sequence: | 193212088 |
Mesh Term | Hypertension | Mesh Term | Vascular Diseases | Mesh Term | Cardiovascular Diseases |
Downcase Mesh Term | hypertension | Downcase Mesh Term | vascular diseases | Downcase Mesh Term | cardiovascular diseases |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48255196 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | The First Affiliated Hospital of Xiamen University |
Overall Officials
Sequence: | 29245217 |
Role | Study Chair |
Name | Weihua Li, Ph.D. |
Affiliation | The First Affiliated Hospital of Xiamen University |
Central Contacts
Sequence: | 11993860 | Sequence: | 11993861 |
Contact Type | primary | Contact Type | backup |
Name | Zhibin Li, Ph.D. | Name | Haihua Zhu, Master |
Phone | 86592-2137364 | Phone | 86592-2137278 |
zhibinli33@hotmail.com | |||
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 68056445 |
Design Group Id | 55517395 |
Intervention Id | 52415405 |
Eligibilities
Sequence: | 30725386 |
Sampling Method | Probability Sample |
Gender | All |
Minimum Age | 20 Years |
Maximum Age | N/A |
Healthy Volunteers | Accepts Healthy Volunteers |
Population | Registered nurses in public hospitals in Xiamen, China; Aged 20 years or over and living in Xiamen for at least 1 year and will not move out of Xiamen for at least 5 years; |
Criteria | Inclusion Criteria:
Registered nurses of public hospitals in Xiamen, China; Exclusion Criteria: who are unambulatory; |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253974151 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 20 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 1 |
Designs
Sequence: | 30471834 |
Observational Model | Cohort |
Time Perspective | Prospective |
Responsible Parties
Sequence: | 28838265 |
Responsible Party Type | Principal Investigator |
Name | Zhibin LI |
Title | Director |
Affiliation | The First Affiliated Hospital of Xiamen University |
]]>
https://zephyrnet.com/NCT03799640
2018-12-05
https://zephyrnet.com/?p=NCT03799640
NCT03799640https://www.clinicaltrials.gov/study/NCT03799640?tab=tableNANANAOlder individuals, 60-90, will be provided regular or cognitively based yoga training. They will then be evaluated using standard cognitive testing devices.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-08 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2019-09-10 |
Start Month Year | December 5, 2018 |
Primary Completion Month Year | August 15, 2019 |
Verification Month Year | September 2019 |
Verification Date | 2019-09-30 |
Last Update Posted Date | 2019-09-10 |
Detailed Descriptions
Sequence: | 20716261 |
Description | Reductions in executive function are common with age. Along with these declines come reductions in simple functional patterns of daily living such as crossing a street, walking in a crowded area, or performing any functions that occurs in an open (changing) environment. This study will use a newly developed yoga program incorporating multi-directional movements, cognitive challenges and visuomotor disturbances to improve executive function and associated movements in persons over 60 years of age. |
Facilities
Sequence: | 200053121 | Sequence: | 200053122 |
Name | Max Orovitz Laboratories | Name | Laboratory of Neruomuscular Research and Active Aging |
City | Coral Gables | City | Coral Gables |
State | Florida | State | Florida |
Zip | 33146-2416 | Zip | 33147 |
Country | United States | Country | United States |
Conditions
Sequence: | 52156381 | Sequence: | 52156382 | Sequence: | 52156383 |
Name | Standard Yoga | Name | Multi-directional Yoga | Name | Educational Control |
Downcase Name | standard yoga | Downcase Name | multi-directional yoga | Downcase Name | educational control |
Id Information
Sequence: | 40148150 |
Id Source | org_study_id |
Id Value | 20180704 |
Countries
Sequence: | 42557676 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55577810 | Sequence: | 55577811 | Sequence: | 55577812 |
Group Type | Experimental | Group Type | Experimental | Group Type | Experimental |
Title | Standard Yoga | Title | Multi-directional Yoga | Title | Educational Control |
Description | Yoga will be performed using linear forward and backward movements. | Description | The multidirectional yoga training program will use both simple and complex movement sequences (asana or postures) that include a cognitive component. For example, participants will be taught a movement sequence that includes 16-20 yoga postures that increase in difficulty as the training progresses. . | Description | Lectures on Health and Wellness |
Interventions
Sequence: | 52471920 | Sequence: | 52471921 | Sequence: | 52471922 |
Intervention Type | Other | Intervention Type | Other | Intervention Type | Other |
Name | Standard Yoga | Name | Multi-directional Yoga | Name | Educational Control |
Description | Yoga using standard poses and linear movements | Description | The multidirectional yoga training program will use both simple and complex movement sequences (asana or postures) that include a cognitive component. For example, participants will be taught a movement sequence that includes 16-20 yoga postures that increase in difficulty as the training progresses. | Description | Lectures on health and fitness |
Design Outcomes
Sequence: | 177327613 | Sequence: | 177327608 | Sequence: | 177327609 | Sequence: | 177327610 | Sequence: | 177327611 | Sequence: | 177327612 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary |
Measure | Timed up-and-go | Measure | NIH Toolbox: Picture Sequence Memory Test | Measure | NIH Toolbox Flanker test | Measure | NIH Toolbox List Sorting test | Measure | NIH Toolbox Pattern Comparison Processing Speed test | Measure | Walking Executive Function Tests |
Time Frame | 5 minutes | Time Frame | 5 minutes | Time Frame | 5 minutes | Time Frame | 5 minutes | Time Frame | 5 minutes | Time Frame | 10 minutes |
Description | Rising from a chair, circumventing a cone and returning to the chair. | Description | Measures episodic memory. Participants are asked to reproduce a sequence of pictures that is shown on the screen. | Description | Measures attention and inhibitory control. Participant focuses on a given stimulus while inhibiting attention to stimuli flanking it. | Description | Measures working memory. Participant recalls and sequences different visually and orally presented stimuli. | Description | Measures speed of processing. Participants discern whether two side-by-side pictures are the same or not, with 85 seconds to respond to as many items as possible. Items are simple so as to purely measure processing speed. | Description | Walking and responding to visual cues presented on a 60 inch monitor. |
Sponsors
Sequence: | 48305978 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | University of Miami |
Overall Officials
Sequence: | 29277886 |
Role | Principal Investigator |
Name | Joseph Signorile, PhD |
Affiliation | University of Miami |
Design Group Interventions
Sequence: | 68130757 | Sequence: | 68130758 | Sequence: | 68130759 | Sequence: | 68130760 | Sequence: | 68130761 | Sequence: | 68130762 |
Design Group Id | 55577812 | Design Group Id | 55577811 | Design Group Id | 55577812 | Design Group Id | 55577810 | Design Group Id | 55577811 | Design Group Id | 55577810 |
Intervention Id | 52471920 | Intervention Id | 52471920 | Intervention Id | 52471921 | Intervention Id | 52471921 | Intervention Id | 52471922 | Intervention Id | 52471922 |
Eligibilities
Sequence: | 30757302 |
Gender | All |
Minimum Age | 60 Years |
Maximum Age | 90 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
60-90 years of age Exclusion Criteria: Regularly participating in yoga or other balance training program |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254225747 |
Number Of Facilities | 2 |
Registered In Calendar Year | 2019 |
Actual Duration | 8 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | False |
Minimum Age Num | 60 |
Maximum Age Num | 90 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 6 |
Designs
Sequence: | 30503527 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Single |
Masking Description | Tests will not be performed by the investigators providing the interventions.. |
Intervention Model Description | Comparison of Yoga Interventions |
Investigator Masked | True |
Responsible Parties
Sequence: | 28869805 |
Responsible Party Type | Principal Investigator |
Name | Joseph Signorile |
Title | Professor |
Affiliation | University of Miami |
]]>
https://zephyrnet.com/NCT03799627
2019-01-31
https://zephyrnet.com/?p=NCT03799627
NCT03799627https://www.clinicaltrials.gov/study/NCT03799627?tab=tableNANANAThis is a Phase 2 open-label efficacy, safety, and pharmacokinetic/pharmacodynamic (PK/PD) study to evaluate oral Vadadustat for the treatment of anemia in hemodialysis participants converting from Epoetin Alfa therapy.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-03 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2022-09-29 |
Start Month Year | January 31, 2019 |
Primary Completion Month Year | June 5, 2020 |
Verification Month Year | September 2022 |
Verification Date | 2022-09-30 |
Last Update Posted Date | 2022-09-29 |
Results First Posted Date | 2022-09-29 |
Detailed Descriptions
Sequence: | 20730274 |
Description | This is a Phase 2, randomized, open-label study to evaluate efficacy and safety of oral Vadadustat for the treatment of anemia in hemodialysis participants converting from Epoetin Alfa therapy. The study will be conducted in two parts running in parallel: Part 1, Main Study in a hemodialysis population on maintenance treatment with Epoetin Alfa; Part 2 is in a hemodialysis population that are erythropoiesis-stimulating agent (ESA) hyporesponders on maintenance treatment with Epoetin Alfa. For all participants (Main and ESA hyporesponder parallel study), the study will include a Screening Period, a Treatment Period, and a Safety Follow-Up Period. PK and PD sampling will be done throughout the study. The aim is to achieve and maintain hemoglobin (Hb) levels within the target range of 10.0 to 11.0 grams per deciliter (g/dL), inclusive, while targeting the middle of the range and minimizing excursions outside the target range. |
Facilities
Sequence: | 200189835 | Sequence: | 200189836 | Sequence: | 200189837 | Sequence: | 200189838 | Sequence: | 200189839 | Sequence: | 200189840 | Sequence: | 200189841 | Sequence: | 200189842 | Sequence: | 200189843 | Sequence: | 200189844 | Sequence: | 200189845 | Sequence: | 200189846 | Sequence: | 200189847 | Sequence: | 200189848 | Sequence: | 200189849 | Sequence: | 200189850 | Sequence: | 200189851 | Sequence: | 200189852 | Sequence: | 200189853 | Sequence: | 200189854 | Sequence: | 200189855 | Sequence: | 200189856 | Sequence: | 200189857 | Sequence: | 200189858 | Sequence: | 200189859 | Sequence: | 200189860 | Sequence: | 200189861 | Sequence: | 200189862 | Sequence: | 200189863 | Sequence: | 200189864 | Sequence: | 200189865 | Sequence: | 200189866 | Sequence: | 200189867 | Sequence: | 200189868 | Sequence: | 200189869 | Sequence: | 200189870 | Sequence: | 200189871 | Sequence: | 200189872 | Sequence: | 200189873 | Sequence: | 200189874 | Sequence: | 200189875 |
Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site #1 | Name | Research Site #2 | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site #1 | Name | Research Site #2 | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site |
City | Fresno | City | Granada Hills | City | Los Angeles | City | Northridge | City | Riverside | City | San Dimas | City | San Dimas | City | San Gabriel | City | Tarzana | City | Vacaville | City | Victorville | City | Denver | City | Bridgeport | City | Hartford | City | Coral Gables | City | Hollywood | City | Miami | City | Miami | City | Miami | City | Tampa | City | Tampa | City | Winter Park | City | Augusta | City | Statesboro | City | Roseville | City | Minneapolis | City | Minneapolis | City | Kansas City | City | Las Vegas | City | Bronx | City | Asheville | City | Wilmington | City | Canton | City | Oklahoma City | City | El Paso | City | Houston | City | San Antonio | City | San Antonio | City | Chesapeake | City | Norfolk | City | Wauwatosa |
State | California | State | California | State | California | State | California | State | California | State | California | State | California | State | California | State | California | State | California | State | California | State | Colorado | State | Connecticut | State | Connecticut | State | Florida | State | Florida | State | Florida | State | Florida | State | Florida | State | Florida | State | Florida | State | Florida | State | Georgia | State | Georgia | State | Michigan | State | Minnesota | State | Minnesota | State | Missouri | State | Nevada | State | New York | State | North Carolina | State | North Carolina | State | Ohio | State | Oklahoma | State | Texas | State | Texas | State | Texas | State | Texas | State | Virginia | State | Virginia | State | Wisconsin |
Zip | 93720 | Zip | 91344 | Zip | 90022 | Zip | 91324 | Zip | 92501 | Zip | 91773 | Zip | 91773 | Zip | 91776 | Zip | 91356 | Zip | 95688 | Zip | 92394 | Zip | 80230 | Zip | 06606 | Zip | 06762 | Zip | 33134 | Zip | 33024 | Zip | 33126 | Zip | 33134 | Zip | 33150 | Zip | 33607 | Zip | 33614 | Zip | 32789 | Zip | 30909 | Zip | 30458 | Zip | 48066 | Zip | 55404 | Zip | 55404 | Zip | 64111 | Zip | 89107 | Zip | 10461 | Zip | 28801 | Zip | 28401 | Zip | 44718 | Zip | 73116 | Zip | 79915 | Zip | 77004 | Zip | 78229 | Zip | 78258 | Zip | 23320 | Zip | 23510 | Zip | 53226 |
Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States |
Browse Interventions
Sequence: | 96089741 | Sequence: | 96089742 | Sequence: | 96089743 | Sequence: | 96089744 | Sequence: | 96089745 | Sequence: | 96089746 | Sequence: | 96089747 |
Mesh Term | Epoetin Alfa | Mesh Term | Glycine | Mesh Term | Hematinics | Mesh Term | Glycine Agents | Mesh Term | Neurotransmitter Agents | Mesh Term | Molecular Mechanisms of Pharmacological Action | Mesh Term | Physiological Effects of Drugs |
Downcase Mesh Term | epoetin alfa | Downcase Mesh Term | glycine | Downcase Mesh Term | hematinics | Downcase Mesh Term | glycine agents | Downcase Mesh Term | neurotransmitter agents | Downcase Mesh Term | molecular mechanisms of pharmacological action | Downcase Mesh Term | physiological effects of drugs |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52193549 | Sequence: | 52193550 |
Name | Anemia | Name | Dialysis-dependent Chronic Kidney Disease |
Downcase Name | anemia | Downcase Name | dialysis-dependent chronic kidney disease |
Id Information
Sequence: | 40175451 |
Id Source | org_study_id |
Id Value | AKB-6548-CI-0025 |
Countries
Sequence: | 42587798 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55618914 | Sequence: | 55618915 | Sequence: | 55618916 |
Group Type | Experimental | Group Type | Experimental | Group Type | Active Comparator |
Title | Vadadustat | Title | Vadadustat TIW | Title | Epoetin Alfa |
Description | The initial dose of Vadadustat (300, 450, or 600 milligrams [mg]) will be based upon the dose of Epoetin Alfa dose participants had received prior to Vadadustat treatment | Description | Participants randomized to Vadadustat (Main and erythropoiesis-stimulating agent [ESA] hyporesponder parallel studies) who complete a once-daily dosing regimen treatment period and meet eligibility criteria for transition to three times weekly (TIW) dosing will switch to TIW dosing | Description | Epoetin Alfa |
Interventions
Sequence: | 52508185 | Sequence: | 52508186 | Sequence: | 52508187 |
Intervention Type | Drug | Intervention Type | Drug | Intervention Type | Drug |
Name | Vadadustat | Name | Epoetin Alfa | Name | Vadadustat TIW |
Description | Vadadustat Tablets 150 mg | Description | Epoetin Alfa | Description | Oral Vadadustat |
Keywords
Sequence: | 79901507 | Sequence: | 79901508 | Sequence: | 79901509 | Sequence: | 79901510 | Sequence: | 79901511 |
Name | Vadadustat | Name | AKB-6548 | Name | Anemia | Name | Chronic kidney disease (CKD) | Name | erythropoietin |
Downcase Name | vadadustat | Downcase Name | akb-6548 | Downcase Name | anemia | Downcase Name | chronic kidney disease (ckd) | Downcase Name | erythropoietin |
Design Outcomes
Sequence: | 177461945 | Sequence: | 177461946 | Sequence: | 177461947 | Sequence: | 177461948 | Sequence: | 177461949 | Sequence: | 177461950 | Sequence: | 177461951 | Sequence: | 177461952 | Sequence: | 177461953 | Sequence: | 177461954 | Sequence: | 177461955 | Sequence: | 177461956 | Sequence: | 177461957 | Sequence: | 177461958 | Sequence: | 177461959 | Sequence: | 177461960 | Sequence: | 177461961 | Sequence: | 177461962 | Sequence: | 177461963 | Sequence: | 177461964 | Sequence: | 177461965 | Sequence: | 177461966 | Sequence: | 177461967 | Sequence: | 177461968 | Sequence: | 177461969 | Sequence: | 177461970 | Sequence: | 177461971 | Sequence: | 177461972 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP) | Measure | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Measure | Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values | Measure | Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Values | Measure | Number of Participants Classified as Hb Outliers | Measure | Number of Participants With Hb Values Within the Target Range at the PEP | Measure | Mean Change in Hb From the PEP to the Secondary Evaluation Period (SEP) in Participants Who Transitioned to Three Times Per Week (TIW) Vadadustat Dosing After Week 12 | Measure | Mean Change in Hb Between Baseline and the SEP | Measure | Number of Participants With Hb Values Within the Target Range at the SEP | Measure | Number of Participants With Hb Values Within the Target Range at the SEP in Participants Who Transitioned to TIW Vadadustat Dosing | Measure | Number of Participants With a Mean Increase in Hb From Baseline to the PEP ≥0.5 g/dL or With Hb Values Within the Target Range at the PEP | Measure | Number of Participants With a Mean Increase in Hb From Baseline to the SEP ≥0.5 g/dL or With Hb Values Within the Target Range at the SEP | Measure | Number of Participants Requiring at Least One Intravenous (IV) Elemental Iron Supplementation | Measure | Number of Participants Requiring Erythropoiesis-stimulating Agent (ESA) Rescue | Measure | Number of Participants Requiring Red Blood Cell (RBC) Transfusion | Measure | Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group | Measure | Mean Change From Baseline in Reticulocyte Count | Measure | Mean Change From Baseline in Iron Concentration | Measure | Mean Change From Baseline in Ferritin Concentration | Measure | Mean Change From Baseline in Total Iron Binding Capacity | Measure | Mean Change From Baseline in Hepcidin Concentration | Measure | Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Vadadustat Following a Single Dose | Measure | Geometric Mean Area Under the Concentration-time Curve (AUC) From Time 0 to 24 Hours (AUC0-24) of Vadadustat Following a Single Dose | Measure | Median Terminal Half-life (t1/2) of Vadadustat Following a Single Dose | Measure | Median Time to Reach Cmax (Tmax) of Vadadustat Following a Single Dose | Measure | Geometric Mean Elimination Rate Constant (λz) of Vadadustat Following a Single Dose | Measure | Geometric Mean Apparent Total Body Clearance (CLss/F) of Vadadustat Following a Single Dose | Measure | Geometric Mean Apparent Volume of Distribution (Vz/F) of Vadadustat Following a Single Dose |
Time Frame | Baseline; Week 10 to Week 12 | Time Frame | Up to Week 24 | Time Frame | Up to Week 24 | Time Frame | Up to Week 24 | Time Frame | Weeks 13 – 20 | Time Frame | Week 10 to Week 12 | Time Frame | Week 10 to Week 12; Week 18 to Week 20 | Time Frame | Baseline; Week 18 to Week 20 | Time Frame | Week 18 to Week 20 | Time Frame | Week 18 to Week 20 | Time Frame | Week 10 to Week 12 | Time Frame | Week 18 to Week 20 | Time Frame | Up to Week 20 | Time Frame | Up to Week 20 | Time Frame | Up to Week 20 | Time Frame | Baseline; Week 1 (pre-dose), Week 1 +1 (Day 8; pre-dose), Week 11 (pre-dose), and Week 13 (pre-dose) | Time Frame | Baseline; Week 1, Week 4, Week 8, Week 11, Week 12, Week 13, Week 16, and Week 20 | Time Frame | Baseline; Week 4, Week 8, Week 12, Week 16, and Week 20 | Time Frame | Baseline; Week 4, Week 8, Week 12, Week 16, and Week 20 | Time Frame | Baseline; Week 4, Week 8, Week 12, Week 16, and Week 20 | Time Frame | Baseline; Week 12 and Week 20 | Time Frame | Day 1; Week 1, Week 1 +1 (Day 8), Week 11, Week 13: pre-dose, 2 hours (h), 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose | Time Frame | Day 1; Week 1, Week 1 +1 (Day 8), Week 11: pre-dose, 2h, 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose | Time Frame | Day 1; Week 1, Week 1 +1 (Day 8), Week 11, Week 13: pre-dose, 2 hours (h), 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose | Time Frame | Day 1; Week 1, Week 1 +1 (Day 8), Week 11, Week 13: pre-dose, 2 hours (h), 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose | Time Frame | Day 1; Week 1, Week 1 +1 (Day 8), Week 11, Week 13: pre-dose, 2 hours (h), 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose | Time Frame | Day 1; Week 1, Week 1 +1 (Day 8), Week 11: pre-dose, 2h, 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose | Time Frame | Day 1; Week 1, Week 1 +1 (Day 8), Week 11: pre-dose, 2h, 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose |
Description | Change from Baseline in Hb value was calculated as the PEP Hb value minus the Baseline Hb value. The PEP value was the average Hb value from Week 10 to Week 12. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. | Description | An adverse event (AE) was defined as any untoward medical occurrence (including a clinically significant abnormal laboratory finding) that occurred in the protocol-specified AE reporting period. An AE included medical conditions, signs, and symptoms not previously observed in the participant that emerged during the protocol-specified AE reporting period, including signs or symptoms associated with pre-existing underlying conditions that were not present prior to the AE reporting period. TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. | Description | Parameters assessed for laboratory values included hematology (excluding the primary and secondary efficacy endpoint results related to Hb), clinical chemistry, lipid profiles, and glucose. The investigator was responsible for reviewing laboratory results for clinically significant changes. | Description | Parameters assessed for vital signs included sitting (at rest for a minimum of 5 minutes) heart rate, respiratory rate, body temperature, and blood pressure. The investigator was responsible for reviewing vital sign values for clinically significant changes. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 g/dL, inclusive. The PEP was comprised of Week 10 to Week 12. | Description | Change from PEP was calculated as the SEP value minus the PEP value. The PEP value was the average Hb value from Week 10 to Week 12. The SEP value was the average Hb value from Week 18 to Week 20. For the Main Study, analysis is presented per dose level according to the starting dose in TIW regimen, as well as being presented as a combined arm for "Vadadustat Total (TIW dosing regimen)". For the ESA Hyporesponder Parallel Study, a starting dose classification for TIW dosing regimen was not applicable due to no participants switching from Vadadustat QD to TIW dosing. | Description | Change from Baseline was calculated as the SEP value minus the Baseline value. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. The SEP value was the average Hb value from Week 18 to Week 20. | Description | The target range for Hb was from 10.0 to 11.0 g/dL. The SEP was comprised of Week 18 to Week 20. | Description | The target range for Hb was from 10.0 to 11.0 g/dL. The SEP was comprised of Week 18 to Week 20. For the Main Study, analysis is presented per dose level according to the starting dose in TIW regimen, as well as being presented as a combined arm for "Vadadustat Total (TIW dosing regimen)". For the ESA Hyporesponder Parallel Study, a starting dose classification for TIW dosing regimen was not applicable due to no participants switching from Vadadustat QD to TIW dosing. | Description | The target range for Hb was from 10.0 to 11.0 g/dL. The PEP was comprised of Week 10 to Week 12. | Description | The target range for Hb was from 10.0 to 11.0 grams per g/dL. The SEP was comprised of Week 18 to Week 20. | Description | Iron supplementation was performed to maintain ferritin ≥200 nanograms/milliliters (ng/mL) and transferrin saturation (TSAT) ≥20%. | Description | ESA rescue therapy was administered in participants with Hb ≥8.5 g/dL, and was stopped when Hb reached ≥9.0 g/dL. | Description | RBC transfusion was administered as rescue therapy in the event of an acute or severe loss of blood. | Description | Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of Cmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of AUC and AUC0-24 of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of t1/2 of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Tmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of λz of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of CLss/F of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Vz/F of Vadadustat following a single dose. |
Browse Conditions
Sequence: | 193571852 | Sequence: | 193571853 | Sequence: | 193571854 | Sequence: | 193571855 | Sequence: | 193571856 | Sequence: | 193571860 | Sequence: | 193571861 | Sequence: | 193571862 | Sequence: | 193571863 | Sequence: | 193571864 | Sequence: | 193571857 | Sequence: | 193571858 | Sequence: | 193571859 |
Mesh Term | Kidney Diseases | Mesh Term | Renal Insufficiency, Chronic | Mesh Term | Anemia | Mesh Term | Hematologic Diseases | Mesh Term | Urologic Diseases | Mesh Term | Male Urogenital Diseases | Mesh Term | Renal Insufficiency | Mesh Term | Chronic Disease | Mesh Term | Disease Attributes | Mesh Term | Pathologic Processes | Mesh Term | Female Urogenital Diseases | Mesh Term | Female Urogenital Diseases and Pregnancy Complications | Mesh Term | Urogenital Diseases |
Downcase Mesh Term | kidney diseases | Downcase Mesh Term | renal insufficiency, chronic | Downcase Mesh Term | anemia | Downcase Mesh Term | hematologic diseases | Downcase Mesh Term | urologic diseases | Downcase Mesh Term | male urogenital diseases | Downcase Mesh Term | renal insufficiency | Downcase Mesh Term | chronic disease | Downcase Mesh Term | disease attributes | Downcase Mesh Term | pathologic processes | Downcase Mesh Term | female urogenital diseases | Downcase Mesh Term | female urogenital diseases and pregnancy complications | Downcase Mesh Term | urogenital diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48340187 |
Agency Class | INDUSTRY |
Lead Or Collaborator | lead |
Name | Akebia Therapeutics |
Overall Officials
Sequence: | 29297915 |
Role | Study Director |
Name | Chief Medical Officer |
Affiliation | Akebia Therapeutics Inc. |
Design Group Interventions
Sequence: | 68180082 | Sequence: | 68180083 | Sequence: | 68180084 |
Design Group Id | 55618914 | Design Group Id | 55618916 | Design Group Id | 55618915 |
Intervention Id | 52508185 | Intervention Id | 52508186 | Intervention Id | 52508187 |
Eligibilities
Sequence: | 30778529 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 99 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
≥18 years of age, providing informed consent Eligibility in the Main study and erythropoiesis-stimulating agent (ESA) hyporesponder parallel study is based on the following mean weekly Epoetin Alfa doses: Main study: Mean weekly Epoetin Alfa dose <300 Units per kilogram per week (U/kg/week) for 8 weeks prior to SV2; Two Hb values measured by the central laboratory at least 4 days apart between Screening Visit 1 (SV1) and SV2 as indicated:. Main study: 2 Hb values between 8.5 and 11.0 g/dL, inclusive; Exclusion Criteria: Anemia due to a cause other than chronic kidney disease (e.g., sickle cell disease, myelodysplastic syndromes, bone marrow fibrosis, hematologic malignancy, myeloma, hemolytic anemia, thalassemia, or pure red cell aplasia) For female participants of non-childbearing potential: inability to confirm surgical sterility (e.g., hysterectomy, bilateral tubal ligation, bilateral oophorectomy) at least 1 month prior to Screening; For female participants of childbearing potential: lack of confirmation of the use of acceptable forms of contraception* for a minimum of one complete menstrual cycle prior to Screening; Any other reason, which in the opinion of the Investigator, would make the participant not suitable for participation in the study Acceptable forms of contraception include: Established use of oral, injected or implanted hormonal methods of contraception; |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253971225 |
Number Of Facilities | 41 |
Number Of Nsae Subjects | 192 |
Number Of Sae Subjects | 96 |
Registered In Calendar Year | 2018 |
Actual Duration | 16 |
Were Results Reported | True |
Months To Report Results | 23 |
Has Us Facility | True |
Has Single Facility | False |
Minimum Age Num | 18 |
Maximum Age Num | 99 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 5 |
Number Of Secondary Outcomes To Measure | 23 |
Designs
Sequence: | 30524632 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Intervention Model Description | Randomized, Open-Label, Active-Controlled |
Drop Withdrawals
Sequence: | 29004199 | Sequence: | 29004200 | Sequence: | 29004201 | Sequence: | 29004202 | Sequence: | 29004203 | Sequence: | 29004204 | Sequence: | 29004205 | Sequence: | 29004206 | Sequence: | 29004207 | Sequence: | 29004208 | Sequence: | 29004209 | Sequence: | 29004210 | Sequence: | 29004211 | Sequence: | 29004212 | Sequence: | 29004213 | Sequence: | 29004214 | Sequence: | 29004215 | Sequence: | 29004216 | Sequence: | 29004217 | Sequence: | 29004218 | Sequence: | 29004219 | Sequence: | 29004220 | Sequence: | 29004221 | Sequence: | 29004222 | Sequence: | 29004223 | Sequence: | 29004224 | Sequence: | 29004225 | Sequence: | 29004226 | Sequence: | 29004227 | Sequence: | 29004228 | Sequence: | 29004229 | Sequence: | 29004230 | Sequence: | 29004231 | Sequence: | 29004232 | Sequence: | 29004233 | Sequence: | 29004234 | Sequence: | 29004235 | Sequence: | 29004236 | Sequence: | 29004237 | Sequence: | 29004238 | Sequence: | 29004239 | Sequence: | 29004240 | Sequence: | 29004241 | Sequence: | 29004242 | Sequence: | 29004243 | Sequence: | 29004244 | Sequence: | 29004245 | Sequence: | 29004246 | Sequence: | 29004247 | Sequence: | 29004248 | Sequence: | 29004249 | Sequence: | 29004250 | Sequence: | 29004251 | Sequence: | 29004252 | Sequence: | 29004253 | Sequence: | 29004254 | Sequence: | 29004255 | Sequence: | 29004256 | Sequence: | 29004257 | Sequence: | 29004258 | Sequence: | 29004259 | Sequence: | 29004260 | Sequence: | 29004261 | Sequence: | 29004262 | Sequence: | 29004263 | Sequence: | 29004264 | Sequence: | 29004265 | Sequence: | 29004266 | Sequence: | 29004267 | Sequence: | 29004268 | Sequence: | 29004269 | Sequence: | 29004270 | Sequence: | 29004271 | Sequence: | 29004272 | Sequence: | 29004273 | Sequence: | 29004274 | Sequence: | 29004275 | Sequence: | 29004276 | Sequence: | 29004277 | Sequence: | 29004278 | Sequence: | 29004279 | Sequence: | 29004280 | Sequence: | 29004281 | Sequence: | 29004282 | Sequence: | 29004283 | Sequence: | 29004284 | Sequence: | 29004285 | Sequence: | 29004286 | Sequence: | 29004287 | Sequence: | 29004288 | Sequence: | 29004289 | Sequence: | 29004290 | Sequence: | 29004291 | Sequence: | 29004292 | Sequence: | 29004293 | Sequence: | 29004294 | Sequence: | 29004295 | Sequence: | 29004296 | Sequence: | 29004297 | Sequence: | 29004298 | Sequence: | 29004299 | Sequence: | 29004300 | Sequence: | 29004301 | Sequence: | 29004302 | Sequence: | 29004303 | Sequence: | 29004304 | Sequence: | 29004305 | Sequence: | 29004306 | Sequence: | 29004307 | Sequence: | 29004308 | Sequence: | 29004309 | Sequence: | 29004310 | Sequence: | 29004311 | Sequence: | 29004312 | Sequence: | 29004313 | Sequence: | 29004314 | Sequence: | 29004315 | Sequence: | 29004316 | Sequence: | 29004317 | Sequence: | 29004318 | Sequence: | 29004319 | Sequence: | 29004320 | Sequence: | 29004321 | Sequence: | 29004322 | Sequence: | 29004323 | Sequence: | 29004324 | Sequence: | 29004325 | Sequence: | 29004326 | Sequence: | 29004327 | Sequence: | 29004328 | Sequence: | 29004329 | Sequence: | 29004330 | Sequence: | 29004331 | Sequence: | 29004332 | Sequence: | 29004333 | Sequence: | 29004334 | Sequence: | 29004335 | Sequence: | 29004336 | Sequence: | 29004337 | Sequence: | 29004338 | Sequence: | 29004339 | Sequence: | 29004340 | Sequence: | 29004341 | Sequence: | 29004342 | Sequence: | 29004343 | Sequence: | 29004344 | Sequence: | 29004345 | Sequence: | 29004346 | Sequence: | 29004347 | Sequence: | 29004348 | Sequence: | 29004349 | Sequence: | 29004350 | Sequence: | 29004351 | Sequence: | 29004352 | Sequence: | 29004353 | Sequence: | 29004354 | Sequence: | 29004355 | Sequence: | 29004356 | Sequence: | 29004357 | Sequence: | 29004358 | Sequence: | 29004359 | Sequence: | 29004360 |
Result Group Id | 56112532 | Result Group Id | 56112533 | Result Group Id | 56112534 | Result Group Id | 56112535 | Result Group Id | 56112536 | Result Group Id | 56112537 | Result Group Id | 56112538 | Result Group Id | 56112539 | Result Group Id | 56112540 | Result Group Id | 56112532 | Result Group Id | 56112533 | Result Group Id | 56112534 | Result Group Id | 56112535 | Result Group Id | 56112536 | Result Group Id | 56112537 | Result Group Id | 56112538 | Result Group Id | 56112539 | Result Group Id | 56112540 | Result Group Id | 56112532 | Result Group Id | 56112533 | Result Group Id | 56112534 | Result Group Id | 56112535 | Result Group Id | 56112536 | Result Group Id | 56112537 | Result Group Id | 56112538 | Result Group Id | 56112539 | Result Group Id | 56112540 | Result Group Id | 56112532 | Result Group Id | 56112533 | Result Group Id | 56112534 | Result Group Id | 56112535 | Result Group Id | 56112536 | Result Group Id | 56112537 | Result Group Id | 56112538 | Result Group Id | 56112539 | Result Group Id | 56112540 | Result Group Id | 56112532 | Result Group Id | 56112533 | Result Group Id | 56112534 | Result Group Id | 56112535 | Result Group Id | 56112536 | Result Group Id | 56112537 | Result Group Id | 56112538 | Result Group Id | 56112539 | Result Group Id | 56112540 | Result Group Id | 56112532 | Result Group Id | 56112533 | Result Group Id | 56112534 | Result Group Id | 56112535 | Result Group Id | 56112536 | Result Group Id | 56112537 | Result Group Id | 56112538 | Result Group Id | 56112539 | Result Group Id | 56112540 | Result Group Id | 56112532 | Result Group Id | 56112533 | Result Group Id | 56112534 | Result Group Id | 56112535 | Result Group Id | 56112536 | Result Group Id | 56112537 | Result Group Id | 56112538 | Result Group Id | 56112539 | Result Group Id | 56112540 | Result Group Id | 56112532 | Result Group Id | 56112533 | Result Group Id | 56112534 | Result Group Id | 56112535 | Result Group Id | 56112536 | Result Group Id | 56112537 | Result Group Id | 56112538 | Result Group Id | 56112539 | Result Group Id | 56112540 | Result Group Id | 56112532 | Result Group Id | 56112533 | Result Group Id | 56112534 | Result Group Id | 56112535 | Result Group Id | 56112536 | Result Group Id | 56112537 | Result Group Id | 56112538 | Result Group Id | 56112539 | Result Group Id | 56112540 | Result Group Id | 56112532 | Result Group Id | 56112533 | Result Group Id | 56112534 | Result Group Id | 56112535 | Result Group Id | 56112536 | Result Group Id | 56112537 | Result Group Id | 56112538 | Result Group Id | 56112539 | Result Group Id | 56112540 | Result Group Id | 56112532 | Result Group Id | 56112533 | Result Group Id | 56112534 | Result Group Id | 56112535 | Result Group Id | 56112536 | Result Group Id | 56112537 | Result Group Id | 56112538 | Result Group Id | 56112539 | Result Group Id | 56112540 | Result Group Id | 56112532 | Result Group Id | 56112533 | Result Group Id | 56112534 | Result Group Id | 56112535 | Result Group Id | 56112536 | Result Group Id | 56112537 | Result Group Id | 56112538 | Result Group Id | 56112539 | Result Group Id | 56112540 | Result Group Id | 56112532 | Result Group Id | 56112533 | Result Group Id | 56112534 | Result Group Id | 56112535 | Result Group Id | 56112536 | Result Group Id | 56112537 | Result Group Id | 56112538 | Result Group Id | 56112539 | Result Group Id | 56112540 | Result Group Id | 56112532 | Result Group Id | 56112533 | Result Group Id | 56112534 | Result Group Id | 56112535 | Result Group Id | 56112536 | Result Group Id | 56112537 | Result Group Id | 56112538 | Result Group Id | 56112539 | Result Group Id | 56112540 | Result Group Id | 56112532 | Result Group Id | 56112533 | Result Group Id | 56112534 | Result Group Id | 56112535 | Result Group Id | 56112536 | Result Group Id | 56112537 | Result Group Id | 56112538 | Result Group Id | 56112539 | Result Group Id | 56112540 | Result Group Id | 56112532 | Result Group Id | 56112533 | Result Group Id | 56112534 | Result Group Id | 56112535 | Result Group Id | 56112536 | Result Group Id | 56112537 | Result Group Id | 56112538 | Result Group Id | 56112539 | Result Group Id | 56112540 | Result Group Id | 56112532 | Result Group Id | 56112533 | Result Group Id | 56112534 | Result Group Id | 56112535 | Result Group Id | 56112536 | Result Group Id | 56112537 | Result Group Id | 56112538 | Result Group Id | 56112539 | Result Group Id | 56112540 | Result Group Id | 56112532 | Result Group Id | 56112533 | Result Group Id | 56112534 | Result Group Id | 56112535 | Result Group Id | 56112536 | Result Group Id | 56112537 | Result Group Id | 56112538 | Result Group Id | 56112539 | Result Group Id | 56112540 |
Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG006 | Ctgov Group Code | FG007 | Ctgov Group Code | FG008 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG006 | Ctgov Group Code | FG007 | Ctgov Group Code | FG008 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG006 | Ctgov Group Code | FG007 | Ctgov Group Code | FG008 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG006 | Ctgov Group Code | FG007 | Ctgov Group Code | FG008 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG006 | Ctgov Group Code | FG007 | Ctgov Group Code | FG008 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG006 | Ctgov Group Code | FG007 | Ctgov Group Code | FG008 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG006 | Ctgov Group Code | FG007 | Ctgov Group Code | FG008 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG006 | Ctgov Group Code | FG007 | Ctgov Group Code | FG008 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG006 | Ctgov Group Code | FG007 | Ctgov Group Code | FG008 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG006 | Ctgov Group Code | FG007 | Ctgov Group Code | FG008 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG006 | Ctgov Group Code | FG007 | Ctgov Group Code | FG008 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG006 | Ctgov Group Code | FG007 | Ctgov Group Code | FG008 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG006 | Ctgov Group Code | FG007 | Ctgov Group Code | FG008 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG006 | Ctgov Group Code | FG007 | Ctgov Group Code | FG008 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG006 | Ctgov Group Code | FG007 | Ctgov Group Code | FG008 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG006 | Ctgov Group Code | FG007 | Ctgov Group Code | FG008 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG006 | Ctgov Group Code | FG007 | Ctgov Group Code | FG008 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG006 | Ctgov Group Code | FG007 | Ctgov Group Code | FG008 |
Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study |
Reason | Adverse Event | Reason | Adverse Event | Reason | Adverse Event | Reason | Adverse Event | Reason | Adverse Event | Reason | Adverse Event | Reason | Adverse Event | Reason | Adverse Event | Reason | Adverse Event | Reason | Physician Decision | Reason | Physician Decision | Reason | Physician Decision | Reason | Physician Decision | Reason | Physician Decision | Reason | Physician Decision | Reason | Physician Decision | Reason | Physician Decision | Reason | Physician Decision | Reason | Withdrawal by Subject | Reason | Withdrawal by Subject | Reason | Withdrawal by Subject | Reason | Withdrawal by Subject | Reason | Withdrawal by Subject | Reason | Withdrawal by Subject | Reason | Withdrawal by Subject | Reason | Withdrawal by Subject | Reason | Withdrawal by Subject | Reason | Lack of Efficacy | Reason | Lack of Efficacy | Reason | Lack of Efficacy | Reason | Lack of Efficacy | Reason | Lack of Efficacy | Reason | Lack of Efficacy | Reason | Lack of Efficacy | Reason | Lack of Efficacy | Reason | Lack of Efficacy | Reason | Lost to Follow-up | Reason | Lost to Follow-up | Reason | Lost to Follow-up | Reason | Lost to Follow-up | Reason | Lost to Follow-up | Reason | Lost to Follow-up | Reason | Lost to Follow-up | Reason | Lost to Follow-up | Reason | Lost to Follow-up | Reason | Death | Reason | Death | Reason | Death | Reason | Death | Reason | Death | Reason | Death | Reason | Death | Reason | Death | Reason | Death | Reason | Study Drug Put on Hold | Reason | Study Drug Put on Hold | Reason | Study Drug Put on Hold | Reason | Study Drug Put on Hold | Reason | Study Drug Put on Hold | Reason | Study Drug Put on Hold | Reason | Study Drug Put on Hold | Reason | Study Drug Put on Hold | Reason | Study Drug Put on Hold | Reason | Due to Urgent Safety Measures Letter | Reason | Due to Urgent Safety Measures Letter | Reason | Due to Urgent Safety Measures Letter | Reason | Due to Urgent Safety Measures Letter | Reason | Due to Urgent Safety Measures Letter | Reason | Due to Urgent Safety Measures Letter | Reason | Due to Urgent Safety Measures Letter | Reason | Due to Urgent Safety Measures Letter | Reason | Due to Urgent Safety Measures Letter | Reason | Kidney Transplantation | Reason | Kidney Transplantation | Reason | Kidney Transplantation | Reason | Kidney Transplantation | Reason | Kidney Transplantation | Reason | Kidney Transplantation | Reason | Kidney Transplantation | Reason | Kidney Transplantation | Reason | Kidney Transplantation | Reason | Participant Was on Rescue Epogen | Reason | Participant Was on Rescue Epogen | Reason | Participant Was on Rescue Epogen | Reason | Participant Was on Rescue Epogen | Reason | Participant Was on Rescue Epogen | Reason | Participant Was on Rescue Epogen | Reason | Participant Was on Rescue Epogen | Reason | Participant Was on Rescue Epogen | Reason | Participant Was on Rescue Epogen | Reason | Placed on Dose Hold Until End of Treatment | Reason | Placed on Dose Hold Until End of Treatment | Reason | Placed on Dose Hold Until End of Treatment | Reason | Placed on Dose Hold Until End of Treatment | Reason | Placed on Dose Hold Until End of Treatment | Reason | Placed on Dose Hold Until End of Treatment | Reason | Placed on Dose Hold Until End of Treatment | Reason | Placed on Dose Hold Until End of Treatment | Reason | Placed on Dose Hold Until End of Treatment | Reason | Met Exclusion Criteria | Reason | Met Exclusion Criteria | Reason | Met Exclusion Criteria | Reason | Met Exclusion Criteria | Reason | Met Exclusion Criteria | Reason | Met Exclusion Criteria | Reason | Met Exclusion Criteria | Reason | Met Exclusion Criteria | Reason | Met Exclusion Criteria | Reason | Investigational Product Noncompliance | Reason | Investigational Product Noncompliance | Reason | Investigational Product Noncompliance | Reason | Investigational Product Noncompliance | Reason | Investigational Product Noncompliance | Reason | Investigational Product Noncompliance | Reason | Investigational Product Noncompliance | Reason | Investigational Product Noncompliance | Reason | Investigational Product Noncompliance | Reason | Participant Relocation | Reason | Participant Relocation | Reason | Participant Relocation | Reason | Participant Relocation | Reason | Participant Relocation | Reason | Participant Relocation | Reason | Participant Relocation | Reason | Participant Relocation | Reason | Participant Relocation | Reason | Eurofin Issue | Reason | Eurofin Issue | Reason | Eurofin Issue | Reason | Eurofin Issue | Reason | Eurofin Issue | Reason | Eurofin Issue | Reason | Eurofin Issue | Reason | Eurofin Issue | Reason | Eurofin Issue | Reason | Noncompliance with Site Instructions | Reason | Noncompliance with Site Instructions | Reason | Noncompliance with Site Instructions | Reason | Noncompliance with Site Instructions | Reason | Noncompliance with Site Instructions | Reason | Noncompliance with Site Instructions | Reason | Noncompliance with Site Instructions | Reason | Noncompliance with Site Instructions | Reason | Noncompliance with Site Instructions | Reason | Participant's Last Dose Prior to End of Treatment | Reason | Participant's Last Dose Prior to End of Treatment | Reason | Participant's Last Dose Prior to End of Treatment | Reason | Participant's Last Dose Prior to End of Treatment | Reason | Participant's Last Dose Prior to End of Treatment | Reason | Participant's Last Dose Prior to End of Treatment | Reason | Participant's Last Dose Prior to End of Treatment | Reason | Participant's Last Dose Prior to End of Treatment | Reason | Participant's Last Dose Prior to End of Treatment | Reason | Changes In Hemoglobin Values | Reason | Changes In Hemoglobin Values | Reason | Changes In Hemoglobin Values | Reason | Changes In Hemoglobin Values | Reason | Changes In Hemoglobin Values | Reason | Changes In Hemoglobin Values | Reason | Changes In Hemoglobin Values | Reason | Changes In Hemoglobin Values | Reason | Changes In Hemoglobin Values |
Count | 1 | Count | 2 | Count | 0 | Count | 0 | Count | 2 | Count | 5 | Count | 0 | Count | 2 | Count | 0 | Count | 2 | Count | 2 | Count | 0 | Count | 0 | Count | 2 | Count | 2 | Count | 0 | Count | 0 | Count | 0 | Count | 1 | Count | 1 | Count | 0 | Count | 2 | Count | 0 | Count | 3 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 1 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 1 | Count | 0 | Count | 1 | Count | 0 | Count | 0 | Count | 0 | Count | 1 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 1 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 1 | Count | 2 | Count | 0 | Count | 2 | Count | 1 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 1 | Count | 0 | Count | 0 | Count | 1 | Count | 1 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 1 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 1 | Count | 0 | Count | 1 | Count | 0 | Count | 1 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 1 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 1 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 1 | Count | 0 | Count | 1 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 1 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 1 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 1 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 1 | Count | 2 | Count | 1 | Count | 0 | Count | 0 | Count | 2 | Count | 1 | Count | 0 | Count | 1 |
Intervention Other Names
Sequence: | 26684156 | Sequence: | 26684157 | Sequence: | 26684158 |
Intervention Id | 52508185 | Intervention Id | 52508186 | Intervention Id | 52508186 |
Name | AKB-6548 | Name | Procrit | Name | Epogen |
Milestones
Sequence: | 41027678 | Sequence: | 41027679 | Sequence: | 41027680 | Sequence: | 41027681 | Sequence: | 41027682 | Sequence: | 41027683 | Sequence: | 41027684 | Sequence: | 41027685 | Sequence: | 41027686 | Sequence: | 41027687 | Sequence: | 41027688 | Sequence: | 41027689 | Sequence: | 41027690 | Sequence: | 41027691 | Sequence: | 41027692 | Sequence: | 41027693 | Sequence: | 41027694 | Sequence: | 41027695 | Sequence: | 41027696 | Sequence: | 41027697 | Sequence: | 41027698 | Sequence: | 41027699 | Sequence: | 41027700 | Sequence: | 41027701 | Sequence: | 41027702 | Sequence: | 41027703 | Sequence: | 41027704 |
Result Group Id | 56112532 | Result Group Id | 56112533 | Result Group Id | 56112534 | Result Group Id | 56112535 | Result Group Id | 56112536 | Result Group Id | 56112537 | Result Group Id | 56112538 | Result Group Id | 56112539 | Result Group Id | 56112540 | Result Group Id | 56112532 | Result Group Id | 56112533 | Result Group Id | 56112534 | Result Group Id | 56112535 | Result Group Id | 56112536 | Result Group Id | 56112537 | Result Group Id | 56112538 | Result Group Id | 56112539 | Result Group Id | 56112540 | Result Group Id | 56112532 | Result Group Id | 56112533 | Result Group Id | 56112534 | Result Group Id | 56112535 | Result Group Id | 56112536 | Result Group Id | 56112537 | Result Group Id | 56112538 | Result Group Id | 56112539 | Result Group Id | 56112540 |
Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG006 | Ctgov Group Code | FG007 | Ctgov Group Code | FG008 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG006 | Ctgov Group Code | FG007 | Ctgov Group Code | FG008 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG006 | Ctgov Group Code | FG007 | Ctgov Group Code | FG008 |
Title | STARTED | Title | STARTED | Title | STARTED | Title | STARTED | Title | STARTED | Title | STARTED | Title | STARTED | Title | STARTED | Title | STARTED | Title | COMPLETED | Title | COMPLETED | Title | COMPLETED | Title | COMPLETED | Title | COMPLETED | Title | COMPLETED | Title | COMPLETED | Title | COMPLETED | Title | COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED |
Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study |
Count | 35 | Count | 34 | Count | 23 | Count | 18 | Count | 21 | Count | 21 | Count | 13 | Count | 5 | Count | 5 | Count | 27 | Count | 23 | Count | 22 | Count | 8 | Count | 12 | Count | 8 | Count | 10 | Count | 3 | Count | 2 | Count | 8 | Count | 11 | Count | 1 | Count | 10 | Count | 9 | Count | 13 | Count | 3 | Count | 2 | Count | 3 |
Participant Flows
Sequence: | 3922864 |
Pre Assignment Details | A total of 540 participants were screened, of which 175 participants were enrolled and randomized into the 2 parts of this study (Main Study; n=165; Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study: n=10). A total of 365 participants failed screening. Participants were randomized to either a Vadadustat or Epoetin Alfa treatment group, and randomization was stratified by mean weekly Epoetin Alfa dose calculated over a period of 8 weeks prior to Screening Visit 2. |
Outcome Counts
Sequence: | 74039013 | Sequence: | 74039014 | Sequence: | 74039015 | Sequence: | 74039016 | Sequence: | 74039017 | Sequence: | 74039018 | Sequence: | 74039019 | Sequence: | 74039020 | Sequence: | 74039021 | Sequence: | 74039022 | Sequence: | 74039023 | Sequence: | 74039024 | Sequence: | 74039025 | Sequence: | 74039026 | Sequence: | 74039027 | Sequence: | 74039028 | Sequence: | 74039029 | Sequence: | 74039030 | Sequence: | 74039031 | Sequence: | 74039032 | Sequence: | 74039033 | Sequence: | 74039034 | Sequence: | 74039035 | Sequence: | 74039036 | Sequence: | 74039037 | Sequence: | 74039038 | Sequence: | 74039039 | Sequence: | 74039040 | Sequence: | 74039041 | Sequence: | 74039042 | Sequence: | 74039043 | Sequence: | 74039044 | Sequence: | 74039045 | Sequence: | 74039046 | Sequence: | 74039047 | Sequence: | 74039048 | Sequence: | 74039049 | Sequence: | 74039050 | Sequence: | 74039051 | Sequence: | 74039052 | Sequence: | 74039053 | Sequence: | 74039054 | Sequence: | 74039055 | Sequence: | 74039056 | Sequence: | 74039057 | Sequence: | 74039058 | Sequence: | 74039059 | Sequence: | 74039060 | Sequence: | 74039061 | Sequence: | 74039062 | Sequence: | 74039063 | Sequence: | 74039064 | Sequence: | 74039065 | Sequence: | 74039066 | Sequence: | 74039067 | Sequence: | 74039068 | Sequence: | 74039069 | Sequence: | 74039070 | Sequence: | 74039071 | Sequence: | 74039072 | Sequence: | 74039073 | Sequence: | 74039074 | Sequence: | 74039075 | Sequence: | 74039076 | Sequence: | 74039077 | Sequence: | 74039078 | Sequence: | 74039079 | Sequence: | 74039080 | Sequence: | 74039081 | Sequence: | 74039082 | Sequence: | 74039083 | Sequence: | 74039084 | Sequence: | 74039085 | Sequence: | 74039086 | Sequence: | 74039087 | Sequence: | 74039088 | Sequence: | 74039089 | Sequence: | 74039090 | Sequence: | 74039091 | Sequence: | 74039092 | Sequence: | 74039093 | Sequence: | 74039094 | Sequence: | 74039095 | Sequence: | 74039096 | Sequence: | 74039097 | Sequence: | 74039098 | Sequence: | 74039099 | Sequence: | 74039100 | Sequence: | 74039101 | Sequence: | 74039102 | Sequence: | 74039103 | Sequence: | 74039104 | Sequence: | 74039105 | Sequence: | 74039106 | Sequence: | 74039107 | Sequence: | 74039108 | Sequence: | 74039109 | Sequence: | 74039110 | Sequence: | 74039111 | Sequence: | 74039112 | Sequence: | 74039113 | Sequence: | 74039114 | Sequence: | 74039115 | Sequence: | 74039116 | Sequence: | 74039117 | Sequence: | 74039118 | Sequence: | 74039119 | Sequence: | 74039120 | Sequence: | 74039121 | Sequence: | 74039122 | Sequence: | 74039123 | Sequence: | 74039124 | Sequence: | 74039125 | Sequence: | 74039126 | Sequence: | 74039127 | Sequence: | 74039128 | Sequence: | 74039129 | Sequence: | 74039130 | Sequence: | 74039131 | Sequence: | 74039132 | Sequence: | 74039133 | Sequence: | 74039134 | Sequence: | 74039135 | Sequence: | 74039136 | Sequence: | 74039137 | Sequence: | 74039138 | Sequence: | 74039139 | Sequence: | 74039140 | Sequence: | 74039141 | Sequence: | 74039142 | Sequence: | 74039143 | Sequence: | 74039144 | Sequence: | 74039145 | Sequence: | 74039146 | Sequence: | 74039147 | Sequence: | 74039148 | Sequence: | 74039149 | Sequence: | 74039150 | Sequence: | 74039151 | Sequence: | 74039152 | Sequence: | 74039153 | Sequence: | 74039154 | Sequence: | 74039155 | Sequence: | 74039156 | Sequence: | 74039157 | Sequence: | 74039158 | Sequence: | 74039159 | Sequence: | 74039160 | Sequence: | 74039161 | Sequence: | 74039162 | Sequence: | 74039163 | Sequence: | 74039164 | Sequence: | 74039165 | Sequence: | 74039166 | Sequence: | 74039167 | Sequence: | 74039168 | Sequence: | 74039169 | Sequence: | 74039170 | Sequence: | 74039171 | Sequence: | 74039172 | Sequence: | 74039173 | Sequence: | 74039174 | Sequence: | 74039175 | Sequence: | 74039176 | Sequence: | 74039177 | Sequence: | 74039178 | Sequence: | 74039179 | Sequence: | 74039180 | Sequence: | 74039181 | Sequence: | 74039182 | Sequence: | 74039183 | Sequence: | 74039184 | Sequence: | 74039185 | Sequence: | 74039186 | Sequence: | 74039187 | Sequence: | 74039188 | Sequence: | 74039189 | Sequence: | 74039190 | Sequence: | 74039191 | Sequence: | 74039192 | Sequence: | 74039193 | Sequence: | 74039194 | Sequence: | 74039195 | Sequence: | 74039196 | Sequence: | 74039197 | Sequence: | 74039198 | Sequence: | 74039199 | Sequence: | 74039200 | Sequence: | 74039201 | Sequence: | 74039202 | Sequence: | 74039203 | Sequence: | 74039204 | Sequence: | 74039205 | Sequence: | 74039206 | Sequence: | 74039207 | Sequence: | 74039208 | Sequence: | 74039209 | Sequence: | 74039210 | Sequence: | 74039211 | Sequence: | 74039212 | Sequence: | 74039213 | Sequence: | 74039214 | Sequence: | 74039215 | Sequence: | 74039216 | Sequence: | 74039217 | Sequence: | 74039218 | Sequence: | 74039219 | Sequence: | 74039220 | Sequence: | 74039221 | Sequence: | 74039222 | Sequence: | 74039223 | Sequence: | 74039224 | Sequence: | 74039225 | Sequence: | 74039226 | Sequence: | 74039227 | Sequence: | 74039228 | Sequence: | 74039229 | Sequence: | 74039230 | Sequence: | 74039231 | Sequence: | 74039232 | Sequence: | 74039233 | Sequence: | 74039234 |
Outcome Id | 30820437 | Outcome Id | 30820437 | Outcome Id | 30820437 | Outcome Id | 30820437 | Outcome Id | 30820437 | Outcome Id | 30820437 | Outcome Id | 30820437 | Outcome Id | 30820437 | Outcome Id | 30820437 | Outcome Id | 30820438 | Outcome Id | 30820438 | Outcome Id | 30820438 | Outcome Id | 30820438 | Outcome Id | 30820438 | Outcome Id | 30820438 | Outcome Id | 30820438 | Outcome Id | 30820438 | Outcome Id | 30820438 | Outcome Id | 30820439 | Outcome Id | 30820439 | Outcome Id | 30820439 | Outcome Id | 30820439 | Outcome Id | 30820439 | Outcome Id | 30820439 | Outcome Id | 30820439 | Outcome Id | 30820439 | Outcome Id | 30820439 | Outcome Id | 30820440 | Outcome Id | 30820440 | Outcome Id | 30820440 | Outcome Id | 30820440 | Outcome Id | 30820440 | Outcome Id | 30820440 | Outcome Id | 30820440 | Outcome Id | 30820440 | Outcome Id | 30820440 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820442 | Outcome Id | 30820442 | Outcome Id | 30820442 | Outcome Id | 30820442 | Outcome Id | 30820442 | Outcome Id | 30820442 | Outcome Id | 30820442 | Outcome Id | 30820442 | Outcome Id | 30820442 | Outcome Id | 30820443 | Outcome Id | 30820443 | Outcome Id | 30820443 | Outcome Id | 30820443 | Outcome Id | 30820443 | Outcome Id | 30820443 | Outcome Id | 30820444 | Outcome Id | 30820444 | Outcome Id | 30820444 | Outcome Id | 30820444 | Outcome Id | 30820444 | Outcome Id | 30820444 | Outcome Id | 30820444 | Outcome Id | 30820444 | Outcome Id | 30820444 | Outcome Id | 30820445 | Outcome Id | 30820445 | Outcome Id | 30820445 | Outcome Id | 30820445 | Outcome Id | 30820445 | Outcome Id | 30820445 | Outcome Id | 30820445 | Outcome Id | 30820445 | Outcome Id | 30820445 | Outcome Id | 30820446 | Outcome Id | 30820446 | Outcome Id | 30820446 | Outcome Id | 30820446 | Outcome Id | 30820446 | Outcome Id | 30820446 | Outcome Id | 30820447 | Outcome Id | 30820447 | Outcome Id | 30820447 | Outcome Id | 30820447 | Outcome Id | 30820447 | Outcome Id | 30820447 | Outcome Id | 30820447 | Outcome Id | 30820447 | Outcome Id | 30820447 | Outcome Id | 30820448 | Outcome Id | 30820448 | Outcome Id | 30820448 | Outcome Id | 30820448 | Outcome Id | 30820448 | Outcome Id | 30820448 | Outcome Id | 30820448 | Outcome Id | 30820448 | Outcome Id | 30820448 | Outcome Id | 30820449 | Outcome Id | 30820449 | Outcome Id | 30820449 | Outcome Id | 30820449 | Outcome Id | 30820449 | Outcome Id | 30820449 | Outcome Id | 30820449 | Outcome Id | 30820449 | Outcome Id | 30820449 | Outcome Id | 30820450 | Outcome Id | 30820450 | Outcome Id | 30820450 | Outcome Id | 30820450 | Outcome Id | 30820450 | Outcome Id | 30820450 | Outcome Id | 30820450 | Outcome Id | 30820450 | Outcome Id | 30820450 | Outcome Id | 30820451 | Outcome Id | 30820451 | Outcome Id | 30820451 | Outcome Id | 30820451 | Outcome Id | 30820451 | Outcome Id | 30820451 | Outcome Id | 30820451 | Outcome Id | 30820451 | Outcome Id | 30820451 | Outcome Id | 30820452 | Outcome Id | 30820452 | Outcome Id | 30820452 | Outcome Id | 30820452 | Outcome Id | 30820452 | Outcome Id | 30820452 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820457 | Outcome Id | 30820457 | Outcome Id | 30820457 | Outcome Id | 30820457 | Outcome Id | 30820457 | Outcome Id | 30820457 | Outcome Id | 30820457 | Outcome Id | 30820457 | Outcome Id | 30820457 | Outcome Id | 30820458 | Outcome Id | 30820458 | Outcome Id | 30820458 | Outcome Id | 30820458 | Outcome Id | 30820458 | Outcome Id | 30820458 | Outcome Id | 30820459 | Outcome Id | 30820459 | Outcome Id | 30820459 | Outcome Id | 30820459 | Outcome Id | 30820459 | Outcome Id | 30820459 | Outcome Id | 30820460 | Outcome Id | 30820460 | Outcome Id | 30820460 | Outcome Id | 30820460 | Outcome Id | 30820460 | Outcome Id | 30820460 | Outcome Id | 30820461 | Outcome Id | 30820461 | Outcome Id | 30820461 | Outcome Id | 30820461 | Outcome Id | 30820461 | Outcome Id | 30820461 | Outcome Id | 30820462 | Outcome Id | 30820462 | Outcome Id | 30820462 | Outcome Id | 30820462 | Outcome Id | 30820462 | Outcome Id | 30820462 | Outcome Id | 30820463 | Outcome Id | 30820463 | Outcome Id | 30820463 | Outcome Id | 30820463 | Outcome Id | 30820463 | Outcome Id | 30820463 | Outcome Id | 30820464 | Outcome Id | 30820464 | Outcome Id | 30820464 | Outcome Id | 30820464 | Outcome Id | 30820464 | Outcome Id | 30820464 |
Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112543 | Result Group Id | 56112544 | Result Group Id | 56112545 | Result Group Id | 56112546 | Result Group Id | 56112547 | Result Group Id | 56112548 | Result Group Id | 56112549 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112543 | Result Group Id | 56112544 | Result Group Id | 56112545 | Result Group Id | 56112546 | Result Group Id | 56112547 | Result Group Id | 56112548 | Result Group Id | 56112549 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112550 | Result Group Id | 56112544 | Result Group Id | 56112545 | Result Group Id | 56112546 | Result Group Id | 56112547 | Result Group Id | 56112548 | Result Group Id | 56112549 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112550 | Result Group Id | 56112544 | Result Group Id | 56112545 | Result Group Id | 56112546 | Result Group Id | 56112547 | Result Group Id | 56112548 | Result Group Id | 56112549 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112550 | Result Group Id | 56112544 | Result Group Id | 56112545 | Result Group Id | 56112546 | Result Group Id | 56112547 | Result Group Id | 56112548 | Result Group Id | 56112549 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112550 | Result Group Id | 56112544 | Result Group Id | 56112545 | Result Group Id | 56112546 | Result Group Id | 56112547 | Result Group Id | 56112548 | Result Group Id | 56112549 | Result Group Id | 56112551 | Result Group Id | 56112552 | Result Group Id | 56112553 | Result Group Id | 56112554 | Result Group Id | 56112555 | Result Group Id | 56112556 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112550 | Result Group Id | 56112544 | Result Group Id | 56112545 | Result Group Id | 56112546 | Result Group Id | 56112547 | Result Group Id | 56112548 | Result Group Id | 56112549 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112550 | Result Group Id | 56112544 | Result Group Id | 56112545 | Result Group Id | 56112546 | Result Group Id | 56112547 | Result Group Id | 56112548 | Result Group Id | 56112549 | Result Group Id | 56112551 | Result Group Id | 56112552 | Result Group Id | 56112553 | Result Group Id | 56112554 | Result Group Id | 56112555 | Result Group Id | 56112557 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112550 | Result Group Id | 56112544 | Result Group Id | 56112545 | Result Group Id | 56112546 | Result Group Id | 56112547 | Result Group Id | 56112548 | Result Group Id | 56112549 | Result Group Id | 56112558 | Result Group Id | 56112559 | Result Group Id | 56112560 | Result Group Id | 56112544 | Result Group Id | 56112545 | Result Group Id | 56112546 | Result Group Id | 56112547 | Result Group Id | 56112561 | Result Group Id | 56112562 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112550 | Result Group Id | 56112544 | Result Group Id | 56112545 | Result Group Id | 56112546 | Result Group Id | 56112547 | Result Group Id | 56112548 | Result Group Id | 56112549 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112550 | Result Group Id | 56112544 | Result Group Id | 56112545 | Result Group Id | 56112546 | Result Group Id | 56112547 | Result Group Id | 56112548 | Result Group Id | 56112549 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112550 | Result Group Id | 56112544 | Result Group Id | 56112545 | Result Group Id | 56112546 | Result Group Id | 56112547 | Result Group Id | 56112548 | Result Group Id | 56112549 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112563 | Result Group Id | 56112564 | Result Group Id | 56112565 | Result Group Id | 56112566 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112543 | Result Group Id | 56112544 | Result Group Id | 56112545 | Result Group Id | 56112546 | Result Group Id | 56112547 | Result Group Id | 56112548 | Result Group Id | 56112567 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112543 | Result Group Id | 56112544 | Result Group Id | 56112545 | Result Group Id | 56112546 | Result Group Id | 56112547 | Result Group Id | 56112548 | Result Group Id | 56112567 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112543 | Result Group Id | 56112544 | Result Group Id | 56112545 | Result Group Id | 56112546 | Result Group Id | 56112547 | Result Group Id | 56112548 | Result Group Id | 56112567 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112543 | Result Group Id | 56112544 | Result Group Id | 56112545 | Result Group Id | 56112546 | Result Group Id | 56112547 | Result Group Id | 56112548 | Result Group Id | 56112567 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112543 | Result Group Id | 56112544 | Result Group Id | 56112545 | Result Group Id | 56112546 | Result Group Id | 56112547 | Result Group Id | 56112548 | Result Group Id | 56112568 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112563 | Result Group Id | 56112564 | Result Group Id | 56112565 | Result Group Id | 56112566 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112563 | Result Group Id | 56112564 | Result Group Id | 56112565 | Result Group Id | 56112566 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112563 | Result Group Id | 56112564 | Result Group Id | 56112565 | Result Group Id | 56112566 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112563 | Result Group Id | 56112564 | Result Group Id | 56112565 | Result Group Id | 56112566 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112563 | Result Group Id | 56112564 | Result Group Id | 56112565 | Result Group Id | 56112566 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112563 | Result Group Id | 56112564 | Result Group Id | 56112565 | Result Group Id | 56112566 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112563 | Result Group Id | 56112564 | Result Group Id | 56112565 | Result Group Id | 56112566 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | 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Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 |
Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure |
Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants |
Count | 35 | Count | 34 | Count | 23 | Count | 18 | Count | 21 | Count | 21 | Count | 13 | Count | 5 | Count | 5 | Count | 34 | Count | 35 | Count | 23 | Count | 18 | Count | 21 | Count | 21 | Count | 13 | Count | 5 | Count | 5 | Count | 34 | Count | 35 | Count | 23 | Count | 18 | Count | 21 | Count | 21 | Count | 13 | Count | 5 | Count | 5 | Count | 34 | Count | 35 | Count | 23 | Count | 18 | Count | 21 | Count | 21 | Count | 13 | Count | 5 | Count | 5 | Count | 30 | Count | 27 | Count | 23 | Count | 10 | Count | 16 | Count | 13 | Count | 12 | Count | 3 | Count | 5 | Count | 30 | Count | 30 | Count | 23 | Count | 12 | Count | 18 | Count | 14 | Count | 12 | Count | 4 | Count | 5 | Count | 1 | Count | 4 | Count | 7 | Count | 5 | Count | 17 | Count | 0 | Count | 26 | Count | 24 | Count | 23 | Count | 7 | Count | 14 | Count | 10 | Count | 12 | Count | 3 | Count | 4 | Count | 26 | Count | 24 | Count | 23 | Count | 7 | Count | 14 | Count | 10 | Count | 12 | Count | 3 | Count | 4 | Count | 1 | Count | 4 | Count | 7 | Count | 5 | Count | 17 | Count | 0 | Count | 30 | Count | 30 | Count | 23 | Count | 12 | Count | 18 | Count | 14 | Count | 12 | Count | 4 | Count | 5 | Count | 26 | Count | 24 | Count | 23 | Count | 7 | Count | 14 | Count | 10 | Count | 12 | Count | 3 | Count | 4 | Count | 35 | Count | 34 | Count | 23 | Count | 18 | Count | 21 | Count | 21 | Count | 13 | Count | 5 | Count | 5 | Count | 35 | Count | 34 | Count | 23 | Count | 18 | Count | 21 | Count | 21 | Count | 13 | Count | 5 | Count | 5 | Count | 35 | Count | 34 | Count | 23 | Count | 18 | Count | 21 | Count | 21 | Count | 13 | Count | 5 | Count | 5 | Count | 33 | Count | 30 | Count | 15 | Count | 21 | Count | 15 | Count | 5 | Count | 30 | Count | 32 | Count | 21 | Count | 18 | Count | 20 | Count | 21 | Count | 11 | Count | 5 | Count | 5 | Count | 35 | Count | 34 | Count | 23 | Count | 18 | Count | 21 | Count | 21 | Count | 13 | Count | 5 | Count | 5 | Count | 34 | Count | 34 | Count | 23 | Count | 18 | Count | 21 | Count | 21 | Count | 13 | Count | 5 | Count | 5 | Count | 35 | Count | 34 | Count | 23 | Count | 18 | Count | 21 | Count | 21 | Count | 13 | Count | 5 | Count | 5 | Count | 35 | Count | 34 | Count | 21 | Count | 17 | Count | 21 | Count | 21 | Count | 13 | Count | 5 | Count | 5 | Count | 32 | Count | 30 | Count | 14 | Count | 21 | Count | 17 | Count | 5 | Count | 29 | Count | 28 | Count | 13 | Count | 21 | Count | 13 | Count | 5 | Count | 17 | Count | 17 | Count | 8 | Count | 8 | Count | 6 | Count | 2 | Count | 32 | Count | 30 | Count | 14 | Count | 21 | Count | 17 | Count | 5 | Count | 17 | Count | 17 | Count | 8 | Count | 8 | Count | 6 | Count | 2 | Count | 29 | Count | 28 | Count | 13 | Count | 21 | Count | 13 | Count | 5 | Count | 16 | Count | 15 | Count | 8 | Count | 8 | Count | 6 | Count | 2 |
Provided Documents
Sequence: | 2581571 | Sequence: | 2581572 |
Document Type | Study Protocol | Document Type | Statistical Analysis Plan |
Has Protocol | True | Has Protocol | False |
Has Icf | False | Has Icf | False |
Has Sap | False | Has Sap | True |
Document Date | 2018-06-27 | Document Date | 2020-07-02 |
Url | https://ClinicalTrials.gov/ProvidedDocs/27/NCT03799627/Prot_000.pdf | Url | https://ClinicalTrials.gov/ProvidedDocs/27/NCT03799627/SAP_001.pdf |
Reported Event Totals
Sequence: | 27955798 | Sequence: | 27955799 | Sequence: | 27955800 | Sequence: | 27955801 | Sequence: | 27955802 | Sequence: | 27955803 | Sequence: | 27955804 | Sequence: | 27955805 | Sequence: | 27955806 | Sequence: | 27955807 | Sequence: | 27955808 | Sequence: | 27955809 | Sequence: | 27955810 | Sequence: | 27955811 | Sequence: | 27955812 | Sequence: | 27955813 | Sequence: | 27955814 | Sequence: | 27955815 | Sequence: | 27955816 | Sequence: | 27955817 | Sequence: | 27955818 | Sequence: | 27955819 | Sequence: | 27955820 | Sequence: | 27955821 | Sequence: | 27955822 | Sequence: | 27955823 | Sequence: | 27955824 |
Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG001 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG002 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG003 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG004 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG005 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG006 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG007 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG008 | Ctgov Group Code | EG008 |
Event Type | serious | Event Type | other | Event Type | deaths | Event Type | serious | Event Type | other | Event Type | deaths | Event Type | serious | Event Type | other | Event Type | deaths | Event Type | serious | Event Type | other | Event Type | deaths | Event Type | serious | Event Type | other | Event Type | deaths | Event Type | serious | Event Type | other | Event Type | deaths | Event Type | serious | Event Type | other | Event Type | deaths | Event Type | serious | Event Type | other | Event Type | deaths | Event Type | serious | Event Type | other | Event Type | deaths |
Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality | Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality | Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality | Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality | Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality | Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality | Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality | Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality | Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality |
Subjects Affected | 9 | Subjects Affected | 11 | Subjects Affected | 0 | Subjects Affected | 7 | Subjects Affected | 20 | Subjects Affected | 0 | Subjects Affected | 5 | Subjects Affected | 10 | Subjects Affected | 0 | Subjects Affected | 8 | Subjects Affected | 9 | Subjects Affected | 1 | Subjects Affected | 6 | Subjects Affected | 9 | Subjects Affected | 1 | Subjects Affected | 10 | Subjects Affected | 10 | Subjects Affected | 1 | Subjects Affected | 5 | Subjects Affected | 8 | Subjects Affected | 1 | Subjects Affected | 4 | Subjects Affected | 4 | Subjects Affected | 0 | Subjects Affected | 3 | Subjects Affected | 2 | Subjects Affected | 0 |
Subjects At Risk | 34 | Subjects At Risk | 34 | Subjects At Risk | 34 | Subjects At Risk | 35 | Subjects At Risk | 35 | Subjects At Risk | 35 | Subjects At Risk | 23 | Subjects At Risk | 23 | Subjects At Risk | 23 | Subjects At Risk | 18 | Subjects At Risk | 18 | Subjects At Risk | 18 | Subjects At Risk | 21 | Subjects At Risk | 21 | Subjects At Risk | 21 | Subjects At Risk | 21 | Subjects At Risk | 21 | Subjects At Risk | 21 | Subjects At Risk | 13 | Subjects At Risk | 13 | Subjects At Risk | 13 | Subjects At Risk | 5 | Subjects At Risk | 5 | Subjects At Risk | 5 | Subjects At Risk | 5 | Subjects At Risk | 5 | Subjects At Risk | 5 |
Created At | 2023-08-09 03:55:44.020012 | Created At | 2023-08-09 03:55:44.020012 | Created At | 2023-08-09 03:55:44.020012 | Created At | 2023-08-09 03:55:44.020012 | Created At | 2023-08-09 03:55:44.020012 | Created At | 2023-08-09 03:55:44.020012 | Created At | 2023-08-09 03:55:44.020012 | Created At | 2023-08-09 03:55:44.020012 | Created At | 2023-08-09 03:55:44.020012 | Created At | 2023-08-09 03:55:44.020012 | Created At | 2023-08-09 03:55:44.020012 | Created At | 2023-08-09 03:55:44.020012 | Created At | 2023-08-09 03:55:44.020012 | Created At | 2023-08-09 03:55:44.020012 | Created At | 2023-08-09 03:55:44.020012 | Created At | 2023-08-09 03:55:44.020012 | Created At | 2023-08-09 03:55:44.020012 | Created At | 2023-08-09 03:55:44.020012 | Created At | 2023-08-09 03:55:44.020012 | Created At | 2023-08-09 03:55:44.020012 | Created At | 2023-08-09 03:55:44.020012 | Created At | 2023-08-09 03:55:44.020012 | Created At | 2023-08-09 03:55:44.020012 | Created At | 2023-08-09 03:55:44.020012 | Created At | 2023-08-09 03:55:44.020012 | Created At | 2023-08-09 03:55:44.020012 | Created At | 2023-08-09 03:55:44.020012 |
Updated At | 2023-08-09 03:55:44.020012 | Updated At | 2023-08-09 03:55:44.020012 | Updated At | 2023-08-09 03:55:44.020012 | Updated At | 2023-08-09 03:55:44.020012 | Updated At | 2023-08-09 03:55:44.020012 | Updated At | 2023-08-09 03:55:44.020012 | Updated At | 2023-08-09 03:55:44.020012 | Updated At | 2023-08-09 03:55:44.020012 | Updated At | 2023-08-09 03:55:44.020012 | Updated At | 2023-08-09 03:55:44.020012 | Updated At | 2023-08-09 03:55:44.020012 | Updated At | 2023-08-09 03:55:44.020012 | Updated At | 2023-08-09 03:55:44.020012 | Updated At | 2023-08-09 03:55:44.020012 | Updated At | 2023-08-09 03:55:44.020012 | Updated At | 2023-08-09 03:55:44.020012 | Updated At | 2023-08-09 03:55:44.020012 | Updated At | 2023-08-09 03:55:44.020012 | Updated At | 2023-08-09 03:55:44.020012 | Updated At | 2023-08-09 03:55:44.020012 | Updated At | 2023-08-09 03:55:44.020012 | Updated At | 2023-08-09 03:55:44.020012 | Updated At | 2023-08-09 03:55:44.020012 | Updated At | 2023-08-09 03:55:44.020012 | Updated At | 2023-08-09 03:55:44.020012 | Updated At | 2023-08-09 03:55:44.020012 | Updated At | 2023-08-09 03:55:44.020012 |
Reported Events
Sequence: | 528504815 | Sequence: | 528504736 | Sequence: | 528504737 | Sequence: | 528504738 | Sequence: | 528504816 | Sequence: | 528504817 | Sequence: | 528504818 | Sequence: | 528504819 | Sequence: | 528504739 | Sequence: | 528504820 | Sequence: | 528504740 | Sequence: | 528504741 | Sequence: | 528504742 | Sequence: | 528504743 | Sequence: | 528504733 | Sequence: | 528504734 | Sequence: | 528504735 | Sequence: | 528504744 | Sequence: | 528504745 | Sequence: | 528504746 | Sequence: | 528504747 | Sequence: | 528504748 | Sequence: | 528504749 | Sequence: | 528504750 | Sequence: | 528504751 | Sequence: | 528504752 | Sequence: | 528504753 | Sequence: | 528504754 | Sequence: | 528504755 | Sequence: | 528504756 | Sequence: | 528504757 | Sequence: | 528504758 | Sequence: | 528504759 | Sequence: | 528504760 | Sequence: | 528504761 | Sequence: | 528504762 | Sequence: | 528504763 | Sequence: | 528504764 | Sequence: | 528504765 | Sequence: | 528504766 | Sequence: | 528504767 | Sequence: | 528504768 | Sequence: | 528504769 | Sequence: | 528504770 | Sequence: | 528504771 | Sequence: | 528504772 | Sequence: | 528504773 | Sequence: | 528504774 | Sequence: | 528504775 | Sequence: | 528504776 | Sequence: | 528504777 | Sequence: | 528504778 | Sequence: | 528504779 | Sequence: | 528504780 | Sequence: | 528504781 | Sequence: | 528504782 | Sequence: | 528504783 | Sequence: | 528504784 | Sequence: | 528504785 | Sequence: | 528504786 | Sequence: | 528504787 | Sequence: | 528504788 | Sequence: | 528504789 | Sequence: | 528504790 | Sequence: | 528504791 | Sequence: | 528504792 | Sequence: | 528504793 | Sequence: | 528504794 | Sequence: | 528504795 | Sequence: | 528504796 | Sequence: | 528504797 | Sequence: | 528504798 | Sequence: | 528504799 | Sequence: | 528504800 | Sequence: | 528504801 | Sequence: | 528504802 | Sequence: | 528504803 | Sequence: | 528504804 | Sequence: | 528504805 | Sequence: | 528504806 | Sequence: | 528504807 | Sequence: | 528504808 | Sequence: | 528504809 | Sequence: | 528504810 | Sequence: | 528504811 | Sequence: | 528504812 | Sequence: | 528504813 | Sequence: | 528504814 | Sequence: | 528504821 | Sequence: | 528504822 | Sequence: | 528504823 | Sequence: | 528504824 | Sequence: | 528504825 | Sequence: | 528504826 | Sequence: | 528504827 | Sequence: | 528504828 | Sequence: | 528504829 | Sequence: | 528504830 | Sequence: | 528504831 | Sequence: | 528504832 | Sequence: | 528504833 | Sequence: | 528504834 | Sequence: | 528504835 | Sequence: | 528504836 | Sequence: | 528504837 | Sequence: | 528504838 | Sequence: | 528504839 | Sequence: | 528504840 | Sequence: | 528504841 | Sequence: | 528504842 | Sequence: | 528504843 | Sequence: | 528504844 | Sequence: | 528504845 | Sequence: | 528504846 | Sequence: | 528504847 | Sequence: | 528504848 | Sequence: | 528504849 | Sequence: | 528504850 | Sequence: | 528504851 | Sequence: | 528504852 | Sequence: | 528504853 | Sequence: | 528504854 | Sequence: | 528504855 | Sequence: | 528504856 | Sequence: | 528504857 | Sequence: | 528504858 | Sequence: | 528504859 | Sequence: | 528504860 | Sequence: | 528504861 | Sequence: | 528504862 | Sequence: | 528504863 | Sequence: | 528504864 | Sequence: | 528504865 | Sequence: | 528504866 | Sequence: | 528504867 | Sequence: | 528504868 | Sequence: | 528504869 | Sequence: | 528504870 | Sequence: | 528504871 | Sequence: | 528504872 | Sequence: | 528504873 | Sequence: | 528504874 | Sequence: | 528504875 | Sequence: | 528504876 | Sequence: | 528504877 | Sequence: | 528504878 | Sequence: | 528504879 | Sequence: | 528504880 | Sequence: | 528504881 | Sequence: | 528504882 | Sequence: | 528504883 | Sequence: | 528504884 | Sequence: | 528504885 | Sequence: | 528504886 | Sequence: | 528504887 | Sequence: | 528504888 | Sequence: | 528504889 | Sequence: | 528504890 | Sequence: | 528504891 | Sequence: | 528504892 | Sequence: | 528504893 | Sequence: | 528504894 | Sequence: | 528504895 | Sequence: | 528504896 | Sequence: | 528504897 | Sequence: | 528504898 | Sequence: | 528504899 | Sequence: | 528504900 | Sequence: | 528504901 | Sequence: | 528504902 | Sequence: | 528504903 | Sequence: | 528504904 | Sequence: | 528504905 | Sequence: | 528504906 | Sequence: | 528504907 | Sequence: | 528504908 | Sequence: | 528504909 | Sequence: | 528504910 | Sequence: | 528504911 | Sequence: | 528504912 | Sequence: | 528504913 | Sequence: | 528504914 | Sequence: | 528504915 | Sequence: | 528504916 | Sequence: | 528504917 | Sequence: | 528504918 | Sequence: | 528504919 | Sequence: | 528504920 | Sequence: | 528504921 | Sequence: | 528504922 | Sequence: | 528504923 | Sequence: | 528504924 | Sequence: | 528504925 | Sequence: | 528504926 | Sequence: | 528504927 | Sequence: | 528504928 | Sequence: | 528504929 | Sequence: | 528504930 | Sequence: | 528504931 | Sequence: | 528504932 | Sequence: | 528504933 | Sequence: | 528504934 | Sequence: | 528504935 | Sequence: | 528504936 | Sequence: | 528504937 | Sequence: | 528504938 | Sequence: | 528504939 | Sequence: | 528504940 | Sequence: | 528504941 | Sequence: | 528504942 | Sequence: | 528504943 | Sequence: | 528504944 | Sequence: | 528504945 | Sequence: | 528504946 | Sequence: | 528504947 | Sequence: | 528504948 | Sequence: | 528504949 | Sequence: | 528504950 | Sequence: | 528504951 | Sequence: | 528504952 | Sequence: | 528504953 | Sequence: | 528504954 | Sequence: | 528504955 | Sequence: | 528504956 | Sequence: | 528504957 | Sequence: | 528504958 | Sequence: | 528504959 | Sequence: | 528504960 | Sequence: | 528504961 | Sequence: | 528504962 | Sequence: | 528504963 | Sequence: | 528504964 | Sequence: | 528504965 | Sequence: | 528504966 | Sequence: | 528504967 | Sequence: | 528504968 | Sequence: | 528504969 | Sequence: | 528504970 | Sequence: | 528504971 | Sequence: | 528504972 | Sequence: | 528504973 | Sequence: | 528504974 | Sequence: | 528504975 | Sequence: | 528504976 | Sequence: | 528504977 | Sequence: | 528504978 | Sequence: | 528504979 | Sequence: | 528504980 | Sequence: | 528504981 | Sequence: | 528504982 | Sequence: | 528504983 | Sequence: | 528504984 | Sequence: | 528504985 | Sequence: | 528504986 | Sequence: | 528504987 | Sequence: | 528504988 | Sequence: | 528504989 | Sequence: | 528504990 | Sequence: | 528504991 | Sequence: | 528504992 | Sequence: | 528504993 | Sequence: | 528504994 | Sequence: | 528504995 | Sequence: | 528504996 | Sequence: | 528504997 | Sequence: | 528504998 | Sequence: | 528504999 | Sequence: | 528505000 | Sequence: | 528505001 | Sequence: | 528505002 | Sequence: | 528505003 | Sequence: | 528505004 | Sequence: | 528505005 | Sequence: | 528505006 | Sequence: | 528505007 | Sequence: | 528505008 | Sequence: | 528505009 | Sequence: | 528505010 | Sequence: | 528505011 | Sequence: | 528505012 | Sequence: | 528505013 | Sequence: | 528505014 | Sequence: | 528505015 | Sequence: | 528505016 | Sequence: | 528505017 | Sequence: | 528505018 | Sequence: | 528505019 | Sequence: | 528505020 | Sequence: | 528505021 | Sequence: | 528505022 | Sequence: | 528505023 | Sequence: | 528505024 | Sequence: | 528505025 | Sequence: | 528505026 | Sequence: | 528505027 | Sequence: | 528505028 | Sequence: | 528505029 | Sequence: | 528505030 | Sequence: | 528505031 | Sequence: | 528505032 | Sequence: | 528505033 | Sequence: | 528505034 | Sequence: | 528505035 | Sequence: | 528505036 | Sequence: | 528505037 | Sequence: | 528505038 | Sequence: | 528505039 | Sequence: | 528505040 | Sequence: | 528505041 | Sequence: | 528505042 | Sequence: | 528505043 | Sequence: | 528505044 | Sequence: | 528505045 | Sequence: | 528505046 | Sequence: | 528505047 | Sequence: | 528505048 | Sequence: | 528505049 | Sequence: | 528505050 | Sequence: | 528505051 | Sequence: | 528505052 | Sequence: | 528505053 | Sequence: | 528505054 | Sequence: | 528505055 | Sequence: | 528505056 | Sequence: | 528505057 | Sequence: | 528505058 | Sequence: | 528505059 | Sequence: | 528505060 | Sequence: | 528505061 | Sequence: | 528505062 | Sequence: | 528505063 | Sequence: | 528505064 | Sequence: | 528505065 | Sequence: | 528505066 | Sequence: | 528505067 | Sequence: | 528505068 | Sequence: | 528505069 | Sequence: | 528505070 | Sequence: | 528505071 | Sequence: | 528505072 | Sequence: | 528505073 | Sequence: | 528505074 | Sequence: | 528505075 | Sequence: | 528505076 | Sequence: | 528505077 | Sequence: | 528505078 | Sequence: | 528505079 | Sequence: | 528505080 | Sequence: | 528505081 | Sequence: | 528505082 | Sequence: | 528505083 | Sequence: | 528505084 | Sequence: | 528505085 | Sequence: | 528505086 | Sequence: | 528505087 | Sequence: | 528505088 | Sequence: | 528505089 | Sequence: | 528505090 | Sequence: | 528505091 | Sequence: | 528505092 | Sequence: | 528505093 | Sequence: | 528505094 | Sequence: | 528505095 | Sequence: | 528505096 | Sequence: | 528505097 | Sequence: | 528505098 | Sequence: | 528505099 | Sequence: | 528505100 | Sequence: | 528505101 | Sequence: | 528505102 | Sequence: | 528505103 | Sequence: | 528505104 | Sequence: | 528505105 | Sequence: | 528505106 | Sequence: | 528505107 | Sequence: | 528505108 | Sequence: | 528505109 | Sequence: | 528505110 | Sequence: | 528505111 | Sequence: | 528505112 | Sequence: | 528505113 | Sequence: | 528505114 | Sequence: | 528505115 | Sequence: | 528505116 | Sequence: | 528505117 | Sequence: | 528505118 | Sequence: | 528505119 | Sequence: | 528505120 | Sequence: | 528505121 | Sequence: | 528505122 | Sequence: | 528505123 | Sequence: | 528505124 | Sequence: | 528505125 | Sequence: | 528505126 | Sequence: | 528505127 | Sequence: | 528505128 | Sequence: | 528505129 | Sequence: | 528505130 | Sequence: | 528505131 | Sequence: | 528505132 | Sequence: | 528505133 | Sequence: | 528505134 | Sequence: | 528505135 | Sequence: | 528505136 | Sequence: | 528505137 | Sequence: | 528505138 | Sequence: | 528505139 | Sequence: | 528505140 | Sequence: | 528505141 | Sequence: | 528505142 | Sequence: | 528505143 | Sequence: | 528505144 | Sequence: | 528505145 | Sequence: | 528505146 | Sequence: | 528505147 | Sequence: | 528505148 | Sequence: | 528505149 | Sequence: | 528505150 | Sequence: | 528505151 | Sequence: | 528505152 | Sequence: | 528505153 | Sequence: | 528505154 | Sequence: | 528505155 | Sequence: | 528505156 | Sequence: | 528505157 | Sequence: | 528505158 | Sequence: | 528505159 | Sequence: | 528505160 | Sequence: | 528505161 | Sequence: | 528505162 | Sequence: | 528505163 | Sequence: | 528505164 | Sequence: | 528505165 | Sequence: | 528505166 | Sequence: | 528505167 | Sequence: | 528505168 | Sequence: | 528505169 | Sequence: | 528505170 | Sequence: | 528505171 | Sequence: | 528505172 | Sequence: | 528505173 | Sequence: | 528505174 | Sequence: | 528505175 | Sequence: | 528505176 | Sequence: | 528505177 | Sequence: | 528505178 | Sequence: | 528505179 | Sequence: | 528505180 | Sequence: | 528505181 | Sequence: | 528505182 | Sequence: | 528505183 | Sequence: | 528505184 | Sequence: | 528505185 | Sequence: | 528505186 | Sequence: | 528505187 | Sequence: | 528505188 | Sequence: | 528505189 | Sequence: | 528505190 | Sequence: | 528505191 | Sequence: | 528505192 | Sequence: | 528505193 | Sequence: | 528505194 | Sequence: | 528505195 | Sequence: | 528505196 | Sequence: | 528505197 | Sequence: | 528505198 | Sequence: | 528505199 | Sequence: | 528505200 | Sequence: | 528505201 | Sequence: | 528505202 | Sequence: | 528505203 | Sequence: | 528505204 | Sequence: | 528505205 | Sequence: | 528505206 | Sequence: | 528505207 | Sequence: | 528505208 | Sequence: | 528505209 | Sequence: | 528505210 | Sequence: | 528505211 | Sequence: | 528505212 | Sequence: | 528505213 | Sequence: | 528505214 | Sequence: | 528505215 | Sequence: | 528505216 | Sequence: | 528505217 | Sequence: | 528505218 | Sequence: | 528505219 | Sequence: | 528505220 | Sequence: | 528505221 | Sequence: | 528505222 | Sequence: | 528505223 | Sequence: | 528505224 | Sequence: | 528505225 | Sequence: | 528505226 | Sequence: | 528505227 | Sequence: | 528505228 | Sequence: | 528505229 | Sequence: | 528505230 | Sequence: | 528505231 | Sequence: | 528505232 | Sequence: | 528505233 | Sequence: | 528505234 | Sequence: | 528505235 | Sequence: | 528505236 | Sequence: | 528505237 | Sequence: | 528505238 | Sequence: | 528505239 | Sequence: | 528505240 | Sequence: | 528505241 | Sequence: | 528505242 | Sequence: | 528505243 | Sequence: | 528505244 | Sequence: | 528505245 | Sequence: | 528505246 | Sequence: | 528505247 | Sequence: | 528505248 | Sequence: | 528505249 | Sequence: | 528505250 | Sequence: | 528505251 | Sequence: | 528505252 | Sequence: | 528505253 | Sequence: | 528505254 | Sequence: | 528505255 | Sequence: | 528505256 | Sequence: | 528505257 | Sequence: | 528505258 | Sequence: | 528505259 | Sequence: | 528505260 | Sequence: | 528505261 | Sequence: | 528505262 | Sequence: | 528505263 | Sequence: | 528505264 | Sequence: | 528505265 | Sequence: | 528505266 | Sequence: | 528505267 | Sequence: | 528505268 | Sequence: | 528505269 | Sequence: | 528505270 | Sequence: | 528505271 | Sequence: | 528505272 | Sequence: | 528505273 | Sequence: | 528505274 | Sequence: | 528505275 | Sequence: | 528505276 | Sequence: | 528505277 | Sequence: | 528505278 | Sequence: | 528505279 | Sequence: | 528505280 | Sequence: | 528505281 | Sequence: | 528505282 | Sequence: | 528505283 | Sequence: | 528505284 | Sequence: | 528505285 | Sequence: | 528505286 | Sequence: | 528505287 | Sequence: | 528505288 | Sequence: | 528505289 | Sequence: | 528505290 | Sequence: | 528505291 | Sequence: | 528505292 | Sequence: | 528505293 | Sequence: | 528505294 | Sequence: | 528505295 | Sequence: | 528505296 | Sequence: | 528505297 | Sequence: | 528505298 | Sequence: | 528505299 | Sequence: | 528505300 | Sequence: | 528505301 | Sequence: | 528505302 | Sequence: | 528505303 | Sequence: | 528505304 | Sequence: | 528505305 | Sequence: | 528505306 | Sequence: | 528505307 | Sequence: | 528505308 | Sequence: | 528505309 | Sequence: | 528505310 | Sequence: | 528505311 | Sequence: | 528505312 | Sequence: | 528505313 | Sequence: | 528505314 | Sequence: | 528505315 | Sequence: | 528505316 | Sequence: | 528505317 | Sequence: | 528505318 | Sequence: | 528505319 | Sequence: | 528505320 | Sequence: | 528505321 | Sequence: | 528505322 | Sequence: | 528505323 | Sequence: | 528505324 | Sequence: | 528505325 | Sequence: | 528505326 | Sequence: | 528505327 | Sequence: | 528505328 | Sequence: | 528505329 | Sequence: | 528505330 | Sequence: | 528505331 | Sequence: | 528505332 | Sequence: | 528505333 | Sequence: | 528505334 | Sequence: | 528505335 | Sequence: | 528505336 | Sequence: | 528505337 | Sequence: | 528505338 | Sequence: | 528505339 | Sequence: | 528505340 | Sequence: | 528505341 | Sequence: | 528505342 | Sequence: | 528505343 | Sequence: | 528505344 | Sequence: | 528505345 | Sequence: | 528505346 | Sequence: | 528505347 | Sequence: | 528505348 | Sequence: | 528505349 | Sequence: | 528505350 | Sequence: | 528505351 | Sequence: | 528505352 | Sequence: | 528505353 | Sequence: | 528505354 | Sequence: | 528505355 | Sequence: | 528505356 | Sequence: | 528505357 | Sequence: | 528505358 | Sequence: | 528505359 | Sequence: | 528505360 | Sequence: | 528505361 | Sequence: | 528505362 | Sequence: | 528505363 | Sequence: | 528505364 | Sequence: | 528505365 | Sequence: | 528505366 | Sequence: | 528505367 | Sequence: | 528505368 | Sequence: | 528505369 | Sequence: | 528505370 | Sequence: | 528505371 | Sequence: | 528505372 | Sequence: | 528505373 | Sequence: | 528505374 | Sequence: | 528505375 | Sequence: | 528505376 | Sequence: | 528505377 | Sequence: | 528505378 | Sequence: | 528505379 | Sequence: | 528505380 | Sequence: | 528505381 | Sequence: | 528505382 | Sequence: | 528505383 | Sequence: | 528505384 | Sequence: | 528505385 | Sequence: | 528505386 | Sequence: | 528505387 | Sequence: | 528505388 | Sequence: | 528505389 | Sequence: | 528505390 | Sequence: | 528505391 | Sequence: | 528505392 | Sequence: | 528505393 | Sequence: | 528505394 | Sequence: | 528505395 | Sequence: | 528505396 | Sequence: | 528505397 | Sequence: | 528505398 | Sequence: | 528505399 | Sequence: | 528505400 | Sequence: | 528505401 | Sequence: | 528505402 | Sequence: | 528505403 | Sequence: | 528505404 | Sequence: | 528505405 | Sequence: | 528505406 | Sequence: | 528505407 | Sequence: | 528505408 | Sequence: | 528505409 | Sequence: | 528505410 | Sequence: | 528505411 | Sequence: | 528505412 | Sequence: | 528505413 | Sequence: | 528505414 | Sequence: | 528505415 | Sequence: | 528505416 | Sequence: | 528505417 | Sequence: | 528505418 | Sequence: | 528505419 | Sequence: | 528505420 | Sequence: | 528505421 | Sequence: | 528505422 | Sequence: | 528505423 | Sequence: | 528505424 | Sequence: | 528505425 | Sequence: | 528505426 | Sequence: | 528505427 | Sequence: | 528505428 | Sequence: | 528505429 | Sequence: | 528505430 | Sequence: | 528505431 | Sequence: | 528505432 | Sequence: | 528505433 | Sequence: | 528505434 | Sequence: | 528505435 | Sequence: | 528505436 | Sequence: | 528505437 | Sequence: | 528505438 | Sequence: | 528505439 | Sequence: | 528505440 | Sequence: | 528505441 | Sequence: | 528505442 | Sequence: | 528505443 | Sequence: | 528505444 | Sequence: | 528505445 | Sequence: | 528505446 | Sequence: | 528505447 | Sequence: | 528505448 | Sequence: | 528505449 | Sequence: | 528505450 | Sequence: | 528505451 | Sequence: | 528505452 | Sequence: | 528505453 | Sequence: | 528505454 | Sequence: | 528505455 | Sequence: | 528505456 | Sequence: | 528505457 | Sequence: | 528505458 | Sequence: | 528505459 | Sequence: | 528505460 | Sequence: | 528505461 | Sequence: | 528505462 | Sequence: | 528505463 | Sequence: | 528505464 | Sequence: | 528505465 | Sequence: | 528505466 | Sequence: | 528505467 | Sequence: | 528505468 | Sequence: | 528505469 | Sequence: | 528505470 | Sequence: | 528505471 | Sequence: | 528505472 | Sequence: | 528505473 | Sequence: | 528505474 | Sequence: | 528505475 | Sequence: | 528505476 | Sequence: | 528505477 | Sequence: | 528505478 | Sequence: | 528505479 | Sequence: | 528505480 | Sequence: | 528505481 | Sequence: | 528505482 | Sequence: | 528505483 | Sequence: | 528505484 | Sequence: | 528505485 | Sequence: | 528505486 | Sequence: | 528505487 | Sequence: | 528505488 | Sequence: | 528505489 | Sequence: | 528505490 | Sequence: | 528505491 | Sequence: | 528505492 | Sequence: | 528505493 | Sequence: | 528505494 | Sequence: | 528505495 | Sequence: | 528505496 | Sequence: | 528505497 | Sequence: | 528505498 | Sequence: | 528505499 | Sequence: | 528505500 | Sequence: | 528505501 | Sequence: | 528505502 | Sequence: | 528505503 | Sequence: | 528505504 | Sequence: | 528505505 | Sequence: | 528505506 | Sequence: | 528505507 | Sequence: | 528505508 | Sequence: | 528505509 | Sequence: | 528505510 | Sequence: | 528505511 | Sequence: | 528505512 | Sequence: | 528505513 | Sequence: | 528505514 | Sequence: | 528505515 | Sequence: | 528505516 | Sequence: | 528505517 | Sequence: | 528505518 | Sequence: | 528505519 | Sequence: | 528505520 | Sequence: | 528505521 | Sequence: | 528505522 | Sequence: | 528505523 | Sequence: | 528505524 | Sequence: | 528505525 | Sequence: | 528505526 | Sequence: | 528505527 | Sequence: | 528505528 | Sequence: | 528505529 | Sequence: | 528505530 | Sequence: | 528505531 | Sequence: | 528505532 | Sequence: | 528505533 | Sequence: | 528505534 | Sequence: | 528505535 | Sequence: | 528505536 | Sequence: | 528505537 | Sequence: | 528505538 | Sequence: | 528505539 | Sequence: | 528505540 | Sequence: | 528505541 | Sequence: | 528505542 | Sequence: | 528505543 | Sequence: | 528505544 | Sequence: | 528505545 | Sequence: | 528505546 | Sequence: | 528505547 | Sequence: | 528505548 | Sequence: | 528505549 | Sequence: | 528505550 | Sequence: | 528505551 | Sequence: | 528505552 | Sequence: | 528505553 | Sequence: | 528505554 | Sequence: | 528505555 | Sequence: | 528505556 | Sequence: | 528505557 | Sequence: | 528505558 | Sequence: | 528505559 | Sequence: | 528505560 | Sequence: | 528505561 | Sequence: | 528505562 | Sequence: | 528505563 | Sequence: | 528505564 | Sequence: | 528505565 | Sequence: | 528505566 | Sequence: | 528505567 | Sequence: | 528505568 | Sequence: | 528505569 | Sequence: | 528505570 | Sequence: | 528505571 | Sequence: | 528505572 | Sequence: | 528505573 | Sequence: | 528505574 | Sequence: | 528505575 | Sequence: | 528505576 | Sequence: | 528505577 | Sequence: | 528505578 | Sequence: | 528505579 | Sequence: | 528505580 | Sequence: | 528505581 | Sequence: | 528505582 | Sequence: | 528505583 | Sequence: | 528505584 | Sequence: | 528505585 | Sequence: | 528505586 | Sequence: | 528505587 | Sequence: | 528505588 | Sequence: | 528505589 | Sequence: | 528505590 | Sequence: | 528505591 | Sequence: | 528505592 | Sequence: | 528505593 | Sequence: | 528505594 | Sequence: | 528505595 | Sequence: | 528505596 | Sequence: | 528505597 | Sequence: | 528505598 | Sequence: | 528505599 | Sequence: | 528505600 | Sequence: | 528505601 | Sequence: | 528505602 | Sequence: | 528505603 | Sequence: | 528505604 | Sequence: | 528505605 | Sequence: | 528505606 | Sequence: | 528505607 | Sequence: | 528505608 | Sequence: | 528505609 | Sequence: | 528505610 | Sequence: | 528505611 | Sequence: | 528505612 | Sequence: | 528505613 | Sequence: | 528505614 | Sequence: | 528505615 | Sequence: | 528505616 | Sequence: | 528505617 | Sequence: | 528505618 | Sequence: | 528505619 | Sequence: | 528505620 | Sequence: | 528505621 | Sequence: | 528505622 | Sequence: | 528505623 | Sequence: | 528505624 | Sequence: | 528505625 | Sequence: | 528505626 | Sequence: | 528505627 | Sequence: | 528505628 | Sequence: | 528505629 | Sequence: | 528505630 | Sequence: | 528505631 | Sequence: | 528505632 | Sequence: | 528505633 | Sequence: | 528505634 | Sequence: | 528505635 | Sequence: | 528505636 | Sequence: | 528505637 | Sequence: | 528505638 | Sequence: | 528505639 | Sequence: | 528505640 | Sequence: | 528505641 | Sequence: | 528505642 | Sequence: | 528505643 | Sequence: | 528505644 | Sequence: | 528505645 | Sequence: | 528505646 | Sequence: | 528505647 | Sequence: | 528505648 | Sequence: | 528505649 | Sequence: | 528505650 | Sequence: | 528505651 | Sequence: | 528505652 | Sequence: | 528505653 | Sequence: | 528505654 | Sequence: | 528505655 | Sequence: | 528505656 | Sequence: | 528505657 | Sequence: | 528505658 | Sequence: | 528505659 | Sequence: | 528505660 | Sequence: | 528505661 | Sequence: | 528505662 | Sequence: | 528505663 | Sequence: | 528505664 | Sequence: | 528505665 | Sequence: | 528505666 | Sequence: | 528505667 | Sequence: | 528505668 | Sequence: | 528505669 | Sequence: | 528505670 | Sequence: | 528505671 | Sequence: | 528505672 | Sequence: | 528505673 | Sequence: | 528505674 | Sequence: | 528505675 | Sequence: | 528505676 | Sequence: | 528505677 | Sequence: | 528505678 | Sequence: | 528505679 | Sequence: | 528505680 | Sequence: | 528505681 | Sequence: | 528505682 | Sequence: | 528505683 | Sequence: | 528505684 | Sequence: | 528505685 | Sequence: | 528505686 | Sequence: | 528505687 | Sequence: | 528505688 | Sequence: | 528505689 | Sequence: | 528505690 | Sequence: | 528505691 | Sequence: | 528505692 | Sequence: | 528505693 | Sequence: | 528505694 | Sequence: | 528505695 | Sequence: | 528505696 | Sequence: | 528505697 | Sequence: | 528505698 | Sequence: | 528505699 | Sequence: | 528505700 | Sequence: | 528505701 | Sequence: | 528505702 | Sequence: | 528505703 | Sequence: | 528505704 | Sequence: | 528505705 | Sequence: | 528505706 | Sequence: | 528505707 | Sequence: | 528505708 | Sequence: | 528505709 | Sequence: | 528505710 | Sequence: | 528505711 | Sequence: | 528505712 | Sequence: | 528505713 | Sequence: | 528505714 | Sequence: | 528505715 | Sequence: | 528505716 | Sequence: | 528505717 | Sequence: | 528505718 | Sequence: | 528505719 | Sequence: | 528505720 | Sequence: | 528505721 | Sequence: | 528505722 | Sequence: | 528505723 | Sequence: | 528505724 | Sequence: | 528505725 | Sequence: | 528505726 | Sequence: | 528505727 | Sequence: | 528505728 | Sequence: | 528505729 | Sequence: | 528505730 | Sequence: | 528505731 | Sequence: | 528505732 | Sequence: | 528505733 | Sequence: | 528505734 | Sequence: | 528505735 | Sequence: | 528505736 | Sequence: | 528505737 | Sequence: | 528505738 | Sequence: | 528505739 | Sequence: | 528505740 | Sequence: | 528505741 | Sequence: | 528505742 | Sequence: | 528505743 | Sequence: | 528505744 | Sequence: | 528505745 | Sequence: | 528505746 | Sequence: | 528505747 | Sequence: | 528505748 | Sequence: | 528505749 | Sequence: | 528505750 | Sequence: | 528505751 | Sequence: | 528505752 | Sequence: | 528505753 | Sequence: | 528505754 | Sequence: | 528505755 | Sequence: | 528505756 | Sequence: | 528505757 | Sequence: | 528505758 | Sequence: | 528505759 | Sequence: | 528505760 | Sequence: | 528505761 | Sequence: | 528505762 | Sequence: | 528505763 | Sequence: | 528505764 | Sequence: | 528505765 | Sequence: | 528505766 | Sequence: | 528505767 | Sequence: | 528505768 | Sequence: | 528505769 | Sequence: | 528505770 | Sequence: | 528505771 | Sequence: | 528505772 | Sequence: | 528505773 | Sequence: | 528505774 | Sequence: | 528505775 | Sequence: | 528505776 | Sequence: | 528505777 | Sequence: | 528505778 | Sequence: | 528505779 | Sequence: | 528505780 | Sequence: | 528505781 | Sequence: | 528505782 | Sequence: | 528505783 | Sequence: | 528505784 | Sequence: | 528505785 | Sequence: | 528505786 | Sequence: | 528505787 | Sequence: | 528505788 | Sequence: | 528505789 | Sequence: | 528505790 | Sequence: | 528505791 | Sequence: | 528505792 | Sequence: | 528505793 | Sequence: | 528505794 | Sequence: | 528505795 | Sequence: | 528505796 | Sequence: | 528505797 | Sequence: | 528505798 | Sequence: | 528505799 | Sequence: | 528505800 | Sequence: | 528505801 | Sequence: | 528505802 | Sequence: | 528505803 | Sequence: | 528505804 | Sequence: | 528505805 | Sequence: | 528505806 | Sequence: | 528505807 | Sequence: | 528505808 | Sequence: | 528505809 | Sequence: | 528505810 | Sequence: | 528505811 | Sequence: | 528505812 | Sequence: | 528505813 | Sequence: | 528505814 | Sequence: | 528505815 | Sequence: | 528505816 | Sequence: | 528505817 | Sequence: | 528505818 | Sequence: | 528505819 | Sequence: | 528505820 | Sequence: | 528505821 | Sequence: | 528505822 | Sequence: | 528505823 | Sequence: | 528505824 | Sequence: | 528505825 | Sequence: | 528505826 | Sequence: | 528505827 | Sequence: | 528505828 | Sequence: | 528505829 | Sequence: | 528505830 | Sequence: | 528505831 | Sequence: | 528505832 | Sequence: | 528505833 | Sequence: | 528505834 | Sequence: | 528505835 | Sequence: | 528505836 | Sequence: | 528505837 | Sequence: | 528505838 | Sequence: | 528505839 | Sequence: | 528505840 | Sequence: | 528505841 | Sequence: | 528505842 | Sequence: | 528505843 | Sequence: | 528505844 | Sequence: | 528505845 | Sequence: | 528505846 | Sequence: | 528505847 | Sequence: | 528505848 | Sequence: | 528505849 | Sequence: | 528505850 | Sequence: | 528505851 | Sequence: | 528505852 | Sequence: | 528505853 | Sequence: | 528505854 | Sequence: | 528505855 | Sequence: | 528505856 | Sequence: | 528505857 | Sequence: | 528505858 | Sequence: | 528505859 | Sequence: | 528505860 | Sequence: | 528505861 | Sequence: | 528505862 | Sequence: | 528505863 | Sequence: | 528505864 | Sequence: | 528505865 | Sequence: | 528505866 | Sequence: | 528505867 | Sequence: | 528505868 | Sequence: | 528505869 | Sequence: | 528505870 | Sequence: | 528505871 | Sequence: | 528505872 | Sequence: | 528505873 | Sequence: | 528505874 | Sequence: | 528505875 | Sequence: | 528505876 | Sequence: | 528505877 | Sequence: | 528505878 | Sequence: | 528505879 | Sequence: | 528505880 | Sequence: | 528505881 | Sequence: | 528505882 | Sequence: | 528505883 | Sequence: | 528505884 | Sequence: | 528505885 | Sequence: | 528505886 | Sequence: | 528505887 | Sequence: | 528505888 | Sequence: | 528505889 | Sequence: | 528505890 | Sequence: | 528505891 | Sequence: | 528505892 | Sequence: | 528505893 | Sequence: | 528505894 | Sequence: | 528505895 | Sequence: | 528505896 | Sequence: | 528505897 | Sequence: | 528505898 | Sequence: | 528505899 | Sequence: | 528505900 | Sequence: | 528505901 | Sequence: | 528505902 | Sequence: | 528505903 | Sequence: | 528505904 | Sequence: | 528505905 | Sequence: | 528505906 | Sequence: | 528505907 | Sequence: | 528505908 | Sequence: | 528505909 | Sequence: | 528505910 | Sequence: | 528505911 | Sequence: | 528505912 | Sequence: | 528505913 | Sequence: | 528505914 | Sequence: | 528505915 | Sequence: | 528505916 | Sequence: | 528505917 | Sequence: | 528505918 | Sequence: | 528505919 | Sequence: | 528505920 | Sequence: | 528505921 | Sequence: | 528505922 | Sequence: | 528505923 | Sequence: | 528505924 | Sequence: | 528505925 | Sequence: | 528505926 | Sequence: | 528505927 | Sequence: | 528505928 | Sequence: | 528505929 | Sequence: | 528505930 | Sequence: | 528505931 | Sequence: | 528505932 | Sequence: | 528505933 | Sequence: | 528505934 | Sequence: | 528505935 | Sequence: | 528505936 | Sequence: | 528505937 | Sequence: | 528505938 | Sequence: | 528505939 | Sequence: | 528505940 | Sequence: | 528505941 | Sequence: | 528505942 | Sequence: | 528505943 | Sequence: | 528505944 | Sequence: | 528505945 | Sequence: | 528505946 | Sequence: | 528505947 | Sequence: | 528505948 | Sequence: | 528505949 | Sequence: | 528505950 | Sequence: | 528505951 | Sequence: | 528505952 | Sequence: | 528505953 | Sequence: | 528505954 | Sequence: | 528505955 | Sequence: | 528505956 | Sequence: | 528505957 | Sequence: | 528505958 | Sequence: | 528505959 | Sequence: | 528505960 | Sequence: | 528505961 | Sequence: | 528505962 | Sequence: | 528505963 | Sequence: | 528505964 | Sequence: | 528505965 | Sequence: | 528505966 | Sequence: | 528505967 | Sequence: | 528505968 | Sequence: | 528505969 | Sequence: | 528505970 | Sequence: | 528505971 | Sequence: | 528505972 | Sequence: | 528505973 | Sequence: | 528505974 | Sequence: | 528505975 | Sequence: | 528505976 | Sequence: | 528505977 | Sequence: | 528505978 | Sequence: | 528505979 | Sequence: | 528505980 | Sequence: | 528505981 | Sequence: | 528505982 | Sequence: | 528505983 | Sequence: | 528505984 | Sequence: | 528505985 | Sequence: | 528505986 | Sequence: | 528505987 | Sequence: | 528505988 | Sequence: | 528505989 | Sequence: | 528505990 | Sequence: | 528505991 | Sequence: | 528505992 | Sequence: | 528505993 | Sequence: | 528505994 | Sequence: | 528505995 | Sequence: | 528505996 | Sequence: | 528505997 | Sequence: | 528505998 | Sequence: | 528505999 | Sequence: | 528506000 | Sequence: | 528506001 | Sequence: | 528506002 | Sequence: | 528506003 | Sequence: | 528506004 | Sequence: | 528506005 | Sequence: | 528506006 | Sequence: | 528506007 | Sequence: | 528506008 | Sequence: | 528506009 | Sequence: | 528506010 | Sequence: | 528506011 | Sequence: | 528506012 | Sequence: | 528506013 | Sequence: | 528506014 | Sequence: | 528506015 | Sequence: | 528506016 | Sequence: | 528506017 | Sequence: | 528506018 | Sequence: | 528506019 | Sequence: | 528506020 | Sequence: | 528506021 | Sequence: | 528506022 | Sequence: | 528506023 | Sequence: | 528506024 | Sequence: | 528506025 | Sequence: | 528506026 | Sequence: | 528506027 | Sequence: | 528506028 | Sequence: | 528506029 | Sequence: | 528506030 | Sequence: | 528506031 | Sequence: | 528506032 | Sequence: | 528506033 | Sequence: | 528506034 | Sequence: | 528506035 | Sequence: | 528506036 | Sequence: | 528506037 | Sequence: | 528506038 | Sequence: | 528506039 | Sequence: | 528506040 | Sequence: | 528506041 | Sequence: | 528506042 | Sequence: | 528506043 | Sequence: | 528506044 | Sequence: | 528506045 | Sequence: | 528506046 | Sequence: | 528506047 | Sequence: | 528506048 | Sequence: | 528506049 | Sequence: | 528506050 | Sequence: | 528506051 | Sequence: | 528506052 | Sequence: | 528506053 | Sequence: | 528506054 | Sequence: | 528506055 | Sequence: | 528506056 | Sequence: | 528506057 | Sequence: | 528506058 | Sequence: | 528506059 | Sequence: | 528506060 | Sequence: | 528506061 | Sequence: | 528506062 | Sequence: | 528506063 | Sequence: | 528506064 | Sequence: | 528506065 | Sequence: | 528506066 | Sequence: | 528506067 | Sequence: | 528506068 | Sequence: | 528506069 | Sequence: | 528506070 | Sequence: | 528506071 | Sequence: | 528506072 | Sequence: | 528506073 | Sequence: | 528506074 | Sequence: | 528506075 | Sequence: | 528506076 | Sequence: | 528506077 | Sequence: | 528506078 | Sequence: | 528506079 | Sequence: | 528506080 | Sequence: | 528506081 | Sequence: | 528506082 | Sequence: | 528506083 | Sequence: | 528506084 | Sequence: | 528506085 | Sequence: | 528506086 | Sequence: | 528506087 | Sequence: | 528506088 | Sequence: | 528506089 | Sequence: | 528506090 | Sequence: | 528506091 | Sequence: | 528506092 | Sequence: | 528506093 | Sequence: | 528506094 | Sequence: | 528506095 | Sequence: | 528506096 | Sequence: | 528506097 | Sequence: | 528506098 | Sequence: | 528506099 | Sequence: | 528506100 | Sequence: | 528506101 | Sequence: | 528506102 | Sequence: | 528506103 | Sequence: | 528506104 | Sequence: | 528506105 | Sequence: | 528506106 | Sequence: | 528506107 | Sequence: | 528506108 | Sequence: | 528506109 | Sequence: | 528506110 | Sequence: | 528506111 | Sequence: | 528506112 | Sequence: | 528506113 | Sequence: | 528506114 | Sequence: | 528506115 | Sequence: | 528506116 | Sequence: | 528506117 | Sequence: | 528506118 | Sequence: | 528506119 | Sequence: | 528506120 | Sequence: | 528506121 | Sequence: | 528506122 | Sequence: | 528506123 | Sequence: | 528506124 | Sequence: | 528506125 | Sequence: | 528506126 | Sequence: | 528506127 |
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| Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 |
Ctgov Group Code | EG001 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | 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Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 |
Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) |
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Subjects At Risk | 13 | Subjects At Risk | 5 | Subjects At Risk | 5 | Subjects At Risk | 34 | Subjects At Risk | 35 | Subjects At Risk | 23 | Subjects At Risk | 18 | Subjects At Risk | 21 | Subjects At Risk | 21 | Subjects At Risk | 13 | Subjects At Risk | 5 | Subjects At Risk | 5 | Subjects At Risk | 34 | Subjects At Risk | 35 | Subjects At Risk | 23 | Subjects At Risk | 18 | Subjects At Risk | 21 | Subjects At Risk | 21 | Subjects At Risk | 13 | Subjects At Risk | 5 | Subjects At Risk | 5 | Subjects At Risk | 34 | Subjects At Risk | 35 | Subjects At Risk | 23 | Subjects At Risk | 18 | Subjects At Risk | 21 | Subjects At Risk | 21 | Subjects At Risk | 13 | Subjects At Risk | 5 | Subjects At Risk | 5 | Subjects At Risk | 34 | Subjects At Risk | 35 | Subjects At Risk | 23 | Subjects At Risk | 18 | Subjects At Risk | 21 | Subjects At Risk | 21 | Subjects At Risk | 13 | Subjects At Risk | 5 | Subjects At Risk | 5 | Subjects At Risk | 34 | Subjects At Risk | 35 | Subjects At Risk | 23 | Subjects At Risk | 18 | Subjects At Risk | 21 | Subjects At Risk | 21 | Subjects At Risk | 13 | Subjects At Risk | 5 | Subjects At Risk | 5 | Subjects At Risk | 34 | Subjects At Risk | 35 | Subjects At Risk | 23 | Subjects At Risk | 18 | Subjects At Risk | 21 | Subjects At Risk | 21 | Subjects At Risk | 13 | Subjects At Risk | 5 | Subjects At Risk | 5 | Subjects At Risk | 34 | Subjects At Risk | 35 | Subjects At Risk | 23 | Subjects At Risk | 18 | Subjects At Risk | 21 | Subjects At Risk | 21 | Subjects At Risk | 13 | Subjects At Risk | 5 | Subjects At Risk | 5 | Subjects At Risk | 34 | Subjects At Risk | 35 | Subjects At Risk | 23 | Subjects At Risk | 18 | Subjects At Risk | 21 | Subjects At Risk | 21 | Subjects At Risk | 13 | Subjects At Risk | 5 | Subjects At Risk | 5 | Subjects At Risk | 34 | Subjects At Risk | 35 | Subjects At Risk | 23 | Subjects At Risk | 18 | Subjects At Risk | 21 | Subjects At Risk | 21 | Subjects At Risk | 13 | Subjects At Risk | 5 | Subjects At Risk | 5 | Subjects At Risk | 34 | Subjects At Risk | 35 | Subjects At Risk | 23 | Subjects At Risk | 18 | Subjects At Risk | 21 | Subjects At Risk | 21 | Subjects At Risk | 13 | Subjects At Risk | 5 | Subjects At Risk | 5 | Subjects At Risk | 34 | Subjects At Risk | 35 | Subjects At Risk | 23 | Subjects At Risk | 18 | Subjects At Risk | 21 | Subjects At Risk | 21 | Subjects At Risk | 13 | Subjects At Risk | 5 | Subjects At Risk | 5 | Subjects At Risk | 34 | Subjects At Risk | 35 | Subjects At Risk | 23 | Subjects At Risk | 18 | Subjects At Risk | 21 | Subjects At Risk | 21 | Subjects At Risk | 13 | Subjects At Risk | 5 | Subjects At Risk | 5 | Subjects At Risk | 34 | Subjects At Risk | 35 | Subjects At Risk | 23 | Subjects At Risk | 18 | Subjects At Risk | 21 | Subjects At Risk | 21 | Subjects At Risk | 13 | Subjects At Risk | 5 | Subjects At Risk | 5 | Subjects At Risk | 34 | Subjects At Risk | 35 | Subjects At Risk | 23 | Subjects At Risk | 18 | Subjects At Risk | 21 | Subjects At Risk | 21 | Subjects At Risk | 13 | Subjects At Risk | 5 | Subjects At Risk | 5 | Subjects At Risk | 34 | Subjects At Risk | 35 | Subjects At Risk | 23 | Subjects At Risk | 18 | Subjects At Risk | 21 | Subjects At Risk | 21 | Subjects At Risk | 13 | Subjects At Risk | 5 | Subjects At Risk | 5 | Subjects At Risk | 34 | Subjects At Risk | 35 | Subjects At Risk | 23 | Subjects At Risk | 18 | Subjects At Risk | 21 | Subjects At Risk | 21 | Subjects At Risk | 13 | Subjects At Risk | 5 | Subjects At Risk | 5 | Subjects At Risk | 34 | Subjects At Risk | 35 | Subjects At Risk | 23 | Subjects At Risk | 18 | Subjects At Risk | 21 | Subjects At Risk | 21 | Subjects At Risk | 13 | Subjects At Risk | 5 | Subjects At Risk | 5 | Subjects At Risk | 34 | Subjects At Risk | 35 | Subjects At Risk | 23 | Subjects At Risk | 18 | Subjects At Risk | 21 | Subjects At Risk | 21 | Subjects At Risk | 13 | Subjects At Risk | 5 | Subjects At Risk | 5 | Subjects At Risk | 34 | Subjects At Risk | 35 | Subjects At Risk | 23 | Subjects At Risk | 18 | Subjects At Risk | 21 | Subjects At Risk | 21 | Subjects At Risk | 13 | Subjects At Risk | 5 | Subjects At Risk | 5 | Subjects At Risk | 34 | Subjects At Risk | 35 | Subjects At Risk | 23 | Subjects At Risk | 18 | Subjects At Risk | 21 | Subjects At Risk | 21 | Subjects At Risk | 13 | Subjects At Risk | 5 | Subjects At Risk | 5 | Subjects At Risk | 34 | Subjects At Risk | 35 | Subjects At Risk | 23 | Subjects At Risk | 18 | Subjects At Risk | 21 | Subjects At Risk | 21 | Subjects At Risk | 13 | Subjects At Risk | 5 | Subjects At Risk | 5 | Subjects At Risk | 34 | Subjects At Risk | 35 | Subjects At Risk | 23 | Subjects At Risk | 18 | Subjects At Risk | 21 | Subjects At Risk | 21 | Subjects At Risk | 13 | Subjects At Risk | 5 | Subjects At Risk | 5 | Subjects At Risk | 34 | Subjects At Risk | 35 | Subjects At Risk | 23 | Subjects At Risk | 18 | Subjects At Risk | 21 | Subjects At Risk | 21 | Subjects At Risk | 13 | Subjects At Risk | 5 | Subjects At Risk | 5 | Subjects At Risk | 34 | Subjects At Risk | 35 | Subjects At Risk | 23 | Subjects At Risk | 18 | Subjects At Risk | 21 | Subjects At Risk | 21 | Subjects At Risk | 13 | Subjects At Risk | 5 | Subjects At Risk | 5 |
Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. |
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| Event Count | 1 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 0 | Event Count | 2 | Event Count | 2 | Event Count | 2 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 1 | Event 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| Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 1 | Event Count | 1 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 1 | Event Count | 1 | Event Count | 3 | Event Count | 0 | Event Count | 0 | Event Count | 1 | Event Count | 3 | Event Count | 1 | Event Count | 1 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 |
Organ System | Cardiac disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Blood and lymphatic system disorders | Organ System | Cardiac disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | Hepatobiliary disorders | Organ System | Hepatobiliary disorders | Organ System | Hepatobiliary disorders | Organ System | Hepatobiliary disorders | Organ System | Hepatobiliary disorders | Organ System | Hepatobiliary disorders | Organ System | Hepatobiliary disorders | Organ System | Hepatobiliary disorders | Organ System | Hepatobiliary disorders | Organ System | Hepatobiliary disorders | Organ System | Hepatobiliary disorders | Organ System | Hepatobiliary disorders | Organ System | Hepatobiliary disorders | Organ System | Hepatobiliary disorders | Organ System | Hepatobiliary disorders | Organ System | Hepatobiliary disorders | Organ System | Hepatobiliary disorders | Organ System | Hepatobiliary disorders | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections 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infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Reproductive system and breast disorders | Organ System | Reproductive system and breast disorders | Organ System | Reproductive system and breast disorders | Organ System | Reproductive system and breast disorders | Organ System | Reproductive system and breast disorders | Organ System | Reproductive system and breast disorders | Organ System | Reproductive system and breast disorders | Organ System | Reproductive system and breast disorders | Organ System | Reproductive system and breast disorders | Organ System | Reproductive system and breast disorders | Organ System | Reproductive system and breast disorders | Organ System | Reproductive system and breast disorders | Organ System | Reproductive system and breast disorders | Organ System | Reproductive system and breast disorders | Organ System | Reproductive system and breast disorders | Organ System | Reproductive system and breast disorders | Organ System | Reproductive system and breast disorders | Organ System | Reproductive system and breast disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Surgical and medical procedures | Organ System | Surgical and medical procedures | Organ System | Surgical and medical procedures | Organ System | Surgical and medical procedures | Organ System | Surgical and medical procedures | Organ System | Surgical and medical procedures | Organ System | Surgical and medical procedures | Organ System | Surgical and medical procedures | Organ System | Surgical and medical procedures | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Ear and labyrinth disorders | Organ System | Ear and labyrinth disorders | Organ System | Ear and labyrinth disorders | Organ System | Ear and labyrinth disorders | Organ System | Ear and labyrinth disorders | Organ System | Ear and labyrinth disorders | Organ System | Ear and labyrinth disorders | Organ System | Ear and labyrinth disorders | Organ System | Ear and labyrinth disorders | Organ System | Eye disorders | Organ System | Eye disorders | Organ System | Eye disorders | Organ System | Eye disorders | Organ System | Eye disorders | Organ System | Eye disorders | Organ System | Eye disorders | Organ System | Eye disorders | Organ System | Eye disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Psychiatric disorders | Organ System | Psychiatric disorders | Organ System | Psychiatric disorders | Organ System | Psychiatric disorders | Organ System | Psychiatric disorders | Organ System | Psychiatric disorders | Organ System | Psychiatric disorders | Organ System | Psychiatric disorders | Organ System | Psychiatric disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Reproductive system and breast disorders | Organ System | Reproductive system and breast disorders | Organ System | Reproductive system and breast disorders | Organ System | Reproductive system and breast disorders | Organ System | Reproductive system and breast disorders | Organ System | Reproductive system and breast disorders | Organ System | Reproductive system and breast disorders | Organ System | Reproductive system and breast disorders | Organ System | Reproductive system and breast disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders |
Adverse Event Term | Tachycardia | Adverse Event Term | Anaemia | Adverse Event Term | Anaemia | Adverse Event Term | Anaemia | Adverse Event Term | Tachycardia | Adverse Event Term | Tachycardia | Adverse Event Term | Tachycardia | Adverse Event Term | Tachycardia | Adverse Event Term | Anaemia | Adverse Event Term | Tachycardia | Adverse Event Term | Anaemia | Adverse Event Term | Anaemia | Adverse Event Term | Nephrogenic anaemia | Adverse Event Term | Nephrogenic anaemia | Adverse Event Term | Anaemia | Adverse Event Term | Anaemia | Adverse Event Term | Anaemia | Adverse Event Term | Nephrogenic anaemia | Adverse Event Term | Nephrogenic anaemia | Adverse Event Term | Nephrogenic anaemia | Adverse Event Term | Nephrogenic anaemia | Adverse Event Term | Nephrogenic anaemia | Adverse Event Term | Nephrogenic anaemia | Adverse Event Term | Nephrogenic anaemia | Adverse Event Term | Thrombocytopenia | Adverse Event Term | Thrombocytopenia | Adverse Event Term | Thrombocytopenia | Adverse Event Term | Thrombocytopenia | Adverse Event Term | Thrombocytopenia | Adverse Event Term | Thrombocytopenia | Adverse Event Term | Thrombocytopenia | Adverse Event Term | Thrombocytopenia | Adverse Event Term | Thrombocytopenia | Adverse Event Term | Acute coronary syndrome | Adverse Event Term | Acute coronary syndrome | Adverse Event Term | Acute coronary syndrome | Adverse Event Term | Acute coronary syndrome | Adverse Event Term | Acute coronary syndrome | Adverse Event Term | Acute coronary syndrome | Adverse Event Term | Acute coronary syndrome | Adverse Event Term | Acute coronary syndrome | Adverse Event Term | Acute coronary syndrome | Adverse Event Term | Acute left ventricular failure | Adverse Event Term | Acute left ventricular failure | Adverse Event Term | Acute left ventricular failure | Adverse Event Term | Acute left ventricular failure | Adverse Event Term | Acute left ventricular failure | Adverse Event Term | Acute left ventricular failure | Adverse Event Term | Acute left ventricular failure | Adverse Event Term | Acute left ventricular failure | Adverse Event Term | Acute left ventricular failure | Adverse Event Term | Acute myocardial infarction | Adverse Event Term | Acute myocardial infarction | Adverse Event Term | Acute myocardial infarction | Adverse Event Term | Acute myocardial infarction | Adverse Event Term | Acute myocardial infarction | Adverse Event Term | Acute myocardial infarction | Adverse Event Term | Acute myocardial infarction | Adverse Event Term | Acute myocardial infarction | Adverse Event Term | Acute myocardial infarction | Adverse Event Term | Atrial flutter | Adverse Event Term | Atrial flutter | Adverse Event Term | Atrial flutter | Adverse Event Term | Atrial flutter | Adverse Event Term | Atrial flutter | Adverse Event Term | Atrial flutter | Adverse Event Term | Atrial flutter | Adverse Event Term | Atrial flutter | Adverse Event Term | Atrial flutter | Adverse Event Term | Cardiac arrest | Adverse Event Term | Cardiac arrest | Adverse Event Term | Cardiac arrest | Adverse Event Term | Cardiac arrest | Adverse Event Term | Cardiac arrest | Adverse Event Term | Cardiac arrest | Adverse Event Term | Cardiac arrest | Adverse Event Term | Cardiac arrest | Adverse Event Term | Cardiac arrest | Adverse Event Term | Cardiac failure | Adverse Event Term | Cardiac failure | Adverse Event Term | Cardiac failure | Adverse Event Term | Cardiac failure | Adverse Event Term | Cardiac failure | Adverse Event Term | Cardiac failure | Adverse Event Term | Cardiac failure | Adverse Event Term | Cardiac failure | Adverse Event Term | Cardiac failure | Adverse Event Term | Tachycardia | Adverse Event Term | Tachycardia | Adverse Event Term | Tachycardia | Adverse Event Term | Diarrhoea | Adverse Event Term | Diarrhoea | Adverse Event Term | Diarrhoea | Adverse Event Term | Diarrhoea | Adverse Event Term | Diarrhoea | Adverse Event Term | Diarrhoea | Adverse Event Term | Diarrhoea | Adverse Event Term | Diarrhoea | Adverse Event Term | Diarrhoea | Adverse Event Term | Gastrointestinal haemorrhage | Adverse Event Term | Gastrointestinal haemorrhage | Adverse Event Term | Gastrointestinal haemorrhage | Adverse Event Term | Gastrointestinal haemorrhage | Adverse Event Term | Gastrointestinal haemorrhage | Adverse Event Term | Gastrointestinal haemorrhage | Adverse Event Term | Gastrointestinal haemorrhage | Adverse Event Term | Gastrointestinal haemorrhage | Adverse Event Term | Gastrointestinal haemorrhage | Adverse Event Term | Gastrooesophageal reflux disease | Adverse Event Term | Gastrooesophageal reflux disease | Adverse Event Term | Gastrooesophageal reflux disease | Adverse Event Term | Gastrooesophageal reflux disease | Adverse Event Term | Gastrooesophageal reflux disease | Adverse Event Term | Gastrooesophageal reflux disease | Adverse Event Term | Gastrooesophageal reflux disease | Adverse Event Term | Gastrooesophageal reflux disease | Adverse Event Term | Gastrooesophageal reflux disease | Adverse Event Term | Incarcerated inguinal hernia | Adverse Event Term | Incarcerated inguinal hernia | Adverse Event Term | Incarcerated inguinal hernia | Adverse Event Term | Incarcerated inguinal hernia | Adverse Event Term | Incarcerated inguinal hernia | Adverse Event Term | Incarcerated inguinal hernia | Adverse Event Term | Incarcerated inguinal hernia | Adverse Event Term | Incarcerated inguinal hernia | Adverse Event Term | Incarcerated inguinal hernia | Adverse Event Term | Incarcerated umbilical hernia | Adverse Event Term | Incarcerated umbilical hernia | Adverse Event Term | Incarcerated umbilical hernia | Adverse Event Term | Incarcerated umbilical hernia | Adverse Event Term | Incarcerated umbilical hernia | Adverse Event Term | Incarcerated umbilical hernia | Adverse Event Term | Incarcerated umbilical hernia | Adverse Event Term | Incarcerated umbilical hernia | Adverse Event Term | Incarcerated umbilical hernia | Adverse Event Term | Nausea | Adverse Event Term | Nausea | Adverse Event Term | Nausea | Adverse Event Term | Nausea | Adverse Event Term | Nausea | Adverse Event Term | Nausea | Adverse Event Term | Nausea | Adverse Event Term | Nausea | Adverse Event Term | Nausea | Adverse Event Term | Pancreatitis | Adverse Event Term | Pancreatitis | Adverse Event Term | Pancreatitis | Adverse Event Term | Pancreatitis | Adverse Event Term | Pancreatitis | Adverse Event Term | Pancreatitis | Adverse Event Term | Pancreatitis | Adverse Event Term | Pancreatitis | Adverse Event Term | Pancreatitis | Adverse Event Term | Vomiting | Adverse Event Term | Vomiting | Adverse Event Term | Vomiting | Adverse Event Term | Vomiting | Adverse Event Term | Vomiting | Adverse Event Term | Vomiting | Adverse Event Term | Vomiting | Adverse Event Term | Vomiting | Adverse Event Term | Vomiting | Adverse Event Term | Catheter site thrombosis | Adverse Event Term | Catheter site thrombosis | Adverse Event Term | Catheter site thrombosis | Adverse Event Term | Catheter site thrombosis | Adverse Event Term | Catheter site thrombosis | Adverse Event Term | Catheter site thrombosis | Adverse Event Term | Catheter site thrombosis | Adverse Event Term | Catheter site thrombosis | Adverse Event Term | Catheter site thrombosis | Adverse Event Term | Death | Adverse Event Term | Death | Adverse Event Term | Death | Adverse Event Term | Death | Adverse Event Term | Death | Adverse Event Term | Death | Adverse Event Term | Death | Adverse Event Term | Death | Adverse Event Term | Death | Adverse Event Term | Fatigue | Adverse Event Term | Fatigue | Adverse Event Term | Fatigue | Adverse Event Term | Fatigue | Adverse Event Term | Fatigue | Adverse Event Term | Fatigue | Adverse Event Term | Fatigue | Adverse Event Term | Fatigue | Adverse Event Term | Fatigue | Adverse Event Term | Non-cardiac chest pain | Adverse Event Term | Non-cardiac chest pain | Adverse Event Term | Non-cardiac chest pain | Adverse Event Term | Non-cardiac chest pain | Adverse Event Term | Non-cardiac chest pain | Adverse Event Term | Non-cardiac chest pain | Adverse Event Term | Non-cardiac chest pain | Adverse Event Term | Non-cardiac chest pain | Adverse Event Term | Non-cardiac chest pain | Adverse Event Term | Cholecystitis acute | Adverse Event Term | Cholecystitis acute | Adverse Event Term | Cholecystitis acute | Adverse Event Term | Cholecystitis acute | Adverse Event Term | Cholecystitis acute | Adverse Event Term | Cholecystitis acute | Adverse Event Term | Cholecystitis acute | Adverse Event Term | Cholecystitis acute | Adverse Event Term | Cholecystitis acute | Adverse Event Term | Liver injury | Adverse Event Term | Liver injury | Adverse Event Term | Liver injury | Adverse Event Term | Liver injury | Adverse Event Term | Liver injury | Adverse Event Term | Liver injury | Adverse Event Term | Liver injury | Adverse Event Term | Liver injury | Adverse Event Term | Liver injury | Adverse Event Term | Cellulitis | Adverse Event Term | Cellulitis | Adverse Event Term | Cellulitis | Adverse Event Term | Cellulitis | Adverse Event Term | Cellulitis | Adverse Event Term | Cellulitis | Adverse Event Term | Cellulitis | Adverse Event Term | Cellulitis | Adverse Event Term | Cellulitis | Adverse Event Term | Gangrene | Adverse Event Term | Gangrene | Adverse Event Term | Gangrene | Adverse Event Term | Gangrene | Adverse Event Term | Gangrene | Adverse Event Term | Gangrene | Adverse Event Term | Gangrene | Adverse Event Term | Gangrene | Adverse Event Term | Gangrene | Adverse Event Term | Influenza | Adverse Event Term | Influenza | Adverse Event Term | Influenza | Adverse Event Term | Influenza | Adverse Event Term | Influenza | Adverse Event Term | Influenza | Adverse Event Term | Influenza | Adverse Event Term | Influenza | Adverse Event Term | Influenza | Adverse Event Term | Localised infection | Adverse Event Term | Localised infection | Adverse Event Term | Localised infection | Adverse Event Term | Localised infection | Adverse Event Term | Localised infection | Adverse Event Term | Localised infection | Adverse Event Term | Localised infection | Adverse Event Term | Localised infection | Adverse Event Term | Localised infection | Adverse Event Term | Osteomyelitis | Adverse Event Term | Osteomyelitis | Adverse Event Term | Osteomyelitis | Adverse Event Term | Osteomyelitis | Adverse Event Term | Osteomyelitis | Adverse Event Term | Osteomyelitis | Adverse Event Term | Osteomyelitis | Adverse Event Term | Osteomyelitis | Adverse Event Term | Osteomyelitis | Adverse Event Term | Pneumonia | Adverse Event Term | Pneumonia | Adverse Event Term | Pneumonia | Adverse Event Term | Pneumonia | Adverse Event Term | Pneumonia | Adverse Event Term | Pneumonia | Adverse Event Term | Pneumonia | Adverse Event Term | Pneumonia | Adverse Event Term | Pneumonia | Adverse Event Term | Pneumonia bacterial | Adverse Event Term | Pneumonia bacterial | Adverse Event Term | Pneumonia bacterial | Adverse Event Term | Pneumonia bacterial | Adverse Event Term | Pneumonia bacterial | Adverse Event Term | Pneumonia bacterial | Adverse Event Term | Pneumonia bacterial | Adverse Event Term | Pneumonia bacterial | Adverse Event Term | Pneumonia bacterial | Adverse Event Term | Sepsis | Adverse Event Term | Sepsis | Adverse Event Term | Sepsis | Adverse Event Term | Sepsis | Adverse Event Term | Sepsis | Adverse Event Term | Sepsis | Adverse Event Term | Sepsis | Adverse Event Term | Sepsis | Adverse Event Term | Sepsis | Adverse Event Term | Staphylococcal bacteraemia | Adverse Event Term | Staphylococcal bacteraemia | Adverse Event Term | Staphylococcal bacteraemia | Adverse Event Term | Staphylococcal bacteraemia | Adverse Event Term | Staphylococcal bacteraemia | Adverse Event Term | Staphylococcal bacteraemia | Adverse Event Term | Staphylococcal bacteraemia | Adverse Event Term | Staphylococcal bacteraemia | Adverse Event Term | Staphylococcal bacteraemia | Adverse Event Term | Urinary tract infection | Adverse Event Term | Urinary tract infection | Adverse Event Term | Urinary tract infection | Adverse Event Term | Urinary tract infection | Adverse Event Term | Urinary tract infection | Adverse Event Term | Urinary tract infection | Adverse Event Term | Urinary tract infection | Adverse Event Term | Urinary tract infection | Adverse Event Term | Urinary tract infection | Adverse Event Term | Arteriovenous fistula site complication | Adverse Event Term | Arteriovenous fistula site complication | Adverse Event Term | Arteriovenous fistula site complication | Adverse Event Term | Arteriovenous fistula site complication | Adverse Event Term | Arteriovenous fistula site complication | Adverse Event Term | Arteriovenous fistula site complication | Adverse Event Term | Arteriovenous fistula site complication | Adverse Event Term | Arteriovenous fistula site complication | Adverse Event Term | Arteriovenous fistula site complication | Adverse Event Term | Arteriovenous fistula thrombosis | Adverse Event Term | Arteriovenous fistula thrombosis | Adverse Event Term | Arteriovenous fistula thrombosis | Adverse Event Term | Arteriovenous fistula thrombosis | Adverse Event Term | Arteriovenous fistula thrombosis | Adverse Event Term | Arteriovenous fistula thrombosis | Adverse Event Term | Arteriovenous fistula thrombosis | Adverse Event Term | Arteriovenous fistula thrombosis | Adverse Event Term | Arteriovenous fistula thrombosis | Adverse Event Term | Arteriovenous graft thrombosis | Adverse Event Term | Arteriovenous graft thrombosis | Adverse Event Term | Arteriovenous graft thrombosis | Adverse Event Term | Arteriovenous graft thrombosis | Adverse Event Term | Arteriovenous graft thrombosis | Adverse Event Term | Arteriovenous graft thrombosis | Adverse Event Term | Arteriovenous graft thrombosis | Adverse Event Term | Arteriovenous graft thrombosis | Adverse Event Term | Arteriovenous graft thrombosis | Adverse Event Term | Facial bones fracture | Adverse Event Term | Facial bones fracture | Adverse Event Term | Facial bones fracture | Adverse Event Term | Facial bones fracture | Adverse Event Term | Facial bones fracture | Adverse Event Term | Facial bones fracture | Adverse Event Term | Facial bones fracture | Adverse Event Term | Facial bones fracture | Adverse Event Term | Facial bones fracture | Adverse Event Term | Fall | Adverse Event Term | Fall | Adverse Event Term | Fall | Adverse Event Term | Fall | Adverse Event Term | Fall | Adverse Event Term | Fall | Adverse Event Term | Fall | Adverse Event Term | Fall | Adverse Event Term | Fall | Adverse Event Term | Humerus fracture | Adverse Event Term | Humerus fracture | Adverse Event Term | Humerus fracture | Adverse Event Term | Humerus fracture | Adverse Event Term | Humerus fracture | Adverse Event Term | Humerus fracture | Adverse Event Term | Humerus fracture | Adverse Event Term | Humerus fracture | Adverse Event Term | Humerus fracture | Adverse Event Term | Rib fracture | Adverse Event Term | Rib fracture | Adverse Event Term | Rib fracture | Adverse Event Term | Rib fracture | Adverse Event Term | Rib fracture | Adverse Event Term | Rib fracture | Adverse Event Term | Rib fracture | Adverse Event Term | Rib fracture | Adverse Event Term | Rib fracture | Adverse Event Term | Subdural haematoma | Adverse Event Term | Subdural haematoma | Adverse Event Term | Subdural haematoma | Adverse Event Term | Subdural haematoma | Adverse Event Term | Subdural haematoma | Adverse Event Term | Subdural haematoma | Adverse Event Term | Subdural haematoma | Adverse Event Term | Subdural haematoma | Adverse Event Term | Subdural haematoma | Adverse Event Term | Vascular pseudoaneurysm | Adverse Event Term | Vascular pseudoaneurysm | Adverse Event Term | Vascular pseudoaneurysm | Adverse Event Term | Vascular pseudoaneurysm | Adverse Event Term | Vascular pseudoaneurysm | Adverse Event Term | Vascular pseudoaneurysm | Adverse Event Term | Vascular pseudoaneurysm | Adverse Event Term | Vascular pseudoaneurysm | Adverse Event Term | Vascular pseudoaneurysm | Adverse Event Term | Fluid overload | Adverse Event Term | Fluid overload | Adverse Event Term | Fluid overload | Adverse Event Term | Fluid overload | Adverse Event Term | Fluid overload | Adverse Event Term | Fluid overload | Adverse Event Term | Fluid overload | Adverse Event Term | Fluid overload | Adverse Event Term | Fluid overload | Adverse Event Term | Hyperkalaemia | Adverse Event Term | Hyperkalaemia | Adverse Event Term | Hyperkalaemia | Adverse Event Term | Hyperkalaemia | Adverse Event Term | Hyperkalaemia | Adverse Event Term | Hyperkalaemia | Adverse Event Term | Hyperkalaemia | Adverse Event Term | Hyperkalaemia | Adverse Event Term | Hyperkalaemia | Adverse Event Term | Hypoglycaemia | Adverse Event Term | Hypoglycaemia | Adverse Event Term | Hypoglycaemia | Adverse Event Term | Hypoglycaemia | Adverse Event Term | Hypoglycaemia | Adverse Event Term | Hypoglycaemia | Adverse Event Term | Hypoglycaemia | Adverse Event Term | Hypoglycaemia | Adverse Event Term | Hypoglycaemia | Adverse Event Term | Intervertebral disc protrusion | Adverse Event Term | Intervertebral disc protrusion | Adverse Event Term | Intervertebral disc protrusion | Adverse Event Term | Intervertebral disc protrusion | Adverse Event Term | Intervertebral disc protrusion | Adverse Event Term | Intervertebral disc protrusion | Adverse Event Term | Intervertebral disc protrusion | Adverse Event Term | Intervertebral disc protrusion | Adverse Event Term | Intervertebral disc protrusion | Adverse Event Term | Osteoarthritis | Adverse Event Term | Osteoarthritis | Adverse Event Term | Osteoarthritis | Adverse Event Term | Osteoarthritis | Adverse Event Term | Osteoarthritis | Adverse Event Term | Osteoarthritis | Adverse Event Term | Osteoarthritis | Adverse Event Term | Osteoarthritis | Adverse Event Term | Osteoarthritis | Adverse Event Term | Facial paralysis | Adverse Event Term | Facial paralysis | Adverse Event Term | Facial paralysis | Adverse Event Term | Facial paralysis | Adverse Event Term | Facial paralysis | Adverse Event Term | Facial paralysis | Adverse Event Term | Facial paralysis | Adverse Event Term | Facial paralysis | Adverse Event Term | Facial paralysis | Adverse Event Term | Hypertensive encephalopathy | Adverse Event Term | Hypertensive encephalopathy | Adverse Event Term | Hypertensive encephalopathy | Adverse Event Term | Hypertensive encephalopathy | Adverse Event Term | Hypertensive encephalopathy | Adverse Event Term | Hypertensive encephalopathy | Adverse Event Term | Hypertensive encephalopathy | Adverse Event Term | Hypertensive encephalopathy | Adverse Event Term | Hypertensive encephalopathy | Adverse Event Term | Metabolic encephalopathy | Adverse Event Term | Metabolic encephalopathy | Adverse Event Term | Metabolic encephalopathy | Adverse Event Term | Metabolic encephalopathy | Adverse Event Term | Metabolic encephalopathy | Adverse Event Term | Metabolic encephalopathy | Adverse Event Term | Metabolic encephalopathy | Adverse Event Term | Metabolic encephalopathy | Adverse Event Term | Metabolic encephalopathy | Adverse Event Term | Seizure | Adverse Event Term | Seizure | Adverse Event Term | Seizure | Adverse Event Term | Seizure | Adverse Event Term | Seizure | Adverse Event Term | Seizure | Adverse Event Term | Seizure | Adverse Event Term | Seizure | Adverse Event Term | Seizure | Adverse Event Term | Subarachnoid haemorrhage | Adverse Event Term | Subarachnoid haemorrhage | Adverse Event Term | Subarachnoid haemorrhage | Adverse Event Term | Subarachnoid haemorrhage | Adverse Event Term | Subarachnoid haemorrhage | Adverse Event Term | Subarachnoid haemorrhage | Adverse Event Term | Subarachnoid haemorrhage | Adverse Event Term | Subarachnoid haemorrhage | Adverse Event Term | Subarachnoid haemorrhage | Adverse Event Term | Transient ischaemic attack | Adverse Event Term | Transient ischaemic attack | Adverse Event Term | Transient ischaemic attack | Adverse Event Term | Transient ischaemic attack | Adverse Event Term | Transient ischaemic attack | Adverse Event Term | Transient ischaemic attack | Adverse Event Term | Transient ischaemic attack | Adverse Event Term | Transient ischaemic attack | Adverse Event Term | Transient ischaemic attack | Adverse Event Term | Haematuria | Adverse Event Term | Haematuria | Adverse Event Term | Haematuria | Adverse Event Term | Haematuria | Adverse Event Term | Haematuria | Adverse Event Term | Haematuria | Adverse Event Term | Haematuria | Adverse Event Term | Haematuria | Adverse Event Term | Haematuria | Adverse Event Term | Subcapsular renal haematoma | Adverse Event Term | Subcapsular renal haematoma | Adverse Event Term | Subcapsular renal haematoma | Adverse Event Term | Subcapsular renal haematoma | Adverse Event Term | Subcapsular renal haematoma | Adverse Event Term | Subcapsular renal haematoma | Adverse Event Term | Subcapsular renal haematoma | Adverse Event Term | Subcapsular renal haematoma | Adverse Event Term | Subcapsular renal haematoma | Adverse Event Term | Nipple pain | Adverse Event Term | Nipple pain | Adverse Event Term | Nipple pain | Adverse Event Term | Nipple pain | Adverse Event Term | Nipple pain | Adverse Event Term | Nipple pain | Adverse Event Term | Nipple pain | Adverse Event Term | Nipple pain | Adverse Event Term | Nipple pain | Adverse Event Term | Uterine mass | Adverse Event Term | Uterine mass | Adverse Event Term | Uterine mass | Adverse Event Term | Uterine mass | Adverse Event Term | Uterine mass | Adverse Event Term | Uterine mass | Adverse Event Term | Uterine mass | Adverse Event Term | Uterine mass | Adverse Event Term | Uterine mass | Adverse Event Term | Acute pulmonary oedema | Adverse Event Term | Acute pulmonary oedema | Adverse Event Term | Acute pulmonary oedema | Adverse Event Term | Acute pulmonary oedema | Adverse Event Term | Acute pulmonary oedema | Adverse Event Term | Acute pulmonary oedema | Adverse Event Term | Acute pulmonary oedema | Adverse Event Term | Acute pulmonary oedema | Adverse Event Term | Acute pulmonary oedema | Adverse Event Term | Dyspnoea | Adverse Event Term | Dyspnoea | Adverse Event Term | Dyspnoea | Adverse Event Term | Dyspnoea | Adverse Event Term | Dyspnoea | Adverse Event Term | Dyspnoea | Adverse Event Term | Dyspnoea | Adverse Event Term | Dyspnoea | Adverse Event Term | Dyspnoea | Adverse Event Term | Pleural effusion | Adverse Event Term | Pleural effusion | Adverse Event Term | Pleural effusion | Adverse Event Term | Pleural effusion | Adverse Event Term | Pleural effusion | Adverse Event Term | Pleural effusion | Adverse Event Term | Pleural effusion | Adverse Event Term | Pleural effusion | Adverse Event Term | Pleural effusion | Adverse Event Term | Pulmonary embolism | Adverse Event Term | Pulmonary embolism | Adverse Event Term | Pulmonary embolism | Adverse Event Term | Pulmonary embolism | Adverse Event Term | Pulmonary embolism | Adverse Event Term | Pulmonary embolism | Adverse Event Term | Pulmonary embolism | Adverse Event Term | Pulmonary embolism | Adverse Event Term | Pulmonary embolism | Adverse Event Term | Diabetic foot | Adverse Event Term | Diabetic foot | Adverse Event Term | Diabetic foot | Adverse Event Term | Diabetic foot | Adverse Event Term | Diabetic foot | Adverse Event Term | Diabetic foot | Adverse Event Term | Diabetic foot | Adverse Event Term | Diabetic foot | Adverse Event Term | Diabetic foot | Adverse Event Term | Petechiae | Adverse Event Term | Petechiae | Adverse Event Term | Petechiae | Adverse Event Term | Petechiae | Adverse Event Term | Petechiae | Adverse Event Term | Petechiae | Adverse Event Term | Petechiae | Adverse Event Term | Petechiae | Adverse Event Term | Petechiae | Adverse Event Term | Pancreas transplant | Adverse Event Term | Pancreas transplant | Adverse Event Term | Pancreas transplant | Adverse Event Term | Pancreas transplant | Adverse Event Term | Pancreas transplant | Adverse Event Term | Pancreas transplant | Adverse Event Term | Pancreas transplant | Adverse Event Term | Pancreas transplant | Adverse Event Term | Pancreas transplant | Adverse Event Term | Accelerated hypertension | Adverse Event Term | Accelerated hypertension | Adverse Event Term | Accelerated hypertension | Adverse Event Term | Accelerated hypertension | Adverse Event Term | Accelerated hypertension | Adverse Event Term | Accelerated hypertension | Adverse Event Term | Accelerated hypertension | Adverse Event Term | Accelerated hypertension | Adverse Event Term | Accelerated hypertension | Adverse Event Term | Hypertension | Adverse Event Term | Hypertension | Adverse Event Term | Hypertension | Adverse Event Term | Hypertension | Adverse Event Term | Hypertension | Adverse Event Term | Hypertension | Adverse Event Term | Hypertension | Adverse Event Term | Hypertension | Adverse Event Term | Hypertension | Adverse Event Term | Hypertensive crisis | Adverse Event Term | Hypertensive crisis | Adverse Event Term | Hypertensive crisis | Adverse Event Term | Hypertensive crisis | Adverse Event Term | Hypertensive crisis | Adverse Event Term | Hypertensive crisis | Adverse Event Term | Hypertensive crisis | Adverse Event Term | Hypertensive crisis | Adverse Event Term | Hypertensive crisis | Adverse Event Term | Hypertensive urgency | Adverse Event Term | Hypertensive urgency | Adverse Event Term | Hypertensive urgency | Adverse Event Term | Hypertensive urgency | Adverse Event Term | Hypertensive urgency | Adverse Event Term | Hypertensive urgency | Adverse Event Term | Hypertensive urgency | Adverse Event Term | Hypertensive urgency | Adverse Event Term | Hypertensive urgency | Adverse Event Term | Hypotension | Adverse Event Term | Hypotension | Adverse Event Term | Hypotension | Adverse Event Term | Hypotension | Adverse Event Term | Hypotension | Adverse Event Term | Hypotension | Adverse Event Term | Hypotension | Adverse Event Term | Hypotension | Adverse Event Term | Hypotension | Adverse Event Term | Subclavian artery stenosis | Adverse Event Term | Subclavian artery stenosis | Adverse Event Term | Subclavian artery stenosis | Adverse Event Term | Subclavian artery stenosis | Adverse Event Term | Subclavian artery stenosis | Adverse Event Term | Subclavian artery stenosis | Adverse Event Term | Subclavian artery stenosis | Adverse Event Term | Subclavian artery stenosis | Adverse Event Term | Subclavian artery stenosis | Adverse Event Term | Anaemia | Adverse Event Term | Anaemia | Adverse Event Term | Anaemia | Adverse Event Term | Anaemia | Adverse Event Term | Anaemia | Adverse Event Term | Anaemia | Adverse Event Term | Anaemia | Adverse Event Term | Anaemia | Adverse Event Term | Anaemia | Adverse Event Term | Nephrogenic anaemia | Adverse Event Term | Nephrogenic anaemia | Adverse Event Term | Nephrogenic anaemia | Adverse Event Term | Nephrogenic anaemia | Adverse Event Term | Nephrogenic anaemia | Adverse Event Term | Nephrogenic anaemia | Adverse Event Term | Nephrogenic anaemia | Adverse Event Term | Nephrogenic anaemia | Adverse Event Term | Nephrogenic anaemia | Adverse Event Term | Thrombocytopenia | Adverse Event Term | Thrombocytopenia | Adverse Event Term | Thrombocytopenia | Adverse Event Term | Thrombocytopenia | Adverse Event Term | Thrombocytopenia | Adverse Event Term | Thrombocytopenia | Adverse Event Term | Thrombocytopenia | Adverse Event Term | Thrombocytopenia | Adverse Event Term | Thrombocytopenia | Adverse Event Term | Arteriosclerosis coronary artery | Adverse Event Term | Arteriosclerosis coronary artery | Adverse Event Term | Arteriosclerosis coronary artery | Adverse Event Term | Arteriosclerosis coronary artery | Adverse Event Term | Arteriosclerosis coronary artery | Adverse Event Term | Arteriosclerosis coronary artery | Adverse Event Term | Arteriosclerosis coronary artery | Adverse Event Term | Arteriosclerosis coronary artery | Adverse Event Term | Arteriosclerosis coronary artery | Adverse Event Term | Bundle branch block right | Adverse Event Term | Bundle branch block right | Adverse Event Term | Bundle branch block right | Adverse Event Term | Bundle branch block right | Adverse Event Term | Bundle branch block right | Adverse Event Term | Bundle branch block right | Adverse Event Term | Bundle branch block right | Adverse Event Term | Bundle branch block right | Adverse Event Term | Bundle branch block right | Adverse Event Term | Diastolic dysfunction | Adverse Event Term | Diastolic dysfunction | Adverse Event Term | Diastolic dysfunction | Adverse Event Term | Diastolic dysfunction | Adverse Event Term | Diastolic dysfunction | Adverse Event Term | Diastolic dysfunction | Adverse Event Term | Diastolic dysfunction | Adverse Event Term | Diastolic dysfunction | Adverse Event Term | Diastolic dysfunction | Adverse Event Term | Left atrial enlargement | Adverse Event Term | Left atrial enlargement | Adverse Event Term | Left atrial enlargement | Adverse Event Term | Left atrial enlargement | Adverse Event Term | Left atrial enlargement | Adverse Event Term | Left atrial enlargement | Adverse Event Term | Left atrial enlargement | Adverse Event Term | Left atrial enlargement | Adverse Event Term | Left atrial enlargement | Adverse Event Term | Mitral valve incompetence | Adverse Event Term | Mitral valve incompetence | Adverse Event Term | Mitral valve incompetence | Adverse Event Term | Mitral valve incompetence | Adverse Event Term | Mitral valve incompetence | Adverse Event Term | Mitral valve incompetence | Adverse Event Term | Mitral valve incompetence | Adverse Event Term | Mitral valve incompetence | Adverse Event Term | Mitral valve incompetence | Adverse Event Term | Right atrial enlargement | Adverse Event Term | Right atrial enlargement | Adverse Event Term | Right atrial enlargement | Adverse Event Term | Right atrial enlargement | Adverse Event Term | Right atrial enlargement | Adverse Event Term | Right atrial enlargement | Adverse Event Term | Right atrial enlargement | Adverse Event Term | Right atrial enlargement | Adverse Event Term | Right atrial enlargement | Adverse Event Term | Sinus tachycardia | Adverse Event Term | Sinus tachycardia | Adverse Event Term | Sinus tachycardia | Adverse Event Term | Sinus tachycardia | Adverse Event Term | Sinus tachycardia | Adverse Event Term | Sinus tachycardia | Adverse Event Term | Sinus tachycardia | Adverse Event Term | Sinus tachycardia | Adverse Event Term | Sinus tachycardia | Adverse Event Term | Supraventricular tachycardia | Adverse Event Term | Supraventricular tachycardia | Adverse Event Term | Supraventricular tachycardia | Adverse Event Term | Supraventricular tachycardia | Adverse Event Term | Supraventricular tachycardia | Adverse Event Term | Supraventricular tachycardia | Adverse Event Term | Supraventricular tachycardia | Adverse Event Term | Supraventricular tachycardia | Adverse Event Term | Supraventricular tachycardia | Adverse Event Term | Systolic dysfunction | Adverse Event Term | Systolic dysfunction | Adverse Event Term | Systolic dysfunction | Adverse Event Term | Systolic dysfunction | Adverse Event Term | Systolic dysfunction | Adverse Event Term | Systolic dysfunction | Adverse Event Term | Systolic dysfunction | Adverse Event Term | Systolic dysfunction | Adverse Event Term | Systolic dysfunction | Adverse Event Term | Tinnitus | Adverse Event Term | Tinnitus | Adverse Event Term | Tinnitus | Adverse Event Term | Tinnitus | Adverse Event Term | Tinnitus | Adverse Event Term | Tinnitus | Adverse Event Term | Tinnitus | Adverse Event Term | Tinnitus | Adverse Event Term | Tinnitus | Adverse Event Term | Cataract | Adverse Event Term | Cataract | Adverse Event Term | Cataract | Adverse Event Term | Cataract | Adverse Event Term | Cataract | Adverse Event Term | Cataract | Adverse Event Term | Cataract | Adverse Event Term | Cataract | Adverse Event Term | Cataract | Adverse Event Term | Abdominal discomfort | Adverse Event Term | Abdominal discomfort | Adverse Event Term | Abdominal discomfort | Adverse Event Term | Abdominal discomfort | Adverse Event Term | Abdominal discomfort | Adverse Event Term | Abdominal discomfort | Adverse Event Term | Abdominal discomfort | Adverse Event Term | Abdominal discomfort | Adverse Event Term | Abdominal discomfort | Adverse Event Term | Abdominal pain | Adverse Event Term | Abdominal pain | Adverse Event Term | Abdominal pain | Adverse Event Term | Abdominal pain | Adverse Event Term | Abdominal pain | Adverse Event Term | Abdominal pain | Adverse Event Term | Abdominal pain | Adverse Event Term | Abdominal pain | Adverse Event Term | Abdominal pain | Adverse Event Term | Diarrhoea | Adverse Event Term | Diarrhoea | Adverse Event Term | Diarrhoea | Adverse Event Term | Diarrhoea | Adverse Event Term | Diarrhoea | Adverse Event Term | Diarrhoea | Adverse Event Term | Diarrhoea | Adverse Event Term | Diarrhoea | Adverse Event Term | Diarrhoea | Adverse Event Term | Haematemesis | Adverse Event Term | Haematemesis | Adverse Event Term | Haematemesis | Adverse Event Term | Haematemesis | Adverse Event Term | Haematemesis | Adverse Event Term | Haematemesis | Adverse Event Term | Haematemesis | Adverse Event Term | Haematemesis | Adverse Event Term | Haematemesis | Adverse Event Term | Nausea | Adverse Event Term | Nausea | Adverse Event Term | Nausea | Adverse Event Term | Nausea | Adverse Event Term | Nausea | Adverse Event Term | Nausea | Adverse Event Term | Nausea | Adverse Event Term | Nausea | Adverse Event Term | Nausea | Adverse Event Term | Toothache | Adverse Event Term | Toothache | Adverse Event Term | Toothache | Adverse Event Term | Toothache | Adverse Event Term | Toothache | Adverse Event Term | Toothache | Adverse Event Term | Toothache | Adverse Event Term | Toothache | Adverse Event Term | Toothache | Adverse Event Term | Vomiting | Adverse Event Term | Vomiting | Adverse Event Term | Vomiting | Adverse Event Term | Vomiting | Adverse Event Term | Vomiting | Adverse Event Term | Vomiting | Adverse Event Term | Vomiting | Adverse Event Term | Vomiting | Adverse Event Term | Vomiting | Adverse Event Term | Asthenia | Adverse Event Term | Asthenia | Adverse Event Term | Asthenia | Adverse Event Term | Asthenia | Adverse Event Term | Asthenia | Adverse Event Term | Asthenia | Adverse Event Term | Asthenia | Adverse Event Term | Asthenia | Adverse Event Term | Asthenia | Adverse Event Term | Fatigue | Adverse Event Term | Fatigue | Adverse Event Term | Fatigue | Adverse Event Term | Fatigue | Adverse Event Term | Fatigue | Adverse Event Term | Fatigue | Adverse Event Term | Fatigue | Adverse Event Term | Fatigue | Adverse Event Term | Fatigue | Adverse Event Term | Pain | Adverse Event Term | Pain | Adverse Event Term | Pain | Adverse Event Term | Pain | Adverse Event Term | Pain | Adverse Event Term | Pain | Adverse Event Term | Pain | Adverse Event Term | Pain | Adverse Event Term | Pain | Adverse Event Term | Pyrexia | Adverse Event Term | Pyrexia | Adverse Event Term | Pyrexia | Adverse Event Term | Pyrexia | Adverse Event Term | Pyrexia | Adverse Event Term | Pyrexia | Adverse Event Term | Pyrexia | Adverse Event Term | Pyrexia | Adverse Event Term | Pyrexia | Adverse Event Term | Ulcer haemorrhage | Adverse Event Term | Ulcer haemorrhage | Adverse Event Term | Ulcer haemorrhage | Adverse Event Term | Ulcer haemorrhage | Adverse Event Term | Ulcer haemorrhage | Adverse Event Term | Ulcer haemorrhage | Adverse Event Term | Ulcer haemorrhage | Adverse Event Term | Ulcer haemorrhage | Adverse Event Term | Ulcer haemorrhage | Adverse Event Term | Acarodermatitis | Adverse Event Term | Acarodermatitis | Adverse Event Term | Acarodermatitis | Adverse Event Term | Acarodermatitis | Adverse Event Term | Acarodermatitis | Adverse Event Term | Acarodermatitis | Adverse Event Term | Acarodermatitis | Adverse Event Term | Acarodermatitis | Adverse Event Term | Acarodermatitis | Adverse Event Term | Cellulitis | Adverse Event Term | Cellulitis | Adverse Event Term | Cellulitis | Adverse Event Term | Cellulitis | Adverse Event Term | Cellulitis | Adverse Event Term | Cellulitis | Adverse Event Term | Cellulitis | Adverse Event Term | Cellulitis | Adverse Event Term | Cellulitis | Adverse Event Term | Clostridium difficile infection | Adverse Event Term | Clostridium difficile infection | Adverse Event Term | Clostridium difficile infection | Adverse Event Term | Clostridium difficile infection | Adverse Event Term | Clostridium difficile infection | Adverse Event Term | Clostridium difficile infection | Adverse Event Term | Clostridium difficile infection | Adverse Event Term | Clostridium difficile infection | Adverse Event Term | Clostridium difficile infection | Adverse Event Term | Gastroenteritis | Adverse Event Term | Gastroenteritis | Adverse Event Term | Gastroenteritis | Adverse Event Term | Gastroenteritis | Adverse Event Term | Gastroenteritis | Adverse Event Term | Gastroenteritis | Adverse Event Term | Gastroenteritis | Adverse Event Term | Gastroenteritis | Adverse Event Term | Gastroenteritis | Adverse Event Term | Influenza | Adverse Event Term | Influenza | Adverse Event Term | Influenza | Adverse Event Term | Influenza | Adverse Event Term | Influenza | Adverse Event Term | Influenza | Adverse Event Term | Influenza | Adverse Event Term | Influenza | Adverse Event Term | Influenza | Adverse Event Term | Localised infection | Adverse Event Term | Localised infection | Adverse Event Term | Localised infection | Adverse Event Term | Localised infection | Adverse Event Term | Localised infection | Adverse Event Term | Localised infection | Adverse Event Term | Localised infection | Adverse Event Term | Localised infection | Adverse Event Term | Localised infection | Adverse Event Term | Nail infection | Adverse Event Term | Nail infection | Adverse Event Term | Nail infection | Adverse Event Term | Nail infection | Adverse Event Term | Nail infection | Adverse Event Term | Nail infection | Adverse Event Term | Nail infection | Adverse Event Term | Nail infection | Adverse Event Term | Nail infection | Adverse Event Term | Nasopharyngitis | Adverse Event Term | Nasopharyngitis | Adverse Event Term | Nasopharyngitis | Adverse Event Term | Nasopharyngitis | Adverse Event Term | Nasopharyngitis | Adverse Event Term | Nasopharyngitis | Adverse Event Term | Nasopharyngitis | Adverse Event Term | Nasopharyngitis | Adverse Event Term | Nasopharyngitis | Adverse Event Term | Pneumonia | Adverse Event Term | Pneumonia | Adverse Event Term | Pneumonia | Adverse Event Term | Pneumonia | Adverse Event Term | Pneumonia | Adverse Event Term | Pneumonia | Adverse Event Term | Pneumonia | Adverse Event Term | Pneumonia | Adverse Event Term | Pneumonia | Adverse Event Term | Upper respiratory tract infection | Adverse Event Term | Upper respiratory tract infection | Adverse Event Term | Upper respiratory tract infection | Adverse Event Term | Upper respiratory tract infection | Adverse Event Term | Upper respiratory tract infection | Adverse Event Term | Upper respiratory tract infection | Adverse Event Term | Upper respiratory tract infection | Adverse Event Term | Upper respiratory tract infection | Adverse Event Term | Upper respiratory tract infection | Adverse Event Term | Urinary tract infection | Adverse Event Term | Urinary tract infection | Adverse Event Term | Urinary tract infection | Adverse Event Term | Urinary tract infection | Adverse Event Term | Urinary tract infection | Adverse Event Term | Urinary tract infection | Adverse Event Term | Urinary tract infection | Adverse Event Term | Urinary tract infection | Adverse Event Term | Urinary tract infection | Adverse Event Term | Urosepsis | Adverse Event Term | Urosepsis | Adverse Event Term | Urosepsis | Adverse Event Term | Urosepsis | Adverse Event Term | Urosepsis | Adverse Event Term | Urosepsis | Adverse Event Term | Urosepsis | Adverse Event Term | Urosepsis | Adverse Event Term | Urosepsis | Adverse Event Term | Arteriovenous fistula thrombosis | Adverse Event Term | Arteriovenous fistula thrombosis | Adverse Event Term | Arteriovenous fistula thrombosis | Adverse Event Term | Arteriovenous fistula thrombosis | Adverse Event Term | Arteriovenous fistula thrombosis | Adverse Event Term | Arteriovenous fistula thrombosis | Adverse Event Term | Arteriovenous fistula thrombosis | Adverse Event Term | Arteriovenous fistula thrombosis | Adverse Event Term | Arteriovenous fistula thrombosis | Adverse Event Term | Contusion | Adverse Event Term | Contusion | Adverse Event Term | Contusion | Adverse Event Term | Contusion | Adverse Event Term | Contusion | Adverse Event Term | Contusion | Adverse Event Term | Contusion | Adverse Event Term | Contusion | Adverse Event Term | Contusion | Adverse Event Term | Fall | Adverse Event Term | Fall | Adverse Event Term | Fall | Adverse Event Term | Fall | Adverse Event Term | Fall | Adverse Event Term | Fall | Adverse Event Term | Fall | Adverse Event Term | Fall | Adverse Event Term | Fall | Adverse Event Term | Graft thrombosis | Adverse Event Term | Graft thrombosis | Adverse Event Term | Graft thrombosis | Adverse Event Term | Graft thrombosis | Adverse Event Term | Graft thrombosis | Adverse Event Term | Graft thrombosis | Adverse Event Term | Graft thrombosis | Adverse Event Term | Graft thrombosis | Adverse Event Term | Graft thrombosis | Adverse Event Term | Joint injury | Adverse Event Term | Joint injury | Adverse Event Term | Joint injury | Adverse Event Term | Joint injury | Adverse Event Term | Joint injury | Adverse Event Term | Joint injury | Adverse Event Term | Joint injury | Adverse Event Term | Joint injury | Adverse Event Term | Joint injury | Adverse Event Term | Transfusion reaction | Adverse Event Term | Transfusion reaction | Adverse Event Term | Transfusion reaction | Adverse Event Term | Transfusion reaction | Adverse Event Term | Transfusion reaction | Adverse Event Term | Transfusion reaction | Adverse Event Term | Transfusion reaction | Adverse Event Term | Transfusion reaction | Adverse Event Term | Transfusion reaction | Adverse Event Term | Vascular access complication | Adverse Event Term | Vascular access complication | Adverse Event Term | Vascular access complication | Adverse Event Term | Vascular access complication | Adverse Event Term | Vascular access complication | Adverse Event Term | Vascular access complication | Adverse Event Term | Vascular access complication | Adverse Event Term | Vascular access complication | Adverse Event Term | Vascular access complication | Adverse Event Term | Vascular pseudoaneurysm ruptured | Adverse Event Term | Vascular pseudoaneurysm ruptured | Adverse Event Term | Vascular pseudoaneurysm ruptured | Adverse Event Term | Vascular pseudoaneurysm ruptured | Adverse Event Term | Vascular pseudoaneurysm ruptured | Adverse Event Term | Vascular pseudoaneurysm ruptured | Adverse Event Term | Vascular pseudoaneurysm ruptured | Adverse Event Term | Vascular pseudoaneurysm ruptured | Adverse Event Term | Vascular pseudoaneurysm ruptured | Adverse Event Term | Weight decreased | Adverse Event Term | Weight decreased | Adverse Event Term | Weight decreased | Adverse Event Term | Weight decreased | Adverse Event Term | Weight decreased | Adverse Event Term | Weight decreased | Adverse Event Term | Weight decreased | Adverse Event Term | Weight decreased | Adverse Event Term | Weight decreased | Adverse Event Term | Decreased appetite | Adverse Event Term | Decreased appetite | Adverse Event Term | Decreased appetite | Adverse Event Term | Decreased appetite | Adverse Event Term | Decreased appetite | Adverse Event Term | Decreased appetite | Adverse Event Term | Decreased appetite | Adverse Event Term | Decreased appetite | Adverse Event Term | Decreased appetite | Adverse Event Term | Fluid overload | Adverse Event Term | Fluid overload | Adverse Event Term | Fluid overload | Adverse Event Term | Fluid overload | Adverse Event Term | Fluid overload | Adverse Event Term | Fluid overload | Adverse Event Term | Fluid overload | Adverse Event Term | Fluid overload | Adverse Event Term | Fluid overload | Adverse Event Term | Hyperkalaemia | Adverse Event Term | Hyperkalaemia | Adverse Event Term | Hyperkalaemia | Adverse Event Term | Hyperkalaemia | Adverse Event Term | Hyperkalaemia | Adverse Event Term | Hyperkalaemia | Adverse Event Term | Hyperkalaemia | Adverse Event Term | Hyperkalaemia | Adverse Event Term | Hyperkalaemia | Adverse Event Term | Hypovolaemia | Adverse Event Term | Hypovolaemia | Adverse Event Term | Hypovolaemia | Adverse Event Term | Hypovolaemia | Adverse Event Term | Hypovolaemia | Adverse Event Term | Hypovolaemia | Adverse Event Term | Hypovolaemia | Adverse Event Term | Hypovolaemia | Adverse Event Term | Hypovolaemia | Adverse Event Term | Type 2 diabetes mellitus | Adverse Event Term | Type 2 diabetes mellitus | Adverse Event Term | Type 2 diabetes mellitus | Adverse Event Term | Type 2 diabetes mellitus | Adverse Event Term | Type 2 diabetes mellitus | Adverse Event Term | Type 2 diabetes mellitus | Adverse Event Term | Type 2 diabetes mellitus | Adverse Event Term | Type 2 diabetes mellitus | Adverse Event Term | Type 2 diabetes mellitus | Adverse Event Term | Back pain | Adverse Event Term | Back pain | Adverse Event Term | Back pain | Adverse Event Term | Back pain | Adverse Event Term | Back pain | Adverse Event Term | Back pain | Adverse Event Term | Back pain | Adverse Event Term | Back pain | Adverse Event Term | Back pain | Adverse Event Term | Intervertebral disc degeneration | Adverse Event Term | Intervertebral disc degeneration | Adverse Event Term | Intervertebral disc degeneration | Adverse Event Term | Intervertebral disc degeneration | Adverse Event Term | Intervertebral disc degeneration | Adverse Event Term | Intervertebral disc degeneration | Adverse Event Term | Intervertebral disc degeneration | Adverse Event Term | Intervertebral disc degeneration | Adverse Event Term | Intervertebral disc degeneration | Adverse Event Term | Muscle spasms | Adverse Event Term | Muscle spasms | Adverse Event Term | Muscle spasms | Adverse Event Term | Muscle spasms | Adverse Event Term | Muscle spasms | Adverse Event Term | Muscle spasms | Adverse Event Term | Muscle spasms | Adverse Event Term | Muscle spasms | Adverse Event Term | Muscle spasms | Adverse Event Term | Musculoskeletal pain | Adverse Event Term | Musculoskeletal pain | Adverse Event Term | Musculoskeletal pain | Adverse Event Term | Musculoskeletal pain | Adverse Event Term | Musculoskeletal pain | Adverse Event Term | Musculoskeletal pain | Adverse Event Term | Musculoskeletal pain | Adverse Event Term | Musculoskeletal pain | Adverse Event Term | Musculoskeletal pain | Adverse Event Term | Pain in extremity | Adverse Event Term | Pain in extremity | Adverse Event Term | Pain in extremity | Adverse Event Term | Pain in extremity | Adverse Event Term | Pain in extremity | Adverse Event Term | Pain in extremity | Adverse Event Term | Pain in extremity | Adverse Event Term | Pain in extremity | Adverse Event Term | Pain in extremity | Adverse Event Term | Headache | Adverse Event Term | Headache | Adverse Event Term | Headache | Adverse Event Term | Headache | Adverse Event Term | Headache | Adverse Event Term | Headache | Adverse Event Term | Headache | Adverse Event Term | Headache | Adverse Event Term | Headache | Adverse Event Term | Loss of consciousness | Adverse Event Term | Loss of consciousness | Adverse Event Term | Loss of consciousness | Adverse Event Term | Loss of consciousness | Adverse Event Term | Loss of consciousness | Adverse Event Term | Loss of consciousness | Adverse Event Term | Loss of consciousness | Adverse Event Term | Loss of consciousness | Adverse Event Term | Loss of consciousness | Adverse Event Term | Presyncope | Adverse Event Term | Presyncope | Adverse Event Term | Presyncope | Adverse Event Term | Presyncope | Adverse Event Term | Presyncope | Adverse Event Term | Presyncope | Adverse Event Term | Presyncope | Adverse Event Term | Presyncope | Adverse Event Term | Presyncope | Adverse Event Term | Syncope | Adverse Event Term | Syncope | Adverse Event Term | Syncope | Adverse Event Term | Syncope | Adverse Event Term | Syncope | Adverse Event Term | Syncope | Adverse Event Term | Syncope | Adverse Event Term | Syncope | Adverse Event Term | Syncope | Adverse Event Term | Mental status changes | Adverse Event Term | Mental status changes | Adverse Event Term | Mental status changes | Adverse Event Term | Mental status changes | Adverse Event Term | Mental status changes | Adverse Event Term | Mental status changes | Adverse Event Term | Mental status changes | Adverse Event Term | Mental status changes | Adverse Event Term | Mental status changes | Adverse Event Term | Costovertebral angle tenderness | Adverse Event Term | Costovertebral angle tenderness | Adverse Event Term | Costovertebral angle tenderness | Adverse Event Term | Costovertebral angle tenderness | Adverse Event Term | Costovertebral angle tenderness | Adverse Event Term | Costovertebral angle tenderness | Adverse Event Term | Costovertebral angle tenderness | Adverse Event Term | Costovertebral angle tenderness | Adverse Event Term | Costovertebral angle tenderness | Adverse Event Term | Urinary retention | Adverse Event Term | Urinary retention | Adverse Event Term | Urinary retention | Adverse Event Term | Urinary retention | Adverse Event Term | Urinary retention | Adverse Event Term | Urinary retention | Adverse Event Term | Urinary retention | Adverse Event Term | Urinary retention | Adverse Event Term | Urinary retention | Adverse Event Term | Urinary tract obstruction | Adverse Event Term | Urinary tract obstruction | Adverse Event Term | Urinary tract obstruction | Adverse Event Term | Urinary tract obstruction | Adverse Event Term | Urinary tract obstruction | Adverse Event Term | Urinary tract obstruction | Adverse Event Term | Urinary tract obstruction | Adverse Event Term | Urinary tract obstruction | Adverse Event Term | Urinary tract obstruction | Adverse Event Term | Uterine haemorrhage | Adverse Event Term | Uterine haemorrhage | Adverse Event Term | Uterine haemorrhage | Adverse Event Term | Uterine haemorrhage | Adverse Event Term | Uterine haemorrhage | Adverse Event Term | Uterine haemorrhage | Adverse Event Term | Uterine haemorrhage | Adverse Event Term | Uterine haemorrhage | Adverse Event Term | Uterine haemorrhage | Adverse Event Term | Acute respiratory failure | Adverse Event Term | Acute respiratory failure | Adverse Event Term | Acute respiratory failure | Adverse Event Term | Acute respiratory failure | Adverse Event Term | Acute respiratory failure | Adverse Event Term | Acute respiratory failure | Adverse Event Term | Acute respiratory failure | Adverse Event Term | Acute respiratory failure | Adverse Event Term | Acute respiratory failure | Adverse Event Term | Chronic obstructive pulmonary disease | Adverse Event Term | Chronic obstructive pulmonary disease | Adverse Event Term | Chronic obstructive pulmonary disease | Adverse Event Term | Chronic obstructive pulmonary disease | Adverse Event Term | Chronic obstructive pulmonary disease | Adverse Event Term | Chronic obstructive pulmonary disease | Adverse Event Term | Chronic obstructive pulmonary disease | Adverse Event Term | Chronic obstructive pulmonary disease | Adverse Event Term | Chronic obstructive pulmonary disease | Adverse Event Term | Cough | Adverse Event Term | Cough | Adverse Event Term | Cough | Adverse Event Term | Cough | Adverse Event Term | Cough | Adverse Event Term | Cough | Adverse Event Term | Cough | Adverse Event Term | Cough | Adverse Event Term | Cough | Adverse Event Term | Epistaxis | Adverse Event Term | Epistaxis | Adverse Event Term | Epistaxis | Adverse Event Term | Epistaxis | Adverse Event Term | Epistaxis | Adverse Event Term | Epistaxis | Adverse Event Term | Epistaxis | Adverse Event Term | Epistaxis | Adverse Event Term | Epistaxis | Adverse Event Term | Hypoxia | Adverse Event Term | Hypoxia | Adverse Event Term | Hypoxia | Adverse Event Term | Hypoxia | Adverse Event Term | Hypoxia | Adverse Event Term | Hypoxia | Adverse Event Term | Hypoxia | Adverse Event Term | Hypoxia | Adverse Event Term | Hypoxia | Adverse Event Term | Pleural effusion | Adverse Event Term | Pleural effusion | Adverse Event Term | Pleural effusion | Adverse Event Term | Pleural effusion | Adverse Event Term | Pleural effusion | Adverse Event Term | Pleural effusion | Adverse Event Term | Pleural effusion | Adverse Event Term | Pleural effusion | Adverse Event Term | Pleural effusion | Adverse Event Term | Pulmonary hypertension | Adverse Event Term | Pulmonary hypertension | Adverse Event Term | Pulmonary hypertension | Adverse Event Term | Pulmonary hypertension | Adverse Event Term | Pulmonary hypertension | Adverse Event Term | Pulmonary hypertension | Adverse Event Term | Pulmonary hypertension | Adverse Event Term | Pulmonary hypertension | Adverse Event Term | Pulmonary hypertension | Adverse Event Term | Pulmonary oedema | Adverse Event Term | Pulmonary oedema | Adverse Event Term | Pulmonary oedema | Adverse Event Term | Pulmonary oedema | Adverse Event Term | Pulmonary oedema | Adverse Event Term | Pulmonary oedema | Adverse Event Term | Pulmonary oedema | Adverse Event Term | Pulmonary oedema | Adverse Event Term | Pulmonary oedema | Adverse Event Term | Diabetic foot | Adverse Event Term | Diabetic foot | Adverse Event Term | Diabetic foot | Adverse Event Term | Diabetic foot | Adverse Event Term | Diabetic foot | Adverse Event Term | Diabetic foot | Adverse Event Term | Diabetic foot | Adverse Event Term | Diabetic foot | Adverse Event Term | Diabetic foot | Adverse Event Term | Pruritus | Adverse Event Term | Pruritus | Adverse Event Term | Pruritus | Adverse Event Term | Pruritus | Adverse Event Term | Pruritus | Adverse Event Term | Pruritus | Adverse Event Term | Pruritus | Adverse Event Term | Pruritus | Adverse Event Term | Pruritus | Adverse Event Term | Skin ulcer | Adverse Event Term | Skin ulcer | Adverse Event Term | Skin ulcer | Adverse Event Term | Skin ulcer | Adverse Event Term | Skin ulcer | Adverse Event Term | Skin ulcer | Adverse Event Term | Skin ulcer | Adverse Event Term | Skin ulcer | Adverse Event Term | Skin ulcer | Adverse Event Term | Uraemic pruritus | Adverse Event Term | Uraemic pruritus | Adverse Event Term | Uraemic pruritus | Adverse Event Term | Uraemic pruritus | Adverse Event Term | Uraemic pruritus | Adverse Event Term | Uraemic pruritus | Adverse Event Term | Uraemic pruritus | Adverse Event Term | Uraemic pruritus | Adverse Event Term | Uraemic pruritus | Adverse Event Term | Deep vein thrombosis | Adverse Event Term | Deep vein thrombosis | Adverse Event Term | Deep vein thrombosis | Adverse Event Term | Deep vein thrombosis | Adverse Event Term | Deep vein thrombosis | Adverse Event Term | Deep vein thrombosis | Adverse Event Term | Deep vein thrombosis | Adverse Event Term | Deep vein thrombosis | Adverse Event Term | Deep vein thrombosis | Adverse Event Term | Haematoma | Adverse Event Term | Haematoma | Adverse Event Term | Haematoma | Adverse Event Term | Haematoma | Adverse Event Term | Haematoma | Adverse Event Term | Haematoma | Adverse Event Term | Haematoma | Adverse Event Term | Haematoma | Adverse Event Term | Haematoma | Adverse Event Term | Hypertension | Adverse Event Term | Hypertension | Adverse Event Term | Hypertension | Adverse Event Term | Hypertension | Adverse Event Term | Hypertension | Adverse Event Term | Hypertension | Adverse Event Term | Hypertension | Adverse Event Term | Hypertension | Adverse Event Term | Hypertension | Adverse Event Term | Hypovolaemic shock | Adverse Event Term | Hypovolaemic shock | Adverse Event Term | Hypovolaemic shock | Adverse Event Term | Hypovolaemic shock | Adverse Event Term | Hypovolaemic shock | Adverse Event Term | Hypovolaemic shock | Adverse Event Term | Hypovolaemic shock | Adverse Event Term | Hypovolaemic shock | Adverse Event Term | Hypovolaemic shock | Adverse Event Term | Shock haemorrhagic | Adverse Event Term | Shock haemorrhagic | Adverse Event Term | Shock haemorrhagic | Adverse Event Term | Shock haemorrhagic | Adverse Event Term | Shock haemorrhagic | Adverse Event Term | Shock haemorrhagic | Adverse Event Term | Shock haemorrhagic | Adverse Event Term | Shock haemorrhagic | Adverse Event Term | Shock haemorrhagic | Adverse Event Term | Vascular calcification | Adverse Event Term | Vascular calcification | Adverse Event Term | Vascular calcification | Adverse Event Term | Vascular calcification | Adverse Event Term | Vascular calcification | Adverse Event Term | Vascular calcification | Adverse Event Term | Vascular calcification | Adverse Event Term | Vascular calcification | Adverse Event Term | Vascular calcification |
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Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 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Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | 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23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | 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Responsible Parties
Sequence: | 28890942 |
Responsible Party Type | Sponsor |
Result Agreements
Sequence: | 3853608 |
Pi Employee | No |
Result Contacts
Sequence: | 3853573 |
Organization | Akebia Therapeutics, Inc |
Name | Akebia Therapeutics, Inc |
Phone | 617-844-6128 |
trials@akebia.com | |
Outcomes
Sequence: | 30820453 | Sequence: | 30820437 | Sequence: | 30820438 | Sequence: | 30820439 | Sequence: | 30820440 | Sequence: | 30820441 | Sequence: | 30820442 | Sequence: | 30820443 | Sequence: | 30820444 | Sequence: | 30820445 | Sequence: | 30820446 | Sequence: | 30820447 | Sequence: | 30820448 | Sequence: | 30820449 | Sequence: | 30820450 | Sequence: | 30820451 | Sequence: | 30820452 | Sequence: | 30820454 | Sequence: | 30820455 | Sequence: | 30820456 | Sequence: | 30820457 | Sequence: | 30820458 | Sequence: | 30820459 | Sequence: | 30820460 | Sequence: | 30820461 | Sequence: | 30820462 | Sequence: | 30820463 | Sequence: | 30820464 |
Outcome Type | Secondary | Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary |
Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP) | Title | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Title | Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values | Title | Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Values | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants With Hb Values Within the Target Range at the PEP | Title | Mean Change in Hb From the PEP to the Secondary Evaluation Period (SEP) in Participants Who Transitioned to Three Times Per Week (TIW) Vadadustat Dosing After Week 12 | Title | Mean Change in Hb Between Baseline and the SEP | Title | Number of Participants With Hb Values Within the Target Range at the SEP | Title | Number of Participants With Hb Values Within the Target Range at the SEP in Participants Who Transitioned to TIW Vadadustat Dosing | Title | Number of Participants With a Mean Increase in Hb From Baseline to the PEP ≥0.5 g/dL or With Hb Values Within the Target Range at the PEP | Title | Number of Participants With a Mean Increase in Hb From Baseline to the SEP ≥0.5 g/dL or With Hb Values Within the Target Range at the SEP | Title | Number of Participants Requiring at Least One Intravenous (IV) Elemental Iron Supplementation | Title | Number of Participants Requiring Erythropoiesis-stimulating Agent (ESA) Rescue | Title | Number of Participants Requiring Red Blood Cell (RBC) Transfusion | Title | Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Hepcidin Concentration | Title | Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Vadadustat Following a Single Dose | Title | Geometric Mean Area Under the Concentration-time Curve (AUC) From Time 0 to 24 Hours (AUC0-24) of Vadadustat Following a Single Dose | Title | Median Terminal Half-life (t1/2) of Vadadustat Following a Single Dose | Title | Median Time to Reach Cmax (Tmax) of Vadadustat Following a Single Dose | Title | Geometric Mean Elimination Rate Constant (λz) of Vadadustat Following a Single Dose | Title | Geometric Mean Apparent Total Body Clearance (CLss/F) of Vadadustat Following a Single Dose | Title | Geometric Mean Apparent Volume of Distribution (Vz/F) of Vadadustat Following a Single Dose |
Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Change from Baseline in Hb value was calculated as the PEP Hb value minus the Baseline Hb value. The PEP value was the average Hb value from Week 10 to Week 12. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. | Description | An adverse event (AE) was defined as any untoward medical occurrence (including a clinically significant abnormal laboratory finding) that occurred in the protocol-specified AE reporting period. An AE included medical conditions, signs, and symptoms not previously observed in the participant that emerged during the protocol-specified AE reporting period, including signs or symptoms associated with pre-existing underlying conditions that were not present prior to the AE reporting period. TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. | Description | Parameters assessed for laboratory values included hematology (excluding the primary and secondary efficacy endpoint results related to Hb), clinical chemistry, lipid profiles, and glucose. The investigator was responsible for reviewing laboratory results for clinically significant changes. | Description | Parameters assessed for vital signs included sitting (at rest for a minimum of 5 minutes) heart rate, respiratory rate, body temperature, and blood pressure. The investigator was responsible for reviewing vital sign values for clinically significant changes. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 g/dL, inclusive. The PEP was comprised of Week 10 to Week 12. | Description | Change from PEP was calculated as the SEP value minus the PEP value. The PEP value was the average Hb value from Week 10 to Week 12. The SEP value was the average Hb value from Week 18 to Week 20. For the Main Study, analysis is presented per dose level according to the starting dose in TIW regimen, as well as being presented as a combined arm for "Vadadustat Total (TIW dosing regimen)". For the ESA Hyporesponder Parallel Study, a starting dose classification for TIW dosing regimen was not applicable due to no participants switching from Vadadustat QD to TIW dosing. | Description | Change from Baseline was calculated as the SEP value minus the Baseline value. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. The SEP value was the average Hb value from Week 18 to Week 20. | Description | The target range for Hb was from 10.0 to 11.0 g/dL. The SEP was comprised of Week 18 to Week 20. | Description | The target range for Hb was from 10.0 to 11.0 g/dL. The SEP was comprised of Week 18 to Week 20. For the Main Study, analysis is presented per dose level according to the starting dose in TIW regimen, as well as being presented as a combined arm for "Vadadustat Total (TIW dosing regimen)". For the ESA Hyporesponder Parallel Study, a starting dose classification for TIW dosing regimen was not applicable due to no participants switching from Vadadustat QD to TIW dosing. | Description | The target range for Hb was from 10.0 to 11.0 g/dL. The PEP was comprised of Week 10 to Week 12. | Description | The target range for Hb was from 10.0 to 11.0 grams per g/dL. The SEP was comprised of Week 18 to Week 20. | Description | Iron supplementation was performed to maintain ferritin ≥200 nanograms/milliliters (ng/mL) and transferrin saturation (TSAT) ≥20%. | Description | ESA rescue therapy was administered in participants with Hb ≥8.5 g/dL, and was stopped when Hb reached ≥9.0 g/dL. | Description | RBC transfusion was administered as rescue therapy in the event of an acute or severe loss of blood. | Description | Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of Cmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of AUC and AUC0-24 of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of t1/2 of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Tmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of λz of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of CLss/F of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Vz/F of Vadadustat following a single dose. |
Time Frame | Baseline; Week 1, Week 4, Week 8, Week 11, Week 12, Week 13, Week 16, and Week 20 | Time Frame | Baseline; Week 10 to Week 12 | Time Frame | Up to Week 24 | Time Frame | Up to Week 24 | Time Frame | Up to Week 24 | Time Frame | Weeks 13 – 20 | Time Frame | Week 10 to Week 12 | Time Frame | Week 10 to Week 12; Week 18 to Week 20 | Time Frame | Baseline; Week 18 to Week 20 | Time Frame | Week 18 to Week 20 | Time Frame | Week 18 to Week 20 | Time Frame | Week 10 to Week 12 | Time Frame | Week 18 to Week 20 | Time Frame | Up to Week 20 | Time Frame | Up to Week 20 | Time Frame | Up to Week 20 | Time Frame | Baseline; Week 1 (pre-dose), Week 1 +1 (Day 8; pre-dose), Week 11 (pre-dose), and Week 13 (pre-dose) | Time Frame | Baseline; Week 4, Week 8, Week 12, Week 16, and Week 20 | Time Frame | Baseline; Week 4, Week 8, Week 12, Week 16, and Week 20 | Time Frame | Baseline; Week 4, Week 8, Week 12, Week 16, and Week 20 | Time Frame | Baseline; Week 12 and Week 20 | Time Frame | Day 1; Week 1, Week 1 +1 (Day 8), Week 11, Week 13: pre-dose, 2 hours (h), 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose | Time Frame | Day 1; Week 1, Week 1 +1 (Day 8), Week 11: pre-dose, 2h, 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose | Time Frame | Day 1; Week 1, Week 1 +1 (Day 8), Week 11, Week 13: pre-dose, 2 hours (h), 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose | Time Frame | Day 1; Week 1, Week 1 +1 (Day 8), Week 11, Week 13: pre-dose, 2 hours (h), 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose | Time Frame | Day 1; Week 1, Week 1 +1 (Day 8), Week 11, Week 13: pre-dose, 2 hours (h), 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose | Time Frame | Day 1; Week 1, Week 1 +1 (Day 8), Week 11: pre-dose, 2h, 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose | Time Frame | Day 1; Week 1, Week 1 +1 (Day 8), Week 11: pre-dose, 2h, 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose |
Population | Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis. | Population | Randomized Population: All randomized participants. Analysis of this population was based on the randomized treatment. | Population | Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. Participants who received Vadadustat and Epoetin Alfa in error were classified by the more frequently received drug. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Population | Safety Population. Analysis of this population was based on the actual treatment received. Participants who received Vadadustat and Epoetin Alfa in error were classified by the more frequently received drug. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Population | Safety Population. Analysis of this population was based on the actual treatment received. Participants who received Vadadustat and Epoetin Alfa in error were classified by the more frequently received drug. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Population | Safety Population. Analysis of this population was based on the actual treatment received. Participants who received Vadadustat and Epoetin Alfa in error were classified by the more frequently received drug. Only participants with available data were included in the analysis. The rows presenting data for HB > 12.0 g/dL, HB > 13.0 g/dL and HB > 14.0 g/dL are mutually exclusive. | Population | Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis. | Population | Randomized Population. Analysis of this population was based on the randomized treatment. Only those who switched from Vadadustat QD to TIW dosing after Week 12 were included in the analysis (17 participants overall in Main Study and 0 participants in ESA Hyporesponder Parallel Study). | Population | Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis. | Population | Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis. | Population | Randomized Population. Analysis of this population was based on the randomized treatment. Only those who switched from Vadadustat QD to TIW dosing after Week 12 were included in the analysis (17 participants overall in Main Study and 0 participants in ESA Hyporesponder Parallel Study). | Population | Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis. | Population | Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis. | Population | Randomized Population. Analysis of this population was based on the randomized treatment. | Population | Randomized Population. Analysis of this population was based on the randomized treatment. | Population | Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis. | Population | Pharmacokinetic (PK) Population: all randomized participants who received study drug and had enough drug concentrations to estimate AUC and Cmax. Analysis of this population was based on the dose amount taken at the date of PK sampling for the Vadadustat group. Participants with concentrations below the limit of quantitation (BLQ) for all the time points were excluded from the analysis. | Population | Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis. | Population | Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis. | Population | Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis. | Population | Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis. | Population | PK Population. Analysis of this population was based on the dose amount taken at the date of PK sampling for the Vadadustat group. Participants with non-missing values were included in the analysis. PK parameter of plasma Vadadustat concentration for Vadadustat treatment groups without dose normalization by strata of Epoetin Alfa dose group were included for the analysis. | Population | PK Population. Analysis of this population was based on the dose amount taken at the date of PK sampling for the Vadadustat group. Participants with non-missing values were included in the analysis. PK parameter of plasma Vadadustat concentration for Vadadustat treatment groups without dose normalization by strata of Epoetin Alfa dose group were included for the analysis. | Population | PK Population. Analysis of this population was based on the dose amount taken at the date of PK sampling for the Vadadustat group. Participants with non-missing values were included in the analysis. PK parameter of plasma Vadadustat concentration for Vadadustat treatment groups without dose normalization by strata of Epoetin Alfa dose group were included for the analysis. | Population | PK Population. Analysis of this population was based on the dose amount taken at the date of PK sampling for Vadadustat group. Participants with non-missing values were included in the analysis. PK parameter of plasma Vadadustat concentration for Vadadustat treatment groups without dose normalization by strata of Epoetin Alfa dose group were included for the analysis. | Population | PK Population. Analysis of this population was based on the dose amount taken at the date of PK sampling for the Vadadustat group. Participants with non-missing values were included in the analysis. PK parameter of plasma Vadadustat concentration for Vadadustat treatment groups without dose normalization by strata of Epoetin Alfa dose group were included for the analysis. | Population | PK Population. Analysis of this population was based on the dose amount taken at the date of PK sampling for the Vadadustat group. Participants with non-missing values were included in the analysis. PK parameter of plasma Vadadustat concentration for Vadadustat treatment groups without dose normalization by strata of Epoetin Alfa dose group were included for the analysis. | Population | PK Population. Analysis of this population was based on the dose amount taken at the date of PK sampling for the Vadadustat group. Participants with non-missing values were included in the analysis. PK parameter of plasma Vadadustat concentration for Vadadustat treatment groups without dose normalization by strata of Epoetin Alfa dose group were included for the analysis. |
Units | 10^3 cells/microliter (µL) | Units | grams per deciliter (g/dL) | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | g/dL | Units | g/dL | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Milliunits per milliliter | Units | micrograms per deciliter (µg/dL) | Units | micrograms per liter (µg/L) | Units | µg/dL | Units | nanograms per milliliter (ng/mL) | Units | Micrograms per milliliter (μg/mL) | Units | hours*µg/mL | Units | Hours | Units | Hours | Units | 1/hour | Units | liters per hour | Units | Liters |
Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Full Range | Dispersion Type | Full Range | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | ||||||||||||||||||||||||
Param Type | Mean | Param Type | Mean | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Mean | Param Type | Mean | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Geometric Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Median | Param Type | Median | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean |
Outcome Measurements
Sequence: | 235800598 | Sequence: | 235800699 | Sequence: | 235800539 | Sequence: | 235800700 | Sequence: | 235800674 | Sequence: | 235800531 | Sequence: | 235800532 | Sequence: | 235800533 | Sequence: | 235800534 | Sequence: | 235800535 | Sequence: | 235800536 | Sequence: | 235800537 | Sequence: | 235800538 | Sequence: | 235800540 | Sequence: | 235800541 | Sequence: | 235800542 | Sequence: | 235800543 | Sequence: | 235800544 | Sequence: | 235800545 | Sequence: | 235800546 | Sequence: | 235800547 | Sequence: | 235800548 | Sequence: | 235800549 | Sequence: | 235800550 | Sequence: | 235800558 | Sequence: | 235800551 | Sequence: | 235800552 | Sequence: | 235800553 | Sequence: | 235800554 | Sequence: | 235800555 | Sequence: | 235800556 | Sequence: | 235800557 | Sequence: | 235800559 | Sequence: | 235800560 | Sequence: | 235800561 | Sequence: | 235800562 | Sequence: | 235800563 | Sequence: | 235800564 | Sequence: | 235800565 | Sequence: | 235800566 | Sequence: | 235800567 | Sequence: | 235800568 | Sequence: | 235800569 | Sequence: | 235800570 | Sequence: | 235800571 | Sequence: | 235800572 | Sequence: | 235800573 | Sequence: | 235800574 | Sequence: | 235800575 | Sequence: | 235800576 | Sequence: | 235800577 | Sequence: | 235800578 | Sequence: | 235800579 | Sequence: | 235800580 | Sequence: | 235800581 | Sequence: | 235800582 | Sequence: | 235800583 | Sequence: | 235800584 | Sequence: | 235800585 | Sequence: | 235800586 | Sequence: | 235800587 | Sequence: | 235800588 | Sequence: | 235800589 | Sequence: | 235800590 | Sequence: | 235800591 | Sequence: | 235800592 | Sequence: | 235800593 | Sequence: | 235800594 | Sequence: | 235800595 | Sequence: | 235800596 | Sequence: | 235800597 | Sequence: | 235800675 | Sequence: | 235800599 | Sequence: | 235800600 | Sequence: | 235800601 | Sequence: | 235800602 | Sequence: | 235800603 | Sequence: | 235800604 | Sequence: | 235800605 | Sequence: | 235800606 | Sequence: | 235800607 | Sequence: | 235800608 | Sequence: | 235800609 | Sequence: | 235800610 | Sequence: | 235800611 | Sequence: | 235800612 | Sequence: | 235800613 | Sequence: | 235800614 | Sequence: | 235800615 | Sequence: | 235800616 | Sequence: | 235800617 | Sequence: | 235800618 | Sequence: | 235800619 | Sequence: | 235800620 | Sequence: | 235800621 | Sequence: | 235800622 | Sequence: | 235800623 | Sequence: | 235800624 | Sequence: | 235800625 | Sequence: | 235800626 | Sequence: | 235800627 | Sequence: | 235800628 | Sequence: | 235800629 | Sequence: | 235800630 | Sequence: | 235800631 | Sequence: | 235800632 | Sequence: | 235800633 | Sequence: | 235800634 | Sequence: | 235800635 | Sequence: | 235800636 | Sequence: | 235800637 | Sequence: | 235800638 | Sequence: | 235800639 | Sequence: | 235800676 | Sequence: | 235800640 | Sequence: | 235800641 | Sequence: | 235800642 | Sequence: | 235800643 | Sequence: | 235800644 | Sequence: | 235800645 | Sequence: | 235800646 | Sequence: | 235800647 | Sequence: | 235800648 | Sequence: | 235800649 | Sequence: | 235800650 | Sequence: | 235800651 | Sequence: | 235800652 | Sequence: | 235800653 | Sequence: | 235800654 | Sequence: | 235800655 | Sequence: | 235800656 | Sequence: | 235800657 | Sequence: | 235800658 | Sequence: | 235800659 | Sequence: | 235800660 | Sequence: | 235800661 | Sequence: | 235800662 | Sequence: | 235800663 | Sequence: | 235800664 | Sequence: | 235800665 | Sequence: | 235800666 | Sequence: | 235800667 | Sequence: | 235800668 | Sequence: | 235800669 | Sequence: | 235800670 | Sequence: | 235800671 | Sequence: | 235800672 | Sequence: | 235800673 | Sequence: | 235800677 | Sequence: | 235800678 | Sequence: | 235800679 | Sequence: | 235800680 | Sequence: | 235800681 | Sequence: | 235800682 | Sequence: | 235800683 | Sequence: | 235800684 | Sequence: | 235800685 | Sequence: | 235800686 | Sequence: | 235800687 | Sequence: | 235800688 | Sequence: | 235800689 | Sequence: | 235800690 | Sequence: | 235800691 | Sequence: | 235800692 | Sequence: | 235800693 | Sequence: | 235800694 | Sequence: | 235800695 | Sequence: | 235800696 | Sequence: | 235800697 | Sequence: | 235800698 | Sequence: | 235800701 | Sequence: | 235800702 | Sequence: | 235800703 | Sequence: | 235800704 | Sequence: | 235800705 | Sequence: | 235800706 | Sequence: | 235800707 | Sequence: | 235800708 | Sequence: | 235800709 | Sequence: | 235800710 | Sequence: | 235800711 | Sequence: | 235800712 | Sequence: | 235800713 | Sequence: | 235800714 | Sequence: | 235800715 | Sequence: | 235800716 | Sequence: | 235800717 | Sequence: | 235800718 | Sequence: | 235800719 | Sequence: | 235800720 | Sequence: | 235800721 | Sequence: | 235800722 | Sequence: | 235800723 | Sequence: | 235800724 | Sequence: | 235800725 | Sequence: | 235800726 | Sequence: | 235800727 | Sequence: | 235800728 | Sequence: | 235800729 | Sequence: | 235800730 | Sequence: | 235800731 | Sequence: | 235800732 | Sequence: | 235800733 | Sequence: | 235800734 | Sequence: | 235800735 | Sequence: | 235800736 | Sequence: | 235800737 | Sequence: | 235800738 | Sequence: | 235800739 | Sequence: | 235800740 | Sequence: | 235800741 | Sequence: | 235800742 | Sequence: | 235800743 | Sequence: | 235800744 | Sequence: | 235800745 | Sequence: | 235800746 | Sequence: | 235800747 | Sequence: | 235800748 | Sequence: | 235800749 | Sequence: | 235800750 | Sequence: | 235800751 | Sequence: | 235800752 | Sequence: | 235800753 | Sequence: | 235800754 | Sequence: | 235800755 | Sequence: | 235800756 | Sequence: | 235800757 | Sequence: | 235800758 | Sequence: | 235800759 | Sequence: | 235800760 | Sequence: | 235800761 | Sequence: | 235800762 | Sequence: | 235800763 | Sequence: | 235800764 | Sequence: | 235800765 | Sequence: | 235800766 | Sequence: | 235800767 | Sequence: | 235800768 | Sequence: | 235800769 | Sequence: | 235800770 | Sequence: | 235800771 | Sequence: | 235800772 | Sequence: | 235800773 | Sequence: | 235800774 | Sequence: | 235800775 | Sequence: | 235800776 | Sequence: | 235800777 | Sequence: | 235800778 | Sequence: | 235800779 | Sequence: | 235800780 | Sequence: | 235800781 | Sequence: | 235800782 | Sequence: | 235800783 | Sequence: | 235800784 | Sequence: | 235801049 | Sequence: | 235800785 | Sequence: | 235800786 | Sequence: | 235800787 | Sequence: | 235800788 | Sequence: | 235800789 | Sequence: | 235800790 | Sequence: | 235800791 | Sequence: | 235800792 | Sequence: | 235800793 | Sequence: | 235800794 | Sequence: | 235800795 | Sequence: | 235800796 | Sequence: | 235800797 | Sequence: | 235800798 | Sequence: | 235800799 | Sequence: | 235800800 | Sequence: | 235800801 | Sequence: | 235800802 | Sequence: | 235800803 | Sequence: | 235800804 | Sequence: | 235800805 | Sequence: | 235800806 | Sequence: | 235800807 | Sequence: | 235800808 | Sequence: | 235800809 | Sequence: | 235800810 | Sequence: | 235800811 | Sequence: | 235800812 | Sequence: | 235800813 | Sequence: | 235800814 | Sequence: | 235800815 | Sequence: | 235800816 | Sequence: | 235800817 | Sequence: | 235800818 | Sequence: | 235800819 | Sequence: | 235800820 | Sequence: | 235800821 | Sequence: | 235800822 | Sequence: | 235800823 | Sequence: | 235800824 | Sequence: | 235800825 | Sequence: | 235800826 | Sequence: | 235800827 | Sequence: | 235800828 | Sequence: | 235800829 | Sequence: | 235800830 | Sequence: | 235800831 | Sequence: | 235800832 | Sequence: | 235800833 | Sequence: | 235800834 | Sequence: | 235800835 | Sequence: | 235800836 | Sequence: | 235800837 | Sequence: | 235800838 | Sequence: | 235800839 | Sequence: | 235800840 | Sequence: | 235800841 | Sequence: | 235800842 | Sequence: | 235800843 | Sequence: | 235800844 | Sequence: | 235800845 | Sequence: | 235800846 | Sequence: | 235800847 | Sequence: | 235800848 | Sequence: | 235800849 | Sequence: | 235800850 | Sequence: | 235800851 | Sequence: | 235800852 | Sequence: | 235800853 | Sequence: | 235800854 | Sequence: | 235800855 | Sequence: | 235800856 | Sequence: | 235800857 | Sequence: | 235800858 | Sequence: | 235800859 | Sequence: | 235800860 | Sequence: | 235800861 | Sequence: | 235800862 | Sequence: | 235800863 | Sequence: | 235800864 | Sequence: | 235800865 | Sequence: | 235800866 | Sequence: | 235800867 | Sequence: | 235800868 | Sequence: | 235800869 | Sequence: | 235800870 | Sequence: | 235800871 | Sequence: | 235800872 | Sequence: | 235800873 | Sequence: | 235800874 | Sequence: | 235800875 | Sequence: | 235800876 | Sequence: | 235800877 | Sequence: | 235800878 | Sequence: | 235800879 | Sequence: | 235800880 | Sequence: | 235800881 | Sequence: | 235800882 | Sequence: | 235800883 | Sequence: | 235800884 | Sequence: | 235800885 | Sequence: | 235800886 | Sequence: | 235800887 | Sequence: | 235800888 | Sequence: | 235800889 | Sequence: | 235800890 | Sequence: | 235800891 | Sequence: | 235800892 | Sequence: | 235800893 | Sequence: | 235800894 | Sequence: | 235800895 | Sequence: | 235800896 | Sequence: | 235800897 | Sequence: | 235800898 | Sequence: | 235800899 | Sequence: | 235800900 | Sequence: | 235800901 | Sequence: | 235800902 | Sequence: | 235800903 | Sequence: | 235800904 | Sequence: | 235801050 | Sequence: | 235800905 | Sequence: | 235800906 | Sequence: | 235800907 | Sequence: | 235800908 | Sequence: | 235800909 | Sequence: | 235800910 | Sequence: | 235800911 | Sequence: | 235800912 | Sequence: | 235800913 | Sequence: | 235800914 | Sequence: | 235800915 | Sequence: | 235800916 | Sequence: | 235800917 | Sequence: | 235800918 | Sequence: | 235800919 | Sequence: | 235801051 | Sequence: | 235800920 | Sequence: | 235800921 | Sequence: | 235800922 | Sequence: | 235800923 | Sequence: | 235800924 | Sequence: | 235800925 | Sequence: | 235800926 | Sequence: | 235800927 | Sequence: | 235800928 | Sequence: | 235800929 | Sequence: | 235800930 | Sequence: | 235800931 | Sequence: | 235800932 | Sequence: | 235800933 | Sequence: | 235800934 | Sequence: | 235800935 | Sequence: | 235800936 | Sequence: | 235800937 | Sequence: | 235800938 | Sequence: | 235800939 | Sequence: | 235800940 | Sequence: | 235800941 | Sequence: | 235800942 | Sequence: | 235800943 | Sequence: | 235800944 | Sequence: | 235800945 | Sequence: | 235800946 | Sequence: | 235800947 | Sequence: | 235800948 | Sequence: | 235800949 | Sequence: | 235800950 | Sequence: | 235800951 | Sequence: | 235800952 | Sequence: | 235800953 | Sequence: | 235800954 | Sequence: | 235800955 | Sequence: | 235800956 | Sequence: | 235800957 | Sequence: | 235800976 | Sequence: | 235800958 | Sequence: | 235800959 | Sequence: | 235800960 | Sequence: | 235800961 | Sequence: | 235801047 | Sequence: | 235800962 | Sequence: | 235800963 | Sequence: | 235800964 | Sequence: | 235800965 | Sequence: | 235800966 | Sequence: | 235800967 | Sequence: | 235800968 | Sequence: | 235800969 | Sequence: | 235800970 | Sequence: | 235800971 | Sequence: | 235800972 | Sequence: | 235800973 | Sequence: | 235800974 | Sequence: | 235800975 | Sequence: | 235800977 | Sequence: | 235800978 | Sequence: | 235800979 | Sequence: | 235800980 | Sequence: | 235800981 | Sequence: | 235800982 | Sequence: | 235800983 | Sequence: | 235800984 | Sequence: | 235800985 | Sequence: | 235800986 | Sequence: | 235800987 | Sequence: | 235800988 | Sequence: | 235800989 | Sequence: | 235800990 | Sequence: | 235800991 | Sequence: | 235800992 | Sequence: | 235800993 | Sequence: | 235800994 | Sequence: | 235800995 | Sequence: | 235800996 | Sequence: | 235800997 | Sequence: | 235800998 | Sequence: | 235800999 | Sequence: | 235801000 | Sequence: | 235801001 | Sequence: | 235801002 | Sequence: | 235801003 | Sequence: | 235801004 | Sequence: | 235801005 | Sequence: | 235801006 | Sequence: | 235801007 | Sequence: | 235801008 | Sequence: | 235801009 | Sequence: | 235801010 | Sequence: | 235801011 | Sequence: | 235801012 | Sequence: | 235801013 | Sequence: | 235801014 | Sequence: | 235801015 | Sequence: | 235801016 | Sequence: | 235801017 | Sequence: | 235801018 | Sequence: | 235801019 | Sequence: | 235801020 | Sequence: | 235801021 | Sequence: | 235801022 | Sequence: | 235801023 | Sequence: | 235801024 | Sequence: | 235801025 | Sequence: | 235801026 | Sequence: | 235801027 | Sequence: | 235801028 | Sequence: | 235801048 | Sequence: | 235801029 | Sequence: | 235801030 | Sequence: | 235801031 | Sequence: | 235801032 | Sequence: | 235801033 | Sequence: | 235801034 | Sequence: | 235801035 | Sequence: | 235801036 | Sequence: | 235801037 | Sequence: | 235801038 | Sequence: | 235801039 | Sequence: | 235801040 | Sequence: | 235801041 | Sequence: | 235801042 | Sequence: | 235801043 | Sequence: | 235801044 | Sequence: | 235801045 | Sequence: | 235801046 | Sequence: | 235801052 | Sequence: | 235801053 | Sequence: | 235801054 | Sequence: | 235801055 | Sequence: | 235801056 | Sequence: | 235801057 | Sequence: | 235801058 | Sequence: | 235801059 | Sequence: | 235801060 | Sequence: | 235801061 | Sequence: | 235801062 | Sequence: | 235801063 | Sequence: | 235801064 | Sequence: | 235801065 | Sequence: | 235801066 | Sequence: | 235801067 | Sequence: | 235801068 | Sequence: | 235801069 | Sequence: | 235801070 | Sequence: | 235801071 | Sequence: | 235801072 | Sequence: | 235801073 | Sequence: | 235801074 | Sequence: | 235801075 | Sequence: | 235801076 | Sequence: | 235801077 | Sequence: | 235801078 | Sequence: | 235801079 | Sequence: | 235801080 | Sequence: | 235801081 | Sequence: | 235801082 | Sequence: | 235801083 | Sequence: | 235801084 | Sequence: | 235801085 | Sequence: | 235801086 | Sequence: | 235801087 | Sequence: | 235801088 | Sequence: | 235801089 | Sequence: | 235801105 | Sequence: | 235801090 | Sequence: | 235801091 | Sequence: | 235801092 | Sequence: | 235801093 | Sequence: | 235801094 | Sequence: | 235801095 | Sequence: | 235801096 | Sequence: | 235801097 | Sequence: | 235801098 | Sequence: | 235801099 | Sequence: | 235801100 | Sequence: | 235801101 | Sequence: | 235801102 | Sequence: | 235801103 | Sequence: | 235801104 | Sequence: | 235801106 | Sequence: | 235801107 | Sequence: | 235801108 | Sequence: | 235801109 | Sequence: | 235801110 | Sequence: | 235801111 | Sequence: | 235801112 | Sequence: | 235801113 | Sequence: | 235801114 | Sequence: | 235801115 | Sequence: | 235801116 | Sequence: | 235801117 | Sequence: | 235801118 | Sequence: | 235801119 | Sequence: | 235801120 | Sequence: | 235801121 | Sequence: | 235801122 | Sequence: | 235801123 | Sequence: | 235801124 | Sequence: | 235801125 | Sequence: | 235801126 | Sequence: | 235801127 |
Outcome Id | 30820441 | Outcome Id | 30820451 | Outcome Id | 30820437 | Outcome Id | 30820451 | Outcome Id | 30820448 | Outcome Id | 30820437 | Outcome Id | 30820437 | Outcome Id | 30820437 | Outcome Id | 30820437 | Outcome Id | 30820437 | Outcome Id | 30820437 | Outcome Id | 30820437 | Outcome Id | 30820437 | Outcome Id | 30820437 | Outcome Id | 30820437 | Outcome Id | 30820437 | Outcome Id | 30820437 | Outcome Id | 30820437 | Outcome Id | 30820437 | Outcome Id | 30820437 | Outcome Id | 30820437 | Outcome Id | 30820437 | Outcome Id | 30820438 | Outcome Id | 30820438 | Outcome Id | 30820439 | Outcome Id | 30820438 | Outcome Id | 30820438 | Outcome Id | 30820438 | Outcome Id | 30820438 | Outcome Id | 30820438 | Outcome Id | 30820438 | Outcome Id | 30820438 | Outcome Id | 30820439 | Outcome Id | 30820439 | Outcome Id | 30820439 | Outcome Id | 30820439 | Outcome Id | 30820439 | Outcome Id | 30820439 | Outcome Id | 30820439 | Outcome Id | 30820439 | Outcome Id | 30820440 | Outcome Id | 30820440 | Outcome Id | 30820440 | Outcome Id | 30820440 | Outcome Id | 30820440 | Outcome Id | 30820440 | Outcome Id | 30820440 | Outcome Id | 30820440 | Outcome Id | 30820440 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820448 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820442 | Outcome Id | 30820442 | Outcome Id | 30820442 | Outcome Id | 30820442 | Outcome Id | 30820442 | Outcome Id | 30820442 | Outcome Id | 30820442 | Outcome Id | 30820442 | Outcome Id | 30820442 | Outcome Id | 30820443 | Outcome Id | 30820443 | Outcome Id | 30820443 | Outcome Id | 30820443 | Outcome Id | 30820443 | Outcome Id | 30820444 | Outcome Id | 30820444 | Outcome Id | 30820444 | Outcome Id | 30820444 | Outcome Id | 30820444 | Outcome Id | 30820449 | Outcome Id | 30820444 | Outcome Id | 30820444 | Outcome Id | 30820444 | Outcome Id | 30820444 | Outcome Id | 30820445 | Outcome Id | 30820445 | Outcome Id | 30820445 | Outcome Id | 30820445 | Outcome Id | 30820445 | Outcome Id | 30820445 | Outcome Id | 30820445 | Outcome Id | 30820445 | Outcome Id | 30820445 | Outcome Id | 30820446 | Outcome Id | 30820446 | Outcome Id | 30820446 | Outcome Id | 30820446 | Outcome Id | 30820446 | Outcome Id | 30820447 | Outcome Id | 30820447 | Outcome Id | 30820447 | Outcome Id | 30820447 | Outcome Id | 30820447 | Outcome Id | 30820447 | Outcome Id | 30820447 | Outcome Id | 30820447 | Outcome Id | 30820447 | Outcome Id | 30820448 | Outcome Id | 30820448 | Outcome Id | 30820448 | Outcome Id | 30820448 | Outcome Id | 30820448 | Outcome Id | 30820448 | Outcome Id | 30820448 | Outcome Id | 30820449 | Outcome Id | 30820449 | Outcome Id | 30820449 | Outcome Id | 30820449 | Outcome Id | 30820449 | Outcome Id | 30820449 | Outcome Id | 30820449 | Outcome Id | 30820449 | Outcome Id | 30820450 | Outcome Id | 30820450 | Outcome Id | 30820450 | Outcome Id | 30820450 | Outcome Id | 30820450 | Outcome Id | 30820450 | Outcome Id | 30820450 | Outcome Id | 30820450 | Outcome Id | 30820450 | Outcome Id | 30820451 | Outcome Id | 30820451 | Outcome Id | 30820451 | Outcome Id | 30820451 | Outcome Id | 30820451 | Outcome Id | 30820451 | Outcome Id | 30820451 | Outcome Id | 30820452 | Outcome Id | 30820452 | Outcome Id | 30820452 | Outcome Id | 30820452 | Outcome Id | 30820452 | Outcome Id | 30820452 | Outcome Id | 30820452 | Outcome Id | 30820452 | Outcome Id | 30820452 | Outcome Id | 30820452 | Outcome Id | 30820452 | Outcome Id | 30820452 | Outcome Id | 30820452 | Outcome Id | 30820452 | Outcome Id | 30820452 | Outcome Id | 30820452 | Outcome Id | 30820452 | Outcome Id | 30820452 | Outcome Id | 30820452 | Outcome Id | 30820452 | Outcome Id | 30820452 | Outcome Id | 30820452 | Outcome Id | 30820452 | Outcome Id | 30820452 | Outcome Id | 30820452 | Outcome Id | 30820452 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820460 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820460 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820460 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820457 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820460 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820457 | Outcome Id | 30820457 | Outcome Id | 30820457 | Outcome Id | 30820457 | Outcome Id | 30820457 | Outcome Id | 30820457 | Outcome Id | 30820457 | Outcome Id | 30820457 | Outcome Id | 30820457 | Outcome Id | 30820457 | Outcome Id | 30820457 | Outcome Id | 30820457 | Outcome Id | 30820457 | Outcome Id | 30820457 | Outcome Id | 30820457 | Outcome Id | 30820457 | Outcome Id | 30820457 | Outcome Id | 30820457 | Outcome Id | 30820457 | Outcome Id | 30820457 | Outcome Id | 30820457 | Outcome Id | 30820457 | Outcome Id | 30820457 | Outcome Id | 30820457 | Outcome Id | 30820457 | Outcome Id | 30820457 | Outcome Id | 30820458 | Outcome Id | 30820458 | Outcome Id | 30820458 | Outcome Id | 30820458 | Outcome Id | 30820458 | Outcome Id | 30820458 | Outcome Id | 30820458 | Outcome Id | 30820458 | Outcome Id | 30820458 | Outcome Id | 30820458 | Outcome Id | 30820458 | Outcome Id | 30820458 | Outcome Id | 30820458 | Outcome Id | 30820458 | Outcome Id | 30820458 | Outcome Id | 30820458 | Outcome Id | 30820458 | Outcome Id | 30820458 | Outcome Id | 30820458 | Outcome Id | 30820458 | Outcome Id | 30820459 | Outcome Id | 30820459 | Outcome Id | 30820459 | Outcome Id | 30820459 | Outcome Id | 30820459 | Outcome Id | 30820459 | Outcome Id | 30820459 | Outcome Id | 30820459 | Outcome Id | 30820459 | Outcome Id | 30820459 | Outcome Id | 30820460 | Outcome Id | 30820459 | Outcome Id | 30820459 | Outcome Id | 30820459 | Outcome Id | 30820459 | Outcome Id | 30820459 | Outcome Id | 30820459 | Outcome Id | 30820459 | Outcome Id | 30820460 | Outcome Id | 30820460 | Outcome Id | 30820460 | Outcome Id | 30820460 | Outcome Id | 30820460 | Outcome Id | 30820460 | Outcome Id | 30820460 | Outcome Id | 30820460 | Outcome Id | 30820460 | Outcome Id | 30820460 | Outcome Id | 30820460 | Outcome Id | 30820460 | Outcome Id | 30820460 | Outcome Id | 30820460 | Outcome Id | 30820461 | Outcome Id | 30820461 | Outcome Id | 30820461 | Outcome Id | 30820461 | Outcome Id | 30820461 | Outcome Id | 30820461 | Outcome Id | 30820461 | Outcome Id | 30820461 | Outcome Id | 30820461 | Outcome Id | 30820461 | Outcome Id | 30820461 | Outcome Id | 30820461 | Outcome Id | 30820461 | Outcome Id | 30820461 | Outcome Id | 30820461 | Outcome Id | 30820461 | Outcome Id | 30820461 | Outcome Id | 30820461 | Outcome Id | 30820461 | Outcome Id | 30820461 | Outcome Id | 30820462 | Outcome Id | 30820462 | Outcome Id | 30820462 | Outcome Id | 30820462 | Outcome Id | 30820462 | Outcome Id | 30820462 | Outcome Id | 30820462 | Outcome Id | 30820462 | Outcome Id | 30820462 | Outcome Id | 30820462 | Outcome Id | 30820462 | Outcome Id | 30820462 | Outcome Id | 30820462 | Outcome Id | 30820462 | Outcome Id | 30820462 | Outcome Id | 30820463 | Outcome Id | 30820462 | Outcome Id | 30820462 | Outcome Id | 30820462 | Outcome Id | 30820462 | Outcome Id | 30820463 | Outcome Id | 30820463 | Outcome Id | 30820463 | Outcome Id | 30820463 | Outcome Id | 30820463 | Outcome Id | 30820463 | Outcome Id | 30820463 | Outcome Id | 30820463 | Outcome Id | 30820463 | Outcome Id | 30820463 | Outcome Id | 30820463 | Outcome Id | 30820463 | Outcome Id | 30820463 | Outcome Id | 30820463 | Outcome Id | 30820463 | Outcome Id | 30820463 | Outcome Id | 30820464 | Outcome Id | 30820464 | Outcome Id | 30820464 | Outcome Id | 30820464 | Outcome Id | 30820464 | Outcome Id | 30820464 | Outcome Id | 30820464 | Outcome Id | 30820464 | Outcome Id | 30820464 | Outcome Id | 30820464 | Outcome Id | 30820464 | Outcome Id | 30820464 | Outcome Id | 30820464 | Outcome Id | 30820464 | Outcome Id | 30820464 | Outcome Id | 30820464 | Outcome Id | 30820464 |
Result Group Id | 56112545 | Result Group Id | 56112546 | Result Group Id | 56112549 | Result Group Id | 56112547 | Result Group Id | 56112561 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112543 | Result Group Id | 56112544 | Result Group Id | 56112545 | Result Group Id | 56112546 | Result Group Id | 56112547 | Result Group Id | 56112548 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112543 | Result Group Id | 56112544 | Result Group Id | 56112545 | Result Group Id | 56112546 | Result Group Id | 56112547 | Result Group Id | 56112548 | Result Group Id | 56112549 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112541 | Result Group Id | 56112543 | Result Group Id | 56112544 | Result Group Id | 56112545 | Result Group Id | 56112546 | Result Group Id | 56112547 | Result Group Id | 56112548 | Result Group Id | 56112549 | Result Group Id | 56112542 | Result Group Id | 56112550 | Result Group 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| Result Group Id | 56112566 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112563 | Result Group Id | 56112564 | Result Group Id | 56112565 | Result Group Id | 56112542 | Result Group Id | 56112563 | Result Group Id | 56112565 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112563 | Result Group Id | 56112564 | Result Group Id | 56112565 | Result Group Id | 56112566 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112563 | Result Group Id | 56112564 | Result Group Id | 56112541 | Result Group Id | 56112565 | Result Group Id | 56112566 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112563 | Result Group Id | 56112564 | Result Group Id | 56112565 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112563 | Result Group Id | 56112564 | Result Group Id | 56112565 | Result Group Id | 56112566 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112563 | Result Group Id | 56112564 | Result Group Id | 56112565 | Result Group Id | 56112565 | Result Group Id | 56112542 | Result Group Id | 56112565 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112563 | Result Group Id | 56112564 | Result Group Id | 56112565 | Result Group Id | 56112566 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112563 | Result Group Id | 56112564 | Result Group Id | 56112565 | Result Group Id | 56112566 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112563 | Result Group Id | 56112564 | Result Group Id | 56112565 | Result Group Id | 56112542 | Result Group Id | 56112563 | Result Group Id | 56112565 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112563 | Result Group Id | 56112564 | Result Group Id | 56112565 | Result Group Id | 56112566 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112563 | Result Group Id | 56112564 | Result Group Id | 56112565 | Result Group Id | 56112566 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112563 | Result Group Id | 56112566 | Result Group Id | 56112564 | Result Group Id | 56112565 | Result Group Id | 56112542 | Result Group Id | 56112565 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112563 | Result Group Id | 56112564 | Result Group Id | 56112565 | Result Group Id | 56112566 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112563 | Result Group Id | 56112564 | Result Group Id | 56112565 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112563 | Result Group Id | 56112564 | Result Group Id | 56112565 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112563 | Result Group Id | 56112564 | Result Group Id | 56112565 | Result Group Id | 56112566 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112563 | Result Group Id | 56112564 | Result Group Id | 56112565 | Result Group Id | 56112566 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112563 | Result Group Id | 56112564 | Result Group Id | 56112565 |
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Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG008 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG000 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG004 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG002 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG003 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG005 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG004 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG000 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG004 | Ctgov Group Code | OG001 | Ctgov Group Code | OG004 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG004 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG005 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG001 | Ctgov Group Code | OG004 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 |
Classification | Hb >14.0 g/dL | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Change from Baseline at PEP | Classification | Change from Baseline at PEP | Classification | Change from Baseline at PEP | Classification | Change from Baseline at PEP | Classification | Change from Baseline at PEP | Classification | Change from Baseline at PEP | Classification | Change from Baseline at PEP | Classification | Change from Baseline at PEP | Classification | Change from Baseline at PEP | Classification | Hb >12.0 g/dL | Classification | Hb >12.0 g/dL | Classification | Hb >12.0 g/dL | Classification | Hb >12.0 g/dL | Classification | Hb >12.0 g/dL | Classification | Hb >12.0 g/dL | Classification | Hb >12.0 g/dL | Classification | Hb >12.0 g/dL | Classification | Hb >12.0 g/dL | Classification | Hb >13.0 g/dL | Classification | Hb >13.0 g/dL | Classification | Hb >13.0 g/dL | Classification | Hb >13.0 g/dL | Classification | Hb >13.0 g/dL | Classification | Hb >13.0 g/dL | Classification | Hb >13.0 g/dL | Classification | Hb >13.0 g/dL | Classification | Hb >13.0 g/dL | Classification | Hb >14.0 g/dL | Classification | Hb >14.0 g/dL | Classification | Hb >14.0 g/dL | Classification | Hb >14.0 g/dL | Classification | Hb >14.0 g/dL | Classification | Hb >14.0 g/dL | Classification | Hb >14.0 g/dL | Classification | Hb >14.0 g/dL | Classification | Hb <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline | Classification | Hb <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline | Classification | Hb <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline | Classification | Hb <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline | Classification | Hb <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline | Classification | Hb <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline | Classification | Hb <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline | Classification | Hb <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline | Classification | Hb <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline | Classification | Hb increase >1.0 g/dL within any 2-week interval | Classification | Hb increase >1.0 g/dL within any 2-week interval | Classification | Hb increase >1.0 g/dL within any 2-week interval | Classification | Hb increase >1.0 g/dL within any 2-week interval | Classification | Hb increase >1.0 g/dL within any 2-week interval | Classification | Hb increase >1.0 g/dL within any 2-week interval | Classification | Hb increase >1.0 g/dL within any 2-week interval | Classification | Hb increase >1.0 g/dL within any 2-week interval | Classification | Hb increase >1.0 g/dL within any 2-week interval | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 +1 (Day 8) | Classification | Week 1 +1 (Day 8) | Classification | Week 1 +1 (Day 8) | Classification | Week 1 +1 (Day 8) | Classification | Week 1 +1 (Day 8) | Classification | Week 1 +1 (Day 8) | Classification | Week 11 | Classification | Week 11 | Classification | Week 11 | Classification | Week 11 | Classification | Week 11 | Classification | Week 13 | Classification | Week 13 | Classification | Week 13 | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 | Classification | Week 4 | Classification | Week 4 | Classification | Week 4 | Classification | Week 4 | Classification | Week 4 | Classification | Week 4 | Classification | Week 4 | Classification | Week 4 | Classification | Week 4 | Classification | Week 8 | Classification | Week 8 | Classification | Week 8 | Classification | Week 8 | Classification | Week 8 | Classification | Week 8 | Classification | Week 8 | Classification | Week 8 | Classification | Week 8 | Classification | Week 11 | Classification | Week 11 | Classification | Week 11 | Classification | Week 11 | Classification | Week 11 | Classification | Week 11 | Classification | Week 11 | Classification | Week 11 | Classification | Week 11 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 13 | Classification | Week 13 | Classification | Week 11 | Classification | Week 13 | Classification | Week 13 | Classification | Week 13 | Classification | Week 13 | Classification | Week 13 | Classification | Week 13 | Classification | Week 13 | Classification | Week 16 | Classification | Week 16 | Classification | Week 16 | Classification | Week 16 | Classification | Week 16 | Classification | Week 16 | Classification | Week 16 | Classification | Week 16 | Classification | Week 16 | Classification | Week 20 | Classification | Week 20 | Classification | Week 20 | Classification | Week 20 | Classification | Week 20 | Classification | Week 20 | Classification | Week 20 | Classification | Week 20 | Classification | Week 20 | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Week 4 | Classification | Week 4 | Classification | Week 4 | Classification | Week 4 | Classification | Week 4 | Classification | Week 4 | Classification | Week 4 | Classification | Week 4 | Classification | Week 4 | Classification | Week 8 | Classification | Week 8 | Classification | Week 8 | Classification | Week 8 | Classification | Week 8 | Classification | Week 8 | Classification | Week 8 | Classification | Week 8 | Classification | Week 8 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 16 | Classification | Week 16 | Classification | Week 16 | Classification | Week 16 | Classification | Week 16 | Classification | Week 16 | Classification | Week 16 | Classification | Week 16 | Classification | Week 16 | Classification | Week 20 | Classification | Week 20 | Classification | Week 20 | Classification | Week 20 | Classification | Week 20 | Classification | Week 20 | Classification | Week 20 | Classification | Week 20 | Classification | Week 20 | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Week 4 | Classification | Week 4 | Classification | Week 4 | Classification | Week 4 | Classification | Week 4 | Classification | Week 4 | Classification | Week 4 | Classification | Week 4 | Classification | Week 4 | Classification | Week 8 | Classification | Week 8 | Classification | Week 8 | Classification | Week 8 | Classification | Week 8 | Classification | Week 8 | Classification | Week 8 | Classification | Week 8 | Classification | Week 8 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 16 | Classification | Week 16 | Classification | Week 16 | Classification | Week 16 | Classification | Week 16 | Classification | Week 11 | Classification | Week 16 | Classification | Week 16 | Classification | Week 16 | Classification | Week 16 | Classification | Week 20 | Classification | Week 20 | Classification | Week 20 | Classification | Week 20 | Classification | Week 20 | Classification | Week 20 | Classification | Week 20 | Classification | Week 20 | Classification | Week 20 | Classification | Baseline | Classification | Baseline | Classification | Week 11 | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Week 4 | Classification | Week 4 | Classification | Week 4 | Classification | Week 4 | Classification | Week 4 | Classification | Week 4 | Classification | Week 4 | Classification | Week 4 | Classification | Week 4 | Classification | Week 8 | Classification | Week 8 | Classification | Week 8 | Classification | Week 8 | Classification | Week 8 | Classification | Week 8 | Classification | Week 8 | Classification | Week 8 | Classification | Week 8 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 16 | Classification | Week 16 | Classification | Week 16 | Classification | Week 16 | Classification | Baseline | Classification | Week 16 | Classification | Week 16 | Classification | Week 16 | Classification | Week 16 | Classification | Week 1 +1 (Day 8) | Classification | Week 16 | Classification | Week 20 | Classification | Week 20 | Classification | Week 20 | Classification | Week 20 | Classification | Week 20 | Classification | Week 20 | Classification | Week 20 | Classification | Week 20 | Classification | Week 20 | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 20 | Classification | Week 20 | Classification | Week 20 | Classification | Week 20 | Classification | Week 20 | Classification | Week 20 | Classification | Week 20 | Classification | Week 20 | Classification | Week 20 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 +1 (Day 8) | Classification | Week 1 +1 (Day 8) | Classification | Week 1 +1 (Day 8) | Classification | Week 1 +1 (Day 8) | Classification | Week 1 +1 (Day 8) | Classification | Week 1 +1 (Day 8) | Classification | Week 11 | Classification | Week 11 | Classification | Week 11 | Classification | Week 11 | Classification | Week 11 | Classification | Week 13 | Classification | Week 13 | Classification | Week 13 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 +1 (Day 8) | Classification | Week 1 +1 (Day 8) | Classification | Week 1 +1 (Day 8) | Classification | Week 1 +1 (Day 8) | Classification | Week 11 | Classification | Week 1 +1 (Day 8) | Classification | Week 1 +1 (Day 8) | Classification | Week 11 | Classification | Week 11 | Classification | Week 11 | Classification | Week 11 | Classification | Week 11 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 +1 (Day 8) | Classification | Week 1 +1 (Day 8) | Classification | Week 1 +1 (Day 8) | Classification | Week 1 +1 (Day 8) | Classification | Week 1 +1 (Day 8) | Classification | Week 11 | Classification | Week 13 | Classification | Week 13 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 +1 (Day 8) | Classification | Week 1 +1 (Day 8) | Classification | Week 1 +1 (Day 8) | Classification | Week 1 +1 (Day 8) | Classification | Week 1 +1 (Day 8) | Classification | Week 1 +1 (Day 8) | Classification | Week 11 | Classification | Week 11 | Classification | Week 11 | Classification | Week 11 | Classification | Week 11 | Classification | Week 13 | Classification | Week 13 | Classification | Week 13 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 +1 (Day 8) | Classification | Week 1 +1 (Day 8) | Classification | Week 1 +1 (Day 8) | Classification | Week 1 +1 (Day 8) | Classification | Week 1 +1 (Day 8) | Classification | Week 1 +1 (Day 8) | Classification | Week 11 | Classification | Week 11 | Classification | Week 11 | Classification | Week 1 +1 (Day 8) | Classification | Week 11 | Classification | Week 11 | Classification | Week 13 | Classification | Week 13 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 +1 (Day 8) | Classification | Week 1 +1 (Day 8) | Classification | Week 1 +1 (Day 8) | Classification | Week 1 +1 (Day 8) | Classification | Week 1 +1 (Day 8) | Classification | Week 11 | Classification | Week 11 | Classification | Week 11 | Classification | Week 11 | Classification | Week 11 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 +1 (Day 8) | Classification | Week 1 +1 (Day 8) | Classification | Week 1 +1 (Day 8) | Classification | Week 1 +1 (Day 8) | Classification | Week 1 +1 (Day 8) | Classification | Week 1 +1 (Day 8) | Classification | Week 11 | Classification | Week 11 | Classification | Week 11 | Classification | Week 11 | Classification | Week 11 | ||||||||||||||||||||||||
Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Requiring Red Blood Cell (RBC) Transfusion | Title | Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP) | Title | Number of Participants Requiring Red Blood Cell (RBC) Transfusion | Title | Number of Participants With a Mean Increase in Hb From Baseline to the SEP ≥0.5 g/dL or With Hb Values Within the Target Range at the SEP | Title | Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP) | Title | Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP) | Title | Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP) | Title | Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP) | Title | Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP) | Title | Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP) | Title | Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP) | Title | Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP) | Title | Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP) | Title | Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP) | Title | Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP) | Title | Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP) | Title | Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP) | Title | Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP) | Title | Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP) | Title | Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP) | Title | Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP) | Title | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Title | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Title | Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values | Title | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Title | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Title | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Title | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Title | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Title | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Title | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Title | Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values | Title | Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values | Title | Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values | Title | Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values | Title | Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values | Title | Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values | Title | Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values | Title | Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values | Title | Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Values | Title | Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Values | Title | Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Values | Title | Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Values | Title | Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Values | Title | Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Values | Title | Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Values | Title | Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Values | Title | Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Values | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants With a Mean Increase in Hb From Baseline to the SEP ≥0.5 g/dL or With Hb Values Within the Target Range at the SEP | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants With Hb Values Within the Target Range at the PEP | Title | Number of Participants With Hb Values Within the Target Range at the PEP | Title | Number of Participants With Hb Values Within the Target Range at the PEP | Title | Number of Participants With Hb Values Within the Target Range at the PEP | Title | Number of Participants With Hb Values Within the Target Range at the PEP | Title | Number of Participants With Hb Values Within the Target Range at the PEP | Title | Number of Participants With Hb Values Within the Target Range at the PEP | Title | Number of Participants With Hb Values Within the Target Range at the PEP | Title | Number of Participants With Hb Values Within the Target Range at the PEP | Title | Mean Change in Hb From the PEP to the Secondary Evaluation Period (SEP) in Participants Who Transitioned to Three Times Per Week (TIW) Vadadustat Dosing After Week 12 | Title | Mean Change in Hb From the PEP to the Secondary Evaluation Period (SEP) in Participants Who Transitioned to Three Times Per Week (TIW) Vadadustat Dosing After Week 12 | Title | Mean Change in Hb From the PEP to the Secondary Evaluation Period (SEP) in Participants Who Transitioned to Three Times Per Week (TIW) Vadadustat Dosing After Week 12 | Title | Mean Change in Hb From the PEP to the Secondary Evaluation Period (SEP) in Participants Who Transitioned to Three Times Per Week (TIW) Vadadustat Dosing After Week 12 | Title | Mean Change in Hb From the PEP to the Secondary Evaluation Period (SEP) in Participants Who Transitioned to Three Times Per Week (TIW) Vadadustat Dosing After Week 12 | Title | Mean Change in Hb Between Baseline and the SEP | Title | Mean Change in Hb Between Baseline and the SEP | Title | Mean Change in Hb Between Baseline and the SEP | Title | Mean Change in Hb Between Baseline and the SEP | Title | Mean Change in Hb Between Baseline and the SEP | Title | Number of Participants Requiring at Least One Intravenous (IV) Elemental Iron Supplementation | Title | Mean Change in Hb Between Baseline and the SEP | Title | Mean Change in Hb Between Baseline and the SEP | Title | Mean Change in Hb Between Baseline and the SEP | Title | Mean Change in Hb Between Baseline and the SEP | Title | Number of Participants With Hb Values Within the Target Range at the SEP | Title | Number of Participants With Hb Values Within the Target Range at the SEP | Title | Number of Participants With Hb Values Within the Target Range at the SEP | Title | Number of Participants With Hb Values Within the Target Range at the SEP | Title | Number of Participants With Hb Values Within the Target Range at the SEP | Title | Number of Participants With Hb Values Within the Target Range at the SEP | Title | Number of Participants With Hb Values Within the Target Range at the SEP | Title | Number of Participants With Hb Values Within the Target Range at the SEP | Title | Number of Participants With Hb Values Within the Target Range at the SEP | Title | Number of Participants With Hb Values Within the Target Range at the SEP in Participants Who Transitioned to TIW Vadadustat Dosing | Title | Number of Participants With Hb Values Within the Target Range at the SEP in Participants Who Transitioned to TIW Vadadustat Dosing | Title | Number of Participants With Hb Values Within the Target Range at the SEP in Participants Who Transitioned to TIW Vadadustat Dosing | Title | Number of Participants With Hb Values Within the Target Range at the SEP in Participants Who Transitioned to TIW Vadadustat Dosing | Title | Number of Participants With Hb Values Within the Target Range at the SEP in Participants Who Transitioned to TIW Vadadustat Dosing | Title | Number of Participants With a Mean Increase in Hb From Baseline to the PEP ≥0.5 g/dL or With Hb Values Within the Target Range at the PEP | Title | Number of Participants With a Mean Increase in Hb From Baseline to the PEP ≥0.5 g/dL or With Hb Values Within the Target Range at the PEP | Title | Number of Participants With a Mean Increase in Hb From Baseline to the PEP ≥0.5 g/dL or With Hb Values Within the Target Range at the PEP | Title | Number of Participants With a Mean Increase in Hb From Baseline to the PEP ≥0.5 g/dL or With Hb Values Within the Target Range at the PEP | Title | Number of Participants With a Mean Increase in Hb From Baseline to the PEP ≥0.5 g/dL or With Hb Values Within the Target Range at the PEP | Title | Number of Participants With a Mean Increase in Hb From Baseline to the PEP ≥0.5 g/dL or With Hb Values Within the Target Range at the PEP | Title | Number of Participants With a Mean Increase in Hb From Baseline to the PEP ≥0.5 g/dL or With Hb Values Within the Target Range at the PEP | Title | Number of Participants With a Mean Increase in Hb From Baseline to the PEP ≥0.5 g/dL or With Hb Values Within the Target Range at the PEP | Title | Number of Participants With a Mean Increase in Hb From Baseline to the PEP ≥0.5 g/dL or With Hb Values Within the Target Range at the PEP | Title | Number of Participants With a Mean Increase in Hb From Baseline to the SEP ≥0.5 g/dL or With Hb Values Within the Target Range at the SEP | Title | Number of Participants With a Mean Increase in Hb From Baseline to the SEP ≥0.5 g/dL or With Hb Values Within the Target Range at the SEP | Title | Number of Participants With a Mean Increase in Hb From Baseline to the SEP ≥0.5 g/dL or With Hb Values Within the Target Range at the SEP | Title | Number of Participants With a Mean Increase in Hb From Baseline to the SEP ≥0.5 g/dL or With Hb Values Within the Target Range at the SEP | Title | Number of Participants With a Mean Increase in Hb From Baseline to the SEP ≥0.5 g/dL or With Hb Values Within the Target Range at the SEP | Title | Number of Participants With a Mean Increase in Hb From Baseline to the SEP ≥0.5 g/dL or With Hb Values Within the Target Range at the SEP | Title | Number of Participants With a Mean Increase in Hb From Baseline to the SEP ≥0.5 g/dL or With Hb Values Within the Target Range at the SEP | Title | Number of Participants Requiring at Least One Intravenous (IV) Elemental Iron Supplementation | Title | Number of Participants Requiring at Least One Intravenous (IV) Elemental Iron Supplementation | Title | Number of Participants Requiring at Least One Intravenous (IV) Elemental Iron Supplementation | Title | Number of Participants Requiring at Least One Intravenous (IV) Elemental Iron Supplementation | Title | Number of Participants Requiring at Least One Intravenous (IV) Elemental Iron Supplementation | Title | Number of Participants Requiring at Least One Intravenous (IV) Elemental Iron Supplementation | Title | Number of Participants Requiring at Least One Intravenous (IV) Elemental Iron Supplementation | Title | Number of Participants Requiring at Least One Intravenous (IV) Elemental Iron Supplementation | Title | Number of Participants Requiring Erythropoiesis-stimulating Agent (ESA) Rescue | Title | Number of Participants Requiring Erythropoiesis-stimulating Agent (ESA) Rescue | Title | Number of Participants Requiring Erythropoiesis-stimulating Agent (ESA) Rescue | Title | Number of Participants Requiring Erythropoiesis-stimulating Agent (ESA) Rescue | Title | Number of Participants Requiring Erythropoiesis-stimulating Agent (ESA) Rescue | Title | Number of Participants Requiring Erythropoiesis-stimulating Agent (ESA) Rescue | Title | Number of Participants Requiring Erythropoiesis-stimulating Agent (ESA) Rescue | Title | Number of Participants Requiring Erythropoiesis-stimulating Agent (ESA) Rescue | Title | Number of Participants Requiring Erythropoiesis-stimulating Agent (ESA) Rescue | Title | Number of Participants Requiring Red Blood Cell (RBC) Transfusion | Title | Number of Participants Requiring Red Blood Cell (RBC) Transfusion | Title | Number of Participants Requiring Red Blood Cell (RBC) Transfusion | Title | Number of Participants Requiring Red Blood Cell (RBC) Transfusion | Title | Number of Participants Requiring Red Blood Cell (RBC) Transfusion | Title | Number of Participants Requiring Red Blood Cell (RBC) Transfusion | Title | Number of Participants Requiring Red Blood Cell (RBC) Transfusion | Title | Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group | Title | Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group | Title | Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group | Title | Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group | Title | Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group | Title | Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group | Title | Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group | Title | Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group | Title | Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group | Title | Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group | Title | Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group | Title | Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group | Title | Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group | Title | Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group | Title | Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group | Title | Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group | Title | Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group | Title | Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group | Title | Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group | Title | Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group | Title | Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group | Title | Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group | Title | Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group | Title | Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group | Title | Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group | Title | Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Median Terminal Half-life (t1/2) of Vadadustat Following a Single Dose | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Median Terminal Half-life (t1/2) of Vadadustat Following a Single Dose | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Median Terminal Half-life (t1/2) of Vadadustat Following a Single Dose | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Hepcidin Concentration | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Median Terminal Half-life (t1/2) of Vadadustat Following a Single Dose | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Hepcidin Concentration | Title | Mean Change From Baseline in Hepcidin Concentration | Title | Mean Change From Baseline in Hepcidin Concentration | Title | Mean Change From Baseline in Hepcidin Concentration | Title | Mean Change From Baseline in Hepcidin Concentration | Title | Mean Change From Baseline in Hepcidin Concentration | Title | Mean Change From Baseline in Hepcidin Concentration | Title | Mean Change From Baseline in Hepcidin Concentration | Title | Mean Change From Baseline in Hepcidin Concentration | Title | Mean Change From Baseline in Hepcidin Concentration | Title | Mean Change From Baseline in Hepcidin Concentration | Title | Mean Change From Baseline in Hepcidin Concentration | Title | Mean Change From Baseline in Hepcidin Concentration | Title | Mean Change From Baseline in Hepcidin Concentration | Title | Mean Change From Baseline in Hepcidin Concentration | Title | Mean Change From Baseline in Hepcidin Concentration | Title | Mean Change From Baseline in Hepcidin Concentration | Title | Mean Change From Baseline in Hepcidin Concentration | Title | Mean Change From Baseline in Hepcidin Concentration | Title | Mean Change From Baseline in Hepcidin Concentration | Title | Mean Change From Baseline in Hepcidin Concentration | Title | Mean Change From Baseline in Hepcidin Concentration | Title | Mean Change From Baseline in Hepcidin Concentration | Title | Mean Change From Baseline in Hepcidin Concentration | Title | Mean Change From Baseline in Hepcidin Concentration | Title | Mean Change From Baseline in Hepcidin Concentration | Title | Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Vadadustat Following a Single Dose | Title | Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Vadadustat Following a Single Dose | Title | Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Vadadustat Following a Single Dose | Title | Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Vadadustat Following a Single Dose | Title | Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Vadadustat Following a Single Dose | Title | Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Vadadustat Following a Single Dose | Title | Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Vadadustat Following a Single Dose | Title | Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Vadadustat Following a Single Dose | Title | Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Vadadustat Following a Single Dose | Title | Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Vadadustat Following a Single Dose | Title | Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Vadadustat Following a Single Dose | Title | Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Vadadustat Following a Single Dose | Title | Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Vadadustat Following a Single Dose | Title | Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Vadadustat Following a Single Dose | Title | Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Vadadustat Following a Single Dose | Title | Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Vadadustat Following a Single Dose | Title | Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Vadadustat Following a Single Dose | Title | Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Vadadustat Following a Single Dose | Title | Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Vadadustat Following a Single Dose | Title | Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Vadadustat Following a Single Dose | Title | Geometric Mean Area Under the Concentration-time Curve (AUC) From Time 0 to 24 Hours (AUC0-24) of Vadadustat Following a Single Dose | Title | Geometric Mean Area Under the Concentration-time Curve (AUC) From Time 0 to 24 Hours (AUC0-24) of Vadadustat Following a Single Dose | Title | Geometric Mean Area Under the Concentration-time Curve (AUC) From Time 0 to 24 Hours (AUC0-24) of Vadadustat Following a Single Dose | Title | Geometric Mean Area Under the Concentration-time Curve (AUC) From Time 0 to 24 Hours (AUC0-24) of Vadadustat Following a Single Dose | Title | Geometric Mean Area Under the Concentration-time Curve (AUC) From Time 0 to 24 Hours (AUC0-24) of Vadadustat Following a Single Dose | Title | Geometric Mean Area Under the Concentration-time Curve (AUC) From Time 0 to 24 Hours (AUC0-24) of Vadadustat Following a Single Dose | Title | Geometric Mean Area Under the Concentration-time Curve (AUC) From Time 0 to 24 Hours (AUC0-24) of Vadadustat Following a Single Dose | Title | Geometric Mean Area Under the Concentration-time Curve (AUC) From Time 0 to 24 Hours (AUC0-24) of Vadadustat Following a Single Dose | Title | Geometric Mean Area Under the Concentration-time Curve (AUC) From Time 0 to 24 Hours (AUC0-24) of Vadadustat Following a Single Dose | Title | Geometric Mean Area Under the Concentration-time Curve (AUC) From Time 0 to 24 Hours (AUC0-24) of Vadadustat Following a Single Dose | Title | Median Terminal Half-life (t1/2) of Vadadustat Following a Single Dose | Title | Geometric Mean Area Under the Concentration-time Curve (AUC) From Time 0 to 24 Hours (AUC0-24) of Vadadustat Following a Single Dose | Title | Geometric Mean Area Under the Concentration-time Curve (AUC) From Time 0 to 24 Hours (AUC0-24) of Vadadustat Following a Single Dose | Title | Geometric Mean Area Under the Concentration-time Curve (AUC) From Time 0 to 24 Hours (AUC0-24) of Vadadustat Following a Single Dose | Title | Geometric Mean Area Under the Concentration-time Curve (AUC) From Time 0 to 24 Hours (AUC0-24) of Vadadustat Following a Single Dose | Title | Geometric Mean Area Under the Concentration-time Curve (AUC) From Time 0 to 24 Hours (AUC0-24) of Vadadustat Following a Single Dose | Title | Geometric Mean Area Under the Concentration-time Curve (AUC) From Time 0 to 24 Hours (AUC0-24) of Vadadustat Following a Single Dose | Title | Geometric Mean Area Under the Concentration-time Curve (AUC) From Time 0 to 24 Hours (AUC0-24) of Vadadustat Following a Single Dose | Title | Median Terminal Half-life (t1/2) of Vadadustat Following a Single Dose | Title | Median Terminal Half-life (t1/2) of Vadadustat Following a Single Dose | Title | Median Terminal Half-life (t1/2) of Vadadustat Following a Single Dose | Title | Median Terminal Half-life (t1/2) of Vadadustat Following a Single Dose | Title | Median Terminal Half-life (t1/2) of Vadadustat Following a Single Dose | Title | Median Terminal Half-life (t1/2) of Vadadustat Following a Single Dose | Title | Median Terminal Half-life (t1/2) of Vadadustat Following a Single Dose | Title | Median Terminal Half-life (t1/2) of Vadadustat Following a Single Dose | Title | Median Terminal Half-life (t1/2) of Vadadustat Following a Single Dose | Title | Median Terminal Half-life (t1/2) of Vadadustat Following a Single Dose | Title | Median Terminal Half-life (t1/2) of Vadadustat Following a Single Dose | Title | Median Terminal Half-life (t1/2) of Vadadustat Following a Single Dose | Title | Median Terminal Half-life (t1/2) of Vadadustat Following a Single Dose | Title | Median Terminal Half-life (t1/2) of Vadadustat Following a Single Dose | Title | Median Time to Reach Cmax (Tmax) of Vadadustat Following a Single Dose | Title | Median Time to Reach Cmax (Tmax) of Vadadustat Following a Single Dose | Title | Median Time to Reach Cmax (Tmax) of Vadadustat Following a Single Dose | Title | Median Time to Reach Cmax (Tmax) of Vadadustat Following a Single Dose | Title | Median Time to Reach Cmax (Tmax) of Vadadustat Following a Single Dose | Title | Median Time to Reach Cmax (Tmax) of Vadadustat Following a Single Dose | Title | Median Time to Reach Cmax (Tmax) of Vadadustat Following a Single Dose | Title | Median Time to Reach Cmax (Tmax) of Vadadustat Following a Single Dose | Title | Median Time to Reach Cmax (Tmax) of Vadadustat Following a Single Dose | Title | Median Time to Reach Cmax (Tmax) of Vadadustat Following a Single Dose | Title | Median Time to Reach Cmax (Tmax) of Vadadustat Following a Single Dose | Title | Median Time to Reach Cmax (Tmax) of Vadadustat Following a Single Dose | Title | Median Time to Reach Cmax (Tmax) of Vadadustat Following a Single Dose | Title | Median Time to Reach Cmax (Tmax) of Vadadustat Following a Single Dose | Title | Median Time to Reach Cmax (Tmax) of Vadadustat Following a Single Dose | Title | Median Time to Reach Cmax (Tmax) of Vadadustat Following a Single Dose | Title | Median Time to Reach Cmax (Tmax) of Vadadustat Following a Single Dose | Title | Median Time to Reach Cmax (Tmax) of Vadadustat Following a Single Dose | Title | Median Time to Reach Cmax (Tmax) of Vadadustat Following a Single Dose | Title | Median Time to Reach Cmax (Tmax) of Vadadustat Following a Single Dose | Title | Geometric Mean Elimination Rate Constant (λz) of Vadadustat Following a Single Dose | Title | Geometric Mean Elimination Rate Constant (λz) of Vadadustat Following a Single Dose | Title | Geometric Mean Elimination Rate Constant (λz) of Vadadustat Following a Single Dose | Title | Geometric Mean Elimination Rate Constant (λz) of Vadadustat Following a Single Dose | Title | Geometric Mean Elimination Rate Constant (λz) of Vadadustat Following a Single Dose | Title | Geometric Mean Elimination Rate Constant (λz) of Vadadustat Following a Single Dose | Title | Geometric Mean Elimination Rate Constant (λz) of Vadadustat Following a Single Dose | Title | Geometric Mean Elimination Rate Constant (λz) of Vadadustat Following a Single Dose | Title | Geometric Mean Elimination Rate Constant (λz) of Vadadustat Following a Single Dose | Title | Geometric Mean Elimination Rate Constant (λz) of Vadadustat Following a Single Dose | Title | Geometric Mean Elimination Rate Constant (λz) of Vadadustat Following a Single Dose | Title | Geometric Mean Elimination Rate Constant (λz) of Vadadustat Following a Single Dose | Title | Geometric Mean Elimination Rate Constant (λz) of Vadadustat Following a Single Dose | Title | Geometric Mean Elimination Rate Constant (λz) of Vadadustat Following a Single Dose | Title | Geometric Mean Elimination Rate Constant (λz) of Vadadustat Following a Single Dose | Title | Geometric Mean Apparent Total Body Clearance (CLss/F) of Vadadustat Following a Single Dose | Title | Geometric Mean Elimination Rate Constant (λz) of Vadadustat Following a Single Dose | Title | Geometric Mean Elimination Rate Constant (λz) of Vadadustat Following a Single Dose | Title | Geometric Mean Elimination Rate Constant (λz) of Vadadustat Following a Single Dose | Title | Geometric Mean Elimination Rate Constant (λz) of Vadadustat Following a Single Dose | Title | Geometric Mean Apparent Total Body Clearance (CLss/F) of Vadadustat Following a Single Dose | Title | Geometric Mean Apparent Total Body Clearance (CLss/F) of Vadadustat Following a Single Dose | Title | Geometric Mean Apparent Total Body Clearance (CLss/F) of Vadadustat Following a Single Dose | Title | Geometric Mean Apparent Total Body Clearance (CLss/F) of Vadadustat Following a Single Dose | Title | Geometric Mean Apparent Total Body Clearance (CLss/F) of Vadadustat Following a Single Dose | Title | Geometric Mean Apparent Total Body Clearance (CLss/F) of Vadadustat Following a Single Dose | Title | Geometric Mean Apparent Total Body Clearance (CLss/F) of Vadadustat Following a Single Dose | Title | Geometric Mean Apparent Total Body Clearance (CLss/F) of Vadadustat Following a Single Dose | Title | Geometric Mean Apparent Total Body Clearance (CLss/F) of Vadadustat Following a Single Dose | Title | Geometric Mean Apparent Total Body Clearance (CLss/F) of Vadadustat Following a Single Dose | Title | Geometric Mean Apparent Total Body Clearance (CLss/F) of Vadadustat Following a Single Dose | Title | Geometric Mean Apparent Total Body Clearance (CLss/F) of Vadadustat Following a Single Dose | Title | Geometric Mean Apparent Total Body Clearance (CLss/F) of Vadadustat Following a Single Dose | Title | Geometric Mean Apparent Total Body Clearance (CLss/F) of Vadadustat Following a Single Dose | Title | Geometric Mean Apparent Total Body Clearance (CLss/F) of Vadadustat Following a Single Dose | Title | Geometric Mean Apparent Total Body Clearance (CLss/F) of Vadadustat Following a Single Dose | Title | Geometric Mean Apparent Volume of Distribution (Vz/F) of Vadadustat Following a Single Dose | Title | Geometric Mean Apparent Volume of Distribution (Vz/F) of Vadadustat Following a Single Dose | Title | Geometric Mean Apparent Volume of Distribution (Vz/F) of Vadadustat Following a Single Dose | Title | Geometric Mean Apparent Volume of Distribution (Vz/F) of Vadadustat Following a Single Dose | Title | Geometric Mean Apparent Volume of Distribution (Vz/F) of Vadadustat Following a Single Dose | Title | Geometric Mean Apparent Volume of Distribution (Vz/F) of Vadadustat Following a Single Dose | Title | Geometric Mean Apparent Volume of Distribution (Vz/F) of Vadadustat Following a Single Dose | Title | Geometric Mean Apparent Volume of Distribution (Vz/F) of Vadadustat Following a Single Dose | Title | Geometric Mean Apparent Volume of Distribution (Vz/F) of Vadadustat Following a Single Dose | Title | Geometric Mean Apparent Volume of Distribution (Vz/F) of Vadadustat Following a Single Dose | Title | Geometric Mean Apparent Volume of Distribution (Vz/F) of Vadadustat Following a Single Dose | Title | Geometric Mean Apparent Volume of Distribution (Vz/F) of Vadadustat Following a Single Dose | Title | Geometric Mean Apparent Volume of Distribution (Vz/F) of Vadadustat Following a Single Dose | Title | Geometric Mean Apparent Volume of Distribution (Vz/F) of Vadadustat Following a Single Dose | Title | Geometric Mean Apparent Volume of Distribution (Vz/F) of Vadadustat Following a Single Dose | Title | Geometric Mean Apparent Volume of Distribution (Vz/F) of Vadadustat Following a Single Dose | Title | Geometric Mean Apparent Volume of Distribution (Vz/F) of Vadadustat Following a Single Dose |
Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | RBC transfusion was administered as rescue therapy in the event of an acute or severe loss of blood. | Description | Change from Baseline in Hb value was calculated as the PEP Hb value minus the Baseline Hb value. The PEP value was the average Hb value from Week 10 to Week 12. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. | Description | RBC transfusion was administered as rescue therapy in the event of an acute or severe loss of blood. | Description | The target range for Hb was from 10.0 to 11.0 grams per g/dL. The SEP was comprised of Week 18 to Week 20. | Description | Change from Baseline in Hb value was calculated as the PEP Hb value minus the Baseline Hb value. The PEP value was the average Hb value from Week 10 to Week 12. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. | Description | Change from Baseline in Hb value was calculated as the PEP Hb value minus the Baseline Hb value. The PEP value was the average Hb value from Week 10 to Week 12. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. | Description | Change from Baseline in Hb value was calculated as the PEP Hb value minus the Baseline Hb value. The PEP value was the average Hb value from Week 10 to Week 12. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. | Description | Change from Baseline in Hb value was calculated as the PEP Hb value minus the Baseline Hb value. The PEP value was the average Hb value from Week 10 to Week 12. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. | Description | Change from Baseline in Hb value was calculated as the PEP Hb value minus the Baseline Hb value. The PEP value was the average Hb value from Week 10 to Week 12. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. | Description | Change from Baseline in Hb value was calculated as the PEP Hb value minus the Baseline Hb value. The PEP value was the average Hb value from Week 10 to Week 12. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. | Description | Change from Baseline in Hb value was calculated as the PEP Hb value minus the Baseline Hb value. The PEP value was the average Hb value from Week 10 to Week 12. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. | Description | Change from Baseline in Hb value was calculated as the PEP Hb value minus the Baseline Hb value. The PEP value was the average Hb value from Week 10 to Week 12. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. | Description | Change from Baseline in Hb value was calculated as the PEP Hb value minus the Baseline Hb value. The PEP value was the average Hb value from Week 10 to Week 12. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. | Description | Change from Baseline in Hb value was calculated as the PEP Hb value minus the Baseline Hb value. The PEP value was the average Hb value from Week 10 to Week 12. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. | Description | Change from Baseline in Hb value was calculated as the PEP Hb value minus the Baseline Hb value. The PEP value was the average Hb value from Week 10 to Week 12. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. | Description | Change from Baseline in Hb value was calculated as the PEP Hb value minus the Baseline Hb value. The PEP value was the average Hb value from Week 10 to Week 12. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. | Description | Change from Baseline in Hb value was calculated as the PEP Hb value minus the Baseline Hb value. The PEP value was the average Hb value from Week 10 to Week 12. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. | Description | Change from Baseline in Hb value was calculated as the PEP Hb value minus the Baseline Hb value. The PEP value was the average Hb value from Week 10 to Week 12. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. | Description | Change from Baseline in Hb value was calculated as the PEP Hb value minus the Baseline Hb value. The PEP value was the average Hb value from Week 10 to Week 12. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. | Description | Change from Baseline in Hb value was calculated as the PEP Hb value minus the Baseline Hb value. The PEP value was the average Hb value from Week 10 to Week 12. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. | Description | Change from Baseline in Hb value was calculated as the PEP Hb value minus the Baseline Hb value. The PEP value was the average Hb value from Week 10 to Week 12. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. | Description | An adverse event (AE) was defined as any untoward medical occurrence (including a clinically significant abnormal laboratory finding) that occurred in the protocol-specified AE reporting period. An AE included medical conditions, signs, and symptoms not previously observed in the participant that emerged during the protocol-specified AE reporting period, including signs or symptoms associated with pre-existing underlying conditions that were not present prior to the AE reporting period. TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. | Description | An adverse event (AE) was defined as any untoward medical occurrence (including a clinically significant abnormal laboratory finding) that occurred in the protocol-specified AE reporting period. An AE included medical conditions, signs, and symptoms not previously observed in the participant that emerged during the protocol-specified AE reporting period, including signs or symptoms associated with pre-existing underlying conditions that were not present prior to the AE reporting period. TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. | Description | Parameters assessed for laboratory values included hematology (excluding the primary and secondary efficacy endpoint results related to Hb), clinical chemistry, lipid profiles, and glucose. The investigator was responsible for reviewing laboratory results for clinically significant changes. | Description | An adverse event (AE) was defined as any untoward medical occurrence (including a clinically significant abnormal laboratory finding) that occurred in the protocol-specified AE reporting period. An AE included medical conditions, signs, and symptoms not previously observed in the participant that emerged during the protocol-specified AE reporting period, including signs or symptoms associated with pre-existing underlying conditions that were not present prior to the AE reporting period. TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. | Description | An adverse event (AE) was defined as any untoward medical occurrence (including a clinically significant abnormal laboratory finding) that occurred in the protocol-specified AE reporting period. An AE included medical conditions, signs, and symptoms not previously observed in the participant that emerged during the protocol-specified AE reporting period, including signs or symptoms associated with pre-existing underlying conditions that were not present prior to the AE reporting period. TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. | Description | An adverse event (AE) was defined as any untoward medical occurrence (including a clinically significant abnormal laboratory finding) that occurred in the protocol-specified AE reporting period. An AE included medical conditions, signs, and symptoms not previously observed in the participant that emerged during the protocol-specified AE reporting period, including signs or symptoms associated with pre-existing underlying conditions that were not present prior to the AE reporting period. TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. | Description | An adverse event (AE) was defined as any untoward medical occurrence (including a clinically significant abnormal laboratory finding) that occurred in the protocol-specified AE reporting period. An AE included medical conditions, signs, and symptoms not previously observed in the participant that emerged during the protocol-specified AE reporting period, including signs or symptoms associated with pre-existing underlying conditions that were not present prior to the AE reporting period. TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. | Description | An adverse event (AE) was defined as any untoward medical occurrence (including a clinically significant abnormal laboratory finding) that occurred in the protocol-specified AE reporting period. An AE included medical conditions, signs, and symptoms not previously observed in the participant that emerged during the protocol-specified AE reporting period, including signs or symptoms associated with pre-existing underlying conditions that were not present prior to the AE reporting period. TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. | Description | An adverse event (AE) was defined as any untoward medical occurrence (including a clinically significant abnormal laboratory finding) that occurred in the protocol-specified AE reporting period. An AE included medical conditions, signs, and symptoms not previously observed in the participant that emerged during the protocol-specified AE reporting period, including signs or symptoms associated with pre-existing underlying conditions that were not present prior to the AE reporting period. TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. | Description | An adverse event (AE) was defined as any untoward medical occurrence (including a clinically significant abnormal laboratory finding) that occurred in the protocol-specified AE reporting period. An AE included medical conditions, signs, and symptoms not previously observed in the participant that emerged during the protocol-specified AE reporting period, including signs or symptoms associated with pre-existing underlying conditions that were not present prior to the AE reporting period. TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. | Description | Parameters assessed for laboratory values included hematology (excluding the primary and secondary efficacy endpoint results related to Hb), clinical chemistry, lipid profiles, and glucose. The investigator was responsible for reviewing laboratory results for clinically significant changes. | Description | Parameters assessed for laboratory values included hematology (excluding the primary and secondary efficacy endpoint results related to Hb), clinical chemistry, lipid profiles, and glucose. The investigator was responsible for reviewing laboratory results for clinically significant changes. | Description | Parameters assessed for laboratory values included hematology (excluding the primary and secondary efficacy endpoint results related to Hb), clinical chemistry, lipid profiles, and glucose. The investigator was responsible for reviewing laboratory results for clinically significant changes. | Description | Parameters assessed for laboratory values included hematology (excluding the primary and secondary efficacy endpoint results related to Hb), clinical chemistry, lipid profiles, and glucose. The investigator was responsible for reviewing laboratory results for clinically significant changes. | Description | Parameters assessed for laboratory values included hematology (excluding the primary and secondary efficacy endpoint results related to Hb), clinical chemistry, lipid profiles, and glucose. The investigator was responsible for reviewing laboratory results for clinically significant changes. | Description | Parameters assessed for laboratory values included hematology (excluding the primary and secondary efficacy endpoint results related to Hb), clinical chemistry, lipid profiles, and glucose. The investigator was responsible for reviewing laboratory results for clinically significant changes. | Description | Parameters assessed for laboratory values included hematology (excluding the primary and secondary efficacy endpoint results related to Hb), clinical chemistry, lipid profiles, and glucose. The investigator was responsible for reviewing laboratory results for clinically significant changes. | Description | Parameters assessed for laboratory values included hematology (excluding the primary and secondary efficacy endpoint results related to Hb), clinical chemistry, lipid profiles, and glucose. The investigator was responsible for reviewing laboratory results for clinically significant changes. | Description | Parameters assessed for vital signs included sitting (at rest for a minimum of 5 minutes) heart rate, respiratory rate, body temperature, and blood pressure. The investigator was responsible for reviewing vital sign values for clinically significant changes. | Description | Parameters assessed for vital signs included sitting (at rest for a minimum of 5 minutes) heart rate, respiratory rate, body temperature, and blood pressure. The investigator was responsible for reviewing vital sign values for clinically significant changes. | Description | Parameters assessed for vital signs included sitting (at rest for a minimum of 5 minutes) heart rate, respiratory rate, body temperature, and blood pressure. The investigator was responsible for reviewing vital sign values for clinically significant changes. | Description | Parameters assessed for vital signs included sitting (at rest for a minimum of 5 minutes) heart rate, respiratory rate, body temperature, and blood pressure. The investigator was responsible for reviewing vital sign values for clinically significant changes. | Description | Parameters assessed for vital signs included sitting (at rest for a minimum of 5 minutes) heart rate, respiratory rate, body temperature, and blood pressure. The investigator was responsible for reviewing vital sign values for clinically significant changes. | Description | Parameters assessed for vital signs included sitting (at rest for a minimum of 5 minutes) heart rate, respiratory rate, body temperature, and blood pressure. The investigator was responsible for reviewing vital sign values for clinically significant changes. | Description | Parameters assessed for vital signs included sitting (at rest for a minimum of 5 minutes) heart rate, respiratory rate, body temperature, and blood pressure. The investigator was responsible for reviewing vital sign values for clinically significant changes. | Description | Parameters assessed for vital signs included sitting (at rest for a minimum of 5 minutes) heart rate, respiratory rate, body temperature, and blood pressure. The investigator was responsible for reviewing vital sign values for clinically significant changes. | Description | Parameters assessed for vital signs included sitting (at rest for a minimum of 5 minutes) heart rate, respiratory rate, body temperature, and blood pressure. The investigator was responsible for reviewing vital sign values for clinically significant changes. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per g/dL. The SEP was comprised of Week 18 to Week 20. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 g/dL, inclusive. The PEP was comprised of Week 10 to Week 12. | Description | The target range for Hb was from 10.0 to 11.0 g/dL, inclusive. The PEP was comprised of Week 10 to Week 12. | Description | The target range for Hb was from 10.0 to 11.0 g/dL, inclusive. The PEP was comprised of Week 10 to Week 12. | Description | The target range for Hb was from 10.0 to 11.0 g/dL, inclusive. The PEP was comprised of Week 10 to Week 12. | Description | The target range for Hb was from 10.0 to 11.0 g/dL, inclusive. The PEP was comprised of Week 10 to Week 12. | Description | The target range for Hb was from 10.0 to 11.0 g/dL, inclusive. The PEP was comprised of Week 10 to Week 12. | Description | The target range for Hb was from 10.0 to 11.0 g/dL, inclusive. The PEP was comprised of Week 10 to Week 12. | Description | The target range for Hb was from 10.0 to 11.0 g/dL, inclusive. The PEP was comprised of Week 10 to Week 12. | Description | The target range for Hb was from 10.0 to 11.0 g/dL, inclusive. The PEP was comprised of Week 10 to Week 12. | Description | Change from PEP was calculated as the SEP value minus the PEP value. The PEP value was the average Hb value from Week 10 to Week 12. The SEP value was the average Hb value from Week 18 to Week 20. For the Main Study, analysis is presented per dose level according to the starting dose in TIW regimen, as well as being presented as a combined arm for "Vadadustat Total (TIW dosing regimen)". For the ESA Hyporesponder Parallel Study, a starting dose classification for TIW dosing regimen was not applicable due to no participants switching from Vadadustat QD to TIW dosing. | Description | Change from PEP was calculated as the SEP value minus the PEP value. The PEP value was the average Hb value from Week 10 to Week 12. The SEP value was the average Hb value from Week 18 to Week 20. For the Main Study, analysis is presented per dose level according to the starting dose in TIW regimen, as well as being presented as a combined arm for "Vadadustat Total (TIW dosing regimen)". For the ESA Hyporesponder Parallel Study, a starting dose classification for TIW dosing regimen was not applicable due to no participants switching from Vadadustat QD to TIW dosing. | Description | Change from PEP was calculated as the SEP value minus the PEP value. The PEP value was the average Hb value from Week 10 to Week 12. The SEP value was the average Hb value from Week 18 to Week 20. For the Main Study, analysis is presented per dose level according to the starting dose in TIW regimen, as well as being presented as a combined arm for "Vadadustat Total (TIW dosing regimen)". For the ESA Hyporesponder Parallel Study, a starting dose classification for TIW dosing regimen was not applicable due to no participants switching from Vadadustat QD to TIW dosing. | Description | Change from PEP was calculated as the SEP value minus the PEP value. The PEP value was the average Hb value from Week 10 to Week 12. The SEP value was the average Hb value from Week 18 to Week 20. For the Main Study, analysis is presented per dose level according to the starting dose in TIW regimen, as well as being presented as a combined arm for "Vadadustat Total (TIW dosing regimen)". For the ESA Hyporesponder Parallel Study, a starting dose classification for TIW dosing regimen was not applicable due to no participants switching from Vadadustat QD to TIW dosing. | Description | Change from PEP was calculated as the SEP value minus the PEP value. The PEP value was the average Hb value from Week 10 to Week 12. The SEP value was the average Hb value from Week 18 to Week 20. For the Main Study, analysis is presented per dose level according to the starting dose in TIW regimen, as well as being presented as a combined arm for "Vadadustat Total (TIW dosing regimen)". For the ESA Hyporesponder Parallel Study, a starting dose classification for TIW dosing regimen was not applicable due to no participants switching from Vadadustat QD to TIW dosing. | Description | Change from Baseline was calculated as the SEP value minus the Baseline value. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. The SEP value was the average Hb value from Week 18 to Week 20. | Description | Change from Baseline was calculated as the SEP value minus the Baseline value. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. The SEP value was the average Hb value from Week 18 to Week 20. | Description | Change from Baseline was calculated as the SEP value minus the Baseline value. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. The SEP value was the average Hb value from Week 18 to Week 20. | Description | Change from Baseline was calculated as the SEP value minus the Baseline value. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. The SEP value was the average Hb value from Week 18 to Week 20. | Description | Change from Baseline was calculated as the SEP value minus the Baseline value. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. The SEP value was the average Hb value from Week 18 to Week 20. | Description | Iron supplementation was performed to maintain ferritin ≥200 nanograms/milliliters (ng/mL) and transferrin saturation (TSAT) ≥20%. | Description | Change from Baseline was calculated as the SEP value minus the Baseline value. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. The SEP value was the average Hb value from Week 18 to Week 20. | Description | Change from Baseline was calculated as the SEP value minus the Baseline value. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. The SEP value was the average Hb value from Week 18 to Week 20. | Description | Change from Baseline was calculated as the SEP value minus the Baseline value. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. The SEP value was the average Hb value from Week 18 to Week 20. | Description | Change from Baseline was calculated as the SEP value minus the Baseline value. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. The SEP value was the average Hb value from Week 18 to Week 20. | Description | The target range for Hb was from 10.0 to 11.0 g/dL. The SEP was comprised of Week 18 to Week 20. | Description | The target range for Hb was from 10.0 to 11.0 g/dL. The SEP was comprised of Week 18 to Week 20. | Description | The target range for Hb was from 10.0 to 11.0 g/dL. The SEP was comprised of Week 18 to Week 20. | Description | The target range for Hb was from 10.0 to 11.0 g/dL. The SEP was comprised of Week 18 to Week 20. | Description | The target range for Hb was from 10.0 to 11.0 g/dL. The SEP was comprised of Week 18 to Week 20. | Description | The target range for Hb was from 10.0 to 11.0 g/dL. The SEP was comprised of Week 18 to Week 20. | Description | The target range for Hb was from 10.0 to 11.0 g/dL. The SEP was comprised of Week 18 to Week 20. | Description | The target range for Hb was from 10.0 to 11.0 g/dL. The SEP was comprised of Week 18 to Week 20. | Description | The target range for Hb was from 10.0 to 11.0 g/dL. The SEP was comprised of Week 18 to Week 20. | Description | The target range for Hb was from 10.0 to 11.0 g/dL. The SEP was comprised of Week 18 to Week 20. For the Main Study, analysis is presented per dose level according to the starting dose in TIW regimen, as well as being presented as a combined arm for "Vadadustat Total (TIW dosing regimen)". For the ESA Hyporesponder Parallel Study, a starting dose classification for TIW dosing regimen was not applicable due to no participants switching from Vadadustat QD to TIW dosing. | Description | The target range for Hb was from 10.0 to 11.0 g/dL. The SEP was comprised of Week 18 to Week 20. For the Main Study, analysis is presented per dose level according to the starting dose in TIW regimen, as well as being presented as a combined arm for "Vadadustat Total (TIW dosing regimen)". For the ESA Hyporesponder Parallel Study, a starting dose classification for TIW dosing regimen was not applicable due to no participants switching from Vadadustat QD to TIW dosing. | Description | The target range for Hb was from 10.0 to 11.0 g/dL. The SEP was comprised of Week 18 to Week 20. For the Main Study, analysis is presented per dose level according to the starting dose in TIW regimen, as well as being presented as a combined arm for "Vadadustat Total (TIW dosing regimen)". For the ESA Hyporesponder Parallel Study, a starting dose classification for TIW dosing regimen was not applicable due to no participants switching from Vadadustat QD to TIW dosing. | Description | The target range for Hb was from 10.0 to 11.0 g/dL. The SEP was comprised of Week 18 to Week 20. For the Main Study, analysis is presented per dose level according to the starting dose in TIW regimen, as well as being presented as a combined arm for "Vadadustat Total (TIW dosing regimen)". For the ESA Hyporesponder Parallel Study, a starting dose classification for TIW dosing regimen was not applicable due to no participants switching from Vadadustat QD to TIW dosing. | Description | The target range for Hb was from 10.0 to 11.0 g/dL. The SEP was comprised of Week 18 to Week 20. For the Main Study, analysis is presented per dose level according to the starting dose in TIW regimen, as well as being presented as a combined arm for "Vadadustat Total (TIW dosing regimen)". For the ESA Hyporesponder Parallel Study, a starting dose classification for TIW dosing regimen was not applicable due to no participants switching from Vadadustat QD to TIW dosing. | Description | The target range for Hb was from 10.0 to 11.0 g/dL. The PEP was comprised of Week 10 to Week 12. | Description | The target range for Hb was from 10.0 to 11.0 g/dL. The PEP was comprised of Week 10 to Week 12. | Description | The target range for Hb was from 10.0 to 11.0 g/dL. The PEP was comprised of Week 10 to Week 12. | Description | The target range for Hb was from 10.0 to 11.0 g/dL. The PEP was comprised of Week 10 to Week 12. | Description | The target range for Hb was from 10.0 to 11.0 g/dL. The PEP was comprised of Week 10 to Week 12. | Description | The target range for Hb was from 10.0 to 11.0 g/dL. The PEP was comprised of Week 10 to Week 12. | Description | The target range for Hb was from 10.0 to 11.0 g/dL. The PEP was comprised of Week 10 to Week 12. | Description | The target range for Hb was from 10.0 to 11.0 g/dL. The PEP was comprised of Week 10 to Week 12. | Description | The target range for Hb was from 10.0 to 11.0 g/dL. The PEP was comprised of Week 10 to Week 12. | Description | The target range for Hb was from 10.0 to 11.0 grams per g/dL. The SEP was comprised of Week 18 to Week 20. | Description | The target range for Hb was from 10.0 to 11.0 grams per g/dL. The SEP was comprised of Week 18 to Week 20. | Description | The target range for Hb was from 10.0 to 11.0 grams per g/dL. The SEP was comprised of Week 18 to Week 20. | Description | The target range for Hb was from 10.0 to 11.0 grams per g/dL. The SEP was comprised of Week 18 to Week 20. | Description | The target range for Hb was from 10.0 to 11.0 grams per g/dL. The SEP was comprised of Week 18 to Week 20. | Description | The target range for Hb was from 10.0 to 11.0 grams per g/dL. The SEP was comprised of Week 18 to Week 20. | Description | The target range for Hb was from 10.0 to 11.0 grams per g/dL. The SEP was comprised of Week 18 to Week 20. | Description | Iron supplementation was performed to maintain ferritin ≥200 nanograms/milliliters (ng/mL) and transferrin saturation (TSAT) ≥20%. | Description | Iron supplementation was performed to maintain ferritin ≥200 nanograms/milliliters (ng/mL) and transferrin saturation (TSAT) ≥20%. | Description | Iron supplementation was performed to maintain ferritin ≥200 nanograms/milliliters (ng/mL) and transferrin saturation (TSAT) ≥20%. | Description | Iron supplementation was performed to maintain ferritin ≥200 nanograms/milliliters (ng/mL) and transferrin saturation (TSAT) ≥20%. | Description | Iron supplementation was performed to maintain ferritin ≥200 nanograms/milliliters (ng/mL) and transferrin saturation (TSAT) ≥20%. | Description | Iron supplementation was performed to maintain ferritin ≥200 nanograms/milliliters (ng/mL) and transferrin saturation (TSAT) ≥20%. | Description | Iron supplementation was performed to maintain ferritin ≥200 nanograms/milliliters (ng/mL) and transferrin saturation (TSAT) ≥20%. | Description | Iron supplementation was performed to maintain ferritin ≥200 nanograms/milliliters (ng/mL) and transferrin saturation (TSAT) ≥20%. | Description | ESA rescue therapy was administered in participants with Hb ≥8.5 g/dL, and was stopped when Hb reached ≥9.0 g/dL. | Description | ESA rescue therapy was administered in participants with Hb ≥8.5 g/dL, and was stopped when Hb reached ≥9.0 g/dL. | Description | ESA rescue therapy was administered in participants with Hb ≥8.5 g/dL, and was stopped when Hb reached ≥9.0 g/dL. | Description | ESA rescue therapy was administered in participants with Hb ≥8.5 g/dL, and was stopped when Hb reached ≥9.0 g/dL. | Description | ESA rescue therapy was administered in participants with Hb ≥8.5 g/dL, and was stopped when Hb reached ≥9.0 g/dL. | Description | ESA rescue therapy was administered in participants with Hb ≥8.5 g/dL, and was stopped when Hb reached ≥9.0 g/dL. | Description | ESA rescue therapy was administered in participants with Hb ≥8.5 g/dL, and was stopped when Hb reached ≥9.0 g/dL. | Description | ESA rescue therapy was administered in participants with Hb ≥8.5 g/dL, and was stopped when Hb reached ≥9.0 g/dL. | Description | ESA rescue therapy was administered in participants with Hb ≥8.5 g/dL, and was stopped when Hb reached ≥9.0 g/dL. | Description | RBC transfusion was administered as rescue therapy in the event of an acute or severe loss of blood. | Description | RBC transfusion was administered as rescue therapy in the event of an acute or severe loss of blood. | Description | RBC transfusion was administered as rescue therapy in the event of an acute or severe loss of blood. | Description | RBC transfusion was administered as rescue therapy in the event of an acute or severe loss of blood. | Description | RBC transfusion was administered as rescue therapy in the event of an acute or severe loss of blood. | Description | RBC transfusion was administered as rescue therapy in the event of an acute or severe loss of blood. | Description | RBC transfusion was administered as rescue therapy in the event of an acute or severe loss of blood. | Description | Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of t1/2 of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of t1/2 of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of t1/2 of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of t1/2 of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of Cmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Cmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Cmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Cmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Cmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Cmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Cmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Cmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Cmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Cmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Cmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Cmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Cmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Cmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Cmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Cmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Cmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Cmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Cmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Cmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of AUC and AUC0-24 of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of AUC and AUC0-24 of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of AUC and AUC0-24 of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of AUC and AUC0-24 of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of AUC and AUC0-24 of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of AUC and AUC0-24 of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of AUC and AUC0-24 of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of AUC and AUC0-24 of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of AUC and AUC0-24 of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of AUC and AUC0-24 of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of t1/2 of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of AUC and AUC0-24 of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of AUC and AUC0-24 of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of AUC and AUC0-24 of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of AUC and AUC0-24 of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of AUC and AUC0-24 of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of AUC and AUC0-24 of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of AUC and AUC0-24 of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of t1/2 of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of t1/2 of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of t1/2 of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of t1/2 of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of t1/2 of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of t1/2 of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of t1/2 of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of t1/2 of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of t1/2 of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of t1/2 of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of t1/2 of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of t1/2 of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of t1/2 of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of t1/2 of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Tmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Tmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Tmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Tmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Tmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Tmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Tmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Tmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Tmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Tmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Tmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Tmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Tmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Tmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Tmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Tmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Tmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Tmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Tmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Tmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of λz of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of λz of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of λz of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of λz of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of λz of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of λz of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of λz of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of λz of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of λz of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of λz of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of λz of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of λz of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of λz of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of λz of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of λz of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of CLss/F of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of λz of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of λz of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of λz of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of λz of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of CLss/F of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of CLss/F of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of CLss/F of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of CLss/F of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of CLss/F of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of CLss/F of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of CLss/F of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of CLss/F of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of CLss/F of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of CLss/F of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of CLss/F of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of CLss/F of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of CLss/F of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of CLss/F of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of CLss/F of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of CLss/F of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Vz/F of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Vz/F of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Vz/F of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Vz/F of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Vz/F of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Vz/F of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Vz/F of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Vz/F of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Vz/F of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Vz/F of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Vz/F of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Vz/F of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Vz/F of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Vz/F of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Vz/F of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Vz/F of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Vz/F of Vadadustat following a single dose. |
Units | Participants | Units | Participants | Units | grams per deciliter (g/dL) | Units | Participants | Units | Participants | Units | grams per deciliter (g/dL) | Units | grams per deciliter (g/dL) | Units | grams per deciliter (g/dL) | Units | grams per deciliter (g/dL) | Units | grams per deciliter (g/dL) | Units | grams per deciliter (g/dL) | Units | grams per deciliter (g/dL) | Units | grams per deciliter (g/dL) | Units | grams per deciliter (g/dL) | Units | grams per deciliter (g/dL) | Units | grams per deciliter (g/dL) | Units | grams per deciliter (g/dL) | Units | grams per deciliter (g/dL) | Units | grams per deciliter (g/dL) | Units | grams per deciliter (g/dL) | Units | grams per deciliter (g/dL) | Units | grams per deciliter (g/dL) | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | g/dL | Units | g/dL | Units | g/dL | Units | g/dL | Units | g/dL | Units | g/dL | Units | g/dL | Units | g/dL | Units | g/dL | Units | g/dL | Units | Participants | Units | g/dL | Units | g/dL | Units | g/dL | Units | g/dL | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Milliunits per milliliter | Units | Milliunits per milliliter | Units | Milliunits per milliliter | Units | Milliunits per milliliter | Units | Milliunits per milliliter | Units | Milliunits per milliliter | Units | Milliunits per milliliter | Units | Milliunits per milliliter | Units | Milliunits per milliliter | Units | Milliunits per milliliter | Units | Milliunits per milliliter | Units | Milliunits per milliliter | Units | Milliunits per milliliter | Units | Milliunits per milliliter | Units | Milliunits per milliliter | Units | Milliunits per milliliter | Units | Milliunits per milliliter | Units | Milliunits per milliliter | Units | Milliunits per milliliter | Units | Milliunits per milliliter | Units | Milliunits per milliliter | Units | Milliunits per milliliter | Units | Milliunits per milliliter | Units | Milliunits per milliliter | Units | Milliunits per milliliter | Units | Milliunits per milliliter | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | Hours | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | Hours | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | µg/dL | Units | µg/dL | Units | Hours | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | nanograms per milliliter (ng/mL) | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | Hours | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | nanograms per milliliter (ng/mL) | Units | nanograms per milliliter (ng/mL) | Units | nanograms per milliliter (ng/mL) | Units | nanograms per milliliter (ng/mL) | Units | nanograms per milliliter (ng/mL) | Units | nanograms per milliliter (ng/mL) | Units | nanograms per milliliter (ng/mL) | Units | nanograms per milliliter (ng/mL) | Units | nanograms per milliliter (ng/mL) | Units | nanograms per milliliter (ng/mL) | Units | nanograms per milliliter (ng/mL) | Units | nanograms per milliliter (ng/mL) | Units | nanograms per milliliter (ng/mL) | Units | nanograms per milliliter (ng/mL) | Units | nanograms per milliliter (ng/mL) | Units | nanograms per milliliter (ng/mL) | Units | nanograms per milliliter (ng/mL) | Units | nanograms per milliliter (ng/mL) | Units | nanograms per milliliter (ng/mL) | Units | nanograms per milliliter (ng/mL) | Units | nanograms per milliliter (ng/mL) | Units | nanograms per milliliter (ng/mL) | Units | nanograms per milliliter (ng/mL) | Units | nanograms per milliliter (ng/mL) | Units | nanograms per milliliter (ng/mL) | Units | nanograms per milliliter (ng/mL) | Units | Micrograms per milliliter (μg/mL) | Units | Micrograms per milliliter (μg/mL) | Units | Micrograms per milliliter (μg/mL) | Units | Micrograms per milliliter (μg/mL) | Units | Micrograms per milliliter (μg/mL) | Units | Micrograms per milliliter (μg/mL) | Units | Micrograms per milliliter (μg/mL) | Units | Micrograms per milliliter (μg/mL) | Units | Micrograms per milliliter (μg/mL) | Units | Micrograms per milliliter (μg/mL) | Units | Micrograms per milliliter (μg/mL) | Units | Micrograms per milliliter (μg/mL) | Units | Micrograms per milliliter (μg/mL) | Units | Micrograms per milliliter (μg/mL) | Units | Micrograms per milliliter (μg/mL) | Units | Micrograms per milliliter (μg/mL) | Units | Micrograms per milliliter (μg/mL) | Units | Micrograms per milliliter (μg/mL) | Units | Micrograms per milliliter (μg/mL) | Units | Micrograms per milliliter (μg/mL) | Units | hours*µg/mL | Units | hours*µg/mL | Units | hours*µg/mL | Units | hours*µg/mL | Units | hours*µg/mL | Units | hours*µg/mL | Units | hours*µg/mL | Units | hours*µg/mL | Units | hours*µg/mL | Units | hours*µg/mL | Units | Hours | Units | hours*µg/mL | Units | hours*µg/mL | Units | hours*µg/mL | Units | hours*µg/mL | Units | hours*µg/mL | Units | hours*µg/mL | Units | hours*µg/mL | Units | Hours | Units | Hours | Units | Hours | Units | Hours | Units | Hours | Units | Hours | Units | Hours | Units | Hours | Units | Hours | Units | Hours | Units | Hours | Units | Hours | Units | Hours | Units | Hours | Units | Hours | Units | Hours | Units | Hours | Units | Hours | Units | Hours | Units | Hours | Units | Hours | Units | Hours | Units | Hours | Units | Hours | Units | Hours | Units | Hours | Units | Hours | Units | Hours | Units | Hours | Units | Hours | Units | Hours | Units | Hours | Units | Hours | Units | Hours | Units | 1/hour | Units | 1/hour | Units | 1/hour | Units | 1/hour | Units | 1/hour | Units | 1/hour | Units | 1/hour | Units | 1/hour | Units | 1/hour | Units | 1/hour | Units | 1/hour | Units | 1/hour | Units | 1/hour | Units | 1/hour | Units | 1/hour | Units | liters per hour | Units | 1/hour | Units | 1/hour | Units | 1/hour | Units | 1/hour | Units | liters per hour | Units | liters per hour | Units | liters per hour | Units | liters per hour | Units | liters per hour | Units | liters per hour | Units | liters per hour | Units | liters per hour | Units | liters per hour | Units | liters per hour | Units | liters per hour | Units | liters per hour | Units | liters per hour | Units | liters per hour | Units | liters per hour | Units | liters per hour | Units | Liters | Units | Liters | Units | Liters | Units | Liters | Units | Liters | Units | Liters | Units | Liters | Units | Liters | Units | Liters | Units | Liters | Units | Liters | Units | Liters | Units | Liters | Units | Liters | Units | Liters | Units | Liters | Units | Liters |
Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Mean | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Count of Participants | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Median | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Median | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Median | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Median | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Median | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Median | Param Type | Median | Param Type | Median | Param Type | Median | Param Type | Median | Param Type | Median | Param Type | Median | Param Type | Median | Param Type | Median | Param Type | Median | Param Type | Median | Param Type | Median | Param Type | Median | Param Type | Median | Param Type | Median | Param Type | Median | Param Type | Median | Param Type | Median | Param Type | Median | Param Type | Median | Param Type | Median | Param Type | Median | Param Type | Median | Param Type | Median | Param Type | Median | Param Type | Median | Param Type | Median | Param Type | Median | Param Type | Median | Param Type | Median | Param Type | Median | Param Type | Median | Param Type | Median | Param Type | Median | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean |
Param Value | 0 | Param Value | 2 | Param Value | 9.620 | Param Value | 0 | Param Value | 1 | Param Value | 10.223 | Param Value | 10.059 | Param Value | 10.165 | Param Value | 9.778 | Param Value | 10.288 | Param Value | 10.095 | Param Value | 9.950 | Param Value | 9.530 | Param Value | -0.371 | Param Value | 0.072 | Param Value | 0.160 | Param Value | -0.911 | Param Value | -0.284 | Param Value | -0.418 | Param Value | 0.268 | Param Value | -0.671 | Param Value | -0.290 | Param Value | 18 | Param Value | 27 | Param Value | 0 | Param Value | 13 | Param Value | 12 | Param Value | 14 | Param Value | 13 | Param Value | 9 | Param Value | 5 | Param Value | 3 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 2 | Param Value | 2 | Param Value | 3 | Param Value | 0 | Param Value | 1 | Param Value | 0 | Param Value | 1 | Param Value | 0 | Param Value | 0 | Param Value | 1 | Param Value | 0 | Param Value | 1 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 1 | Param Value | 0 | Param Value | 1 | Param Value | 0 | Param Value | 2 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 2 | Param Value | 2 | Param Value | 0 | Param Value | 1 | Param Value | 1 | Param Value | 3 | Param Value | 1 | Param Value | 1 | Param Value | 1 | Param Value | 4 | Param Value | 8 | Param Value | 4 | Param Value | 4 | Param Value | 2 | Param Value | 3 | Param Value | 6 | Param Value | 0 | Param Value | 2 | Param Value | 12 | Param Value | 13 | Param Value | 15 | Param Value | 1 | Param Value | 4 | Param Value | 4 | Param Value | 6 | Param Value | 0 | Param Value | 0 | Param Value | -0.050 | Param Value | -1.021 | Param Value | -0.360 | Param Value | -0.103 | Param Value | -0.422 | Param Value | -0.197 | Param Value | -0.186 | Param Value | 0.070 | Param Value | 0.114 | Param Value | -0.421 | Param Value | 23 | Param Value | -0.545 | Param Value | 0.343 | Param Value | -0.283 | Param Value | -0.400 | Param Value | 6 | Param Value | 7 | Param Value | 9 | Param Value | 2 | Param Value | 3 | Param Value | 2 | Param Value | 6 | Param Value | 1 | Param Value | 1 | Param Value | 0 | Param Value | 2 | Param Value | 2 | Param Value | 3 | Param Value | 7 | Param Value | 14 | Param Value | 19 | Param Value | 18 | Param Value | 1 | Param Value | 6 | Param Value | 6 | Param Value | 8 | Param Value | 0 | Param Value | 1 | Param Value | 10 | Param Value | 11 | Param Value | 14 | Param Value | 3 | Param Value | 5 | Param Value | 2 | Param Value | 8 | Param Value | 21 | Param Value | 16 | Param Value | 10 | Param Value | 14 | Param Value | 18 | Param Value | 10 | Param Value | 4 | Param Value | 5 | Param Value | 2 | Param Value | 8 | Param Value | 3 | Param Value | 5 | Param Value | 5 | Param Value | 3 | Param Value | 1 | Param Value | 3 | Param Value | 1 | Param Value | 0 | Param Value | 1 | Param Value | 0 | Param Value | 3 | Param Value | 1 | Param Value | 1 | Param Value | 1 | Param Value | 7.33 | Param Value | 9.53 | Param Value | 9.93 | Param Value | 8.77 | Param Value | 6.98 | Param Value | 8.03 | Param Value | 12.1 | Param Value | 17.5 | Param Value | 15.3 | Param Value | 14.1 | Param Value | 20.2 | Param Value | 12.9 | Param Value | 15.6 | Param Value | 18.9 | Param Value | 16.1 | Param Value | 18.0 | Param Value | 17.4 | Param Value | 9.49 | Param Value | 14.2 | Param Value | 14.9 | Param Value | 19.4 | Param Value | 20.6 | Param Value | 17.3 | Param Value | 15.7 | Param Value | 39.2 | Param Value | 10.5 | Param Value | 51.9 | Param Value | 47.2 | Param Value | 48.8 | Param Value | 59.3 | Param Value | 48.4 | Param Value | 51.5 | Param Value | 62.6 | Param Value | 77.6 | Param Value | 83.0 | Param Value | 3.1 | Param Value | 6.9 | Param Value | 1.0 | Param Value | -18.1 | Param Value | -3.9 | Param Value | -6.6 | Param Value | 20.4 | Param Value | -35.8 | Param Value | -25.2 | Param Value | 14.6 | Param Value | 14.9 | Param Value | 0.8 | Param Value | -5.6 | Param Value | 2.9 | Param Value | 6.1 | Param Value | 22.5 | Param Value | -26.8 | Param Value | 17.5 | Param Value | 14.0 | Param Value | 23.9 | Param Value | 23.1 | Param Value | 9.1 | Param Value | 20.4 | Param Value | 23.1 | Param Value | 14.0 | Param Value | -3.3 | Param Value | -21.8 | Param Value | 11.7 | Param Value | 20.2 | Param Value | 21.0 | Param Value | 26.2 | Param Value | 32.5 | Param Value | 9.2 | Param Value | 3.9 | Param Value | -6.7 | Param Value | -27.2 | Param Value | 16.1 | Param Value | 16.3 | Param Value | 22.2 | Param Value | 47.7 | Param Value | 20.3 | Param Value | 26.9 | Param Value | 4.6 | Param Value | 3.8 | Param Value | -17.3 | Param Value | 16.7 | Param Value | 12.1 | Param Value | 10.4 | Param Value | 16.4 | Param Value | 46.3 | Param Value | 15.9 | Param Value | 10.5 | Param Value | 0.1 | Param Value | 2.0 | Param Value | 16.3 | Param Value | 13.9 | Param Value | 19.6 | Param Value | 8.3 | Param Value | -2.2 | Param Value | 9.7 | Param Value | 0.2 | Param Value | 26.6 | Param Value | -31.5 | Param Value | 4.0 | Param Value | 14.5 | Param Value | 13.2 | Param Value | 23.8 | Param Value | 10.3 | Param Value | 16.4 | Param Value | 10.9 | Param Value | 38.5 | Param Value | -3.3 | Param Value | 40.0 | Param Value | 87.4 | Param Value | 93.9 | Param Value | 90.1 | Param Value | 57.7 | Param Value | 80.9 | Param Value | 73.1 | Param Value | 65.7 | Param Value | 81.6 | Param Value | 58.4 | Param Value | -8.0 | Param Value | -11.2 | Param Value | -18.3 | Param Value | 3.3 | Param Value | 9.6 | Param Value | 1.7 | Param Value | -6.6 | Param Value | 8.6 | Param Value | 3.8 | Param Value | -5.5 | Param Value | -15.0 | Param Value | -8.6 | Param Value | 4.5 | Param Value | -5.9 | Param Value | 11.7 | Param Value | -12.6 | Param Value | 0.3 | Param Value | 2.0 | Param Value | -2.7 | Param Value | -22.2 | Param Value | -26.0 | Param Value | -2.8 | Param Value | -0.4 | Param Value | -5.1 | Param Value | -16.1 | Param Value | -2.5 | Param Value | -12.6 | Param Value | -22.8 | Param Value | -18.3 | Param Value | -17.9 | Param Value | -0.7 | Param Value | 5.2 | Param Value | -4.6 | Param Value | -13.9 | Param Value | 19.5 | Param Value | -12.0 | Param Value | -14.2 | Param Value | -9.5 | Param Value | -16.6 | Param Value | 28.7 | Param Value | -3.1 | Param Value | 13.4 | Param Value | -8.4 | Param Value | -15.3 | Param Value | -10.3 | Param Value | 939.3 | Param Value | 1043.6 | Param Value | 919.3 | Param Value | 910.2 | Param Value | 745.2 | Param Value | 739.5 | Param Value | 723.6 | Param Value | 1182.2 | Param Value | 449.6 | Param Value | -30.1 | Param Value | -101.9 | Param Value | -23.7 | Param Value | 41.4 | Param Value | 152.9 | Param Value | 45.5 | Param Value | -145.6 | Param Value | 34.8 | Param Value | -61.5 | Param Value | -120.8 | Param Value | -185.4 | Param Value | 24.9 | Param Value | 29.4 | Param Value | -5.6 | Param Value | -87.8 | Param Value | -78.3 | Param Value | 111.3 | Param Value | 397.8 | Param Value | -118.5 | Param Value | -194.8 | Param Value | -42.4 | Param Value | -68.0 | Param Value | -23.8 | Param Value | -30.1 | Param Value | -195.3 | Param Value | -0.5 | Param Value | -35.0 | Param Value | -92.0 | Param Value | -70.9 | Param Value | 99.5 | Param Value | -144.0 | Param Value | 27.8 | Param Value | 6.49 | Param Value | -97.2 | Param Value | -81.8 | Param Value | 80.0 | Param Value | 62.3 | Param Value | -113.6 | Param Value | -166.6 | Param Value | 26.5 | Param Value | -199.4 | Param Value | 4.8 | Param Value | -51.6 | Param Value | -104.8 | Param Value | 249.0 | Param Value | 607.0 | Param Value | 237.8 | Param Value | 230.7 | Param Value | 3.95 | Param Value | 234.8 | Param Value | 210.1 | Param Value | 235.7 | Param Value | 223.6 | Param Value | 218.2 | Param Value | 211.0 | Param Value | 225.6 | Param Value | 35.9 | Param Value | 27.7 | Param Value | -13.4 | Param Value | 27.6 | Param Value | 41.0 | Param Value | 48.2 | Param Value | -0.5 | Param Value | 44.2 | Param Value | 7.8 | Param Value | 30.3 | Param Value | 37.0 | Param Value | -1.1 | Param Value | 26.3 | Param Value | 49.4 | Param Value | 58.8 | Param Value | -7.4 | Param Value | 56.0 | Param Value | -24.8 | Param Value | 42.4 | Param Value | 37.2 | Param Value | -9.9 | Param Value | 25.1 | Param Value | 41.0 | Param Value | 54.5 | Param Value | -3.8 | Param Value | 58.0 | Param Value | -0.6 | Param Value | 35.0 | Param Value | 27.8 | Param Value | -3.0 | Param Value | 55.3 | Param Value | 215.608 | Param Value | 53.1 | Param Value | 60.9 | Param Value | -13.7 | Param Value | 42.5 | Param Value | 11.7 | Param Value | -2.5 | Param Value | 38.0 | Param Value | 44.9 | Param Value | -9.5 | Param Value | 51.7 | Param Value | 68.4 | Param Value | 67.9 | Param Value | -5.4 | Param Value | 66.7 | Param Value | -6.0 | Param Value | 194.870 | Param Value | 208.816 | Param Value | 259.161 | Param Value | 185.852 | Param Value | 160.760 | Param Value | 143.519 | Param Value | 239.958 | Param Value | 74.748 | Param Value | -50.565 | Param Value | -53.675 | Param Value | -66.646 | Param Value | -55.283 | Param Value | -34.868 | Param Value | -74.797 | Param Value | -62.787 | Param Value | -128.587 | Param Value | -1.062 | Param Value | -86.025 | Param Value | -38.627 | Param Value | -83.685 | Param Value | -93.412 | Param Value | -83.012 | Param Value | -43.701 | Param Value | -80.680 | Param Value | -152.243 | Param Value | -9.023 | Param Value | 26.0 | Param Value | 40.8 | Param Value | 26.5 | Param Value | 47.0 | Param Value | 56.5 | Param Value | 44.2 | Param Value | 20.1 | Param Value | 37.6 | Param Value | 23.8 | Param Value | 44.2 | Param Value | 60.1 | Param Value | 31.6 | Param Value | 28.6 | Param Value | 24.4 | Param Value | 32.4 | Param Value | 38.1 | Param Value | 41.2 | Param Value | 30.6 | Param Value | 11.5 | Param Value | 60.2 | Param Value | 338 | Param Value | 518 | Param Value | 342 | Param Value | 605 | Param Value | 786 | Param Value | 464 | Param Value | 289 | Param Value | 465 | Param Value | 310 | Param Value | 566 | Param Value | 6.73 | Param Value | 847 | Param Value | 388 | Param Value | 344 | Param Value | 338 | Param Value | 402 | Param Value | 450 | Param Value | 588 | Param Value | 8.53 | Param Value | 10.5 | Param Value | 12.5 | Param Value | 10.3 | Param Value | 11.0 | Param Value | 9.01 | Param Value | 8.82 | Param Value | 8.83 | Param Value | 10.1 | Param Value | 12.4 | Param Value | 14.6 | Param Value | 5.65 | Param Value | 11.0 | Param Value | 5.01 | Param Value | 2.08 | Param Value | 2.72 | Param Value | 3.48 | Param Value | 3.50 | Param Value | 2.00 | Param Value | 3.28 | Param Value | 3.28 | Param Value | 2.11 | Param Value | 3.33 | Param Value | 3.30 | Param Value | 2.17 | Param Value | 3.42 | Param Value | 3.23 | Param Value | 3.50 | Param Value | 3.50 | Param Value | 2.03 | Param Value | 2.11 | Param Value | 1.98 | Param Value | 4.25 | Param Value | 2.04 | Param Value | 0.0797 | Param Value | 0.0665 | Param Value | 0.0560 | Param Value | 0.0681 | Param Value | 0.0608 | Param Value | 0.0771 | Param Value | 0.0720 | Param Value | 0.0615 | Param Value | 0.0714 | Param Value | 0.0469 | Param Value | 0.0469 | Param Value | 0.0594 | Param Value | 0.0925 | Param Value | 0.0687 | Param Value | 0.124 | Param Value | 1.55 | Param Value | 0.175 | Param Value | 0.116 | Param Value | 0.0632 | Param Value | 0.138 | Param Value | 0.888 | Param Value | 0.869 | Param Value | 0.877 | Param Value | 0.744 | Param Value | 0.763 | Param Value | 1.29 | Param Value | 1.04 | Param Value | 0.967 | Param Value | 0.968 | Param Value | 0.795 | Param Value | 0.708 | Param Value | 0.872 | Param Value | 1.33 | Param Value | 0.747 | Param Value | 1.00 | Param Value | 1.02 | Param Value | 10.9 | Param Value | 14.3 | Param Value | 13.7 | Param Value | 12.1 | Param Value | 13.8 | Param Value | 15.8 | Param Value | 12.5 | Param Value | 13.7 | Param Value | 17.4 | Param Value | 15.3 | Param Value | 15.6 | Param Value | 12.4 | Param Value | 10.2 | Param Value | 10.7 | Param Value | 10.1 | Param Value | 8.24 | Param Value | 8.76 |
Param Value Num | 0.0 | Param Value Num | 2.0 | Param Value Num | 9.62 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 10.223 | Param Value Num | 10.059 | Param Value Num | 10.165 | Param Value Num | 9.778 | Param Value Num | 10.288 | Param Value Num | 10.095 | Param Value Num | 9.95 | Param Value Num | 9.53 | Param Value Num | -0.371 | Param Value Num | 0.072 | Param Value Num | 0.16 | Param Value Num | -0.911 | Param Value Num | -0.284 | Param Value Num | -0.418 | Param Value Num | 0.268 | Param Value Num | -0.671 | Param Value Num | -0.29 | Param Value Num | 18.0 | Param Value Num | 27.0 | Param Value Num | 0.0 | Param Value Num | 13.0 | Param Value Num | 12.0 | Param Value Num | 14.0 | Param Value Num | 13.0 | Param Value Num | 9.0 | Param Value Num | 5.0 | Param Value Num | 3.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 2.0 | Param Value Num | 2.0 | Param Value Num | 3.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 2.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 2.0 | Param Value Num | 2.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 1.0 | Param Value Num | 3.0 | Param Value Num | 1.0 | Param Value Num | 1.0 | Param Value Num | 1.0 | Param Value Num | 4.0 | Param Value Num | 8.0 | Param Value Num | 4.0 | Param Value Num | 4.0 | Param Value Num | 2.0 | Param Value Num | 3.0 | Param Value Num | 6.0 | Param Value Num | 0.0 | Param Value Num | 2.0 | Param Value Num | 12.0 | Param Value Num | 13.0 | Param Value Num | 15.0 | Param Value Num | 1.0 | Param Value Num | 4.0 | Param Value Num | 4.0 | Param Value Num | 6.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | -0.05 | Param Value Num | -1.021 | Param Value Num | -0.36 | Param Value Num | -0.103 | Param Value Num | -0.422 | Param Value Num | -0.197 | Param Value Num | -0.186 | Param Value Num | 0.07 | Param Value Num | 0.114 | Param Value Num | -0.421 | Param Value Num | 23.0 | Param Value Num | -0.545 | Param Value Num | 0.343 | Param Value Num | -0.283 | Param Value Num | -0.4 | Param Value Num | 6.0 | Param Value Num | 7.0 | Param Value Num | 9.0 | Param Value Num | 2.0 | Param Value Num | 3.0 | Param Value Num | 2.0 | Param Value Num | 6.0 | Param Value Num | 1.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 2.0 | Param Value Num | 2.0 | Param Value Num | 3.0 | Param Value Num | 7.0 | Param Value Num | 14.0 | Param Value Num | 19.0 | Param Value Num | 18.0 | Param Value Num | 1.0 | Param Value Num | 6.0 | Param Value Num | 6.0 | Param Value Num | 8.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 10.0 | Param Value Num | 11.0 | Param Value Num | 14.0 | Param Value Num | 3.0 | Param Value Num | 5.0 | Param Value Num | 2.0 | Param Value Num | 8.0 | Param Value Num | 21.0 | Param Value Num | 16.0 | Param Value Num | 10.0 | Param Value Num | 14.0 | Param Value Num | 18.0 | Param Value Num | 10.0 | Param Value Num | 4.0 | Param Value Num | 5.0 | Param Value Num | 2.0 | Param Value Num | 8.0 | Param Value Num | 3.0 | Param Value Num | 5.0 | Param Value Num | 5.0 | Param Value Num | 3.0 | Param Value Num | 1.0 | Param Value Num | 3.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 3.0 | Param Value Num | 1.0 | Param Value Num | 1.0 | Param Value Num | 1.0 | Param Value Num | 7.33 | Param Value Num | 9.53 | Param Value Num | 9.93 | Param Value Num | 8.77 | Param Value Num | 6.98 | Param Value Num | 8.03 | Param Value Num | 12.1 | Param Value Num | 17.5 | Param Value Num | 15.3 | Param Value Num | 14.1 | Param Value Num | 20.2 | Param Value Num | 12.9 | Param Value Num | 15.6 | Param Value Num | 18.9 | Param Value Num | 16.1 | Param Value Num | 18.0 | Param Value Num | 17.4 | Param Value Num | 9.49 | Param Value Num | 14.2 | Param Value Num | 14.9 | Param Value Num | 19.4 | Param Value Num | 20.6 | Param Value Num | 17.3 | Param Value Num | 15.7 | Param Value Num | 39.2 | Param Value Num | 10.5 | Param Value Num | 51.9 | Param Value Num | 47.2 | Param Value Num | 48.8 | Param Value Num | 59.3 | Param Value Num | 48.4 | Param Value Num | 51.5 | Param Value Num | 62.6 | Param Value Num | 77.6 | Param Value Num | 83.0 | Param Value Num | 3.1 | Param Value Num | 6.9 | Param Value Num | 1.0 | Param Value Num | -18.1 | Param Value Num | -3.9 | Param Value Num | -6.6 | Param Value Num | 20.4 | Param Value Num | -35.8 | Param Value Num | -25.2 | Param Value Num | 14.6 | Param Value Num | 14.9 | Param Value Num | 0.8 | Param Value Num | -5.6 | Param Value Num | 2.9 | Param Value Num | 6.1 | Param Value Num | 22.5 | Param Value Num | -26.8 | Param Value Num | 17.5 | Param Value Num | 14.0 | Param Value Num | 23.9 | Param Value Num | 23.1 | Param Value Num | 9.1 | Param Value Num | 20.4 | Param Value Num | 23.1 | Param Value Num | 14.0 | Param Value Num | -3.3 | Param Value Num | -21.8 | Param Value Num | 11.7 | Param Value Num | 20.2 | Param Value Num | 21.0 | Param Value Num | 26.2 | Param Value Num | 32.5 | Param Value Num | 9.2 | Param Value Num | 3.9 | Param Value Num | -6.7 | Param Value Num | -27.2 | Param Value Num | 16.1 | Param Value Num | 16.3 | Param Value Num | 22.2 | Param Value Num | 47.7 | Param Value Num | 20.3 | Param Value Num | 26.9 | Param Value Num | 4.6 | Param Value Num | 3.8 | Param Value Num | -17.3 | Param Value Num | 16.7 | Param Value Num | 12.1 | Param Value Num | 10.4 | Param Value Num | 16.4 | Param Value Num | 46.3 | Param Value Num | 15.9 | Param Value Num | 10.5 | Param Value Num | 0.1 | Param Value Num | 2.0 | Param Value Num | 16.3 | Param Value Num | 13.9 | Param Value Num | 19.6 | Param Value Num | 8.3 | Param Value Num | -2.2 | Param Value Num | 9.7 | Param Value Num | 0.2 | Param Value Num | 26.6 | Param Value Num | -31.5 | Param Value Num | 4.0 | Param Value Num | 14.5 | Param Value Num | 13.2 | Param Value Num | 23.8 | Param Value Num | 10.3 | Param Value Num | 16.4 | Param Value Num | 10.9 | Param Value Num | 38.5 | Param Value Num | -3.3 | Param Value Num | 40.0 | Param Value Num | 87.4 | Param Value Num | 93.9 | Param Value Num | 90.1 | Param Value Num | 57.7 | Param Value Num | 80.9 | Param Value Num | 73.1 | Param Value Num | 65.7 | Param Value Num | 81.6 | Param Value Num | 58.4 | Param Value Num | -8.0 | Param Value Num | -11.2 | Param Value Num | -18.3 | Param Value Num | 3.3 | Param Value Num | 9.6 | Param Value Num | 1.7 | Param Value Num | -6.6 | Param Value Num | 8.6 | Param Value Num | 3.8 | Param Value Num | -5.5 | Param Value Num | -15.0 | Param Value Num | -8.6 | Param Value Num | 4.5 | Param Value Num | -5.9 | Param Value Num | 11.7 | Param Value Num | -12.6 | Param Value Num | 0.3 | Param Value Num | 2.0 | Param Value Num | -2.7 | Param Value Num | -22.2 | Param Value Num | -26.0 | Param Value Num | -2.8 | Param Value Num | -0.4 | Param Value Num | -5.1 | Param Value Num | -16.1 | Param Value Num | -2.5 | Param Value Num | -12.6 | Param Value Num | -22.8 | Param Value Num | -18.3 | Param Value Num | -17.9 | Param Value Num | -0.7 | Param Value Num | 5.2 | Param Value Num | -4.6 | Param Value Num | -13.9 | Param Value Num | 19.5 | Param Value Num | -12.0 | Param Value Num | -14.2 | Param Value Num | -9.5 | Param Value Num | -16.6 | Param Value Num | 28.7 | Param Value Num | -3.1 | Param Value Num | 13.4 | Param Value Num | -8.4 | Param Value Num | -15.3 | Param Value Num | -10.3 | Param Value Num | 939.3 | Param Value Num | 1043.6 | Param Value Num | 919.3 | Param Value Num | 910.2 | Param Value Num | 745.2 | Param Value Num | 739.5 | Param Value Num | 723.6 | Param Value Num | 1182.2 | Param Value Num | 449.6 | Param Value Num | -30.1 | Param Value Num | -101.9 | Param Value Num | -23.7 | Param Value Num | 41.4 | Param Value Num | 152.9 | Param Value Num | 45.5 | Param Value Num | -145.6 | Param Value Num | 34.8 | Param Value Num | -61.5 | Param Value Num | -120.8 | Param Value Num | -185.4 | Param Value Num | 24.9 | Param Value Num | 29.4 | Param Value Num | -5.6 | Param Value Num | -87.8 | Param Value Num | -78.3 | Param Value Num | 111.3 | Param Value Num | 397.8 | Param Value Num | -118.5 | Param Value Num | -194.8 | Param Value Num | -42.4 | Param Value Num | -68.0 | Param Value Num | -23.8 | Param Value Num | -30.1 | Param Value Num | -195.3 | Param Value Num | -0.5 | Param Value Num | -35.0 | Param Value Num | -92.0 | Param Value Num | -70.9 | Param Value Num | 99.5 | Param Value Num | -144.0 | Param Value Num | 27.8 | Param Value Num | 6.49 | Param Value Num | -97.2 | Param Value Num | -81.8 | Param Value Num | 80.0 | Param Value Num | 62.3 | Param Value Num | -113.6 | Param Value Num | -166.6 | Param Value Num | 26.5 | Param Value Num | -199.4 | Param Value Num | 4.8 | Param Value Num | -51.6 | Param Value Num | -104.8 | Param Value Num | 249.0 | Param Value Num | 607.0 | Param Value Num | 237.8 | Param Value Num | 230.7 | Param Value Num | 3.95 | Param Value Num | 234.8 | Param Value Num | 210.1 | Param Value Num | 235.7 | Param Value Num | 223.6 | Param Value Num | 218.2 | Param Value Num | 211.0 | Param Value Num | 225.6 | Param Value Num | 35.9 | Param Value Num | 27.7 | Param Value Num | -13.4 | Param Value Num | 27.6 | Param Value Num | 41.0 | Param Value Num | 48.2 | Param Value Num | -0.5 | Param Value Num | 44.2 | Param Value Num | 7.8 | Param Value Num | 30.3 | Param Value Num | 37.0 | Param Value Num | -1.1 | Param Value Num | 26.3 | Param Value Num | 49.4 | Param Value Num | 58.8 | Param Value Num | -7.4 | Param Value Num | 56.0 | Param Value Num | -24.8 | Param Value Num | 42.4 | Param Value Num | 37.2 | Param Value Num | -9.9 | Param Value Num | 25.1 | Param Value Num | 41.0 | Param Value Num | 54.5 | Param Value Num | -3.8 | Param Value Num | 58.0 | Param Value Num | -0.6 | Param Value Num | 35.0 | Param Value Num | 27.8 | Param Value Num | -3.0 | Param Value Num | 55.3 | Param Value Num | 215.608 | Param Value Num | 53.1 | Param Value Num | 60.9 | Param Value Num | -13.7 | Param Value Num | 42.5 | Param Value Num | 11.7 | Param Value Num | -2.5 | Param Value Num | 38.0 | Param Value Num | 44.9 | Param Value Num | -9.5 | Param Value Num | 51.7 | Param Value Num | 68.4 | Param Value Num | 67.9 | Param Value Num | -5.4 | Param Value Num | 66.7 | Param Value Num | -6.0 | Param Value Num | 194.87 | Param Value Num | 208.816 | Param Value Num | 259.161 | Param Value Num | 185.852 | Param Value Num | 160.76 | Param Value Num | 143.519 | Param Value Num | 239.958 | Param Value Num | 74.748 | Param Value Num | -50.565 | Param Value Num | -53.675 | Param Value Num | -66.646 | Param Value Num | -55.283 | Param Value Num | -34.868 | Param Value Num | -74.797 | Param Value Num | -62.787 | Param Value Num | -128.587 | Param Value Num | -1.062 | Param Value Num | -86.025 | Param Value Num | -38.627 | Param Value Num | -83.685 | Param Value Num | -93.412 | Param Value Num | -83.012 | Param Value Num | -43.701 | Param Value Num | -80.68 | Param Value Num | -152.243 | Param Value Num | -9.023 | Param Value Num | 26.0 | Param Value Num | 40.8 | Param Value Num | 26.5 | Param Value Num | 47.0 | Param Value Num | 56.5 | Param Value Num | 44.2 | Param Value Num | 20.1 | Param Value Num | 37.6 | Param Value Num | 23.8 | Param Value Num | 44.2 | Param Value Num | 60.1 | Param Value Num | 31.6 | Param Value Num | 28.6 | Param Value Num | 24.4 | Param Value Num | 32.4 | Param Value Num | 38.1 | Param Value Num | 41.2 | Param Value Num | 30.6 | Param Value Num | 11.5 | Param Value Num | 60.2 | Param Value Num | 338.0 | Param Value Num | 518.0 | Param Value Num | 342.0 | Param Value Num | 605.0 | Param Value Num | 786.0 | Param Value Num | 464.0 | Param Value Num | 289.0 | Param Value Num | 465.0 | Param Value Num | 310.0 | Param Value Num | 566.0 | Param Value Num | 6.73 | Param Value Num | 847.0 | Param Value Num | 388.0 | Param Value Num | 344.0 | Param Value Num | 338.0 | Param Value Num | 402.0 | Param Value Num | 450.0 | Param Value Num | 588.0 | Param Value Num | 8.53 | Param Value Num | 10.5 | Param Value Num | 12.5 | Param Value Num | 10.3 | Param Value Num | 11.0 | Param Value Num | 9.01 | Param Value Num | 8.82 | Param Value Num | 8.83 | Param Value Num | 10.1 | Param Value Num | 12.4 | Param Value Num | 14.6 | Param Value Num | 5.65 | Param Value Num | 11.0 | Param Value Num | 5.01 | Param Value Num | 2.08 | Param Value Num | 2.72 | Param Value Num | 3.48 | Param Value Num | 3.5 | Param Value Num | 2.0 | Param Value Num | 3.28 | Param Value Num | 3.28 | Param Value Num | 2.11 | Param Value Num | 3.33 | Param Value Num | 3.3 | Param Value Num | 2.17 | Param Value Num | 3.42 | Param Value Num | 3.23 | Param Value Num | 3.5 | Param Value Num | 3.5 | Param Value Num | 2.03 | Param Value Num | 2.11 | Param Value Num | 1.98 | Param Value Num | 4.25 | Param Value Num | 2.04 | Param Value Num | 0.0797 | Param Value Num | 0.0665 | Param Value Num | 0.056 | Param Value Num | 0.0681 | Param Value Num | 0.0608 | Param Value Num | 0.0771 | Param Value Num | 0.072 | Param Value Num | 0.0615 | Param Value Num | 0.0714 | Param Value Num | 0.0469 | Param Value Num | 0.0469 | Param Value Num | 0.0594 | Param Value Num | 0.0925 | Param Value Num | 0.0687 | Param Value Num | 0.124 | Param Value Num | 1.55 | Param Value Num | 0.175 | Param Value Num | 0.116 | Param Value Num | 0.0632 | Param Value Num | 0.138 | Param Value Num | 0.888 | Param Value Num | 0.869 | Param Value Num | 0.877 | Param Value Num | 0.744 | Param Value Num | 0.763 | Param Value Num | 1.29 | Param Value Num | 1.04 | Param Value Num | 0.967 | Param Value Num | 0.968 | Param Value Num | 0.795 | Param Value Num | 0.708 | Param Value Num | 0.872 | Param Value Num | 1.33 | Param Value Num | 0.747 | Param Value Num | 1.0 | Param Value Num | 1.02 | Param Value Num | 10.9 | Param Value Num | 14.3 | Param Value Num | 13.7 | Param Value Num | 12.1 | Param Value Num | 13.8 | Param Value Num | 15.8 | Param Value Num | 12.5 | Param Value Num | 13.7 | Param Value Num | 17.4 | Param Value Num | 15.3 | Param Value Num | 15.6 | Param Value Num | 12.4 | Param Value Num | 10.2 | Param Value Num | 10.7 | Param Value Num | 10.1 | Param Value Num | 8.24 | Param Value Num | 8.76 |
Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Full Range | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Full Range | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Full Range | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Full Range | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Full Range | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Full Range | Dispersion Type | Full Range | Dispersion Type | Full Range | Dispersion Type | Full Range | Dispersion Type | Full Range | Dispersion Type | Full Range | Dispersion Type | Full Range | Dispersion Type | Full Range | Dispersion Type | Full Range | Dispersion Type | Full Range | Dispersion Type | Full Range | Dispersion Type | Full Range | Dispersion Type | Full Range | Dispersion Type | Full Range | Dispersion Type | Full Range | Dispersion Type | Full Range | Dispersion Type | Full Range | Dispersion Type | Full Range | Dispersion Type | Full Range | Dispersion Type | Full Range | Dispersion Type | Full Range | Dispersion Type | Full Range | Dispersion Type | Full Range | Dispersion Type | Full Range | Dispersion Type | Full Range | Dispersion Type | Full Range | Dispersion Type | Full Range | Dispersion Type | Full Range | Dispersion Type | Full Range | Dispersion Type | Full Range | Dispersion Type | Full Range | Dispersion Type | Full Range | Dispersion Type | Full Range | Dispersion Type | Full Range | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dispersion Value | 0.6925 | Dispersion Value | 0.5805 | Dispersion Value | 0.6769 | Dispersion Value | 0.6806 | Dispersion Value | 0.6832 | Dispersion Value | 0.5445 | Dispersion Value | 0.7150 | Dispersion Value | 0.7950 | Dispersion Value | 0.2864 | Dispersion Value | 0.8920 | Dispersion Value | 1.1353 | Dispersion Value | 0.7519 | Dispersion Value | 1.3515 | Dispersion Value | 1.0383 | Dispersion Value | 1.2752 | Dispersion Value | 1.0087 | Dispersion Value | 0.7643 | Dispersion Value | 1.7730 | Dispersion Value | NA | Dispersion Value | 1.0961 | Dispersion Value | 0.4894 | Dispersion Value | 1.9225 | Dispersion Value | 1.1708 | Dispersion Value | 1.1597 | Dispersion Value | 0.8703 | Dispersion Value | 0.9545 | Dispersion Value | 1.0242 | Dispersion Value | 0.8370 | Dispersion Value | 0.9771 | Dispersion Value | 0.8897 | Dispersion Value | 0.7371 | Dispersion Value | 1.0157 | Dispersion Value | 57.3 | Dispersion Value | 54.0 | Dispersion Value | 83.6 | Dispersion Value | 48.2 | Dispersion Value | 61.6 | Dispersion Value | 53.2 | Dispersion Value | 94.3 | Dispersion Value | 97.0 | Dispersion Value | 72.6 | Dispersion Value | 86.4 | Dispersion Value | 90.8 | Dispersion Value | 54.2 | Dispersion Value | 76.3 | Dispersion Value | 98.2 | Dispersion Value | 76.0 | Dispersion Value | 49.8 | Dispersion Value | 104.8 | Dispersion Value | 37.1 | Dispersion Value | 55.9 | Dispersion Value | 106.2 | Dispersion Value | 78.0 | Dispersion Value | 169.6 | Dispersion Value | 53.4 | Dispersion Value | 107.2 | Dispersion Value | NA | Dispersion Value | 47.1 | Dispersion Value | 27.57 | Dispersion Value | 17.81 | Dispersion Value | 27.27 | Dispersion Value | 42.02 | Dispersion Value | 33.45 | Dispersion Value | 25.14 | Dispersion Value | 25.88 | Dispersion Value | 51.04 | Dispersion Value | 45.34 | Dispersion Value | 24.09 | Dispersion Value | 30.60 | Dispersion Value | 22.42 | Dispersion Value | 24.81 | Dispersion Value | 28.51 | Dispersion Value | 33.80 | Dispersion Value | 48.64 | Dispersion Value | 45.06 | Dispersion Value | 29.73 | Dispersion Value | 32.25 | Dispersion Value | 29.45 | Dispersion Value | 40.68 | Dispersion Value | 37.38 | Dispersion Value | 39.68 | Dispersion Value | 33.24 | Dispersion Value | 50.53 | Dispersion Value | 55.44 | Dispersion Value | 26.21 | Dispersion Value | 31.40 | Dispersion Value | 39.26 | Dispersion Value | 38.98 | Dispersion Value | 46.38 | Dispersion Value | 49.42 | Dispersion Value | 20.33 | Dispersion Value | 54.60 | Dispersion Value | 67.56 | Dispersion Value | 69.36 | Dispersion Value | 25.06 | Dispersion Value | 25.80 | Dispersion Value | 35.12 | Dispersion Value | 26.2 | Dispersion Value | 70.42 | Dispersion Value | 41.30 | Dispersion Value | 46.15 | Dispersion Value | 76.89 | Dispersion Value | 71.36 | Dispersion Value | 32.60 | Dispersion Value | 34.27 | Dispersion Value | 26.72 | Dispersion Value | 66.66 | Dispersion Value | 44.30 | Dispersion Value | 52.64 | Dispersion Value | 39.53 | Dispersion Value | 52.72 | Dispersion Value | 67.06 | Dispersion Value | 27.07 | Dispersion Value | 43.12 | Dispersion Value | 26.53 | Dispersion Value | 57.25 | Dispersion Value | 43.79 | Dispersion Value | 28.80 | Dispersion Value | 46.05 | Dispersion Value | 83.44 | Dispersion Value | 11.93 | Dispersion Value | 35.40 | Dispersion Value | 37.61 | Dispersion Value | 34.16 | Dispersion Value | 57.32 | Dispersion Value | 30.17 | Dispersion Value | 22.08 | Dispersion Value | 55.82 | Dispersion Value | 86.97 | Dispersion Value | 16.21 | Dispersion Value | 25.74 | Dispersion Value | 24.50 | Dispersion Value | 26.49 | Dispersion Value | 41.33 | Dispersion Value | 35.54 | Dispersion Value | 29.81 | Dispersion Value | 44.11 | Dispersion Value | 52.58 | Dispersion Value | 7.07 | Dispersion Value | 38.46 | Dispersion Value | 36.56 | Dispersion Value | 35.09 | Dispersion Value | 26.71 | Dispersion Value | 36.94 | Dispersion Value | 22.23 | Dispersion Value | 23.93 | Dispersion Value | 37.01 | Dispersion Value | 18.77 | Dispersion Value | 34.49 | Dispersion Value | 33.59 | Dispersion Value | 22.83 | Dispersion Value | 35.23 | Dispersion Value | 29.67 | Dispersion Value | 23.37 | Dispersion Value | 32.86 | Dispersion Value | 17.36 | Dispersion Value | 25.79 | Dispersion Value | 45.04 | Dispersion Value | 40.51 | Dispersion Value | 44.30 | Dispersion Value | 24.06 | Dispersion Value | 36.91 | Dispersion Value | 40.33 | Dispersion Value | 26.55 | Dispersion Value | 11.09 | Dispersion Value | 20.33 | Dispersion Value | 38.24 | Dispersion Value | 43.14 | Dispersion Value | 33.03 | Dispersion Value | 40.49 | Dispersion Value | 40.20 | Dispersion Value | 27.54 | Dispersion Value | 22.88 | Dispersion Value | 43.94 | Dispersion Value | 28.99 | Dispersion Value | 39.39 | Dispersion Value | 39.85 | Dispersion Value | 53.89 | Dispersion Value | 10.26 | Dispersion Value | 30.27 | Dispersion Value | 30.31 | Dispersion Value | 44.05 | Dispersion Value | 53.03 | Dispersion Value | 24.06 | Dispersion Value | 41.11 | Dispersion Value | 27.87 | Dispersion Value | 46.49 | Dispersion Value | 67.73 | Dispersion Value | 32.43 | Dispersion Value | 16.03 | Dispersion Value | 28.94 | Dispersion Value | 43.19 | Dispersion Value | 21.57 | Dispersion Value | 478.64 | Dispersion Value | 359.10 | Dispersion Value | 298.27 | Dispersion Value | 408.03 | Dispersion Value | 362.98 | Dispersion Value | 329.66 | Dispersion Value | 484.29 | Dispersion Value | 508.67 | Dispersion Value | 423.44 | Dispersion Value | 185.45 | Dispersion Value | 204.51 | Dispersion Value | 274.39 | Dispersion Value | 335.00 | Dispersion Value | 347.97 | Dispersion Value | 320.50 | Dispersion Value | 211.10 | Dispersion Value | 470.43 | Dispersion Value | 17.37 | Dispersion Value | 273.28 | Dispersion Value | 298.19 | Dispersion Value | 334.28 | Dispersion Value | 361.29 | Dispersion Value | 255.10 | Dispersion Value | 285.30 | Dispersion Value | 254.98 | Dispersion Value | 609.61 | Dispersion Value | 453.76 | Dispersion Value | 220.40 | Dispersion Value | 288.47 | Dispersion Value | 356.19 | Dispersion Value | 275.11 | Dispersion Value | 303.39 | Dispersion Value | 386.24 | Dispersion Value | 304.63 | Dispersion Value | 237.99 | Dispersion Value | 157.46 | Dispersion Value | 309.88 | Dispersion Value | 288.34 | Dispersion Value | 567.19 | Dispersion Value | 358.78 | Dispersion Value | 244.67 | Dispersion Value | 188.15 | Dispersion Value | 447.01 | Dispersion Value | 243.24 | Dispersion Value | 186.15 | Dispersion Value | 327.06 | Dispersion Value | 298.67 | Dispersion Value | 497.52 | Dispersion Value | 370.32 | Dispersion Value | 331.76 | Dispersion Value | 253.07 | Dispersion Value | 347.53 | Dispersion Value | 636.33 | Dispersion Value | 607.0 | Dispersion Value | 39.28 | Dispersion Value | 39.09 | Dispersion Value | 44.76 | Dispersion Value | 33.33 | Dispersion Value | 38.80 | Dispersion Value | 34.31 | Dispersion Value | 33.80 | Dispersion Value | 42.99 | Dispersion Value | 98.15 | Dispersion Value | 27.11 | Dispersion Value | 33.58 | Dispersion Value | 26.02 | Dispersion Value | 28.49 | Dispersion Value | 26.22 | Dispersion Value | 37.78 | Dispersion Value | 21.44 | Dispersion Value | 53.58 | Dispersion Value | 14.38 | Dispersion Value | 28.42 | Dispersion Value | 40.99 | Dispersion Value | 18.38 | Dispersion Value | 23.98 | Dispersion Value | 27.34 | Dispersion Value | 24.54 | Dispersion Value | 19.26 | Dispersion Value | 58.15 | Dispersion Value | 58.79 | Dispersion Value | 27.10 | Dispersion Value | 43.09 | Dispersion Value | 25.85 | Dispersion Value | 33.90 | Dispersion Value | 39.05 | Dispersion Value | 44.05 | Dispersion Value | 25.42 | Dispersion Value | 14.45 | Dispersion Value | 15.32 | Dispersion Value | 43.00 | Dispersion Value | 35.16 | Dispersion Value | 25.44 | Dispersion Value | 28.63 | Dispersion Value | 130.7350 | Dispersion Value | 58.33 | Dispersion Value | 70.50 | Dispersion Value | 31.46 | Dispersion Value | 62.93 | Dispersion Value | 18.52 | Dispersion Value | 28.15 | Dispersion Value | 30.71 | Dispersion Value | 29.29 | Dispersion Value | 37.50 | Dispersion Value | 43.40 | Dispersion Value | 58.44 | Dispersion Value | 29.78 | Dispersion Value | 35.22 | Dispersion Value | 21.79 | Dispersion Value | 113.9348 | Dispersion Value | 85.1667 | Dispersion Value | 134.9995 | Dispersion Value | 105.6611 | Dispersion Value | 102.6261 | Dispersion Value | 124.6749 | Dispersion Value | 151.3859 | Dispersion Value | 40.2119 | Dispersion Value | 57.6474 | Dispersion Value | 92.1185 | Dispersion Value | 152.3178 | Dispersion Value | 77.1648 | Dispersion Value | 89.7176 | Dispersion Value | 126.1667 | Dispersion Value | 96.1842 | Dispersion Value | 262.6300 | Dispersion Value | 30.4842 | Dispersion Value | 100.4382 | Dispersion Value | 75.0555 | Dispersion Value | 95.7049 | Dispersion Value | 115.2839 | Dispersion Value | 98.7521 | Dispersion Value | 80.8411 | Dispersion Value | 125.2481 | Dispersion Value | 218.9284 | Dispersion Value | 80.4001 | Dispersion Value | 87.9 | Dispersion Value | 54.8 | Dispersion Value | 59.3 | Dispersion Value | 38.2 | Dispersion Value | 39.2 | Dispersion Value | 73.1 | Dispersion Value | 174.4 | Dispersion Value | 78.9 | Dispersion Value | 69.0 | Dispersion Value | 29.6 | Dispersion Value | 41.6 | Dispersion Value | 151.6 | Dispersion Value | 49.3 | Dispersion Value | 350.6 | Dispersion Value | 26.9 | Dispersion Value | 99.0 | Dispersion Value | 77.7 | Dispersion Value | 102.7 | Dispersion Value | NA | Dispersion Value | 9.2 | Dispersion Value | 63.8 | Dispersion Value | 71.1 | Dispersion Value | 81.7 | Dispersion Value | 54.5 | Dispersion Value | 36.6 | Dispersion Value | 80.9 | Dispersion Value | 76.6 | Dispersion Value | 80.8 | Dispersion Value | 94.7 | Dispersion Value | 41.1 | Dispersion Value | 54.8 | Dispersion Value | 112.4 | Dispersion Value | 53.5 | Dispersion Value | 282.0 | Dispersion Value | 70.8 | Dispersion Value | 68.2 | Dispersion Value | 52.5 | Dispersion Value | 38.7 | Dispersion Value | 50.5 | Dispersion Value | 41.6 | Dispersion Value | 32.7 | Dispersion Value | 46.9 | Dispersion Value | 8.9 | Dispersion Value | 44.2 | Dispersion Value | 70.0 | Dispersion Value | 53.9 | Dispersion Value | 72.2 | Dispersion Value | 74.4 | Dispersion Value | 4.5 | Dispersion Value | 65.5 | Dispersion Value | 26.5 | Dispersion Value | 92.0 | Dispersion Value | 112.4 | Dispersion Value | NA | Dispersion Value | 15.9 | Dispersion Value | NA | Dispersion Value | NA | Dispersion Value | 63.8 | Dispersion Value | 71.1 | Dispersion Value | 81.7 | Dispersion Value | 54.5 | Dispersion Value | 36.6 | Dispersion Value | 80.9 | Dispersion Value | 76.6 | Dispersion Value | 80.8 | Dispersion Value | 94.7 | Dispersion Value | 41.1 | Dispersion Value | 54.8 | Dispersion Value | 53.5 | Dispersion Value | 282.0 | Dispersion Value | 70.8 | Dispersion Value | 68.2 | Dispersion Value | 52.5 | Dispersion Value | 36.2 | Dispersion Value | 53.4 | Dispersion Value | 69.7 | Dispersion Value | 38.6 | Dispersion Value | 16.7 | Dispersion Value | 56.9 | Dispersion Value | 36.6 | Dispersion Value | 41.0 | Dispersion Value | 50.4 | Dispersion Value | 67.4 | Dispersion Value | 27.2 | Dispersion Value | 35.8 | Dispersion Value | 28.7 | Dispersion Value | 37.6 | Dispersion Value | 10.3 | Dispersion Value | NA | Dispersion Value | 18.9 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dispersion Value Num | 0.6925 | Dispersion Value Num | 0.5805 | Dispersion Value Num | 0.6769 | Dispersion Value Num | 0.6806 | Dispersion Value Num | 0.6832 | Dispersion Value Num | 0.5445 | Dispersion Value Num | 0.715 | Dispersion Value Num | 0.795 | Dispersion Value Num | 0.2864 | Dispersion Value Num | 0.892 | Dispersion Value Num | 1.1353 | Dispersion Value Num | 0.7519 | Dispersion Value Num | 1.3515 | Dispersion Value Num | 1.0383 | Dispersion Value Num | 1.2752 | Dispersion Value Num | 1.0087 | Dispersion Value Num | 0.7643 | Dispersion Value Num | 1.773 | Dispersion Value Num | 1.0961 | Dispersion Value Num | 0.4894 | Dispersion Value Num | 1.9225 | Dispersion Value Num | 1.1708 | Dispersion Value Num | 1.1597 | Dispersion Value Num | 0.8703 | Dispersion Value Num | 0.9545 | Dispersion Value Num | 1.0242 | Dispersion Value Num | 0.837 | Dispersion Value Num | 0.9771 | Dispersion Value Num | 0.8897 | Dispersion Value Num | 0.7371 | Dispersion Value Num | 1.0157 | Dispersion Value Num | 57.3 | Dispersion Value Num | 54.0 | Dispersion Value Num | 83.6 | Dispersion Value Num | 48.2 | Dispersion Value Num | 61.6 | Dispersion Value Num | 53.2 | Dispersion Value Num | 94.3 | Dispersion Value Num | 97.0 | Dispersion Value Num | 72.6 | Dispersion Value Num | 86.4 | Dispersion Value Num | 90.8 | Dispersion Value Num | 54.2 | Dispersion Value Num | 76.3 | Dispersion Value Num | 98.2 | Dispersion Value Num | 76.0 | Dispersion Value Num | 49.8 | Dispersion Value Num | 104.8 | Dispersion Value Num | 37.1 | Dispersion Value Num | 55.9 | Dispersion Value Num | 106.2 | Dispersion Value Num | 78.0 | Dispersion Value Num | 169.6 | Dispersion Value Num | 53.4 | Dispersion Value Num | 107.2 | Dispersion Value Num | 47.1 | Dispersion Value Num | 27.57 | Dispersion Value Num | 17.81 | Dispersion Value Num | 27.27 | Dispersion Value Num | 42.02 | Dispersion Value Num | 33.45 | Dispersion Value Num | 25.14 | Dispersion Value Num | 25.88 | Dispersion Value Num | 51.04 | Dispersion Value Num | 45.34 | Dispersion Value Num | 24.09 | Dispersion Value Num | 30.6 | Dispersion Value Num | 22.42 | Dispersion Value Num | 24.81 | Dispersion Value Num | 28.51 | Dispersion Value Num | 33.8 | Dispersion Value Num | 48.64 | Dispersion Value Num | 45.06 | Dispersion Value Num | 29.73 | Dispersion Value Num | 32.25 | Dispersion Value Num | 29.45 | Dispersion Value Num | 40.68 | Dispersion Value Num | 37.38 | Dispersion Value Num | 39.68 | Dispersion Value Num | 33.24 | Dispersion Value Num | 50.53 | Dispersion Value Num | 55.44 | Dispersion Value Num | 26.21 | Dispersion Value Num | 31.4 | Dispersion Value Num | 39.26 | Dispersion Value Num | 38.98 | Dispersion Value Num | 46.38 | Dispersion Value Num | 49.42 | Dispersion Value Num | 20.33 | Dispersion Value Num | 54.6 | Dispersion Value Num | 67.56 | Dispersion Value Num | 69.36 | Dispersion Value Num | 25.06 | Dispersion Value Num | 25.8 | Dispersion Value Num | 35.12 | Dispersion Value Num | 26.2 | Dispersion Value Num | 70.42 | Dispersion Value Num | 41.3 | Dispersion Value Num | 46.15 | Dispersion Value Num | 76.89 | Dispersion Value Num | 71.36 | Dispersion Value Num | 32.6 | Dispersion Value Num | 34.27 | Dispersion Value Num | 26.72 | Dispersion Value Num | 66.66 | Dispersion Value Num | 44.3 | Dispersion Value Num | 52.64 | Dispersion Value Num | 39.53 | Dispersion Value Num | 52.72 | Dispersion Value Num | 67.06 | Dispersion Value Num | 27.07 | Dispersion Value Num | 43.12 | Dispersion Value Num | 26.53 | Dispersion Value Num | 57.25 | Dispersion Value Num | 43.79 | Dispersion Value Num | 28.8 | Dispersion Value Num | 46.05 | Dispersion Value Num | 83.44 | Dispersion Value Num | 11.93 | Dispersion Value Num | 35.4 | Dispersion Value Num | 37.61 | Dispersion Value Num | 34.16 | Dispersion Value Num | 57.32 | Dispersion Value Num | 30.17 | Dispersion Value Num | 22.08 | Dispersion Value Num | 55.82 | Dispersion Value Num | 86.97 | Dispersion Value Num | 16.21 | Dispersion Value Num | 25.74 | Dispersion Value Num | 24.5 | Dispersion Value Num | 26.49 | Dispersion Value Num | 41.33 | Dispersion Value Num | 35.54 | Dispersion Value Num | 29.81 | Dispersion Value Num | 44.11 | Dispersion Value Num | 52.58 | Dispersion Value Num | 7.07 | Dispersion Value Num | 38.46 | Dispersion Value Num | 36.56 | Dispersion Value Num | 35.09 | Dispersion Value Num | 26.71 | Dispersion Value Num | 36.94 | Dispersion Value Num | 22.23 | Dispersion Value Num | 23.93 | Dispersion Value Num | 37.01 | Dispersion Value Num | 18.77 | Dispersion Value Num | 34.49 | Dispersion Value Num | 33.59 | Dispersion Value Num | 22.83 | Dispersion Value Num | 35.23 | Dispersion Value Num | 29.67 | Dispersion Value Num | 23.37 | Dispersion Value Num | 32.86 | Dispersion Value Num | 17.36 | Dispersion Value Num | 25.79 | Dispersion Value Num | 45.04 | Dispersion Value Num | 40.51 | Dispersion Value Num | 44.3 | Dispersion Value Num | 24.06 | Dispersion Value Num | 36.91 | Dispersion Value Num | 40.33 | Dispersion Value Num | 26.55 | Dispersion Value Num | 11.09 | Dispersion Value Num | 20.33 | Dispersion Value Num | 38.24 | Dispersion Value Num | 43.14 | Dispersion Value Num | 33.03 | Dispersion Value Num | 40.49 | Dispersion Value Num | 40.2 | Dispersion Value Num | 27.54 | Dispersion Value Num | 22.88 | Dispersion Value Num | 43.94 | Dispersion Value Num | 28.99 | Dispersion Value Num | 39.39 | Dispersion Value Num | 39.85 | Dispersion Value Num | 53.89 | Dispersion Value Num | 10.26 | Dispersion Value Num | 30.27 | Dispersion Value Num | 30.31 | Dispersion Value Num | 44.05 | Dispersion Value Num | 53.03 | Dispersion Value Num | 24.06 | Dispersion Value Num | 41.11 | Dispersion Value Num | 27.87 | Dispersion Value Num | 46.49 | Dispersion Value Num | 67.73 | Dispersion Value Num | 32.43 | Dispersion Value Num | 16.03 | Dispersion Value Num | 28.94 | Dispersion Value Num | 43.19 | Dispersion Value Num | 21.57 | Dispersion Value Num | 478.64 | Dispersion Value Num | 359.1 | Dispersion Value Num | 298.27 | Dispersion Value Num | 408.03 | Dispersion Value Num | 362.98 | Dispersion Value Num | 329.66 | Dispersion Value Num | 484.29 | Dispersion Value Num | 508.67 | Dispersion Value Num | 423.44 | Dispersion Value Num | 185.45 | Dispersion Value Num | 204.51 | Dispersion Value Num | 274.39 | Dispersion Value Num | 335.0 | Dispersion Value Num | 347.97 | Dispersion Value Num | 320.5 | Dispersion Value Num | 211.1 | Dispersion Value Num | 470.43 | Dispersion Value Num | 17.37 | Dispersion Value Num | 273.28 | Dispersion Value Num | 298.19 | Dispersion Value Num | 334.28 | Dispersion Value Num | 361.29 | Dispersion Value Num | 255.1 | Dispersion Value Num | 285.3 | Dispersion Value Num | 254.98 | Dispersion Value Num | 609.61 | Dispersion Value Num | 453.76 | Dispersion Value Num | 220.4 | Dispersion Value Num | 288.47 | Dispersion Value Num | 356.19 | Dispersion Value Num | 275.11 | Dispersion Value Num | 303.39 | Dispersion Value Num | 386.24 | Dispersion Value Num | 304.63 | Dispersion Value Num | 237.99 | Dispersion Value Num | 157.46 | Dispersion Value Num | 309.88 | Dispersion Value Num | 288.34 | Dispersion Value Num | 567.19 | Dispersion Value Num | 358.78 | Dispersion Value Num | 244.67 | Dispersion Value Num | 188.15 | Dispersion Value Num | 447.01 | Dispersion Value Num | 243.24 | Dispersion Value Num | 186.15 | Dispersion Value Num | 327.06 | Dispersion Value Num | 298.67 | Dispersion Value Num | 497.52 | Dispersion Value Num | 370.32 | Dispersion Value Num | 331.76 | Dispersion Value Num | 253.07 | Dispersion Value Num | 347.53 | Dispersion Value Num | 636.33 | Dispersion Value Num | 607.0 | Dispersion Value Num | 39.28 | Dispersion Value Num | 39.09 | Dispersion Value Num | 44.76 | Dispersion Value Num | 33.33 | Dispersion Value Num | 38.8 | Dispersion Value Num | 34.31 | Dispersion Value Num | 33.8 | Dispersion Value Num | 42.99 | Dispersion Value Num | 98.15 | Dispersion Value Num | 27.11 | Dispersion Value Num | 33.58 | Dispersion Value Num | 26.02 | Dispersion Value Num | 28.49 | Dispersion Value Num | 26.22 | Dispersion Value Num | 37.78 | Dispersion Value Num | 21.44 | Dispersion Value Num | 53.58 | Dispersion Value Num | 14.38 | Dispersion Value Num | 28.42 | Dispersion Value Num | 40.99 | Dispersion Value Num | 18.38 | Dispersion Value Num | 23.98 | Dispersion Value Num | 27.34 | Dispersion Value Num | 24.54 | Dispersion Value Num | 19.26 | Dispersion Value Num | 58.15 | Dispersion Value Num | 58.79 | Dispersion Value Num | 27.1 | Dispersion Value Num | 43.09 | Dispersion Value Num | 25.85 | Dispersion Value Num | 33.9 | Dispersion Value Num | 39.05 | Dispersion Value Num | 44.05 | Dispersion Value Num | 25.42 | Dispersion Value Num | 14.45 | Dispersion Value Num | 15.32 | Dispersion Value Num | 43.0 | Dispersion Value Num | 35.16 | Dispersion Value Num | 25.44 | Dispersion Value Num | 28.63 | Dispersion Value Num | 130.735 | Dispersion Value Num | 58.33 | Dispersion Value Num | 70.5 | Dispersion Value Num | 31.46 | Dispersion Value Num | 62.93 | Dispersion Value Num | 18.52 | Dispersion Value Num | 28.15 | Dispersion Value Num | 30.71 | Dispersion Value Num | 29.29 | Dispersion Value Num | 37.5 | Dispersion Value Num | 43.4 | Dispersion Value Num | 58.44 | Dispersion Value Num | 29.78 | Dispersion Value Num | 35.22 | Dispersion Value Num | 21.79 | Dispersion Value Num | 113.9348 | Dispersion Value Num | 85.1667 | Dispersion Value Num | 134.9995 | Dispersion Value Num | 105.6611 | Dispersion Value Num | 102.6261 | Dispersion Value Num | 124.6749 | Dispersion Value Num | 151.3859 | Dispersion Value Num | 40.2119 | Dispersion Value Num | 57.6474 | Dispersion Value Num | 92.1185 | Dispersion Value Num | 152.3178 | Dispersion Value Num | 77.1648 | Dispersion Value Num | 89.7176 | Dispersion Value Num | 126.1667 | Dispersion Value Num | 96.1842 | Dispersion Value Num | 262.63 | Dispersion Value Num | 30.4842 | Dispersion Value Num | 100.4382 | Dispersion Value Num | 75.0555 | Dispersion Value Num | 95.7049 | Dispersion Value Num | 115.2839 | Dispersion Value Num | 98.7521 | Dispersion Value Num | 80.8411 | Dispersion Value Num | 125.2481 | Dispersion Value Num | 218.9284 | Dispersion Value Num | 80.4001 | Dispersion Value Num | 87.9 | Dispersion Value Num | 54.8 | Dispersion Value Num | 59.3 | Dispersion Value Num | 38.2 | Dispersion Value Num | 39.2 | Dispersion Value Num | 73.1 | Dispersion Value Num | 174.4 | Dispersion Value Num | 78.9 | Dispersion Value Num | 69.0 | Dispersion Value Num | 29.6 | Dispersion Value Num | 41.6 | Dispersion Value Num | 151.6 | Dispersion Value Num | 49.3 | Dispersion Value Num | 350.6 | Dispersion Value Num | 26.9 | Dispersion Value Num | 99.0 | Dispersion Value Num | 77.7 | Dispersion Value Num | 102.7 | Dispersion Value Num | 9.2 | Dispersion Value Num | 63.8 | Dispersion Value Num | 71.1 | Dispersion Value Num | 81.7 | Dispersion Value Num | 54.5 | Dispersion Value Num | 36.6 | Dispersion Value Num | 80.9 | Dispersion Value Num | 76.6 | Dispersion Value Num | 80.8 | Dispersion Value Num | 94.7 | Dispersion Value Num | 41.1 | Dispersion Value Num | 54.8 | Dispersion Value Num | 112.4 | Dispersion Value Num | 53.5 | Dispersion Value Num | 282.0 | Dispersion Value Num | 70.8 | Dispersion Value Num | 68.2 | Dispersion Value Num | 52.5 | Dispersion Value Num | 38.7 | Dispersion Value Num | 50.5 | Dispersion Value Num | 41.6 | Dispersion Value Num | 32.7 | Dispersion Value Num | 46.9 | Dispersion Value Num | 8.9 | Dispersion Value Num | 44.2 | Dispersion Value Num | 70.0 | Dispersion Value Num | 53.9 | Dispersion Value Num | 72.2 | Dispersion Value Num | 74.4 | Dispersion Value Num | 4.5 | Dispersion Value Num | 65.5 | Dispersion Value Num | 26.5 | Dispersion Value Num | 92.0 | Dispersion Value Num | 112.4 | Dispersion Value Num | 15.9 | Dispersion Value Num | 63.8 | Dispersion Value Num | 71.1 | Dispersion Value Num | 81.7 | Dispersion Value Num | 54.5 | Dispersion Value Num | 36.6 | Dispersion Value Num | 80.9 | Dispersion Value Num | 76.6 | Dispersion Value Num | 80.8 | Dispersion Value Num | 94.7 | Dispersion Value Num | 41.1 | Dispersion Value Num | 54.8 | Dispersion Value Num | 53.5 | Dispersion Value Num | 282.0 | Dispersion Value Num | 70.8 | Dispersion Value Num | 68.2 | Dispersion Value Num | 52.5 | Dispersion Value Num | 36.2 | Dispersion Value Num | 53.4 | Dispersion Value Num | 69.7 | Dispersion Value Num | 38.6 | Dispersion Value Num | 16.7 | Dispersion Value Num | 56.9 | Dispersion Value Num | 36.6 | Dispersion Value Num | 41.0 | Dispersion Value Num | 50.4 | Dispersion Value Num | 67.4 | Dispersion Value Num | 27.2 | Dispersion Value Num | 35.8 | Dispersion Value Num | 28.7 | Dispersion Value Num | 37.6 | Dispersion Value Num | 10.3 | Dispersion Value Num | 18.9 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dispersion Lower Limit | 6.46 | Dispersion Lower Limit | 3.22 | Dispersion Lower Limit | 3.95 | Dispersion Lower Limit | 11.3 | Dispersion Lower Limit | 3.55 | Dispersion Lower Limit | 5.36 | Dispersion Lower Limit | 3.26 | Dispersion Lower Limit | 7.33 | Dispersion Lower Limit | 6.33 | Dispersion Lower Limit | 6.51 | Dispersion Lower Limit | 8.45 | Dispersion Lower Limit | 5.8 | Dispersion Lower Limit | 4.98 | Dispersion Lower Limit | 4.79 | Dispersion Lower Limit | 5.73 | Dispersion Lower Limit | 5.61 | Dispersion Lower Limit | 5.26 | Dispersion Lower Limit | 11.0 | Dispersion Lower Limit | 5.01 | Dispersion Lower Limit | 0.0 | Dispersion Lower Limit | 1.83 | Dispersion Lower Limit | 1.92 | Dispersion Lower Limit | 1.58 | Dispersion Lower Limit | 1.75 | Dispersion Lower Limit | 1.83 | Dispersion Lower Limit | 1.75 | Dispersion Lower Limit | 0.0 | Dispersion Lower Limit | 1.8 | Dispersion Lower Limit | 0.0 | Dispersion Lower Limit | 1.75 | Dispersion Lower Limit | 1.8 | Dispersion Lower Limit | 0.0 | Dispersion Lower Limit | 1.75 | Dispersion Lower Limit | 2.0 | Dispersion Lower Limit | 1.75 | Dispersion Lower Limit | 1.8 | Dispersion Lower Limit | 1.75 | Dispersion Lower Limit | 4.25 | Dispersion Lower Limit | 1.97 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dispersion Upper Limit | 13.8 | Dispersion Upper Limit | 9.75 | Dispersion Upper Limit | 3.95 | Dispersion Upper Limit | 12.0 | Dispersion Upper Limit | 22.1 | Dispersion Upper Limit | 26.6 | Dispersion Upper Limit | 21.1 | Dispersion Upper Limit | 20.7 | Dispersion Upper Limit | 18.3 | Dispersion Upper Limit | 18.0 | Dispersion Upper Limit | 9.58 | Dispersion Upper Limit | 22.9 | Dispersion Upper Limit | 70.0 | Dispersion Upper Limit | 17.9 | Dispersion Upper Limit | 47.8 | Dispersion Upper Limit | 31.3 | Dispersion Upper Limit | 7.12 | Dispersion Upper Limit | 11.0 | Dispersion Upper Limit | 5.01 | Dispersion Upper Limit | 11.5 | Dispersion Upper Limit | 5.03 | Dispersion Upper Limit | 10.5 | Dispersion Upper Limit | 9.0 | Dispersion Upper Limit | 5.03 | Dispersion Upper Limit | 4.5 | Dispersion Upper Limit | 6.75 | Dispersion Upper Limit | 5.23 | Dispersion Upper Limit | 5.0 | Dispersion Upper Limit | 5.0 | Dispersion Upper Limit | 5.05 | Dispersion Upper Limit | 4.5 | Dispersion Upper Limit | 4.5 | Dispersion Upper Limit | 10.83 | Dispersion Upper Limit | 4.67 | Dispersion Upper Limit | 3.63 | Dispersion Upper Limit | 5.0 | Dispersion Upper Limit | 5.0 | Dispersion Upper Limit | 4.25 | Dispersion Upper Limit | 2.12 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Explanation Of Na | Standard deviation cannot be calculated due to only one participant with data | Explanation Of Na | Dispersion data are not available for a single participant. | Explanation Of Na | Dispersion data are not available for a single participant | Explanation Of Na | Dispersion data are not available for a single participant | Explanation Of Na | Dispersion data are not available for a single participant | Explanation Of Na | Dispersion data are not available for a single participant | Explanation Of Na | Dispersion data are not available for a single participant |
Study References
Sequence: | 52087708 |
Pmid | 36005278 |
Reference Type | derived |
Citation | Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2. |
Baseline Counts
Sequence: | 11388349 | Sequence: | 11388350 | Sequence: | 11388351 | Sequence: | 11388352 | Sequence: | 11388353 | Sequence: | 11388354 | Sequence: | 11388355 | Sequence: | 11388356 | Sequence: | 11388357 | Sequence: | 11388358 |
Result Group Id | 56112522 | Result Group Id | 56112523 | Result Group Id | 56112524 | Result Group Id | 56112525 | Result Group Id | 56112526 | Result Group Id | 56112527 | Result Group Id | 56112528 | Result Group Id | 56112529 | Result Group Id | 56112530 | Result Group Id | 56112531 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG003 | Ctgov Group Code | BG004 | Ctgov Group Code | BG005 | Ctgov Group Code | BG006 | Ctgov Group Code | BG007 | Ctgov Group Code | BG008 | Ctgov Group Code | BG009 |
Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants |
Scope | overall | Scope | overall | Scope | overall | Scope | overall | Scope | overall | Scope | overall | Scope | overall | Scope | overall | Scope | overall | Scope | overall |
Count | 35 | Count | 34 | Count | 23 | Count | 18 | Count | 21 | Count | 21 | Count | 13 | Count | 5 | Count | 5 | Count | 175 |
Result Groups
Sequence: | 56112522 | Sequence: | 56112523 | Sequence: | 56112524 | Sequence: | 56112525 | Sequence: | 56112526 | Sequence: | 56112527 | Sequence: | 56112528 | Sequence: | 56112529 | Sequence: | 56112530 | Sequence: | 56112531 | Sequence: | 56112554 | Sequence: | 56112532 | Sequence: | 56112533 | Sequence: | 56112534 | Sequence: | 56112535 | Sequence: | 56112536 | Sequence: | 56112537 | Sequence: | 56112538 | Sequence: | 56112539 | Sequence: | 56112540 | Sequence: | 56112541 | Sequence: | 56112542 | Sequence: | 56112543 | Sequence: | 56112544 | Sequence: | 56112545 | Sequence: | 56112546 | Sequence: | 56112547 | Sequence: | 56112548 | Sequence: | 56112549 | Sequence: | 56112550 | Sequence: | 56112551 | Sequence: | 56112552 | Sequence: | 56112553 | Sequence: | 56112555 | Sequence: | 56112556 | Sequence: | 56112557 | Sequence: | 56112558 | Sequence: | 56112559 | Sequence: | 56112560 | Sequence: | 56112561 | Sequence: | 56112562 | Sequence: | 56112563 | Sequence: | 56112564 | Sequence: | 56112565 | Sequence: | 56112566 | Sequence: | 56112567 | Sequence: | 56112568 | Sequence: | 56112569 | Sequence: | 56112570 | Sequence: | 56112571 | Sequence: | 56112572 | Sequence: | 56112573 | Sequence: | 56112574 | Sequence: | 56112575 | Sequence: | 56112576 | Sequence: | 56112577 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG003 | Ctgov Group Code | BG004 | Ctgov Group Code | BG005 | Ctgov Group Code | BG006 | Ctgov Group Code | BG007 | Ctgov Group Code | BG008 | Ctgov Group Code | BG009 | Ctgov Group Code | OG003 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG006 | Ctgov Group Code | FG007 | Ctgov Group Code | FG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG005 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG008 | Ctgov Group Code | OG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 |
Result Type | Baseline | Result Type | Baseline | Result Type | Baseline | Result Type | Baseline | Result Type | Baseline | Result Type | Baseline | Result Type | Baseline | Result Type | Baseline | Result Type | Baseline | Result Type | Baseline | Result Type | Outcome | Result Type | Participant Flow | Result Type | Participant Flow | Result Type | Participant Flow | Result Type | Participant Flow | Result Type | Participant Flow | Result Type | Participant Flow | Result Type | Participant Flow | Result Type | Participant Flow | Result Type | Participant Flow | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Reported Event | Result Type | Reported Event | Result Type | Reported Event | Result Type | Reported Event | Result Type | Reported Event | Result Type | Reported Event | Result Type | Reported Event | Result Type | Reported Event | Result Type | Reported Event |
Title | Low Dose of Epoetin Alfa: Vadadustat 300 mg | Title | Low Dose of Epoetin Alfa: Vadadustat 450 mg | Title | Low Dose of Epoetin Alfa: Epoetin Alfa | Title | High Dose of Epoetin Alfa: Vadadustat 300 mg | Title | High Dose of Epoetin Alfa: Vadadustat 450 mg | Title | High Dose of Epoetin Alfa: Vadadustat 600 mg | Title | High Dose of Epoetin Alfa: Epoetin Alfa | Title | ESA Hyporesponder: Vadadustat 600 mg | Title | ESA Hyporesponder: Epoetin Alfa | Title | Total | Title | Vadadustat 750 mg (Starting Dose in TIW Dosing Regimen) | Title | Low Dose of Epoetin Alfa: Vadadustat 300 mg | Title | Low Dose of Epoetin Alfa: Vadadustat 450 mg | Title | Low Dose of Epoetin Alfa: Epoetin Alfa | Title | High Dose of Epoetin Alfa: Vadadustat 300 mg | Title | High Dose of Epoetin Alfa: Vadadustat 450 mg | Title | High Dose of Epoetin Alfa: Vadadustat 600 mg | Title | High Dose of Epoetin Alfa: Epoetin Alfa | Title | ESA Hyporesponder: Vadadustat 600 mg | Title | ESA Hyporesponder: Epoetin Alfa | Title | Low Dose of Epoetin Alfa: Vadadustat 300 mg | Title | Low Dose of Epoetin Alfa: Vadadustat 450 mg | Title | Low Dose of Epoetin Alfa: Epoetin Alfa | Title | High Dose of Epoetin Alfa: Vadadustat 300 mg | Title | High Dose of Epoetin Alfa: Vadadustat 450 mg | Title | High Dose of Epoetin Alfa: Vadadustat 600 mg | Title | High Dose of Epoetin Alfa: Epoetin Alfa | Title | ESA Hyporesponder: Vadadustat 600 mg | Title | ESA Hyporesponder: Epoetin Alfa | Title | Low Dose of Epoetin Alfa: Epoetin Alfa | Title | Vadadustat 300 mg (Starting Dose in TIW Dosing Regimen) | Title | Vadadustat 450 mg (Starting Dose in TIW Dosing Regimen) | Title | Vadadustat 600 mg (Starting Dose in TIW Dosing Regimen) | Title | Vadadustat Total (TIW Dosing Regimen) | Title | ESA Hyporesponder Parallel Study: Vadadustat ≤ 750 mg (TIW Dosing Regimen) | Title | ESA Hyporesponder Parallel Study: Vadadustat ≤ 750 mg (TIW Dosing Regimen) | Title | Stratum 1 (Epoetin Alfa ≤90 U/kg/Week): Vadadustat 300 mg | Title | Stratum 1 (Epoetin Alfa ≤90 U/kg/Week): Vadadustat 450 mg | Title | Stratum 1 (Epoetin Alfa ≤90 U/kg/Week): Epoetin Alfa | Title | ESA Hyporesponder (Epoetin Alfa ≥300 U/kg/Week): Vadadustat 600 mg | Title | ESA Hyporesponder (Epoetin Alfa ≥300 U/kg/Week): Epoetin Alfa | Title | High Dose of Epoetin Alfa: Vadadustat 300 mg | Title | High Dose of Epoetin Alfa: Vadadustat 450 mg | Title | High Dose of Epoetin Alfa: Vadadustat 600 mg | Title | ESA Hyporesponder: Vadadustat 600 mg | Title | ESA Hyporesponder: Epoetin Alfa | Title | ESA Hyporesponder: Epoetin Alfa | Title | Low Dose of Epoetin Alfa: Vadadustat 300 mg | Title | Low Dose of Epoetin Alfa: Vadadustat 450 mg | Title | Low Dose of Epoetin Alfa: Epoetin Alfa | Title | High Dose of Epoetin Alfa: Vadadustat 300 mg | Title | High Dose of Epoetin Alfa: Vadadustat 450 mg | Title | High Dose of Epoetin Alfa: Vadadustat 600 mg | Title | High Dose of Epoetin Alfa: Epoetin Alfa | Title | ESA Hyporesponder: Vadadustat 600 mg | Title | ESA Hyporesponder: Epoetin Alfa |
Description | Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week [U/kg/week]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20. | Description | Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. | Description | Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with chronic kidney disease (CKD) on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive. | Description | Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. | Description | Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. | Description | Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. | Description | Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive. | Description | In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. | Description | In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive. | Description | Total of all reporting groups | Description | After completing the 12-week QD dosing regimen, eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing to receive a starting dose of Vadadustat 750 mg (1 tablet greater [150 mg] than final dose in QD dosing regimen [600 mg]). Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. | Description | Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week [U/kg/week]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20. | Description | Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. | Description | Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with chronic kidney disease (CKD) on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive. | Description | Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. | Description | Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. | Description | Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. | Description | Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive. | Description | In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. | Description | In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive. | Description | Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week [U/kg/week]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20. | Description | Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. | Description | Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with chronic kidney disease (CKD) on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive. | Description | Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. | Description | Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. | Description | Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. | Description | Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive. | Description | In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. | Description | In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive. | Description | Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the screening period for a minimum of 8 weeks prior to screening visit 2, were administered with three times a week (TIW) dose of Epoetin Alfa based on the participant's central laboratory hemoglobin (Hb) value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with CKD on dialysis. Dose was adjusted to achieve and maintain Hb levels within the target range of 10.0 and 11.0 g/dL, inclusive. | Description | After completing the 12-week QD dosing regimen, eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing to receive a starting dose of Vadadustat 300 mg (1 tablet greater [150 mg] than final dose in QD dosing regimen [150 mg]). Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. | Description | After completing the 12-week QD dosing regimen, eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing to receive a starting dose of Vadadustat 450 mg (1 tablet greater [150 mg] than final dose in QD dosing regimen [300 mg]). Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. | Description | After completing the 12-week QD dosing regimen, eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing to receive a starting dose of Vadadustat 600 mg (1 tablet greater [150 mg] than final dose in QD dosing regimen [450 mg]). Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. | Description | After completing the 12-week QD dosing regimen, eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing to receive a starting dose of Vadadustat 1 tablet greater (150 mg) than final dose in QD dosing regimen. Vadadustat Total comprises all participants who switched from Vadadustat QD to TIW dosing regimen in the Main Study (i.e., combined arm for starting doses of 300mg, 450 mg, 600 mg and 750 mg). Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. | Description | After completing the 12-week QD dosing regimen, eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing to receive a starting dose of Vadadustat ≤ 750 mg (1 tablet greater [150 mg] than final dose in QD dosing regimen). Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. | Description | After completing the 12-week QD dosing regimen, eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing to receive a starting dose of Vadadustat ≤ 750 mg (1 tablet greater [150 mg] than final dose in QD dosing regimen. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. | Description | Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week [U/kg/week]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20. | Description | Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. | Description | Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the screening period for a minimum of 8 weeks prior to screening visit 2, were administered with three times a week (TIW) dose of Epoetin Alfa based on the participant's central laboratory hemoglobin (Hb) value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with CKD on dialysis. Dose was adjusted to achieve and maintain Hb levels within the target range of 10.0 and 11.0 g/dL, inclusive. | Description | In the erythropoiesis-stimulating agent (ESA) hyporesponder parallel study participants who were maintained on ≥300 U/kg/week dose of Epoetin Alfa prior to and including the screening period for a minimum of 8 weeks prior to screening visit 2, were administered with an oral dose of Vadadustat 600 mg tablet per day. | Description | In the ESA hyporesponder parallel study participants who were maintained on ≥300 U/kg/week dose of Epoetin Alfa prior to and including the screening period for a minimum of 8 weeks prior to screening visit 2, were administered with three TIW dose of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. Dose was adjusted to achieve and maintain Hb levels within the target range of 10.0 and 11.0 g/dL, inclusive. | Description | Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. | Description | Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. | Description | Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. | Description | In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. | Description | In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive | Description | In the ESA hyporesponder parallel study participants who were maintained on ≥300 U/kg/week dose of Epoetin Alfa prior to and including the screening period for a minimum of 8 weeks prior to screening visit 2, were administered with three TIW dose of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. Dose was adjusted to achieve and maintain Hb levels within the target range of 10.0 and 11.0 g/dL, inclusive.(US) Package Insert (PI) for adult participants with CKD on dialysis. Dose was adjusted to achieve and maintain Hb levels within the target range of 10.0 and 11.0 g/dL, inclusive" | Description | Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week [U/kg/week]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20. | Description | Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. | Description | Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with chronic kidney disease (CKD) on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive. | Description | Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. | Description | Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. | Description | Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. | Description | Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive. | Description | In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. | Description | In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive. |
Baseline Measurements
Sequence: | 125654974 | Sequence: | 125654975 | Sequence: | 125654976 | Sequence: | 125654977 | Sequence: | 125654978 | Sequence: | 125654979 | Sequence: | 125654980 | Sequence: | 125654981 | Sequence: | 125654982 | Sequence: | 125654983 | Sequence: | 125654984 | Sequence: | 125654985 | Sequence: | 125654986 | Sequence: | 125654987 | Sequence: | 125654988 | Sequence: | 125654989 | Sequence: | 125654990 | Sequence: | 125654991 | Sequence: | 125654992 | Sequence: | 125654993 | Sequence: | 125654994 | Sequence: | 125654995 | Sequence: | 125654996 | Sequence: | 125654997 | Sequence: | 125654998 | Sequence: | 125654999 | Sequence: | 125655000 | Sequence: | 125655001 | Sequence: | 125655002 | Sequence: | 125655003 | Sequence: | 125655004 | Sequence: | 125655005 | Sequence: | 125655006 | Sequence: | 125655007 | Sequence: | 125655008 | Sequence: | 125655009 | Sequence: | 125655010 | Sequence: | 125655011 | Sequence: | 125655012 | Sequence: | 125655013 | Sequence: | 125655014 | Sequence: | 125655015 | Sequence: | 125655016 | Sequence: | 125655017 | Sequence: | 125655018 | Sequence: | 125655019 | Sequence: | 125655020 | Sequence: | 125655021 | Sequence: | 125655022 | Sequence: | 125655023 | Sequence: | 125655024 | Sequence: | 125655025 | Sequence: | 125655026 | Sequence: | 125655027 | Sequence: | 125655028 | Sequence: | 125655029 | Sequence: | 125655030 | Sequence: | 125655031 | Sequence: | 125655032 | Sequence: | 125655033 | Sequence: | 125655034 | Sequence: | 125655035 | Sequence: | 125655036 | Sequence: | 125655037 | Sequence: | 125655038 | Sequence: | 125655039 | Sequence: | 125655040 | Sequence: | 125655041 | Sequence: | 125655042 | Sequence: | 125655043 | Sequence: | 125655044 | Sequence: | 125655045 | Sequence: | 125655046 | Sequence: | 125655047 | Sequence: | 125655048 | Sequence: | 125655049 | Sequence: | 125655050 | Sequence: | 125655051 | Sequence: | 125655052 | Sequence: | 125655053 | Sequence: | 125655054 | Sequence: | 125655055 | Sequence: | 125655056 | Sequence: | 125655057 | Sequence: | 125655058 | Sequence: | 125655059 | Sequence: | 125655060 | Sequence: | 125655061 | Sequence: | 125655062 | Sequence: | 125655063 | Sequence: | 125655064 | Sequence: | 125655065 | Sequence: | 125655066 | Sequence: | 125655067 | Sequence: | 125655068 | Sequence: | 125655069 | Sequence: | 125655070 | Sequence: | 125655071 | Sequence: | 125655072 | Sequence: | 125655073 | Sequence: | 125655074 | Sequence: | 125655075 | Sequence: | 125655076 | Sequence: | 125655077 | Sequence: | 125655078 | Sequence: | 125655079 | Sequence: | 125655080 | Sequence: | 125655081 | Sequence: | 125655082 | Sequence: | 125655083 |
Result Group Id | 56112522 | Result Group Id | 56112523 | Result Group Id | 56112524 | Result Group Id | 56112525 | Result Group Id | 56112526 | Result Group Id | 56112527 | Result Group Id | 56112528 | Result Group Id | 56112529 | Result Group Id | 56112530 | Result Group Id | 56112531 | Result Group Id | 56112522 | Result Group Id | 56112523 | Result Group Id | 56112524 | Result Group Id | 56112525 | Result Group Id | 56112526 | Result Group Id | 56112527 | Result Group Id | 56112528 | Result Group Id | 56112529 | Result Group Id | 56112530 | Result Group Id | 56112531 | Result Group Id | 56112522 | Result Group Id | 56112523 | Result Group Id | 56112524 | Result Group Id | 56112525 | Result Group Id | 56112526 | Result Group Id | 56112527 | Result Group Id | 56112528 | Result Group Id | 56112529 | Result Group Id | 56112530 | Result Group Id | 56112531 | Result Group Id | 56112522 | Result Group Id | 56112523 | Result Group Id | 56112524 | Result Group Id | 56112525 | Result Group Id | 56112526 | Result Group Id | 56112527 | Result Group Id | 56112528 | Result Group Id | 56112529 | Result Group Id | 56112530 | Result Group Id | 56112531 | Result Group Id | 56112522 | Result Group Id | 56112523 | Result Group Id | 56112524 | Result Group Id | 56112525 | Result Group Id | 56112526 | Result Group Id | 56112527 | Result Group Id | 56112528 | Result Group Id | 56112529 | Result Group Id | 56112530 | Result Group Id | 56112531 | Result Group Id | 56112522 | Result Group Id | 56112523 | Result Group Id | 56112524 | Result Group Id | 56112525 | Result Group Id | 56112526 | Result Group Id | 56112527 | Result Group Id | 56112528 | Result Group Id | 56112529 | Result Group Id | 56112530 | Result Group Id | 56112531 | Result Group Id | 56112522 | Result Group Id | 56112523 | Result Group Id | 56112524 | Result Group Id | 56112525 | Result Group Id | 56112526 | Result Group Id | 56112527 | Result Group Id | 56112528 | Result Group Id | 56112529 | Result Group Id | 56112530 | Result Group Id | 56112531 | Result Group Id | 56112522 | Result Group Id | 56112523 | Result Group Id | 56112524 | Result Group Id | 56112525 | Result Group Id | 56112526 | Result Group Id | 56112527 | Result Group Id | 56112528 | Result Group Id | 56112529 | Result Group Id | 56112530 | Result Group Id | 56112531 | Result Group Id | 56112522 | Result Group Id | 56112523 | Result Group Id | 56112524 | Result Group Id | 56112525 | Result Group Id | 56112526 | Result Group Id | 56112527 | Result Group Id | 56112528 | Result Group Id | 56112529 | Result Group Id | 56112530 | Result Group Id | 56112531 | Result Group Id | 56112522 | Result Group Id | 56112523 | Result Group Id | 56112524 | Result Group Id | 56112525 | Result Group Id | 56112526 | Result Group Id | 56112527 | Result Group Id | 56112528 | Result Group Id | 56112529 | Result Group Id | 56112530 | Result Group Id | 56112531 | Result Group Id | 56112522 | Result Group Id | 56112523 | Result Group Id | 56112524 | Result Group Id | 56112525 | Result Group Id | 56112526 | Result Group Id | 56112527 | Result Group Id | 56112528 | Result Group Id | 56112529 | Result Group Id | 56112530 | Result Group Id | 56112531 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG003 | Ctgov Group Code | BG004 | Ctgov Group Code | BG005 | Ctgov Group Code | BG006 | Ctgov Group Code | BG007 | Ctgov Group Code | BG008 | Ctgov Group Code | BG009 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG003 | Ctgov Group Code | BG004 | Ctgov Group Code | BG005 | Ctgov Group Code | BG006 | Ctgov Group Code | BG007 | Ctgov Group Code | BG008 | Ctgov Group Code | BG009 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG003 | Ctgov Group Code | BG004 | Ctgov Group Code | BG005 | Ctgov Group Code | BG006 | Ctgov Group Code | BG007 | Ctgov Group Code | BG008 | Ctgov Group Code | BG009 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG003 | Ctgov Group Code | BG004 | Ctgov Group Code | BG005 | Ctgov Group Code | BG006 | Ctgov Group Code | BG007 | Ctgov Group Code | BG008 | Ctgov Group Code | BG009 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG003 | Ctgov Group Code | BG004 | Ctgov Group Code | BG005 | Ctgov Group Code | BG006 | Ctgov Group Code | BG007 | Ctgov Group Code | BG008 | Ctgov Group Code | BG009 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG003 | Ctgov Group Code | BG004 | Ctgov Group Code | BG005 | Ctgov Group Code | BG006 | Ctgov Group Code | BG007 | Ctgov Group Code | BG008 | Ctgov Group Code | BG009 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG003 | Ctgov Group Code | BG004 | Ctgov Group Code | BG005 | Ctgov Group Code | BG006 | Ctgov Group Code | BG007 | Ctgov Group Code | BG008 | Ctgov Group Code | BG009 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG003 | Ctgov Group Code | BG004 | Ctgov Group Code | BG005 | Ctgov Group Code | BG006 | Ctgov Group Code | BG007 | Ctgov Group Code | BG008 | Ctgov Group Code | BG009 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG003 | Ctgov Group Code | BG004 | Ctgov Group Code | BG005 | Ctgov Group Code | BG006 | Ctgov Group Code | BG007 | Ctgov Group Code | BG008 | Ctgov Group Code | BG009 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG003 | Ctgov Group Code | BG004 | Ctgov Group Code | BG005 | Ctgov Group Code | BG006 | Ctgov Group Code | BG007 | Ctgov Group Code | BG008 | Ctgov Group Code | BG009 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG003 | Ctgov Group Code | BG004 | Ctgov Group Code | BG005 | Ctgov Group Code | BG006 | Ctgov Group Code | BG007 | Ctgov Group Code | BG008 | Ctgov Group Code | BG009 |
Classification | <65 years | Classification | <65 years | Classification | <65 years | Classification | <65 years | Classification | <65 years | Classification | <65 years | Classification | <65 years | Classification | <65 years | Classification | <65 years | Classification | <65 years | Classification | >=65 years | Classification | >=65 years | Classification | >=65 years | Classification | >=65 years | Classification | >=65 years | Classification | >=65 years | Classification | >=65 years | Classification | >=65 years | Classification | >=65 years | Classification | >=65 years | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Category | Female | Category | Female | Category | Female | Category | Female | Category | Female | Category | Female | Category | Female | Category | Female | Category | Female | Category | Female | Category | Male | Category | Male | Category | Male | Category | Male | Category | Male | Category | Male | Category | Male | Category | Male | Category | Male | Category | Male | Category | American Indian or Alaska Native | Category | American Indian or Alaska Native | Category | American Indian or Alaska Native | Category | American Indian or Alaska Native | Category | American Indian or Alaska Native | Category | American Indian or Alaska Native | Category | American Indian or Alaska Native | Category | American Indian or Alaska Native | Category | American Indian or Alaska Native | Category | American Indian or Alaska Native | Category | Asian | Category | Asian | Category | Asian | Category | Asian | Category | Asian | Category | Asian | Category | Asian | Category | Asian | Category | Asian | Category | Asian | Category | Native Hawaiian or Other Pacific Islander | Category | Native Hawaiian or Other Pacific Islander | Category | Native Hawaiian or Other Pacific Islander | Category | Native Hawaiian or Other Pacific Islander | Category | Native Hawaiian or Other Pacific Islander | Category | Native Hawaiian or Other Pacific Islander | Category | Native Hawaiian or Other Pacific Islander | Category | Native Hawaiian or Other Pacific Islander | Category | Native Hawaiian or Other Pacific Islander | Category | Native Hawaiian or Other Pacific Islander | Category | Black or African American | Category | Black or African American | Category | Black or African American | Category | Black or African American | Category | Black or African American | Category | Black or African American | Category | Black or African American | Category | Black or African American | Category | Black or African American | Category | Black or African American | Category | White | Category | White | Category | White | Category | White | Category | White | Category | White | Category | White | Category | White | Category | White | Category | White | Category | More than one race | Category | More than one race | Category | More than one race | Category | More than one race | Category | More than one race | Category | More than one race | Category | More than one race | Category | More than one race | Category | More than one race | Category | More than one race | Category | Unknown or Not Reported | Category | Unknown or Not Reported | Category | Unknown or Not Reported | Category | Unknown or Not Reported | Category | Unknown or Not Reported | Category | Unknown or Not Reported | Category | Unknown or Not Reported | Category | Unknown or Not Reported | Category | Unknown or Not Reported | Category | Unknown or Not Reported | ||||||||||||||||||||||||||||||||||||||||
Title | Age, Customized | Title | Age, Customized | Title | Age, Customized | Title | Age, Customized | Title | Age, Customized | Title | Age, Customized | Title | Age, Customized | Title | Age, Customized | Title | Age, Customized | Title | Age, Customized | Title | Age, Customized | Title | Age, Customized | Title | Age, Customized | Title | Age, Customized | Title | Age, Customized | Title | Age, Customized | Title | Age, Customized | Title | Age, Customized | Title | Age, Customized | Title | Age, Customized | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) |
Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants |
Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants |
Param Value | 20 | Param Value | 22 | Param Value | 15 | Param Value | 11 | Param Value | 18 | Param Value | 13 | Param Value | 7 | Param Value | 4 | Param Value | 3 | Param Value | 113 | Param Value | 15 | Param Value | 12 | Param Value | 8 | Param Value | 7 | Param Value | 3 | Param Value | 8 | Param Value | 6 | Param Value | 1 | Param Value | 2 | Param Value | 62 | Param Value | 14 | Param Value | 13 | Param Value | 4 | Param Value | 7 | Param Value | 7 | Param Value | 9 | Param Value | 6 | Param Value | 4 | Param Value | 3 | Param Value | 67 | Param Value | 21 | Param Value | 21 | Param Value | 19 | Param Value | 11 | Param Value | 14 | Param Value | 12 | Param Value | 7 | Param Value | 1 | Param Value | 2 | Param Value | 108 | Param Value | 0 | Param Value | 1 | Param Value | 0 | Param Value | 2 | Param Value | 0 | Param Value | 1 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 4 | Param Value | 2 | Param Value | 1 | Param Value | 1 | Param Value | 1 | Param Value | 1 | Param Value | 1 | Param Value | 1 | Param Value | 0 | Param Value | 1 | Param Value | 9 | Param Value | 1 | Param Value | 0 | Param Value | 1 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 2 | Param Value | 4 | Param Value | 18 | Param Value | 19 | Param Value | 7 | Param Value | 8 | Param Value | 13 | Param Value | 14 | Param Value | 6 | Param Value | 2 | Param Value | 2 | Param Value | 89 | Param Value | 10 | Param Value | 9 | Param Value | 13 | Param Value | 5 | Param Value | 6 | Param Value | 5 | Param Value | 5 | Param Value | 3 | Param Value | 0 | Param Value | 56 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 4 | Param Value | 4 | Param Value | 1 | Param Value | 2 | Param Value | 1 | Param Value | 0 | Param Value | 1 | Param Value | 0 | Param Value | 0 | Param Value | 13 |
Param Value Num | 20.0 | Param Value Num | 22.0 | Param Value Num | 15.0 | Param Value Num | 11.0 | Param Value Num | 18.0 | Param Value Num | 13.0 | Param Value Num | 7.0 | Param Value Num | 4.0 | Param Value Num | 3.0 | Param Value Num | 113.0 | Param Value Num | 15.0 | Param Value Num | 12.0 | Param Value Num | 8.0 | Param Value Num | 7.0 | Param Value Num | 3.0 | Param Value Num | 8.0 | Param Value Num | 6.0 | Param Value Num | 1.0 | Param Value Num | 2.0 | Param Value Num | 62.0 | Param Value Num | 14.0 | Param Value Num | 13.0 | Param Value Num | 4.0 | Param Value Num | 7.0 | Param Value Num | 7.0 | Param Value Num | 9.0 | Param Value Num | 6.0 | Param Value Num | 4.0 | Param Value Num | 3.0 | Param Value Num | 67.0 | Param Value Num | 21.0 | Param Value Num | 21.0 | Param Value Num | 19.0 | Param Value Num | 11.0 | Param Value Num | 14.0 | Param Value Num | 12.0 | Param Value Num | 7.0 | Param Value Num | 1.0 | Param Value Num | 2.0 | Param Value Num | 108.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 2.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 4.0 | Param Value Num | 2.0 | Param Value Num | 1.0 | Param Value Num | 1.0 | Param Value Num | 1.0 | Param Value Num | 1.0 | Param Value Num | 1.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 9.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 2.0 | Param Value Num | 4.0 | Param Value Num | 18.0 | Param Value Num | 19.0 | Param Value Num | 7.0 | Param Value Num | 8.0 | Param Value Num | 13.0 | Param Value Num | 14.0 | Param Value Num | 6.0 | Param Value Num | 2.0 | Param Value Num | 2.0 | Param Value Num | 89.0 | Param Value Num | 10.0 | Param Value Num | 9.0 | Param Value Num | 13.0 | Param Value Num | 5.0 | Param Value Num | 6.0 | Param Value Num | 5.0 | Param Value Num | 5.0 | Param Value Num | 3.0 | Param Value Num | 0.0 | Param Value Num | 56.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 4.0 | Param Value Num | 4.0 | Param Value Num | 1.0 | Param Value Num | 2.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 13.0 |
Number Analyzed | 35 | Number Analyzed | 34 | Number Analyzed | 23 | Number Analyzed | 18 | Number Analyzed | 21 | Number Analyzed | 21 | Number Analyzed | 13 | Number Analyzed | 5 | Number Analyzed | 5 | Number Analyzed | 175 | Number Analyzed | 35 | Number Analyzed | 34 | Number Analyzed | 23 | Number Analyzed | 18 | Number Analyzed | 21 | Number Analyzed | 21 | Number Analyzed | 13 | Number Analyzed | 5 | Number Analyzed | 5 | Number Analyzed | 175 | Number Analyzed | 35 | Number Analyzed | 34 | Number Analyzed | 23 | Number Analyzed | 18 | Number Analyzed | 21 | Number Analyzed | 21 | Number Analyzed | 13 | Number Analyzed | 5 | Number Analyzed | 5 | Number Analyzed | 175 | Number Analyzed | 35 | Number Analyzed | 34 | Number Analyzed | 23 | Number Analyzed | 18 | Number Analyzed | 21 | Number Analyzed | 21 | Number Analyzed | 13 | Number Analyzed | 5 | Number Analyzed | 5 | Number Analyzed | 175 | Number Analyzed | 35 | Number Analyzed | 34 | Number Analyzed | 23 | Number Analyzed | 18 | Number Analyzed | 21 | Number Analyzed | 21 | Number Analyzed | 13 | Number Analyzed | 5 | Number Analyzed | 5 | Number Analyzed | 175 | Number Analyzed | 35 | Number Analyzed | 34 | Number Analyzed | 23 | Number Analyzed | 18 | Number Analyzed | 21 | Number Analyzed | 21 | Number Analyzed | 13 | Number Analyzed | 5 | Number Analyzed | 5 | Number Analyzed | 175 | Number Analyzed | 35 | Number Analyzed | 34 | Number Analyzed | 23 | Number Analyzed | 18 | Number Analyzed | 21 | Number Analyzed | 21 | Number Analyzed | 13 | Number Analyzed | 5 | Number Analyzed | 5 | Number Analyzed | 175 | Number Analyzed | 35 | Number Analyzed | 34 | Number Analyzed | 23 | Number Analyzed | 18 | Number Analyzed | 21 | Number Analyzed | 21 | Number Analyzed | 13 | Number Analyzed | 5 | Number Analyzed | 5 | Number Analyzed | 175 | Number Analyzed | 35 | Number Analyzed | 34 | Number Analyzed | 23 | Number Analyzed | 18 | Number Analyzed | 21 | Number Analyzed | 21 | Number Analyzed | 13 | Number Analyzed | 5 | Number Analyzed | 5 | Number Analyzed | 175 | Number Analyzed | 35 | Number Analyzed | 34 | Number Analyzed | 23 | Number Analyzed | 18 | Number Analyzed | 21 | Number Analyzed | 21 | Number Analyzed | 13 | Number Analyzed | 5 | Number Analyzed | 5 | Number Analyzed | 175 | Number Analyzed | 35 | Number Analyzed | 34 | Number Analyzed | 23 | Number Analyzed | 18 | Number Analyzed | 21 | Number Analyzed | 21 | Number Analyzed | 13 | Number Analyzed | 5 | Number Analyzed | 5 | Number Analyzed | 175 |
]]>
https://zephyrnet.com/NCT03799614
2019-02-26
https://zephyrnet.com/?p=NCT03799614
NCT03799614https://www.clinicaltrials.gov/study/NCT03799614?tab=tableNANANAThe primary purpose of this study is to test the safety, tolerability and efficacy of vibration (delivered by an experimental device called RMBand that is worn on the subject’s arm) on parkinsonian tremor. The RMBand was developed by Resonate Forward, LLC (RF). This RMBand is designed to administer a vibration to the wearer to decrease or stop tremor in persons with Parkinson’s disease (PD).
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Studies
Study First Submitted Date | 2018-12-19 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2020-12-17 |
Start Month Year | February 26, 2019 |
Primary Completion Month Year | November 27, 2019 |
Verification Month Year | November 2020 |
Verification Date | 2020-11-30 |
Last Update Posted Date | 2020-12-17 |
Results First Posted Date | 2020-12-17 |
Detailed Descriptions
Sequence: | 20573952 |
Description | Participation will be completed in one visit at VCU Parkinson's and Movement Disorders Center. A baseline Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) will be taken prior to vibration therapy. The RMBand (experimental device) will be placed on the arm of the participant to provide the vibration therapy. The MDS-UPDRS Part III will be repeated both during and after the therapy. Participants will be asked to provide feedback about the device, the therapy session and how they are feeling. |
Facilities
Sequence: | 198630695 |
Name | Virginia Commonwealth University |
City | Richmond |
State | Virginia |
Zip | 23298 |
Country | United States |
Conditions
Sequence: | 51790013 |
Name | Parkinson Disease |
Downcase Name | parkinson disease |
Id Information
Sequence: | 39855187 |
Id Source | org_study_id |
Id Value | HM20012404 |
Countries
Sequence: | 42254026 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55210666 | Sequence: | 55210667 |
Group Type | Experimental | Group Type | Experimental |
Title | Lower dose vibration | Title | Higher dose vibration |
Description | RMBand lower dose vibration | Description | RMBand higher dose vibration |
Interventions
Sequence: | 52112621 | Sequence: | 52112622 |
Intervention Type | Device | Intervention Type | Device |
Name | RMBand lower dose | Name | RMBand higher dose |
Description | Light-weight portable device that delivers low dose vibration to the arm | Description | Light-weight portable device that delivers higher dose vibration to the arm |
Design Outcomes
Sequence: | 176153634 | Sequence: | 176153635 | Sequence: | 176153636 | Sequence: | 176153637 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary |
Measure | Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) | Measure | Clinical Rating for Tremor | Measure | Objective Measurement of Tremor Frequency (Hz) | Measure | Objective Measurement of Tremor Amplitude (mm). |
Time Frame | This rating scale will be used at baseline, 5 minutes after vibration starts, and 5 minutes after vibration is turned off. | Time Frame | Data collection times were baseline, 5 minutes after vibration start (vibration duration was 20 minutes), 5 minutes after vibration was stopped. . | Time Frame | Five minutes before vibration is turned on, throughout vibration treatment, and approximately five minutes post treatment. | Time Frame | Five minutes before vibration is turned on, throughout vibration treatment, and approximately five minutes post treatment. |
Description | The "Movement Disorder Society Unified Parkinson Disease Rating Scale" (MDS-UPDRS) Part III, only, will be used at baseline, and repeated during vibration and post vibration data collection times. It is a validated scale administered by a clinician, contains 34 items to score between 0 (normal) and 4 (severe). The score range is 0 – 136. It takes ~ 5 minutes to complete. Lower scores are better. This outcome measure will be used to report a change in PD motor symptoms over time. | Description | Clinical Rating Scale for Tremor (Fahn, Tolosa, & Marin) assesses severity of tremor symptoms. This scale takes 10-minutes, Items 1 – 14 will be used to report average changes in tremor.
Items are rated on a scale of 0=normal to 4=severely abnormal, total summative score range for items 1- 14 points is 0 – 56. Lower scores are better. Total time to complete the Scale for Tremor assessment is 10 minutes. |
Description | This is a device that will objectively measure tremors frequency and amplitude pre, during, and post treatment. | Description | This is a device that will objectively measure tremor amplitude pre, during, and post treatment. |
Browse Conditions
Sequence: | 191950703 | Sequence: | 191950704 | Sequence: | 191950705 | Sequence: | 191950706 | Sequence: | 191950707 | Sequence: | 191950708 | Sequence: | 191950709 | Sequence: | 191950710 | Sequence: | 191950711 |
Mesh Term | Parkinson Disease | Mesh Term | Parkinsonian Disorders | Mesh Term | Basal Ganglia Diseases | Mesh Term | Brain Diseases | Mesh Term | Central Nervous System Diseases | Mesh Term | Nervous System Diseases | Mesh Term | Movement Disorders | Mesh Term | Synucleinopathies | Mesh Term | Neurodegenerative Diseases |
Downcase Mesh Term | parkinson disease | Downcase Mesh Term | parkinsonian disorders | Downcase Mesh Term | basal ganglia diseases | Downcase Mesh Term | brain diseases | Downcase Mesh Term | central nervous system diseases | Downcase Mesh Term | nervous system diseases | Downcase Mesh Term | movement disorders | Downcase Mesh Term | synucleinopathies | Downcase Mesh Term | neurodegenerative diseases |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 47964007 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Virginia Commonwealth University |
Overall Officials
Sequence: | 29060523 |
Role | Principal Investigator |
Name | Ingrid Pretzer-Aboff, PhD, RN |
Affiliation | Virginia Commonwealth University |
Design Group Interventions
Sequence: | 67689829 | Sequence: | 67689830 |
Design Group Id | 55210666 | Design Group Id | 55210667 |
Intervention Id | 52112621 | Intervention Id | 52112622 |
Eligibilities
Sequence: | 30541670 |
Gender | All |
Minimum Age | 21 Years |
Maximum Age | 95 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Parkinson's disease (PD) as diagnosed by a movement disorder specialist Exclusion Criteria: Known diagnosis of Parkinson Plus Syndrome |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254206584 |
Number Of Facilities | 1 |
Number Of Nsae Subjects | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 9 |
Were Results Reported | True |
Months To Report Results | 11 |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 21 |
Maximum Age Num | 95 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 4 |
Designs
Sequence: | 30290204 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Triple |
Subject Masked | True |
Investigator Masked | True |
Outcomes Assessor Masked | True |
Milestones
Sequence: | 40799723 | Sequence: | 40799724 | Sequence: | 40799725 | Sequence: | 40799726 | Sequence: | 40799727 | Sequence: | 40799728 |
Result Group Id | 55879876 | Result Group Id | 55879877 | Result Group Id | 55879876 | Result Group Id | 55879877 | Result Group Id | 55879876 | Result Group Id | 55879877 |
Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 |
Title | STARTED | Title | STARTED | Title | COMPLETED | Title | COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED |
Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study |
Count | 15 | Count | 15 | Count | 15 | Count | 15 | Count | 0 | Count | 0 |
Participant Flows
Sequence: | 3902853 |
Outcome Counts
Sequence: | 73593018 | Sequence: | 73593019 | Sequence: | 73593020 | Sequence: | 73593021 | Sequence: | 73593022 | Sequence: | 73593023 | Sequence: | 73593024 | Sequence: | 73593025 |
Outcome Id | 30636650 | Outcome Id | 30636650 | Outcome Id | 30636651 | Outcome Id | 30636651 | Outcome Id | 30636652 | Outcome Id | 30636652 | Outcome Id | 30636653 | Outcome Id | 30636653 |
Result Group Id | 55879878 | Result Group Id | 55879879 | Result Group Id | 55879880 | Result Group Id | 55879881 | Result Group Id | 55879878 | Result Group Id | 55879879 | Result Group Id | 55879882 | Result Group Id | 55879879 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 |
Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure |
Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants |
Count | 15 | Count | 15 | Count | 15 | Count | 15 | Count | 15 | Count | 15 | Count | 15 | Count | 15 |
Provided Documents
Sequence: | 2568501 | Sequence: | 2568502 |
Document Type | Informed Consent Form | Document Type | Study Protocol and Statistical Analysis Plan |
Has Protocol | False | Has Protocol | True |
Has Icf | True | Has Icf | False |
Has Sap | False | Has Sap | True |
Document Date | 2018-10-01 | Document Date | 2018-10-01 |
Url | https://ClinicalTrials.gov/ProvidedDocs/14/NCT03799614/ICF_001.pdf | Url | https://ClinicalTrials.gov/ProvidedDocs/14/NCT03799614/Prot_SAP_002.pdf |
Reported Event Totals
Sequence: | 27805369 | Sequence: | 27805370 | Sequence: | 27805371 | Sequence: | 27805372 | Sequence: | 27805373 | Sequence: | 27805374 |
Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG001 | Ctgov Group Code | EG001 |
Event Type | serious | Event Type | other | Event Type | deaths | Event Type | serious | Event Type | other | Event Type | deaths |
Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality | Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality |
Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 1 |
Subjects At Risk | 15 | Subjects At Risk | 15 | Subjects At Risk | 15 | Subjects At Risk | 15 | Subjects At Risk | 15 | Subjects At Risk | 15 |
Created At | 2023-08-06 18:18:13.636944 | Created At | 2023-08-06 18:18:13.636944 | Created At | 2023-08-06 18:18:13.636944 | Created At | 2023-08-06 18:18:13.636944 | Created At | 2023-08-06 18:18:13.636944 | Created At | 2023-08-06 18:18:13.636944 |
Updated At | 2023-08-06 18:18:13.636944 | Updated At | 2023-08-06 18:18:13.636944 | Updated At | 2023-08-06 18:18:13.636944 | Updated At | 2023-08-06 18:18:13.636944 | Updated At | 2023-08-06 18:18:13.636944 | Updated At | 2023-08-06 18:18:13.636944 |
Reported Events
Sequence: | 524777665 | Sequence: | 524777666 |
Result Group Id | 55879883 | Result Group Id | 55879884 |
Ctgov Group Code | EG000 | Ctgov Group Code | EG001 |
Time Frame | two hours, during time of study activities | Time Frame | two hours, during time of study activities |
Event Type | other | Event Type | other |
Subjects Affected | 0 | Subjects Affected | 1 |
Subjects At Risk | 15 | Subjects At Risk | 15 |
Event Count | 0 | Event Count | 1 |
Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders |
Adverse Event Term | muscle tightness | Adverse Event Term | muscle tightness |
Frequency Threshold | 0 | Frequency Threshold | 0 |
Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment |
Responsible Parties
Sequence: | 28669164 |
Responsible Party Type | Sponsor |
Result Agreements
Sequence: | 3833597 |
Pi Employee | No |
Restriction Type | GT60 |
Result Contacts
Sequence: | 3833562 |
Organization | Virginia Commonwealth University |
Name | Dr. Ingrid Pretzer-Aboff |
Phone | 804-828-3340 |
iaboff@vcu.edu | |
Outcomes
Sequence: | 30636650 | Sequence: | 30636651 | Sequence: | 30636652 | Sequence: | 30636653 |
Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Primary |
Title | Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) | Title | Clinical Rating for Tremor | Title | Objective Measurement of Tremor Frequency (Hz) | Title | Objective Measurement of Tremor Amplitude (mm). |
Description | The "Movement Disorder Society Unified Parkinson Disease Rating Scale" (MDS-UPDRS) Part III, only, will be used at baseline, and repeated during vibration and post vibration data collection times. It is a validated scale administered by a clinician, contains 34 items to score between 0 (normal) and 4 (severe). The score range is 0 – 136. It takes ~ 5 minutes to complete. Lower scores are better. This outcome measure will be used to report a change in PD motor symptoms over time. | Description | Clinical Rating Scale for Tremor (Fahn, Tolosa, & Marin) assesses severity of tremor symptoms. This scale takes 10-minutes, Items 1 – 14 will be used to report average changes in tremor.
Items are rated on a scale of 0=normal to 4=severely abnormal, total summative score range for items 1- 14 points is 0 – 56. Lower scores are better. Total time to complete the Scale for Tremor assessment is 10 minutes. |
Description | This is a device that will objectively measure tremors frequency and amplitude pre, during, and post treatment. | Description | This is a device that will objectively measure tremor amplitude pre, during, and post treatment. |
Time Frame | This rating scale will be used at baseline, 5 minutes after vibration starts, and 5 minutes after vibration is turned off. | Time Frame | Data collection times were baseline, 5 minutes after vibration start (vibration duration was 20 minutes), 5 minutes after vibration was stopped. . | Time Frame | Five minutes before vibration is turned on, throughout vibration treatment, and approximately five minutes post treatment. | Time Frame | Five minutes before vibration is turned on, throughout vibration treatment, and approximately five minutes post treatment. |
Units | score on a scale | Units | score on a scale | Units | hertz | Units | millimeters |
Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation |
Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean |
Outcome Measurements
Sequence: | 234242622 | Sequence: | 234242623 | Sequence: | 234242624 | Sequence: | 234242625 | Sequence: | 234242626 | Sequence: | 234242627 | Sequence: | 234242628 | Sequence: | 234242629 | Sequence: | 234242633 | Sequence: | 234242630 | Sequence: | 234242631 | Sequence: | 234242632 | Sequence: | 234242634 | Sequence: | 234242635 | Sequence: | 234242636 | Sequence: | 234242637 | Sequence: | 234242638 | Sequence: | 234242639 | Sequence: | 234242640 | Sequence: | 234242641 | Sequence: | 234242642 | Sequence: | 234242643 | Sequence: | 234242644 | Sequence: | 234242645 |
Outcome Id | 30636650 | Outcome Id | 30636650 | Outcome Id | 30636650 | Outcome Id | 30636650 | Outcome Id | 30636650 | Outcome Id | 30636650 | Outcome Id | 30636651 | Outcome Id | 30636651 | Outcome Id | 30636651 | Outcome Id | 30636651 | Outcome Id | 30636651 | Outcome Id | 30636651 | Outcome Id | 30636652 | Outcome Id | 30636652 | Outcome Id | 30636652 | Outcome Id | 30636652 | Outcome Id | 30636652 | Outcome Id | 30636652 | Outcome Id | 30636653 | Outcome Id | 30636653 | Outcome Id | 30636653 | Outcome Id | 30636653 | Outcome Id | 30636653 | Outcome Id | 30636653 |
Result Group Id | 55879878 | Result Group Id | 55879879 | Result Group Id | 55879878 | Result Group Id | 55879879 | Result Group Id | 55879878 | Result Group Id | 55879879 | Result Group Id | 55879880 | Result Group Id | 55879881 | Result Group Id | 55879881 | Result Group Id | 55879880 | Result Group Id | 55879881 | Result Group Id | 55879880 | Result Group Id | 55879878 | Result Group Id | 55879879 | Result Group Id | 55879878 | Result Group Id | 55879879 | Result Group Id | 55879878 | Result Group Id | 55879879 | Result Group Id | 55879882 | Result Group Id | 55879879 | Result Group Id | 55879882 | Result Group Id | 55879879 | Result Group Id | 55879882 | Result Group Id | 55879879 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 |
Classification | Baseline | Classification | Baseline | Classification | During vibration treatment | Classification | During vibration treatment | Classification | Post vibration treatment | Classification | Post vibration treatment | Classification | Baseline | Classification | Baseline | Classification | Post vibration | Classification | During vibration | Classification | During vibration | Classification | Post vibration | Classification | Baseline | Classification | Baseline | Classification | During Vibration | Classification | During Vibration | Classification | Post Vibration | Classification | Post Vibration | Classification | Baseline | Classification | Baseline | Classification | During vibration | Classification | During vibration | Classification | Post vibration | Classification | Post vibration |
Title | Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) | Title | Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) | Title | Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) | Title | Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) | Title | Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) | Title | Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) | Title | Clinical Rating for Tremor | Title | Clinical Rating for Tremor | Title | Clinical Rating for Tremor | Title | Clinical Rating for Tremor | Title | Clinical Rating for Tremor | Title | Clinical Rating for Tremor | Title | Objective Measurement of Tremor Frequency (Hz) | Title | Objective Measurement of Tremor Frequency (Hz) | Title | Objective Measurement of Tremor Frequency (Hz) | Title | Objective Measurement of Tremor Frequency (Hz) | Title | Objective Measurement of Tremor Frequency (Hz) | Title | Objective Measurement of Tremor Frequency (Hz) | Title | Objective Measurement of Tremor Amplitude (mm). | Title | Objective Measurement of Tremor Amplitude (mm). | Title | Objective Measurement of Tremor Amplitude (mm). | Title | Objective Measurement of Tremor Amplitude (mm). | Title | Objective Measurement of Tremor Amplitude (mm). | Title | Objective Measurement of Tremor Amplitude (mm). |
Description | The "Movement Disorder Society Unified Parkinson Disease Rating Scale" (MDS-UPDRS) Part III, only, will be used at baseline, and repeated during vibration and post vibration data collection times. It is a validated scale administered by a clinician, contains 34 items to score between 0 (normal) and 4 (severe). The score range is 0 – 136. It takes ~ 5 minutes to complete. Lower scores are better. This outcome measure will be used to report a change in PD motor symptoms over time. | Description | The "Movement Disorder Society Unified Parkinson Disease Rating Scale" (MDS-UPDRS) Part III, only, will be used at baseline, and repeated during vibration and post vibration data collection times. It is a validated scale administered by a clinician, contains 34 items to score between 0 (normal) and 4 (severe). The score range is 0 – 136. It takes ~ 5 minutes to complete. Lower scores are better. This outcome measure will be used to report a change in PD motor symptoms over time. | Description | The "Movement Disorder Society Unified Parkinson Disease Rating Scale" (MDS-UPDRS) Part III, only, will be used at baseline, and repeated during vibration and post vibration data collection times. It is a validated scale administered by a clinician, contains 34 items to score between 0 (normal) and 4 (severe). The score range is 0 – 136. It takes ~ 5 minutes to complete. Lower scores are better. This outcome measure will be used to report a change in PD motor symptoms over time. | Description | The "Movement Disorder Society Unified Parkinson Disease Rating Scale" (MDS-UPDRS) Part III, only, will be used at baseline, and repeated during vibration and post vibration data collection times. It is a validated scale administered by a clinician, contains 34 items to score between 0 (normal) and 4 (severe). The score range is 0 – 136. It takes ~ 5 minutes to complete. Lower scores are better. This outcome measure will be used to report a change in PD motor symptoms over time. | Description | The "Movement Disorder Society Unified Parkinson Disease Rating Scale" (MDS-UPDRS) Part III, only, will be used at baseline, and repeated during vibration and post vibration data collection times. It is a validated scale administered by a clinician, contains 34 items to score between 0 (normal) and 4 (severe). The score range is 0 – 136. It takes ~ 5 minutes to complete. Lower scores are better. This outcome measure will be used to report a change in PD motor symptoms over time. | Description | The "Movement Disorder Society Unified Parkinson Disease Rating Scale" (MDS-UPDRS) Part III, only, will be used at baseline, and repeated during vibration and post vibration data collection times. It is a validated scale administered by a clinician, contains 34 items to score between 0 (normal) and 4 (severe). The score range is 0 – 136. It takes ~ 5 minutes to complete. Lower scores are better. This outcome measure will be used to report a change in PD motor symptoms over time. | Description | Clinical Rating Scale for Tremor (Fahn, Tolosa, & Marin) assesses severity of tremor symptoms. This scale takes 10-minutes, Items 1 – 14 will be used to report average changes in tremor.
Items are rated on a scale of 0=normal to 4=severely abnormal, total summative score range for items 1- 14 points is 0 – 56. Lower scores are better. Total time to complete the Scale for Tremor assessment is 10 minutes. |
Description | Clinical Rating Scale for Tremor (Fahn, Tolosa, & Marin) assesses severity of tremor symptoms. This scale takes 10-minutes, Items 1 – 14 will be used to report average changes in tremor.
Items are rated on a scale of 0=normal to 4=severely abnormal, total summative score range for items 1- 14 points is 0 – 56. Lower scores are better. Total time to complete the Scale for Tremor assessment is 10 minutes. |
Description | Clinical Rating Scale for Tremor (Fahn, Tolosa, & Marin) assesses severity of tremor symptoms. This scale takes 10-minutes, Items 1 – 14 will be used to report average changes in tremor.
Items are rated on a scale of 0=normal to 4=severely abnormal, total summative score range for items 1- 14 points is 0 – 56. Lower scores are better. Total time to complete the Scale for Tremor assessment is 10 minutes. |
Description | Clinical Rating Scale for Tremor (Fahn, Tolosa, & Marin) assesses severity of tremor symptoms. This scale takes 10-minutes, Items 1 – 14 will be used to report average changes in tremor.
Items are rated on a scale of 0=normal to 4=severely abnormal, total summative score range for items 1- 14 points is 0 – 56. Lower scores are better. Total time to complete the Scale for Tremor assessment is 10 minutes. |
Description | Clinical Rating Scale for Tremor (Fahn, Tolosa, & Marin) assesses severity of tremor symptoms. This scale takes 10-minutes, Items 1 – 14 will be used to report average changes in tremor.
Items are rated on a scale of 0=normal to 4=severely abnormal, total summative score range for items 1- 14 points is 0 – 56. Lower scores are better. Total time to complete the Scale for Tremor assessment is 10 minutes. |
Description | Clinical Rating Scale for Tremor (Fahn, Tolosa, & Marin) assesses severity of tremor symptoms. This scale takes 10-minutes, Items 1 – 14 will be used to report average changes in tremor.
Items are rated on a scale of 0=normal to 4=severely abnormal, total summative score range for items 1- 14 points is 0 – 56. Lower scores are better. Total time to complete the Scale for Tremor assessment is 10 minutes. |
Description | This is a device that will objectively measure tremors frequency and amplitude pre, during, and post treatment. | Description | This is a device that will objectively measure tremors frequency and amplitude pre, during, and post treatment. | Description | This is a device that will objectively measure tremors frequency and amplitude pre, during, and post treatment. | Description | This is a device that will objectively measure tremors frequency and amplitude pre, during, and post treatment. | Description | This is a device that will objectively measure tremors frequency and amplitude pre, during, and post treatment. | Description | This is a device that will objectively measure tremors frequency and amplitude pre, during, and post treatment. | Description | This is a device that will objectively measure tremor amplitude pre, during, and post treatment. | Description | This is a device that will objectively measure tremor amplitude pre, during, and post treatment. | Description | This is a device that will objectively measure tremor amplitude pre, during, and post treatment. | Description | This is a device that will objectively measure tremor amplitude pre, during, and post treatment. | Description | This is a device that will objectively measure tremor amplitude pre, during, and post treatment. | Description | This is a device that will objectively measure tremor amplitude pre, during, and post treatment. |
Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | hertz | Units | hertz | Units | hertz | Units | hertz | Units | hertz | Units | hertz | Units | millimeters | Units | millimeters | Units | millimeters | Units | millimeters | Units | millimeters | Units | millimeters |
Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean |
Param Value | 32.67 | Param Value | 27.4 | Param Value | 33.67 | Param Value | 27.33 | Param Value | 32.67 | Param Value | 28.6 | Param Value | 15.47 | Param Value | 13.87 | Param Value | 14.13 | Param Value | 15.87 | Param Value | 13.20 | Param Value | 14.53 | Param Value | 4.77 | Param Value | 4.51 | Param Value | 4.79 | Param Value | 3.99 | Param Value | 3.36 | Param Value | 4.64 | Param Value | 0.71 | Param Value | 0.43 | Param Value | 0.76 | Param Value | 0.44 | Param Value | 0.70 | Param Value | 0.52 |
Param Value Num | 32.67 | Param Value Num | 27.4 | Param Value Num | 33.67 | Param Value Num | 27.33 | Param Value Num | 32.67 | Param Value Num | 28.6 | Param Value Num | 15.47 | Param Value Num | 13.87 | Param Value Num | 14.13 | Param Value Num | 15.87 | Param Value Num | 13.2 | Param Value Num | 14.53 | Param Value Num | 4.77 | Param Value Num | 4.51 | Param Value Num | 4.79 | Param Value Num | 3.99 | Param Value Num | 3.36 | Param Value Num | 4.64 | Param Value Num | 0.71 | Param Value Num | 0.43 | Param Value Num | 0.76 | Param Value Num | 0.44 | Param Value Num | 0.7 | Param Value Num | 0.52 |
Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation |
Dispersion Value | 12.88 | Dispersion Value | 11.25 | Dispersion Value | 14.31 | Dispersion Value | 11.14 | Dispersion Value | 13.67 | Dispersion Value | 10.39 | Dispersion Value | 7.94 | Dispersion Value | 4.03 | Dispersion Value | 5.63 | Dispersion Value | 8.55 | Dispersion Value | 4.03 | Dispersion Value | 7.98 | Dispersion Value | 1.57 | Dispersion Value | 1.31 | Dispersion Value | 1.13 | Dispersion Value | 1.12 | Dispersion Value | 0.87 | Dispersion Value | 1.48 | Dispersion Value | 0.82 | Dispersion Value | 0.41 | Dispersion Value | 0.72 | Dispersion Value | 0.31 | Dispersion Value | 0.75 | Dispersion Value | 0.47 |
Dispersion Value Num | 12.88 | Dispersion Value Num | 11.25 | Dispersion Value Num | 14.31 | Dispersion Value Num | 11.14 | Dispersion Value Num | 13.67 | Dispersion Value Num | 10.39 | Dispersion Value Num | 7.94 | Dispersion Value Num | 4.03 | Dispersion Value Num | 5.63 | Dispersion Value Num | 8.55 | Dispersion Value Num | 4.03 | Dispersion Value Num | 7.98 | Dispersion Value Num | 1.57 | Dispersion Value Num | 1.31 | Dispersion Value Num | 1.13 | Dispersion Value Num | 1.12 | Dispersion Value Num | 0.87 | Dispersion Value Num | 1.48 | Dispersion Value Num | 0.82 | Dispersion Value Num | 0.41 | Dispersion Value Num | 0.72 | Dispersion Value Num | 0.31 | Dispersion Value Num | 0.75 | Dispersion Value Num | 0.47 |
Baseline Counts
Sequence: | 11328791 | Sequence: | 11328792 | Sequence: | 11328793 |
Result Group Id | 55879873 | Result Group Id | 55879874 | Result Group Id | 55879875 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 |
Units | Participants | Units | Participants | Units | Participants |
Scope | overall | Scope | overall | Scope | overall |
Count | 15 | Count | 15 | Count | 30 |
Result Groups
Sequence: | 55879875 | Sequence: | 55879876 | Sequence: | 55879873 | Sequence: | 55879874 | Sequence: | 55879877 | Sequence: | 55879878 | Sequence: | 55879879 | Sequence: | 55879880 | Sequence: | 55879881 | Sequence: | 55879882 | Sequence: | 55879883 | Sequence: | 55879884 |
Ctgov Group Code | BG002 | Ctgov Group Code | FG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | FG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 |
Result Type | Baseline | Result Type | Participant Flow | Result Type | Baseline | Result Type | Baseline | Result Type | Participant Flow | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Reported Event | Result Type | Reported Event |
Title | Total | Title | Low Dose Vibration | Title | Lower Dose Vibration | Title | Higher Dose Vibration | Title | High Dose Vibration | Title | Low Dose Vibration | Title | Higher Dose Vibration | Title | Lower Dose Vibration | Title | Higher Dose Vibration | Title | Low Dose Vibration Amplitude | Title | Lower Dose Vibration | Title | Higher Dose Vibration |
Description | Total of all reporting groups | Description | RMBand lower dose vibration
RMBand lower dose: Light-weight portable device that delivers low dose vibration to the arm |
Description | RMBand lower dose vibration
RMBand lower dose: Light-weight portable device that delivers low dose vibration to the arm |
Description | RMBand higher dose vibration
RMBand higher dose: Light-weight portable device that delivers higher dose vibration to the arm |
Description | RMBand higher dose vibration
RMBand higher dose: Light-weight portable device that delivers higher dose vibration to the arm |
Description | RMBand low dose vibration
RMBand: Light-weight portable device that delivers low dose vibration to the arm |
Description | RMBand high dose vibration
RMBand: Light-weight portable device that delivers higher dose vibration to the arm |
Description | RMBand lower dose vibration
RMBand lower dose: Light-weight portable device that delivers low dose vibration to the arm |
Description | RMBand higher dose vibration
RMBand higher dose: Light-weight portable device that delivers higher dose vibration to the arm |
Description | RMBand low dose vibration
RMBand: Light-weight portable device that delivers low dose vibration to the arm,reported in mm. |
Description | RMBand lower dose vibration
RMBand lower dose: Light-weight portable device that delivers low dose vibration (frequency of 80 Hz) to the arm |
Description | RMBand higher dose vibration
RMBand higher dose: Light-weight portable device that delivers higher dose (frequency of 160 Hz) vibration to the arm |
Baseline Measurements
Sequence: | 124996019 | Sequence: | 124996020 | Sequence: | 124996021 | Sequence: | 124996022 | Sequence: | 124996023 | Sequence: | 124996024 | Sequence: | 124996025 | Sequence: | 124996026 | Sequence: | 124996027 | Sequence: | 124996028 | Sequence: | 124996029 | Sequence: | 124996030 | Sequence: | 124996031 | Sequence: | 124996032 | Sequence: | 124996033 | Sequence: | 124996034 | Sequence: | 124996035 | Sequence: | 124996036 | Sequence: | 124996037 | Sequence: | 124996038 | Sequence: | 124996039 | Sequence: | 124996040 | Sequence: | 124996041 | Sequence: | 124996042 | Sequence: | 124996043 | Sequence: | 124996044 | Sequence: | 124996045 | Sequence: | 124996046 | Sequence: | 124996047 | Sequence: | 124996048 | Sequence: | 124996049 | Sequence: | 124996050 | Sequence: | 124996051 | Sequence: | 124996052 | Sequence: | 124996053 | Sequence: | 124996054 | Sequence: | 124996055 | Sequence: | 124996056 | Sequence: | 124996057 |
Result Group Id | 55879873 | Result Group Id | 55879874 | Result Group Id | 55879875 | Result Group Id | 55879873 | Result Group Id | 55879874 | Result Group Id | 55879875 | Result Group Id | 55879873 | Result Group Id | 55879874 | Result Group Id | 55879875 | Result Group Id | 55879873 | Result Group Id | 55879874 | Result Group Id | 55879875 | Result Group Id | 55879873 | Result Group Id | 55879874 | Result Group Id | 55879875 | Result Group Id | 55879873 | Result Group Id | 55879874 | Result Group Id | 55879875 | Result Group Id | 55879873 | Result Group Id | 55879874 | Result Group Id | 55879875 | Result Group Id | 55879873 | Result Group Id | 55879874 | Result Group Id | 55879875 | Result Group Id | 55879873 | Result Group Id | 55879874 | Result Group Id | 55879875 | Result Group Id | 55879873 | Result Group Id | 55879874 | Result Group Id | 55879875 | Result Group Id | 55879873 | Result Group Id | 55879874 | Result Group Id | 55879875 | Result Group Id | 55879873 | Result Group Id | 55879874 | Result Group Id | 55879875 | Result Group Id | 55879873 | Result Group Id | 55879874 | Result Group Id | 55879875 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 |
Classification | United States | Classification | United States | Classification | United States | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Category | Female | Category | Female | Category | Female | Category | Male | Category | Male | Category | Male | Category | American Indian or Alaska Native | Category | American Indian or Alaska Native | Category | American Indian or Alaska Native | Category | Asian | Category | Asian | Category | Asian | Category | Native Hawaiian or Other Pacific Islander | Category | Native Hawaiian or Other Pacific Islander | Category | Native Hawaiian or Other Pacific Islander | Category | Black or African American | Category | Black or African American | Category | Black or African American | Category | White | Category | White | Category | White | Category | More than one race | Category | More than one race | Category | More than one race | Category | Unknown or Not Reported | Category | Unknown or Not Reported | Category | Unknown or Not Reported | ||||||||||||||||||||||||
Title | Age, Continuous | Title | Age, Continuous | Title | Age, Continuous | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Region of Enrollment | Title | Region of Enrollment | Title | Region of Enrollment | Title | Clinical Rating Scale for Tremor, total score | Title | Clinical Rating Scale for Tremor, total score | Title | Clinical Rating Scale for Tremor, total score | Title | MDS UPDRS II – IV total | Title | MDS UPDRS II – IV total | Title | MDS UPDRS II – IV total |
Description | Movement Disorder Society Unified Parkinson Rating Scale, (MDS UPDRS, score for parts II – !V. | Description | Movement Disorder Society Unified Parkinson Rating Scale, (MDS UPDRS, score for parts II – !V. | Description | Movement Disorder Society Unified Parkinson Rating Scale, (MDS UPDRS, score for parts II – !V. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Units | years | Units | years | Units | years | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | participants | Units | participants | Units | participants | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale |
Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean |
Param Value | 67.3 | Param Value | 67.6 | Param Value | 67.4 | Param Value | 4 | Param Value | 8 | Param Value | 12 | Param Value | 11 | Param Value | 7 | Param Value | 18 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 1 | Param Value | 1 | Param Value | 15 | Param Value | 14 | Param Value | 29 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 15 | Param Value | 15 | Param Value | 30 | Param Value | 21.13 | Param Value | 18.07 | Param Value | 19.6 | Param Value | 44.26 | Param Value | 38.47 | Param Value | 41.37 |
Param Value Num | 67.3 | Param Value Num | 67.6 | Param Value Num | 67.4 | Param Value Num | 4.0 | Param Value Num | 8.0 | Param Value Num | 12.0 | Param Value Num | 11.0 | Param Value Num | 7.0 | Param Value Num | 18.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 1.0 | Param Value Num | 15.0 | Param Value Num | 14.0 | Param Value Num | 29.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 15.0 | Param Value Num | 15.0 | Param Value Num | 30.0 | Param Value Num | 21.13 | Param Value Num | 18.07 | Param Value Num | 19.6 | Param Value Num | 44.26 | Param Value Num | 38.47 | Param Value Num | 41.37 |
Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dispersion Value | 6.7 | Dispersion Value | 8.4 | Dispersion Value | 7.63 | Dispersion Value | 10.69 | Dispersion Value | 5.22 | Dispersion Value | 8.55 | Dispersion Value | 16.41 | Dispersion Value | 14.08 | Dispersion Value | 15.56 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dispersion Value Num | 6.7 | Dispersion Value Num | 8.4 | Dispersion Value Num | 7.63 | Dispersion Value Num | 10.69 | Dispersion Value Num | 5.22 | Dispersion Value Num | 8.55 | Dispersion Value Num | 16.41 | Dispersion Value Num | 14.08 | Dispersion Value Num | 15.56 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Number Analyzed | 15 | Number Analyzed | 15 | Number Analyzed | 30 | Number Analyzed | 15 | Number Analyzed | 15 | Number Analyzed | 30 | Number Analyzed | 15 | Number Analyzed | 15 | Number Analyzed | 30 | Number Analyzed | 15 | Number Analyzed | 15 | Number Analyzed | 30 | Number Analyzed | 15 | Number Analyzed | 15 | Number Analyzed | 30 | Number Analyzed | 15 | Number Analyzed | 15 | Number Analyzed | 30 | Number Analyzed | 15 | Number Analyzed | 15 | Number Analyzed | 30 | Number Analyzed | 15 | Number Analyzed | 15 | Number Analyzed | 30 | Number Analyzed | 15 | Number Analyzed | 15 | Number Analyzed | 30 | Number Analyzed | 15 | Number Analyzed | 15 | Number Analyzed | 30 | Number Analyzed | 15 | Number Analyzed | 15 | Number Analyzed | 30 | Number Analyzed | 15 | Number Analyzed | 15 | Number Analyzed | 30 | Number Analyzed | 15 | Number Analyzed | 15 | Number Analyzed | 30 |
]]>
https://zephyrnet.com/NCT03799601
2019-03-01
https://zephyrnet.com/?p=NCT03799601
NCT03799601https://www.clinicaltrials.gov/study/NCT03799601?tab=tableXianglin Yuan, MD.xlyuan@tjh.tjmu.cn0086-13667241722Anlotinib which has shown an affirmatory efficacy in ALTER0303 controlled trial as a 3rd-line treatment on advanced NSCLC is a tyrosine kinase inhibitor with a favorable safety profile in phase I trial which mainly targets VEGFR1/2/3, FGFR, PDGFR and c-kit. The purpose of this trail is to establish whether advanced non-squamous NSCLC patients could benefit from the combination treatment of docetaxel, carboplatin and anlotinib as the first-line and maintenance treatment.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-08 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2019-01-10 |
Start Month Year | March 1, 2019 |
Primary Completion Month Year | December 1, 2019 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-10 |
Detailed Descriptions
Sequence: | 20741248 |
Description | First-line patients (or postoperative recurrence) with locally advanced or metastatic NSCLC were enrolled in this trail. The patients (clinical stage ⅢB/Ⅳ, with no sensitizing mutation of the epidermal growth factor receptor gene or translocation of the anaplastic lymphoma kinase gene) were confirmed by histological or cytological diagnosis. The primary endpoint is PFS; secondary endpoint includes OS, DCR and ORR. The study was single-arm, conducted at 8 centers in China mainland. The primary end point was PFS (time from enrollment to first RECIST1.1-defined PD or death). 45 patients were planned for enrollment. This estimate was based on 80% power, with a two-sided 5% significance level. We analyzed PFS and OS using Kaplan-Meier methodology. The research protocol was approved by the relevant ethics committees, and the study was conducted according to the Declaration of Helsinki and Good Clinical Practice guidelines. Patients gave written informed consent to participate in the trial. |
Facilities
Sequence: | 200280799 |
Name | Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology, |
City | Wuhan |
State | Hubei |
Zip | 430000 |
Country | China |
Facility Contacts
Sequence: | 28132917 |
Facility Id | 200280799 |
Contact Type | primary |
Name | Xianglin Yuan, MD. |
xlyuan@tjh.tjmu.cn | |
Phone | 0086-13667241722 |
Browse Interventions
Sequence: | 96133426 | Sequence: | 96133427 | Sequence: | 96133428 | Sequence: | 96133429 | Sequence: | 96133430 | Sequence: | 96133431 | Sequence: | 96133432 |
Mesh Term | Carboplatin | Mesh Term | Docetaxel | Mesh Term | Antineoplastic Agents | Mesh Term | Tubulin Modulators | Mesh Term | Antimitotic Agents | Mesh Term | Mitosis Modulators | Mesh Term | Molecular Mechanisms of Pharmacological Action |
Downcase Mesh Term | carboplatin | Downcase Mesh Term | docetaxel | Downcase Mesh Term | antineoplastic agents | Downcase Mesh Term | tubulin modulators | Downcase Mesh Term | antimitotic agents | Downcase Mesh Term | mitosis modulators | Downcase Mesh Term | molecular mechanisms of pharmacological action |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52221717 |
Name | NSCLC |
Downcase Name | nsclc |
Id Information
Sequence: | 40195766 |
Id Source | org_study_id |
Id Value | TJCC-LC-20190108 |
Countries
Sequence: | 42609750 |
Name | China |
Removed | False |
Design Groups
Sequence: | 55650014 |
Group Type | Experimental |
Title | combination of docetaxel, carboplatin and anlotinib |
Interventions
Sequence: | 52535521 | Sequence: | 52535522 | Sequence: | 52535523 |
Intervention Type | Drug | Intervention Type | Drug | Intervention Type | Drug |
Name | Anlotinib | Name | Docetaxel | Name | Carboplatin |
Description | Anlotinib which has shown an affirmatory efficacy in ALTER0303 controlled trial as a 3rd-line treatment on advanced NSCLC is a tyrosine kinase inhibitor with a favorable safety profile in phase I trial which mainly targets VEGFR1/2/3, FGFR, PDGFR and c-kit. | Description | a chemotherapy medication used to treat a number of types of cancer.This includes breast cancer, head and neck cancer, stomach cancer, prostate cancer and non-small-cell lung cancer.It may be used by itself or along with other chemotherapy medication.It is given by slow injection into a vein. | Description | Carboplatin is used to treat a number of forms of cancer. This includes ovarian cancer, lung cancer, head and neck cancer, brain cancer, and neuroblastoma. It may be used for some types of testicular cancer but cisplatin is generally more effective. |
Keywords
Sequence: | 79942038 | Sequence: | 79942039 | Sequence: | 79942040 | Sequence: | 79942041 |
Name | Anlotinib | Name | Docetaxel | Name | Carboplatin | Name | NSCLC |
Downcase Name | anlotinib | Downcase Name | docetaxel | Downcase Name | carboplatin | Downcase Name | nsclc |
Design Outcomes
Sequence: | 177562120 | Sequence: | 177562121 | Sequence: | 177562122 | Sequence: | 177562123 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | progression-free survival | Measure | Overall Survival | Measure | Disease Control Rate | Measure | Overall Response Rate |
Time Frame | Estimated about 24 months. | Time Frame | Estimated about 24 months. | Time Frame | Estimated about 24 months. | Time Frame | Estimated about 24 months. |
Description | Clinical response of treatment according to RESIST v1.1 criteria (PFS, progression-free survival) | Description | Clinical response of treatment according to RESIST v1.1 criteria (OS, overall survival) | Description | Clinical response of treatment according to RESIST v1.1 criteria (DCR, disease control rate) | Description | Clinical response of treatment according to RESIST v1.1 criteria (ORR, Overall Response Rate) |
Browse Conditions
Sequence: | 193679203 | Sequence: | 193679204 | Sequence: | 193679205 | Sequence: | 193679206 | Sequence: | 193679207 | Sequence: | 193679208 | Sequence: | 193679209 | Sequence: | 193679210 | Sequence: | 193679211 | Sequence: | 193679212 |
Mesh Term | Carcinoma, Non-Small-Cell Lung | Mesh Term | Carcinoma, Bronchogenic | Mesh Term | Bronchial Neoplasms | Mesh Term | Lung Neoplasms | Mesh Term | Respiratory Tract Neoplasms | Mesh Term | Thoracic Neoplasms | Mesh Term | Neoplasms by Site | Mesh Term | Neoplasms | Mesh Term | Lung Diseases | Mesh Term | Respiratory Tract Diseases |
Downcase Mesh Term | carcinoma, non-small-cell lung | Downcase Mesh Term | carcinoma, bronchogenic | Downcase Mesh Term | bronchial neoplasms | Downcase Mesh Term | lung neoplasms | Downcase Mesh Term | respiratory tract neoplasms | Downcase Mesh Term | thoracic neoplasms | Downcase Mesh Term | neoplasms by site | Downcase Mesh Term | neoplasms | Downcase Mesh Term | lung diseases | Downcase Mesh Term | respiratory tract diseases |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48366604 | Sequence: | 48366605 |
Agency Class | OTHER | Agency Class | INDUSTRY |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | Tongji Hospital | Name | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. |
Overall Officials
Sequence: | 29313003 |
Role | Study Chair |
Name | Xianglin Yuan, MD. |
Affiliation | Tongji Hospital |
Central Contacts
Sequence: | 12020631 |
Contact Type | primary |
Name | Xianglin Yuan, MD. |
Phone | 0086-13667241722 |
xlyuan@tjh.tjmu.cn | |
Role | Contact |
Design Group Interventions
Sequence: | 68217635 | Sequence: | 68217636 | Sequence: | 68217637 |
Design Group Id | 55650014 | Design Group Id | 55650014 | Design Group Id | 55650014 |
Intervention Id | 52535521 | Intervention Id | 52535522 | Intervention Id | 52535523 |
Eligibilities
Sequence: | 30794819 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 75 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
≥18 years of age on the day of signing informed consent and with good compliance and agree to accept follow-up of disease progression and adverse events. Women of child-bearing age should take appropriate contraceptive measures and should not breastfeed from screening to 3 months after stopping the study and treatment.Before starting administration, the pregnancy test was negative, or one of the following criteria was met to prove that there was no risk of pregnancy: Postmenopause is defined as amenorrhea at least 12 months after age 50 and cessation of all exogenous hormone replacement therapy; Exclusion Criteria: Small cell lung cancer (including lung cancer mixed with small cell lung cancer and non-small cell lung cancer), Lung sarcomatoid carcinoma; Physical examination and laboratory findings: A known history of HIV testing positive or acquired immunodeficiency syndrome (AIDS); |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254004493 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 75 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 3 |
Designs
Sequence: | 30540859 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Intervention Other Names
Sequence: | 26697011 |
Intervention Id | 52535521 |
Name | Anlotinib Hydrochloride |
Responsible Parties
Sequence: | 28907179 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03799588
2019-01-08
https://zephyrnet.com/?p=NCT03799588
NCT03799588https://www.clinicaltrials.gov/study/NCT03799588?tab=tableNANANAThis study will examine the correlation between the transpulmonary pressure and the actual setting on the biphasic chest cuirass device is the primary study end point.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-08 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2022-03-08 |
Start Month Year | January 8, 2019 |
Primary Completion Month Year | January 31, 2022 |
Verification Month Year | March 2022 |
Verification Date | 2022-03-31 |
Last Update Posted Date | 2022-03-08 |
Detailed Descriptions
Sequence: | 20576911 |
Description | Conventional mechanical ventilation is known as positive pressure ventilation (PPV) because the machine delivers positive pressure directly into the airways to ventilate and expand the lungs. In a healthy lung, inflation occurs when the pressure inside the lung is greater than the pressure outside the lung. This transpulmonary pressure is the difference between the pressure inside the lung (in the alveolus) and the pressure just outside the lung (the pleural cavity). Since positive pressure ventilation delivers pressure directly into the airways, the transpulmonary pressure is increased by making the lung pressure more positive. This is markedly different than physiologic breathing and carries an increased risk of ventilator-associated lung injury1. In the setting of sick lungs, where the pressure required to open collapsed areas of lung may be more than areas of healthy lung, this higher pressure can in turn cause damage to the areas of healthy lung. The known effects of this ventilator-associated lung injury from positive pressure ventilation can be avoided with the use of negative pressure ventilation. In negative pressure ventilation (NPV), the transpulmonary pressure is increased by making the pleural pressure more negative. This is achieved by using a plastic shell that covers the chest and generates negative pressure between the plastic shell and the chest. This pressure is distributed more evenly across a large surface of the chest wall and results in more uniform lung expansion. As a result, NPV results in better oxygen delivery and less lung injury than positive pressure ventilation2.
However, despite the extensive use of NPV in other countries, there is little data available regarding the transpulmonary pressure that these machines can generate; i.e. how well does negative pressure in the plastic shell transmit to the pleural cavity to expand the lung. There is a large amount of data supporting the use of biphasic cuirass ventilation to minimize lung damage3 and improve hemodynamics4-9, but no studies have been done to date that look at the transpulmonary pressure and how it differs depending on age and size. It is still unclear what optimal pressure is required via the chest cuirass to expand and ventilate the lungs via. It is also unknown what maximum pressures can be used before the lung becomes overinflated and complications arise. This study will examine the correlation between the transpulmonary pressure and the actual setting on the biphasic chest cuirass device is the primary study end point. |
Facilities
Sequence: | 198653046 |
Name | Oishei Children's Hospital |
City | Buffalo |
State | New York |
Zip | 14203 |
Country | United States |
Conditions
Sequence: | 51797600 |
Name | Lung Diseases |
Downcase Name | lung diseases |
Id Information
Sequence: | 39861467 |
Id Source | org_study_id |
Id Value | STUDY00002374 |
Countries
Sequence: | 42259143 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55217086 |
Group Type | Experimental |
Title | Biphasic Chest Cuirass Arm |
Description | This is the only arm in the study and all patients will receive negative pressure ventilation via the biphasic chest cuirass. |
Interventions
Sequence: | 52119692 |
Intervention Type | Device |
Name | Biphasic Chest Cuirass |
Description | Patients will have a esophageal manometer placed after intubation and before initiation of negative pressure ventilation. |
Keywords
Sequence: | 79254888 | Sequence: | 79254889 | Sequence: | 79254890 |
Name | Pediatrics | Name | biphasic chest cuirass | Name | transpulmonary pressure |
Downcase Name | pediatrics | Downcase Name | biphasic chest cuirass | Downcase Name | transpulmonary pressure |
Design Outcomes
Sequence: | 176174171 |
Outcome Type | primary |
Measure | Transpulmonary Pressure Deliverance |
Time Frame | 1 year |
Description | Examining the correlation between the transpulmonary pressure and the actual setting on the biphasic chest cuirass device is the primary study end point. |
Browse Conditions
Sequence: | 191981778 | Sequence: | 191981777 |
Mesh Term | Respiratory Tract Diseases | Mesh Term | Lung Diseases |
Downcase Mesh Term | respiratory tract diseases | Downcase Mesh Term | lung diseases |
Mesh Type | mesh-ancestor | Mesh Type | mesh-list |
Sponsors
Sequence: | 47970753 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | State University of New York at Buffalo |
Overall Officials
Sequence: | 29064571 |
Role | Principal Investigator |
Name | Bree C Kramer, DO |
Affiliation | University at Buffalo |
Design Group Interventions
Sequence: | 67697337 |
Design Group Id | 55217086 |
Intervention Id | 52119692 |
Eligibilities
Sequence: | 30545892 |
Gender | Male |
Minimum Age | 6 Months |
Maximum Age | 5 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
Are between the age of 6 months and 5 years Exclusion Criteria: Previous history of chronic lung disease or cyanotic heart disease or |
Adult | False |
Child | True |
Older Adult | False |
Calculated Values
Sequence: | 254224131 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 6 |
Maximum Age Num | 5 |
Minimum Age Unit | Months |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Designs
Sequence: | 30294295 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Other |
Time Perspective | |
Masking | None (Open Label) |
Intervention Model Description | After routine intubation for elective urologic procedures in the OR, the patient will be placed on a biphasic chest cuirass after anesthesia induction. A esophageal manometer will then be placed to measure transpulmonary pressures. The patient will be switched off the anesthesia ventilator and the biphasic chest cuirass will begin negative pressure ventilation. During this time, the patient will continue to receive inhalation anesthetic gas. After 30 minutes, the biphasic chest cuirass will terminate and the patient will again receive positive pressure ventilation via the anesthesia ventilator. |
Responsible Parties
Sequence: | 28672847 |
Responsible Party Type | Principal Investigator |
Name | Bree Cyrene Kramer |
Title | Assistant Clinical Professor of Pediatrics |
Affiliation | State University of New York at Buffalo |
Study References
Sequence: | 51693049 | Sequence: | 51693050 |
Pmid | 9142069 | Pmid | 7653758 |
Reference Type | background | Reference Type | background |
Citation | Scholz SE, Knothe C, Thiel A, Hempelmann G. Improved oxygen delivery by positive pressure ventilation with continuous negative external chest pressure. Lancet. 1997 May 3;349(9061):1295-6. doi: 10.1016/S0140-6736(05)62507-X. No abstract available. | Citation | Petros AJ, Fernando SS, Shenoy VS, al-Saady NM. The Hayek oscillator. Nomograms for tidal volume and minute ventilation using external high frequency oscillation. Anaesthesia. 1995 Jul;50(7):601-6. doi: 10.1111/j.1365-2044.1995.tb15112.x. |
]]>
https://zephyrnet.com/NCT03799575
2019-01-02
https://zephyrnet.com/?p=NCT03799575
NCT03799575https://www.clinicaltrials.gov/study/NCT03799575?tab=tableAndreia L Pinto, MSCandreia.lucia.pinto@gmail.com+351969721099Observational study of Internal Limiting Membrane peeled in macular Hole surgery and studied by Transmission electronic Microscopy (TEM) and Optical Coherence Tomography (OCT) findings in closed holes.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-08 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2019-01-10 |
Start Month Year | January 2, 2019 |
Primary Completion Month Year | July 2, 2019 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-10 |
Detailed Descriptions
Sequence: | 20727133 |
Description | A non-randomized prospective study of eyes with MH willing to have surgery at the Department of Ophthalmology of Santa Maria Hospital, Lisbon.
Surgeries are performed under local or general anesthesia, pars plana vitrectomy with internal limiting membrane peeling, fluid gas exchange and face down position. Two samples of discarded ILM peeled in Macular hole surgery is studied in Laboratory. Laboratory Analysis Two samples of ILM per patient are harvested, one will be immediately fixed and submitted to Optic Microscopy (OM) and Transmission Electron Microscopy (TEM) analysis, and another sample will be incubated in enriched medium 199 (Gibco) for 20 minutes at room temperature, after which it will also be fixed and submitted to OM and TEM analysis. Both samples from same patient will follow the protocol available at dx.doi.org/10.17504/protocols.io.qjiduke. Image acquisition Six electron-micrographs will be acquired for each fragment, using a Hitachi H-7000 electron microscope equipped with a megaview III digital camera. Fields of interest will be randomly selected, and acquisition of 15,000x magnification images. Histology and immunohistochemistry ILM samples will be stained with anti-GFAP antibody (anti-glial fibrillary acidic protein), to detect this protein in glial cells. Results: Only successful macular hole closure will be considered, BCVA will be compared before and after surgery and related to OCT findings. ILM findings in TEM analysis will be compared with and without enriched medium. |
Facilities
Sequence: | 200159071 |
Status | Recruiting |
Name | Hospital Santa Maria |
City | Lisbon |
State | Lisboa |
Zip | 1649-035 |
Country | Portugal |
Facility Contacts
Sequence: | 28113707 |
Facility Id | 200159071 |
Contact Type | primary |
Name | Mun Y Faria, MD |
munfaria1@gmail.com | |
Phone | +351966026791 |
Conditions
Sequence: | 52185355 |
Name | C11.768.740 |
Downcase Name | c11.768.740 |
Id Information
Sequence: | 40168986 |
Id Source | org_study_id |
Id Value | MD26339 |
Countries
Sequence: | 42580596 |
Name | Portugal |
Removed | False |
Design Groups
Sequence: | 55609000 | Sequence: | 55609001 |
Title | A | Title | B |
Description | Two samples of ILM per patient are harvested, group A will be immediately fixed and submitted to Optic Microscopy (OM) and Transmission Electron Microscopy (TEM) analysis, and another sample will be incubated in enriched medium 199 (Gibco) for 20 minutes at room temperature, after which it will also be fixed and submitted to OM and TEM analysis. | Description | Group B sample will be incubated in enriched medium 199 (Gibco) for 20 minutes at room temperature, after which it will also be fixed and submitted to OM and TEM analysis. |
Interventions
Sequence: | 52499322 |
Intervention Type | Behavioral |
Name | Transmission Electron Microscopy analysis |
Description | Morphology of two vitreal side of Internal Limiting Membrane in contact |
Design Outcomes
Sequence: | 177431667 |
Outcome Type | primary |
Measure | Fibrosis in vitreal sides of Internal Limiting Membranes |
Time Frame | 12 months |
Description | Fibrilliary process between two vitreal sides of Internal Limiting Membranes in contact, after incubation in enriched medium |
Browse Conditions
Sequence: | 193539667 | Sequence: | 193539668 | Sequence: | 193539669 |
Mesh Term | Retinal Perforations | Mesh Term | Retinal Diseases | Mesh Term | Eye Diseases |
Downcase Mesh Term | retinal perforations | Downcase Mesh Term | retinal diseases | Downcase Mesh Term | eye diseases |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48332219 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Hospital de Santa Maria, Portugal |
Overall Officials
Sequence: | 29292920 |
Role | Principal Investigator |
Name | Mun Y Faria, MD |
Affiliation | Hospital Santa Maria, Centro Hospitalar Universitário Lisboa Norte, 1649-035 Lisboa, PT |
Central Contacts
Sequence: | 12012279 | Sequence: | 12012280 |
Contact Type | primary | Contact Type | backup |
Name | Nuno P Ferreira, MD | Name | Andreia L Pinto, MSC |
Phone | +351918503467 | Phone | +351969721099 |
ngcpferreira@gmail.com | andreia.lucia.pinto@gmail.com | ||
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 68168041 | Sequence: | 68168042 |
Design Group Id | 55609000 | Design Group Id | 55609001 |
Intervention Id | 52499322 | Intervention Id | 52499322 |
Eligibilities
Sequence: | 30773513 |
Sampling Method | Non-Probability Sample |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 90 Years |
Healthy Volunteers | No |
Population | A non-randomized prospective study of eyes with MH willing to have surgery at the Department of Ophthalmology of Santa Maria Hospital, Lisbon.
Inclusion criteria Full Thickness Macular Hole |
Criteria | Inclusion Criteria:
All macular holes were staged based on recent OCT based classification and only full thickness macular hole, grade 2 to 4 IMH are considered for study. Exclusion Criteria: Excluding criteria are maculopathy other than IMH, surgeries of recurrence of IMH, other retinal diseases, or an axial length greater than 26.0 mm. Mean follow-up will be at least 12 months after surgery. |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253952460 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 90 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Designs
Sequence: | 30519644 |
Observational Model | Cohort |
Time Perspective | Prospective |
Responsible Parties
Sequence: | 28885945 |
Responsible Party Type | Principal Investigator |
Name | Mun Yueh de Faria |
Title | MD |
Affiliation | Hospital de Santa Maria, Portugal |
Study References
Sequence: | 52078780 |
Pmid | 31191990 |
Reference Type | derived |
Citation | Faria MY, Sousa DC, Almeida BC, Pinto AL, Ferreira NP. Morphology of Peeled Internal Limiting Membrane in Macular Hole Surgery. J Ophthalmol. 2019 May 2;2019:1345683. doi: 10.1155/2019/1345683. eCollection 2019. |
]]>
https://zephyrnet.com/NCT03799562
2019-05-01
https://zephyrnet.com/?p=NCT03799562
NCT03799562https://www.clinicaltrials.gov/study/NCT03799562?tab=tableChristine E Marx, MD MAchristine.marx@va.gov(919) 286-0411This study seeks to determine if pregnenolone can improve symptoms of PTSD and other symptoms that commonly occur with PTSD in Iraq/Afghanistan-era Veterans. The total study duration is 10 weeks. Eligible Veterans with PTSD will receive either pregnenolone or placebo throughout the study duration and will complete mental and physical health assessments at each study visit. Eligible participants will attend 6 in-person study visits and receive several short “check-in” phone calls.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-03 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2022-12-13 |
Start Month Year | May 1, 2019 |
Primary Completion Month Year | December 1, 2024 |
Verification Month Year | December 2022 |
Verification Date | 2022-12-31 |
Last Update Posted Date | 2022-12-13 |
Detailed Descriptions
Sequence: | 20818827 |
Description | BACKGROUND: There is an acute and urgent need to develop new and effective posttraumatic stress disorder (PTSD) pharmacotherapies, as there are currently only two FDA-approved medications for the treatment of PTSD (both of which are from the same drug class and have shown only moderate effect sizes in FDA registration trials). Many Veterans with PTSD thus remain symptomatic despite the availability of these treatments, increasing the likelihood of receiving pharmacological treatment interventions for which there is little or no empirical evidence. Multiple national and VA working groups focusing on PTSD have identified the critical need to address the paucity of PTSD pharmacotherapies, and have strongly recommended more randomized clinical trials to evaluate possible effective pharmacological treatments. Both preclinical and clinical data suggest that reductions in neurosteroids are involved in the pathophysiology of PTSD, and that ameliorating these deficits could potentially be clinically therapeutic – the proposed investigation targeting a neurosteroid intervention for the treatment of PTSD could thus be a promising research avenue. The investigators therefore propose to conduct a randomized clinical trial (RCT) to determine the efficacy of a neurosteroid intervention (pregnenolone) for PTSD and commonly co-occurring disorders in Iraq/Afghanistan-era Veterans, an understudied cohort that may be less treatment-refractory.
METHODS: This study will be a 10-week randomized, placebo-controlled, double-blind clinical trial of pregnenolone or matching placebo in Veterans with PTSD. The trial will include a 2-week single-blind placebo lead-in phase followed by 8 weeks of study medication (placebo or pregnenolone). Forty-five subjects meeting DSM-5 criteria for PTSD (as measured by a CAPS-5 score of 30) will be randomized to receive pregnenolone, and 45 subjects meeting DSM-5 criteria for PTSD will be randomized to receive placebo. The primary outcome for this RCT will be changes in total CAPS-5 score at Visit 6 for this modified intent-to-treat sample. Secondary clinical outcomes for this RCT include changes in pain intensity and functional interference, as measured by the Brief Pain Inventory, Short Form (BPI-SF) and depression symptoms by the Hamilton-Depression Rating Scale (HAM-D). Blood samples will be collected for serum analysis at all study visits and frozen in a -80 degree freezer. Upon completion of the study, samples will be thawed and analyzed using Gas Chromatography/Mass Spectrometry for neurosteroid analyses and inflammatory markers will be quantified. Genetic analyses will be conducted to determine therapeutic response. PREDICTED RESULTS: The investigators hypothesize that treatment with pregnenolone will be efficacious in Iraq/Afghanistan-era Veterans with PTSD, and will significantly reduce PTSD symptoms as assessed by the CAPS-5 (primary endpoint) compared to placebo. Secondary endpoints will include the assessment of conditions that frequently co-occur with PTSD; specifically, the investigators hypothesize that pregnenolone will also demonstrate efficacy for co-occurring chronic pain symptoms and depression symptoms. The investigators hypothesize that increases in pregnenolone and other neurosteroids (and decreases in inflammatory markers) will predict improvements in PTSD, depression, and chronic pain symptoms. The investigators also hypothesize that neurosteroids are dysregulated in PTSD, and that specific SNPs of genes coding for neurosteroidogenic enzymes will be associated with therapeutic response. |
Facilities
Sequence: | 200953723 |
Status | Recruiting |
Name | Durham VA Medical Center, Durham, NC |
City | Durham |
State | North Carolina |
Zip | 27705 |
Country | United States |
Facility Contacts
Sequence: | 28246269 | Sequence: | 28246270 |
Facility Id | 200953723 | Facility Id | 200953723 |
Contact Type | primary | Contact Type | backup |
Name | Virginia J Rhodes | Name | John D Whited, MD MHS |
Virginia.Rhodes@va.gov | john.whited@va.gov | ||
Phone | 919-286-0411 | Phone | (919) 286-0411 |
Phone Extension | 177632 | Phone Extension | 176926 |
Facility Investigators
Sequence: | 18419314 |
Facility Id | 200953723 |
Role | Principal Investigator |
Name | Jennifer C Naylor, PhD |
Conditions
Sequence: | 52419868 |
Name | Posttraumatic Stress Disorder |
Downcase Name | posttraumatic stress disorder |
Id Information
Sequence: | 40334795 | Sequence: | 40334796 |
Id Source | org_study_id | Id Source | secondary_id |
Id Value | MHBB-004-18S | Id Value | I01CX001784-01 |
Id Type | U.S. NIH Grant/Contract | ||
Id Link | https://reporter.nih.gov/quickSearch/I01CX001784-01 |
Countries
Sequence: | 42761961 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55868892 | Sequence: | 55868891 |
Group Type | Placebo Comparator | Group Type | Experimental |
Title | Placebo | Title | Pregnenolone |
Description | Same as pregnenolone (active study medication), except placebo dispensed. | Description | Placebo lead in 14 DAYS, followed by Pregnenolone 50 mg BID x 14 DAYS, followed by Pregnenolone 150 mg BID x 14 DAYS, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial |
Interventions
Sequence: | 52728479 | Sequence: | 52728480 |
Intervention Type | Drug | Intervention Type | Drug |
Name | Pregnenolone | Name | Placebo |
Description | Pregnenolone 50 mg BID x 14 DAYS, followed by Pregnenolone 150 mg BID x 14 DAYS, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial. Placebo will be identical to the pregnenolone arm, except placebo will be dispensed. | Description | Same as pregnenolone (active study medication), except placebo dispensed. |
Keywords
Sequence: | 80204244 | Sequence: | 80204245 | Sequence: | 80204246 | Sequence: | 80204247 | Sequence: | 80204248 |
Name | Depression | Name | Pain | Name | Clinical Trial | Name | Veteran | Name | Supplement |
Downcase Name | depression | Downcase Name | pain | Downcase Name | clinical trial | Downcase Name | veteran | Downcase Name | supplement |
Design Outcomes
Sequence: | 178306993 | Sequence: | 178306994 | Sequence: | 178306995 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Change in Clinician Administered PTSD Scale for DSM-5 (Visit 6-Baseline) | Measure | Change in Brief Pain Inventory, Short Form (Visit 6-Baseline) | Measure | Change in Hamilton-Depression Inventory (Visit 6-Baseline) |
Time Frame | Through study completion, an average of 5 years | Time Frame | Through study completion, an average of 5 years | Time Frame | Through study completion, an average of 5 years |
Description | The CAPS is the gold standard in PTSD assessment. The CAPS-5 is a 30-item structured interview that can be used to make a diagnosis of PTSD and assess PTSD symptoms. It assesses the intensity and frequency of PTSD symptoms. Scores range from 0-80; higher score indicates greater severity. | Description | The Brief Pain Inventory, Short Form (BPI-SF) is a self-reported scale that measures the severity of pain and the interference of pain on function. The scores range from 0 (no pain) to 10 (pain as severe as you can imagine). There are 4 questions assessing worst pain, least pain, average pain in the past 24 hours, and the pain right now. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). There are 7 questions assessing the interference of pain in the past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. | Description | The HAM-D measures the severity of depressive symptoms. It is a checklist of 17 items that are ranked on a scale of 0-4 or 0-2. The range for the total score (which is the sum of the scores of all 17 items) is 0-52; a higher score indicates greater severity of symptoms. |
Browse Conditions
Sequence: | 194431101 | Sequence: | 194431102 | Sequence: | 194431103 | Sequence: | 194431104 |
Mesh Term | Stress Disorders, Post-Traumatic | Mesh Term | Stress Disorders, Traumatic | Mesh Term | Trauma and Stressor Related Disorders | Mesh Term | Mental Disorders |
Downcase Mesh Term | stress disorders, post-traumatic | Downcase Mesh Term | stress disorders, traumatic | Downcase Mesh Term | trauma and stressor related disorders | Downcase Mesh Term | mental disorders |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48549974 |
Agency Class | FED |
Lead Or Collaborator | lead |
Name | VA Office of Research and Development |
Overall Officials
Sequence: | 29414361 |
Role | Principal Investigator |
Name | Jennifer C Naylor, PhD |
Affiliation | Durham VA Medical Center, Durham, NC |
Central Contacts
Sequence: | 12074310 | Sequence: | 12074311 |
Contact Type | primary | Contact Type | backup |
Name | Jennifer C Naylor, PhD | Name | Christine E Marx, MD MA |
Phone | (919) 286-0411 | Phone | (919) 286-0411 |
jennifer.naylor2@va.gov | christine.marx@va.gov | ||
Phone Extension | 7722 | Phone Extension | 5112 |
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 68487288 | Sequence: | 68487289 |
Design Group Id | 55868891 | Design Group Id | 55868892 |
Intervention Id | 52728479 | Intervention Id | 52728480 |
Eligibilities
Sequence: | 30908192 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 65 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
DSM-5 diagnosis of PTSD with CAPS-5 Total Score 3 Females will be required to use a medically and study approved contraceptive or otherwise not be of child-bearing potential Birth control methods must be non-hormonal Exclusion Criteria: History of allergy to pregnenolone Current suicidal or homicidal ideation necessitating clinical intervention or representing an imminent concern Prior suicide attempt history or suicidal ideation that does not require clinical intervention or represent an imminent concern is permitted Serious unstable medical illness, such as: history of cerebrovascular accident Standard pharmacological interventions for PTSD will not be exclusionary, including, but not limited to: antidepressant medications such as SSRIs, SNRIs, tricyclics, bupropion, mirtazapine, venlafaxine, and nefazodone Initiation or change in psychotherapy within 3 months of randomization i.e., psychotherapy must be stable for 3 months prior to study start As indicated by the DSM-5, moderate or severe Substance Use Disorders (excluding caffeine and tobacco) within 1 month of study entry Mild Alcohol Use Disorder is not exclusionary, at the judgment of the PI and her medical team |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254167606 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 65 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 2 |
Designs
Sequence: | 30653904 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Quadruple |
Masking Description | This is a randomized, double-blind, placebo-controlled trial. All roles will be masked with the exception of the research pharmacist. |
Intervention Model Description | Participants will be randomized to receive the active study medication (pregnenolone) or placebo. |
Subject Masked | True |
Caregiver Masked | True |
Investigator Masked | True |
Outcomes Assessor Masked | True |
Responsible Parties
Sequence: | 29020559 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03799549
None
https://zephyrnet.com/?p=NCT03799549
NCT03799549https://www.clinicaltrials.gov/study/NCT03799549?tab=tableNANANA[Trial of device that is not approved or cleared by the U.S. FDA]
<![CDATA[
Studies
Study First Submitted Date | 2019-01-08 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2019-04-12 |
Last Update Posted Date | 2019-04-12 |
Id Information
Sequence: | 40266151 |
Id Source | org_study_id |
Id Value | SK-0118 |
Sponsors
Sequence: | 48460040 |
Lead Or Collaborator | lead |
Name | [Redacted] |
Calculated Values
Sequence: | 254272071 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Single Facility | False |
Responsible Parties
Sequence: | 28964691 |
Organization | [Redacted] |
Old Name Title | [Redacted] |
]]>
https://zephyrnet.com/NCT03799536
2019-01-09
https://zephyrnet.com/?p=NCT03799536
NCT03799536https://www.clinicaltrials.gov/study/NCT03799536?tab=tableNANANAThis is an open-label, randomized, single-center, single-dose, two-treatment, two-sequence, two-period, crossover, comparative study, where each subject was randomly assigned to the reference or the test formulation in each period of the study (sequences RT or TR), in order to evaluate if both formulations are bioequivalent.The study was conducted in multiple groups.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-08 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2019-06-07 |
Start Month Year | January 9, 2019 |
Primary Completion Month Year | February 4, 2019 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-06-07 |
Detailed Descriptions
Sequence: | 20721593 |
Description | The objective of this study is to establish if two formulations of sotalol are bioequivalent. The test formulation is Sotalol Tablets, 160 mg (Pharmtechnology LLC, Belarus). The reference formulation is Sotalex®, Tablets, 160 mg (Bristol-Myers Squibb GmbH & Co. KGaA, Germany). 36 healthy adult volunteers of both genders with age ranging from 18 to 55 years old will receive a single tablet (160 mg of sotalol) of the test and the reference products with 200 ml of water after an overnight fast of at least 10 hours, according to the pre-defined randomization list. In the first period, 18 subjects will receive the test product and 18 subjects the reference product.In the second period subjects will receive the products in the opposite order. Subjects will fast 4 hours after administration of the study drugs during each study period. Standardized meals will be provided in each study period. Water will not be accessible to the subjects 1 hour prior to administration of the study drugs and 2 hours after administration of the study drugs in each period. In each period blood samples were collected before dosing and 0,5 ; 1; 1,5; 2 ; 2,5; 3; 3,5; 4; 4,5; 5; 6; 8; 10; 12; 16; 24; 36; 48; 72 hours after dosing (total number: 19). The washout period will be 14 days. A validated HPLC/MS/MS method will be used to determine plasma concentrations of analyte (sotalol). ANOVA will be performed on log transformed pharmacokinetic parameters Cmax, AUC0-t and 90% confidence interval will be constructed for the ratio of geometric least square means of the test and the reference products, obtained from the log-transformed data. Bioequivalence will be concluded if the ratio estimate as well as its 90% confidence interval for the analyte, both falls within the acceptable range of 80.00% to 125.00% for Cmax and AUC0-t. |
Facilities
Sequence: | 200107909 |
Name | National Anti-Doping Laboratory |
City | Settl.Lesnoy |
State | Minsk Region |
Zip | 223040 |
Country | Belarus |
Browse Interventions
Sequence: | 96050076 | Sequence: | 96050077 | Sequence: | 96050078 | Sequence: | 96050079 | Sequence: | 96050080 | Sequence: | 96050081 | Sequence: | 96050082 | Sequence: | 96050083 | Sequence: | 96050084 | Sequence: | 96050085 | Sequence: | 96050086 |
Mesh Term | Sotalol | Mesh Term | Adrenergic beta-Antagonists | Mesh Term | Adrenergic Antagonists | Mesh Term | Adrenergic Agents | Mesh Term | Neurotransmitter Agents | Mesh Term | Molecular Mechanisms of Pharmacological Action | Mesh Term | Physiological Effects of Drugs | Mesh Term | Anti-Arrhythmia Agents | Mesh Term | Sympatholytics | Mesh Term | Autonomic Agents | Mesh Term | Peripheral Nervous System Agents |
Downcase Mesh Term | sotalol | Downcase Mesh Term | adrenergic beta-antagonists | Downcase Mesh Term | adrenergic antagonists | Downcase Mesh Term | adrenergic agents | Downcase Mesh Term | neurotransmitter agents | Downcase Mesh Term | molecular mechanisms of pharmacological action | Downcase Mesh Term | physiological effects of drugs | Downcase Mesh Term | anti-arrhythmia agents | Downcase Mesh Term | sympatholytics | Downcase Mesh Term | autonomic agents | Downcase Mesh Term | peripheral nervous system agents |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52171123 |
Name | Bioequivalence |
Downcase Name | bioequivalence |
Id Information
Sequence: | 40158566 |
Id Source | org_study_id |
Id Value | BE-SOTL-160- 2018 |
Countries
Sequence: | 42568869 |
Name | Belarus |
Removed | False |
Design Groups
Sequence: | 55593071 | Sequence: | 55593072 |
Group Type | Experimental | Group Type | Active Comparator |
Title | Sequence AB | Title | Sequence BA |
Description | Subjects assigned to sequence AB will receive a single 160 mg dose of the test product Sotalol (1 x 160 mg tablet) marked as A in the sequence in the period 1 and a single 160 mg dose of the reference product Sotalex (1 x 160 mg tablet) marked as B in the sequence in the period 2 . These treatments will be administered orally with approximately 200 mL of water at ambient temperature, in the morning, following a 10-hour overnight fast. The tablet must be swallowed whole and must not be chewed or broken. | Description | Subjects assigned to sequence BA will receive a single 160 mg dose of the reference product Sotalex (1 x 160 mg tablet) marked as B in the sequence in the period 1 and a single 160 mg dose of the test product Sotalol (1 x 160 mg tablet) marked as A in the sequence in the period 2 . These treatments will be administered orally with approximately 200 mL of water at ambient temperature, in the morning, following a 10-hour overnight fast. The tablet must be swallowed whole and must not be chewed or broken. |
Interventions
Sequence: | 52485371 | Sequence: | 52485372 |
Intervention Type | Drug | Intervention Type | Drug |
Name | Sotalol | Name | Sotalex |
Description | Sotalol, Tablets,160 mg, manufactured by Pharmtechnology LLC, Belarus | Description | Sotalex, Tablets,160 mg, manufactured by Bristol-Myers Squibb GmbH & Co. KGaA, Germany |
Keywords
Sequence: | 79868375 | Sequence: | 79868376 | Sequence: | 79868377 |
Name | Bioequivalence | Name | Sotalol | Name | Sotalex |
Downcase Name | bioequivalence | Downcase Name | sotalol | Downcase Name | sotalex |
Design Outcomes
Sequence: | 177378503 | Sequence: | 177378496 | Sequence: | 177378497 | Sequence: | 177378498 | Sequence: | 177378499 | Sequence: | 177378500 | Sequence: | 177378501 | Sequence: | 177378502 |
Outcome Type | secondary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Number of treatment-related adverse events (AE) for the test and the reference products as assessed by guidance predefined in the protocol | Measure | Cmax of sotalol for the test and the reference products | Measure | AUC0-t of sotalol for the test and the reference products | Measure | AUC0-∞ of sotalol for the test and the reference products | Measure | Tmax of sotalol for the test and the reference products | Measure | T1/2 of sotalol for the test and the reference products | Measure | Kel of sotalol for the test and the reference products | Measure | AUCresid of sotalol for the test and the reference products |
Time Frame | 28 days | Time Frame | Time points: 0,00 (within 30 minutes before dosing) and 0,5; 1; 1,5; 2; 2,5; 3; 3,5; 4; 4,5; 5; 6; 8; 10; 12; 16; 24; 36; 48; 72 hours after dosing | Time Frame | Time points: 0,00 (within 30 minutes before dosing) and 0,5; 1; 1,5; 2; 2,5; 3; 3,5; 4; 4,5; 5; 6; 8; 10; 12; 16; 24; 36; 48; 72 hours after dosing | Time Frame | Time points: 0,00 (within 30 minutes before dosing) and 0,5; 1; 1,5; 2; 2,5; 3; 3,5; 4; 4,5; 5; 6; 8; 10; 12; 16; 24; 36; 48; 72 hours after dosing | Time Frame | Time points: 0,00 (within 30 minutes before dosing) and 0,5; 1; 1,5; 2; 2,5; 3; 3,5; 4; 4,5; 5; 6; 8; 10; 12; 16; 24; 36; 48; 72 hours after dosing | Time Frame | Time points: 0,00 (within 30 minutes before dosing) and 0,5; 1; 1,5; 2; 2,5; 3; 3,5; 4; 4,5; 5; 6; 8; 10; 12; 16; 24; 36; 48; 72 hours after dosing | Time Frame | Time points: 0,00 (within 30 minutes before dosing) and 0,5; 1; 1,5; 2; 2,5; 3; 3,5; 4; 4,5; 5; 6; 8; 10; 12; 16; 24; 36; 48; 72 hours after dosing | Time Frame | Time points: 0,00 (within 30 minutes before dosing) and 0,5; 1; 1,5; 2; 2,5; 3; 3,5; 4; 4,5; 5; 6; 8; 10; 12; 16; 24; 36; 48; 72 hours after dosing |
Description | An AE is defined as any untoward medical occurrence in a subject administered an investigational product and which does not necessarily have a causal relationship with the treatment. The data from participants who had taken at least one investigational product was analyzed. | Description | Maximum concentration in plasma among observed concentrations at pre-specified time points | Description | Area under the plasma concentration versus time curve from time 0 to the last measured concentration | Description | Area under the plasma concentration versus time curve from time 0 to to infinite time | Description | Time to maximum measured plasma concentration | Description | Elimination or terminal half-life | Description | Elimination rate constant | Description | Residual area |
Sponsors
Sequence: | 48319201 | Sequence: | 48319202 |
Agency Class | INDUSTRY | Agency Class | UNKNOWN |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | Pharmtechnology LLC | Name | National Anti-Doping Labaratory |
Overall Officials
Sequence: | 29285302 |
Role | Principal Investigator |
Name | Anastasia Teteryukova, MD |
Affiliation | National Anti-Doping Labaratory |
Design Group Interventions
Sequence: | 68149001 | Sequence: | 68149002 |
Design Group Id | 55593071 | Design Group Id | 55593072 |
Intervention Id | 52485371 | Intervention Id | 52485372 |
Eligibilities
Sequence: | 30765292 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 55 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
Caucasian men or women aged between 18 to 55 years Exclusion Criteria: Known history of allergy |
Adult | True |
Child | False |
Older Adult | False |
Calculated Values
Sequence: | 253878332 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 0 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 55 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 2 |
Number Of Secondary Outcomes To Measure | 6 |
Designs
Sequence: | 30511459 |
Allocation | Randomized |
Intervention Model | Crossover Assignment |
Observational Model | |
Primary Purpose | Other |
Time Perspective | |
Masking | Single |
Masking Description | The subjects and the investigator will not be blinded towards the identity of the study products. However, analysts will be blinded towards identity of the study products administered. |
Outcomes Assessor Masked | True |
Intervention Other Names
Sequence: | 26673677 | Sequence: | 26673678 |
Intervention Id | 52485371 | Intervention Id | 52485372 |
Name | the test product | Name | the reference product |
Responsible Parties
Sequence: | 28877753 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03799523
2019-01-16
https://zephyrnet.com/?p=NCT03799523
NCT03799523https://www.clinicaltrials.gov/study/NCT03799523?tab=tableNANANAThe first goal of this project is to validate the superiority of semi-permanent marks used in conjunction with specialized light-based surface imaging (SIGRT) in an effort to phase out the use of permanent tattoos for the investigator’s patients. The secondary goal of this project is to validate the superiority of specialized light-based surface imaging for daily radiation set-up compared to standard-of-care imaging methods using ionizing radiation, such as weekly port films or cone-beam CT (CBCT) scans during a radiation therapy course for breast cancer.
<![CDATA[
Studies
Study First Submitted Date | 2018-11-19 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2023-01-25 |
Start Month Year | January 16, 2019 |
Primary Completion Month Year | December 2023 |
Verification Month Year | January 2023 |
Verification Date | 2023-01-31 |
Last Update Posted Date | 2023-01-25 |
Detailed Descriptions
Sequence: | 20815550 |
Description | This study uses surface imaging for breast patients to standardize or normalize planning position & minimize variability of port films thus reducing systematic error. The primary objective of this study is to demonstrate the superiority of using surface imaging to combine an ideally gated treatment planning CT and verification images timed to the breathing cycle, quantified as the total within-subject variation of the measured location relative to current methods of radiation delivery not using this approach. The secondary objective is to demonstrate the superiority of specialized light-based surface imaging for daily radiation set-up without tattoos compared to standard-of-care methods with regard to the total within-subject variation of the measured location determined by weekly port films during a course of radiation for breast cancer. |
Facilities
Sequence: | 200889880 |
Name | UT Health San Antonio Mays Cancer Center |
City | San Antonio |
State | Texas |
Zip | 78229 |
Country | United States |
Conditions
Sequence: | 52410820 |
Name | Breast Cancer |
Downcase Name | breast cancer |
Id Information
Sequence: | 40327860 | Sequence: | 40327861 |
Id Source | org_study_id | Id Source | secondary_id |
Id Value | CTMS# 18-0135 | Id Value | 18-769H |
Id Type | Other Identifier | ||
Id Type Description | UT Health Science Center Institutional Review Board | ||
Countries
Sequence: | 42751098 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55858392 |
Group Type | Experimental |
Title | Subjects undergoing breast radiotherapy |
Description | At the time of CT simulation study participants will receive temporary skin markings to be covered in clear medical grade tape. Light-based surface imaging will be used to determine alignment between the patient and the radiation machine. Radiation treatment will proceed as standard of care. |
Interventions
Sequence: | 52718720 | Sequence: | 52718721 |
Intervention Type | Other | Intervention Type | Other |
Name | Temporary skin markings | Name | Surface imaging |
Description | To use temporary markings in lieu of localization tattoos. | Description | To use light-based surface imaging for patient positioning during radiation treatment. |
Design Outcomes
Sequence: | 178265296 |
Outcome Type | primary |
Measure | Position measurement from Port films. |
Time Frame | Once weekly for 3 weeks up to 5 weeks |
Description | Distance measured (centimeters) from the planned position of radiotherapy to the actual position of radiotherapy on weekly port films. Port films are x-rays of the treatment field which are done to ensure that the patient and the radiation machine are properly aligned to each other. Weekly port films will be obtained for the duration of radiation treatment, which will be from three to five weeks in length. |
Sponsors
Sequence: | 48542077 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | The University of Texas Health Science Center at San Antonio |
Overall Officials
Sequence: | 29409518 |
Role | Principal Investigator |
Name | Eva Galvan, MD |
Affiliation | Principal Investigator |
Design Group Interventions
Sequence: | 68472889 | Sequence: | 68472890 |
Design Group Id | 55858392 | Design Group Id | 55858392 |
Intervention Id | 52718720 | Intervention Id | 52718721 |
Eligibilities
Sequence: | 30903191 |
Gender | Female |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Age ≥ 18 years Exclusion Criteria: Age < 18 years |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254158531 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Designs
Sequence: | 30648908 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Other |
Time Perspective | |
Masking | None (Open Label) |
Responsible Parties
Sequence: | 29015552 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03799510
2018-12-13
https://zephyrnet.com/?p=NCT03799510
NCT03799510https://www.clinicaltrials.gov/study/NCT03799510?tab=tableNANANAThe clinical trial phase 2b is designed to assess the safety and the specific immune response of the active ingredient (protein + adjuvant) in healthy and then in infected school children from 8 to 11 years of age with intestinal and/or urinary schistosomiasis, living in the Valley of the Senegal River, a highly endemic area for schistosomiasis.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-08 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2019-12-09 |
Start Month Year | December 13, 2018 |
Primary Completion Month Year | July 1, 2019 |
Verification Month Year | December 2019 |
Verification Date | 2019-12-31 |
Last Update Posted Date | 2019-12-09 |
Detailed Descriptions
Sequence: | 20709967 |
Description | A phase 2b trial, self-contained, open-label, controlled, randomized study in three parallel arms, two of them formed by groups of healthy or infected school children, both receiving three (3) injections at D0, W4 (Week 4), W8; both groups receiving 50 μg Sm14 vaccine candidate solution, combined with 2.5μg GLA-SE. The third group is composed by non-vaccinated infected school children.
Sm14: recombinant protein produced in yeast following Good Manufacturing Practices (GMP) conditions, presented in vials containing 0.55 ml solution Sm14, 0.4 ml solution is diluted with 0.4 ml of GLA (Synthetic Glucopyranosyl lipid A) for intramuscular administration. Medical examinations are performed at D0 (before injection, 1 hr and 4 hr after), and a safety evaluation at 24 hrs and 48 hrs, after each injection. Blood analysis: Liver function tests – renal function tests – blood counts, at W-1 before inclusion, and at W9 and W21 during the follow-up. Blood samples for immune response analysis at D0, W12 and W21. |
Facilities
Sequence: | 199964475 |
Name | Biomedical Research Center EPLS |
City | Saint Louis |
Zip | BP226 |
Country | Senegal |
Conditions
Sequence: | 52138950 |
Name | Schistosomiasis |
Downcase Name | schistosomiasis |
Id Information
Sequence: | 40135018 |
Id Source | org_study_id |
Id Value | Sm14 Phase 2b – Sn |
Countries
Sequence: | 42542639 |
Name | Senegal |
Removed | False |
Design Groups
Sequence: | 55559287 | Sequence: | 55559288 | Sequence: | 55559289 |
Group Type | Experimental | Group Type | Experimental | Group Type | No Intervention |
Title | Group 1 | Title | Group 2 | Title | Group 3 |
Description | Healthy school children with no infectious history of Schistosomiasis receiving three (3) intramuscular injections of 50 μg Sm14 with 2.5 μg GLA-SE solution at D0, W4, W8 (D=day; W=week). Three-month follow-up (W12, W20). | Description | School children with an infectious history of S. haematobium and-or S. mansoni and pretreated with 1 dose of Praziquantel (2-4 weeks prior to the first vaccine injection) receiving three (3) intramuscular injections of 50 μg Sm14 with 2.5 μg GLA-SE solution at D0, W4, W8 (D=day; W=week). Three-month follow-up (W12, W20). | Description | School children with an infectious history of S. haematobium and S. mansoni and pretreated with 1 dose of Praziquantel (2-4 weeks prior to the first vaccine injection) not receiving vaccine. Control group. |
Interventions
Sequence: | 52454850 | Sequence: | 52454851 |
Intervention Type | Biological | Intervention Type | Drug |
Name | Sm14 | Name | GLA-SE solution |
Description | Three 0.5 mL intra-muscular injections of the vaccine solution (50μg Sm14) will be administered on D0, W4, W8 (D = day, W = week). | Description | The lot concentration 10μg/mL for injection of 2.5μg GLA-SE/injection. |
Keywords
Sequence: | 79822738 | Sequence: | 79822739 | Sequence: | 79822740 | Sequence: | 79822741 | Sequence: | 79822742 | Sequence: | 79822743 | Sequence: | 79822744 |
Name | Schistosomiasis | Name | Recombinant vaccine | Name | rSm14 | Name | GLA-SE | Name | Fatty acid-binding protein (FABP) | Name | Phase II Clinical Trial | Name | Senegal |
Downcase Name | schistosomiasis | Downcase Name | recombinant vaccine | Downcase Name | rsm14 | Downcase Name | gla-se | Downcase Name | fatty acid-binding protein (fabp) | Downcase Name | phase ii clinical trial | Downcase Name | senegal |
Design Outcomes
Sequence: | 177263392 | Sequence: | 177263393 | Sequence: | 177263394 | Sequence: | 177263395 | Sequence: | 177263396 | Sequence: | 177263397 | Sequence: | 177263398 | Sequence: | 177263399 | Sequence: | 177263400 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Number of Participants with Adverse Events as a Measure of Safety and Tolerability | Measure | Number of Participants with Adverse Events as a Measure of Safety and Tolerability | Measure | Number of Participants with Adverse Events as a Measure of Safety and Tolerability | Measure | Number of Participants with Adverse Events as a Measure of Safety and Tolerability | Measure | Number of Participants with Adverse Events as a Measure of Safety and Tolerability | Measure | Number of Participants with Adverse Events as a Measure of Safety and Tolerability | Measure | Qualitative and quantitative assessment of the Immunogenicity | Measure | Qualitative and quantitative assessment of the Immunogenicity | Measure | Qualitative and quantitative assessment of the Immunogenicity |
Time Frame | within 2 days of the administration of the first dose (Day 0) | Time Frame | Day 30-Day 32: within 2 days of the administration of the second dose (Week 4) | Time Frame | Days 60-67 : within 7 days of the administration of the third dose (Week 8) | Time Frame | Day 90: three months after the first injection (Week 12) | Time Frame | Day 120: four months after the first injection (Week 16) | Time Frame | Day 150: five months after the first injection (Week 21) | Time Frame | The Day of first Sm14 vaccine administration (Day 0) | Time Frame | At the 30th day after the third Sm14 vaccine administration (Week 12) | Time Frame | At the 90th day after the third Sm14 vaccine administration (Week 21) |
Description | Local signs and symptoms included Pain, Swelling and Inflammation at the injection site, heaviness or pain upon passive or active movement of the injected limb, Complete physical examination including an examination of general appearance, body weight and forehead temperature, head, eyes, ears, nose and throat, neck, skin, cardiovascular and respiratory system, abdominal system, nervous system, lymphatic area, blood pressure, pulse and respiratory rates.
General signs and symptoms including fever, headache, nausea, vomiting, myalgia, arthralgia, irritability/fussiness and drowsiness, loss of appetite and sleep disturbances. |
Description | Local signs and symptoms included Pain, Swelling and Inflammation at the injection site, Heaviness or pain upon passive or active movement of the injected limb, Complete physical examination including an examination of general appearance, body weight and forehead temperature, head, eyes, ears, nose and throat, neck, skin, cardiovascular and respiratory system, abdominal system, nervous system, lymphatic area, blood pressure, pulse and respiratory rates.
General signs and symptoms including fever, headache, nausea, vomiting, myalgia, arthralgia, irritability/fussiness and drowsiness, loss of appetite and sleep disturbances. |
Description | Local signs and symptoms included Pain, Swelling and Inflammation at the injection site. Heaviness or pain upon passive or active movement of the injected limb, Complete physical examination including an examination of general appearance, body weight and forehead temperature, head, eyes, ears, nose and throat, neck, skin, cardiovascular and respiratory system, abdominal system, nervous system, lymphatic area, blood pressure, pulse and respiratory rates.
General signs and symptoms including fever, headache, nausea, vomiting, myalgia, arthralgia, irritability/fussiness and drowsiness, loss of appetite and sleep disturbances. Laboratory tests (blood count, liver and kidney biological functions). |
Description | Injection local signs and symptoms included pain or tenderness, swelling, induration and erythema at the site of injection. Complete physical examination including an examination of general appearance, body weight and forehead temperature, head, eyes, ears, nose and throat, neck, skin, cardiovascular and respiratory system, abdominal system, nervous system, lymphatic area, blood pressure, pulse and respiratory rates. General signs and symptoms including fever, headache, nausea, vomiting, myalgia, arthralgia, irritability/fussiness and drowsiness, loss of appetite and sleep disturbances. | Description | Local signs and symptoms included pain or tenderness, swelling, induration and erythema at the site of injection.
Complete physical examination including an examination of general appearance, body weight and forehead temperature, head, eyes, ears, nose and throat, neck, skin, cardiovascular and respiratory system, abdominal system, nervous system, lymphatic area, blood pressure, pulse and respiratory rates. General signs and symptoms including fever, headache, nausea, vomiting, myalgia, arthralgia, irritability/fussiness and drowsiness, loss of appetite and sleep disturbances. |
Description | Local signs and symptoms included pain or tenderness, swelling, induration and erythema at the site of injection.
Complete physical examination including an examination of general appearance, body weight and forehead temperature, head, eyes, ears, nose and throat, neck, skin, cardiovascular and respiratory system, abdominal system, nervous system, lymphatic area, blood pressure, pulse and respiratory rates. General signs and symptoms including fever, headache, nausea, vomiting, myalgia, arthralgia, irritability/fussiness and drowsiness, loss of appetite and sleep disturbances. |
Description | Immunogenicity was evaluated by Isotype analysis of the antibodies produced specifically against the rSm14 and vaccine-induced (ELISA) and Specific rSm14 cellular response (on PBMC), production of intracellular cytokines (PBMCs stimulation and cytokine dosing). Cellular immune responses measured by PBMC luminex assay for T-cell cytokines (Milliplex ® MAP kit).
Correlation between the development and magnitude of humoral responses measured by antibody IgG production to the Sm14 Schisto protein using enzyme-linked immunosorbent assay (ELISA). |
Description | Immunogenicity was evaluated by Isotype analysis of the antibodies produced specifically against the rSm14 and vaccine-induced (ELISA) and Specific rSm14 cellular response (on PBMC), production of intracellular cytokines (PBMCs stimulation and cytokine dosing). Cellular immune responses measured by PBMC luminex assay for T-cell cytokines (Milliplex ® MAP kit).
Correlation between the development and magnitude of humoral responses measured by antibody IgG production to the Sm14 Schisto protein using enzyme-linked immunosorbent assay (ELISA). |
Description | Immunogenicity was evaluated by Isotype analysis of the antibodies produced specifically against the rSm14 andvaccine-induced (ELISA) and Specific rSm14 cellular response (on PBMC), production of intracellular cytokines (PBMCs stimulation and cytokine dosing). Cellular immune responses measured by PBMC luminex assay for T-cell cytokines (Milliplex ® MAP kit).
Correlation between the development and magnitude of humoral responses measured by antibody IgG production to the Sm14 Schisto protein using enzyme-linked immunosorbent assay (ELISA). |
Browse Conditions
Sequence: | 193366325 | Sequence: | 193366326 | Sequence: | 193366327 | Sequence: | 193366328 | Sequence: | 193366329 | Sequence: | 193366330 |
Mesh Term | Schistosomiasis | Mesh Term | Trematode Infections | Mesh Term | Helminthiasis | Mesh Term | Parasitic Diseases | Mesh Term | Infections | Mesh Term | Vector Borne Diseases |
Downcase Mesh Term | schistosomiasis | Downcase Mesh Term | trematode infections | Downcase Mesh Term | helminthiasis | Downcase Mesh Term | parasitic diseases | Downcase Mesh Term | infections | Downcase Mesh Term | vector borne diseases |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48290665 | Sequence: | 48290666 | Sequence: | 48290667 | Sequence: | 48290668 |
Agency Class | OTHER | Agency Class | UNKNOWN | Agency Class | OTHER | Agency Class | OTHER |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator |
Name | Oswaldo Cruz Foundation | Name | Orygen Biotecnologia SA | Name | Biomedical Research Center EPLS | Name | Access to Advanced Health Institute (AAHI) |
Overall Officials
Sequence: | 29268506 | Sequence: | 29268507 | Sequence: | 29268508 | Sequence: | 29268509 |
Role | Study Chair | Role | Principal Investigator | Role | Study Director | Role | Study Director |
Name | Miriam Tendler, MD, PhD | Name | Modou DIOP, MD | Name | Gilles RIVEAU, PharmD, PhD | Name | Anne-Marie SCHACHT, CRA |
Affiliation | Oswaldo Cruz Foundation | Affiliation | Biomedical Research Center ESPOIR POUR LA SANTE (BRC-EPLS) | Affiliation | Biomedical Research Center ESPOIR POUR LA SANTE (BRC-EPLS). | Affiliation | Biomedical Research Center ESPOIR POUR LA SANTE (BRC-EPLS). |
Design Group Interventions
Sequence: | 68107378 | Sequence: | 68107379 | Sequence: | 68107380 | Sequence: | 68107381 |
Design Group Id | 55559287 | Design Group Id | 55559288 | Design Group Id | 55559287 | Design Group Id | 55559288 |
Intervention Id | 52454850 | Intervention Id | 52454850 | Intervention Id | 52454851 | Intervention Id | 52454851 |
Eligibilities
Sequence: | 30747692 |
Gender | All |
Minimum Age | 8 Years |
Maximum Age | 11 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
School children, of public schools in villages of Saint Louis region (Senegal), female or male, 8 to 11 years old (inclusive) at the time of inclusion. Exclusion Criteria: School child who does not respond to one of the inclusion criteria |
Adult | False |
Child | True |
Older Adult | False |
Calculated Values
Sequence: | 254121779 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 6 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 8 |
Maximum Age Num | 11 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 6 |
Number Of Secondary Outcomes To Measure | 3 |
Designs
Sequence: | 30493975 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Prevention |
Time Perspective | |
Masking | None (Open Label) |
Masking Description | No masking |
Intervention Other Names
Sequence: | 26655388 | Sequence: | 26655389 | Sequence: | 26655390 | Sequence: | 26655391 |
Intervention Id | 52454850 | Intervention Id | 52454851 | Intervention Id | 52454851 | Intervention Id | 52454851 |
Name | rSm14 | Name | • Glucopyranosyl Lipid A in Stable Emulsion | Name | • Glucopyranosyl Lipid Adjuvant-Stable Emulsion | Name | • Toll-like Receptor 4 Agonist GLA-SE |
Responsible Parties
Sequence: | 28860255 |
Responsible Party Type | Sponsor |
Study References
Sequence: | 52032531 | Sequence: | 52032532 | Sequence: | 52032533 | Sequence: | 52032534 | Sequence: | 52032535 | Sequence: | 52032536 |
Pmid | 2022660 | Pmid | 19150418 | Pmid | 21298114 | Pmid | 26571311 | Pmid | 23284726 | Pmid | 30469320 |
Reference Type | result | Reference Type | result | Reference Type | result | Reference Type | result | Reference Type | result | Reference Type | result |
Citation | Moser D, Tendler M, Griffiths G, Klinkert MQ. A 14-kDa Schistosoma mansoni polypeptide is homologous to a gene family of fatty acid binding proteins. J Biol Chem. 1991 May 5;266(13):8447-54. | Citation | Ramos CR, Spisni A, Oyama S Jr, Sforca ML, Ramos HR, Vilar MM, Alves AC, Figueredo RC, Tendler M, Zanchin NI, Pertinhez TA, Ho PL. Stability improvement of the fatty acid binding protein Sm14 from S. mansoni by Cys replacement: structural and functional characterization of a vaccine candidate. Biochim Biophys Acta. 2009 Apr;1794(4):655-62. doi: 10.1016/j.bbapap.2008.12.010. Epub 2008 Dec 25. | Citation | Coler RN, Bertholet S, Moutaftsi M, Guderian JA, Windish HP, Baldwin SL, Laughlin EM, Duthie MS, Fox CB, Carter D, Friede M, Vedvick TS, Reed SG. Development and characterization of synthetic glucopyranosyl lipid adjuvant system as a vaccine adjuvant. PLoS One. 2011 Jan 26;6(1):e16333. doi: 10.1371/journal.pone.0016333. | Citation | Santini-Oliveira M, Coler RN, Parra J, Veloso V, Jayashankar L, Pinto PM, Ciol MA, Bergquist R, Reed SG, Tendler M. Schistosomiasis vaccine candidate Sm14/GLA-SE: Phase 1 safety and immunogenicity clinical trial in healthy, male adults. Vaccine. 2016 Jan 20;34(4):586-594. doi: 10.1016/j.vaccine.2015.10.027. Epub 2015 Nov 10. | Citation | Lambert SL, Yang CF, Liu Z, Sweetwood R, Zhao J, Cheng L, Jin H, Woo J. Molecular and cellular response profiles induced by the TLR4 agonist-based adjuvant Glucopyranosyl Lipid A. PLoS One. 2012;7(12):e51618. doi: 10.1371/journal.pone.0051618. Epub 2012 Dec 28. | Citation | Tendler M, Almeida MS, Vilar MM, Pinto PM, Limaverde-Sousa G. Current Status of the Sm14/GLA-SE Schistosomiasis Vaccine: Overcoming Barriers and Paradigms towards the First Anti-Parasitic Human(itarian) Vaccine. Trop Med Infect Dis. 2018 Nov 21;3(4):121. doi: 10.3390/tropicalmed3040121. Erratum In: Trop Med Infect Dis. 2019 Jan 19;4(1): |
]]>
https://zephyrnet.com/NCT03799497
2013-06-07
https://zephyrnet.com/?p=NCT03799497
NCT03799497https://www.clinicaltrials.gov/study/NCT03799497?tab=tableNANANABody Image distortion is a key diagnostic feature for Anorexia Nervosa. Patients suffering from Anorexia Nervosa tend to perceive themselves as fatter than they are. This bias might be at the origin of a reinforcement of anorectic behavior which might alter medical care. The objective of this study is to identify neural correlates of self-recognition in Anorexia Nervosa. Patients are hypothesized to activate the self-recognition network when seeing images of a fatter body shape than their own.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-03 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2020-09-16 |
Start Month Year | June 7, 2013 |
Primary Completion Month Year | June 7, 2020 |
Verification Month Year | September 2020 |
Verification Date | 2020-09-30 |
Last Update Posted Date | 2020-09-16 |
Detailed Descriptions
Sequence: | 20762935 |
Description | Patients suffering from Anorexia Nervosa and control subjects (matched by age and study level) are recruited in medical care facilities in Lille's Metropolis. They are asked to identify their body shape when being presented with 3 different stimuli, i.e.real (RBS), estimated (EBS) and neutral body shape (NBS), in a functional magnetic resonance imaging or functional MRI (fMRI) machine. While answering to this identification paradigm, we hoped to identify modifications in the self body-recognition network. |
Facilities
Sequence: | 200458210 |
Name | CHRU,Hôpital Fontan 2 |
City | Lille |
Country | France |
Conditions
Sequence: | 52277473 |
Name | Anorexia Nervosa |
Downcase Name | anorexia nervosa |
Id Information
Sequence: | 40235475 | Sequence: | 40235476 |
Id Source | org_study_id | Id Source | secondary_id |
Id Value | 2009_48 | Id Value | 2010-A00545-34 |
Id Type | Other Identifier | ||
Id Type Description | ID-RCB number, ANSM | ||
Countries
Sequence: | 42653071 |
Name | France |
Removed | False |
Design Groups
Sequence: | 55711604 | Sequence: | 55711605 |
Title | Patients suffering from Anorexia Nervosa | Title | Control group |
Description | Subjects with a diagnostic of anorexia nervosa disorder | Description | Healthy subjects with no psychiatric disorder |
Keywords
Sequence: | 80018988 | Sequence: | 80018989 | Sequence: | 80018990 |
Name | Anorexia nervosa | Name | functional MRI (fMRI) | Name | self body-shape recognition |
Downcase Name | anorexia nervosa | Downcase Name | functional mri (fmri) | Downcase Name | self body-shape recognition |
Design Outcomes
Sequence: | 177770721 |
Outcome Type | primary |
Measure | Measure of the activation brain areas in self body-recognition network |
Time Frame | 15 days |
Description | Level of activation areas in the self body-recognition network measured during fMRI |
Browse Conditions
Sequence: | 193892826 | Sequence: | 193892827 | Sequence: | 193892828 | Sequence: | 193892829 | Sequence: | 193892830 |
Mesh Term | Anorexia | Mesh Term | Anorexia Nervosa | Mesh Term | Signs and Symptoms, Digestive | Mesh Term | Feeding and Eating Disorders | Mesh Term | Mental Disorders |
Downcase Mesh Term | anorexia | Downcase Mesh Term | anorexia nervosa | Downcase Mesh Term | signs and symptoms, digestive | Downcase Mesh Term | feeding and eating disorders | Downcase Mesh Term | mental disorders |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48418656 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | University Hospital, Lille |
Overall Officials
Sequence: | 29342626 |
Role | Principal Investigator |
Name | Olivier Cottencin, MD, PhD |
Affiliation | University Hospital, Lille |
Eligibilities
Sequence: | 30827042 |
Sampling Method | Non-Probability Sample |
Gender | Female |
Minimum Age | 15 Years |
Maximum Age | 45 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Population | Volontary subjects : patients suffering from Anorexia Nervosa and control subjects, matched by age and study level |
Criteria | Inclusion Criteria:
Providing informed, dated and signed consent (for minors, consent must be signed by both parents) Exclusion Criteria: Pregnant or breast-feeding women |
Adult | True |
Child | True |
Older Adult | False |
Calculated Values
Sequence: | 254123737 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 85 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 15 |
Maximum Age Num | 45 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Designs
Sequence: | 30572972 |
Observational Model | Case-Control |
Time Perspective | Prospective |
Responsible Parties
Sequence: | 28939394 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03799484
2019-01-04
https://zephyrnet.com/?p=NCT03799484
NCT03799484https://www.clinicaltrials.gov/study/NCT03799484?tab=tableNANANAThe purpose of this study is to determine whether there is a difference in clinical effect, duration of effect, level of discomfort and patient satisfaction in patients receiving topical anesthesia on one side of the forehead and petrolatum ointment on the other prior to Botulinum Toxin Type A administration for the treatment of forehead rhytides.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-03 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2020-06-18 |
Start Month Year | January 4, 2019 |
Primary Completion Month Year | June 14, 2019 |
Verification Month Year | June 2020 |
Verification Date | 2020-06-30 |
Last Update Posted Date | 2020-06-18 |
Results First Posted Date | 2020-06-18 |
Detailed Descriptions
Sequence: | 20562940 |
Description | This is a prospective, randomized, double-masked, comparative study in patients who present at the Robert Cizik Eye Clinic with horizontal forehead rhytides requiring treatment with botulinum toxin Type A (Botox ®; Allergan, Irvine, CA, USA).
The objective of this study is to determine whether there is a difference in clinical effect (weakness/paralysis of the frontalis muscle), duration of effect, level of discomfort and patient satisfaction in patients receiving topical anesthesia (2.5% lidocaine/2.5 % prilocaine cream, Impax Laboratories, LLC) on one side of the forehead and petrolatum ointment on the other prior to BTX-A administration for the treatment of forehead rhytides. Primary outcome variable is change of eyebrow excursion on each side of the forehead from baseline to each follow-up visit. Secondary outcome variables Duration of effect, defined as the elapsed time from injection to the end of botulinum, such that return of baseline frontalis function, i.e. within 2 mm of baseline value |
Facilities
Sequence: | 198527942 |
Name | Robert Cizik Eye Clinic |
City | Houston |
State | Texas |
Zip | 77030 |
Country | United States |
Browse Interventions
Sequence: | 95244644 | Sequence: | 95244645 | Sequence: | 95244646 | Sequence: | 95244647 | Sequence: | 95244648 | Sequence: | 95244649 | Sequence: | 95244650 | Sequence: | 95244651 | Sequence: | 95244652 | Sequence: | 95244653 | Sequence: | 95244654 | Sequence: | 95244655 | Sequence: | 95244656 | Sequence: | 95244657 | Sequence: | 95244658 | Sequence: | 95244659 | Sequence: | 95244660 | Sequence: | 95244661 | Sequence: | 95244662 | Sequence: | 95244663 | Sequence: | 95244664 | Sequence: | 95244665 | Sequence: | 95244666 |
Mesh Term | Lidocaine | Mesh Term | Prilocaine | Mesh Term | Petrolatum | Mesh Term | Botulinum Toxins | Mesh Term | Botulinum Toxins, Type A | Mesh Term | abobotulinumtoxinA | Mesh Term | Anesthetics, Local | Mesh Term | Anesthetics | Mesh Term | Central Nervous System Depressants | Mesh Term | Physiological Effects of Drugs | Mesh Term | Sensory System Agents | Mesh Term | Peripheral Nervous System Agents | Mesh Term | Anti-Arrhythmia Agents | Mesh Term | Voltage-Gated Sodium Channel Blockers | Mesh Term | Sodium Channel Blockers | Mesh Term | Membrane Transport Modulators | Mesh Term | Molecular Mechanisms of Pharmacological Action | Mesh Term | Acetylcholine Release Inhibitors | Mesh Term | Cholinergic Agents | Mesh Term | Neurotransmitter Agents | Mesh Term | Neuromuscular Agents | Mesh Term | Emollients | Mesh Term | Dermatologic Agents |
Downcase Mesh Term | lidocaine | Downcase Mesh Term | prilocaine | Downcase Mesh Term | petrolatum | Downcase Mesh Term | botulinum toxins | Downcase Mesh Term | botulinum toxins, type a | Downcase Mesh Term | abobotulinumtoxina | Downcase Mesh Term | anesthetics, local | Downcase Mesh Term | anesthetics | Downcase Mesh Term | central nervous system depressants | Downcase Mesh Term | physiological effects of drugs | Downcase Mesh Term | sensory system agents | Downcase Mesh Term | peripheral nervous system agents | Downcase Mesh Term | anti-arrhythmia agents | Downcase Mesh Term | voltage-gated sodium channel blockers | Downcase Mesh Term | sodium channel blockers | Downcase Mesh Term | membrane transport modulators | Downcase Mesh Term | molecular mechanisms of pharmacological action | Downcase Mesh Term | acetylcholine release inhibitors | Downcase Mesh Term | cholinergic agents | Downcase Mesh Term | neurotransmitter agents | Downcase Mesh Term | neuromuscular agents | Downcase Mesh Term | emollients | Downcase Mesh Term | dermatologic agents |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 51763013 | Sequence: | 51763014 |
Name | Forehead Rhytides | Name | Forehead Wrinkles |
Downcase Name | forehead rhytides | Downcase Name | forehead wrinkles |
Id Information
Sequence: | 39832114 |
Id Source | org_study_id |
Id Value | HSC-MS-18-0908 |
Countries
Sequence: | 42231927 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55184009 | Sequence: | 55184010 |
Group Type | Other | Group Type | Other |
Title | Topical Anesthesia | Title | Petrolatum |
Description | 2.5% Lidocaine/2.5% Prilocaine Cream will be applied to one side of the forehead and Petrolatum Ointment to the other prior to administration of Botulinum Toxin Type A Injection | Description | Petrolatum Ointment will be applied to one side of the forehead and 2.5% Lidocaine/2.5% Prilocaine Cream to the other side prior to administration of Botulinum Toxin Type A Injection |
Interventions
Sequence: | 52084252 | Sequence: | 52084253 | Sequence: | 52084254 |
Intervention Type | Drug | Intervention Type | Drug | Intervention Type | Device |
Name | Botulinum toxin type A | Name | 2.5% lidocaine/2.5% prilocaine | Name | petrolatum ointment |
Description | Botulinum toxin type A will be administered to both sides | Description | 2.5% lidocaine/2.5% prilocaine will be applied to one side of the forehead | Description | petrolatum ointment will be applied to one side of the forehead |
Keywords
Sequence: | 79195454 | Sequence: | 79195455 |
Name | Rhytides | Name | Forehead Wrinkles |
Downcase Name | rhytides | Downcase Name | forehead wrinkles |
Design Outcomes
Sequence: | 176065007 | Sequence: | 176064999 | Sequence: | 176065000 | Sequence: | 176065001 | Sequence: | 176065002 | Sequence: | 176065003 | Sequence: | 176065004 | Sequence: | 176065005 | Sequence: | 176065006 | Sequence: | 176065008 | Sequence: | 176065009 | Sequence: | 176065010 | Sequence: | 176065011 | Sequence: | 176065012 | Sequence: | 176065013 | Sequence: | 176065014 | Sequence: | 176065015 | Sequence: | 176065016 |
Outcome Type | secondary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey | Measure | Eyebrow Excursion | Measure | Eyebrow Excursion | Measure | Eyebrow Excursion | Measure | Eyebrow Excursion | Measure | Duration of Botulinum Toxin Type A Effect | Measure | Perception of Pain Immediately After Injection as Assessed by a Visual Analogue Scale | Measure | Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey | Measure | Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey | Measure | Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey | Measure | Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey | Measure | Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey | Measure | Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey | Measure | Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey | Measure | Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey | Measure | Number of Participants Who Perceive a Difference in Efficacy Between the 2 Sides of Their Face | Measure | Number of Participants Who Perceive a Difference in Efficacy Between the 2 Sides of Their Face | Measure | Number of Participants Who Perceive a Difference in Efficacy Between the 2 Sides of Their Face |
Time Frame | Week 16 | Time Frame | Baseline | Time Frame | Week 2 | Time Frame | Week 6 | Time Frame | week 16 | Time Frame | week 16 | Time Frame | Immediately after botox injection | Time Frame | Week 2 | Time Frame | Week 6 | Time Frame | Week 2 | Time Frame | Week 6 | Time Frame | Week 16 | Time Frame | Week 2 | Time Frame | Week 6 | Time Frame | Week 16 | Time Frame | Week 2 | Time Frame | Week 6 | Time Frame | Week 16 |
Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | Participants will be asked to raise the brows, and the excursion of the brow from resting position to maximum elevation will be measured in millimeters. | Description | Participants will be asked to raise the brows, and the excursion of the brow from resting position to maximum elevation will be measured in millimeters. | Description | Participants will be asked to raise the brows, and the excursion of the brow from resting position to maximum elevation will be measured in millimeters. | Description | Loss of Botulinum Toxin Type A effect is defined as return of baseline frontalis muscle function (function prior to injection) as indicated by eyebrow excursion measurement within 2 millimeters of baseline value. | Description | A visual analogue scale will be used to assess pain. The scale ranges from 0 (no pain) to 10 (the worse pain possible), with lower scores indicating a better outcome. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | Participants will be asked if there is a noticeable difference between the 2 sides of their face. | Description | Participants will be asked if there is a noticeable difference between the 2 sides of their face. | Description | Participants will be asked if there is a noticeable difference between the 2 sides of their face. |
Sponsors
Sequence: | 47939525 | Sequence: | 47939526 |
Agency Class | OTHER | Agency Class | UNKNOWN |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | The University of Texas Health Science Center, Houston | Name | Robert Cizik Eye Clinic |
Overall Officials
Sequence: | 29045814 |
Role | Principal Investigator |
Name | Karina Richani-Reverol, MD |
Affiliation | The University of Texas Health Science Center, Houston |
Design Group Interventions
Sequence: | 67654565 | Sequence: | 67654566 | Sequence: | 67654567 | Sequence: | 67654568 |
Design Group Id | 55184010 | Design Group Id | 55184009 | Design Group Id | 55184009 | Design Group Id | 55184010 |
Intervention Id | 52084252 | Intervention Id | 52084252 | Intervention Id | 52084253 | Intervention Id | 52084254 |
Eligibilities
Sequence: | 30526478 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 65 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
18 to 65 years of age Exclusion Criteria: Previous injection of botulinum toxin in the intended treatment area for the study within the last 4 months |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254093111 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 5 |
Were Results Reported | True |
Months To Report Results | 11 |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 65 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 4 |
Number Of Secondary Outcomes To Measure | 14 |
Designs
Sequence: | 30275385 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Other |
Time Perspective | |
Masking | Double |
Masking Description | Randomization will only be known by the principal investigator performing the injections and will not be disclosed to the participants or the brow excursion examiner. |
Subject Masked | True |
Outcomes Assessor Masked | True |
Intervention Other Names
Sequence: | 26476003 | Sequence: | 26476004 | Sequence: | 26476005 |
Intervention Id | 52084252 | Intervention Id | 52084253 | Intervention Id | 52084254 |
Name | BTX-A | Name | EMLA | Name | Aquaphor |
Milestones
Sequence: | 40753554 | Sequence: | 40753555 | Sequence: | 40753556 |
Result Group Id | 55825946 | Result Group Id | 55825946 | Result Group Id | 55825946 |
Ctgov Group Code | FG000 | Ctgov Group Code | FG000 | Ctgov Group Code | FG000 |
Title | STARTED | Title | COMPLETED | Title | NOT COMPLETED |
Period | Overall Study | Period | Overall Study | Period | Overall Study |
Count | 14 | Count | 14 | Count | 0 |
Participant Flows
Sequence: | 3897729 |
Outcome Counts
Sequence: | 73515605 | Sequence: | 73515606 | Sequence: | 73515607 | Sequence: | 73515608 | Sequence: | 73515609 | Sequence: | 73515610 | Sequence: | 73515611 | Sequence: | 73515612 | Sequence: | 73515613 | Sequence: | 73515614 | Sequence: | 73515615 | Sequence: | 73515616 | Sequence: | 73515617 | Sequence: | 73515618 | Sequence: | 73515619 | Sequence: | 73515620 | Sequence: | 73515621 | Sequence: | 73515622 | Sequence: | 73515623 | Sequence: | 73515624 | Sequence: | 73515625 | Sequence: | 73515626 | Sequence: | 73515627 | Sequence: | 73515628 | Sequence: | 73515629 | Sequence: | 73515630 | Sequence: | 73515631 | Sequence: | 73515632 | Sequence: | 73515633 | Sequence: | 73515634 | Sequence: | 73515635 | Sequence: | 73515636 | Sequence: | 73515637 | Sequence: | 73515638 | Sequence: | 73515639 | Sequence: | 73515640 |
Outcome Id | 30603527 | Outcome Id | 30603527 | Outcome Id | 30603527 | Outcome Id | 30603527 | Outcome Id | 30603528 | Outcome Id | 30603528 | Outcome Id | 30603528 | Outcome Id | 30603528 | Outcome Id | 30603529 | Outcome Id | 30603529 | Outcome Id | 30603529 | Outcome Id | 30603529 | Outcome Id | 30603530 | Outcome Id | 30603530 | Outcome Id | 30603530 | Outcome Id | 30603530 | Outcome Id | 30603531 | Outcome Id | 30603531 | Outcome Id | 30603531 | Outcome Id | 30603531 | Outcome Id | 30603532 | Outcome Id | 30603532 | Outcome Id | 30603532 | Outcome Id | 30603532 | Outcome Id | 30603533 | Outcome Id | 30603534 | Outcome Id | 30603535 | Outcome Id | 30603536 | Outcome Id | 30603537 | Outcome Id | 30603538 | Outcome Id | 30603539 | Outcome Id | 30603540 | Outcome Id | 30603541 | Outcome Id | 30603542 | Outcome Id | 30603543 | Outcome Id | 30603544 |
Result Group Id | 55825947 | Result Group Id | 55825948 | Result Group Id | 55825947 | Result Group Id | 55825948 | Result Group Id | 55825947 | Result Group Id | 55825948 | Result Group Id | 55825947 | Result Group Id | 55825948 | Result Group Id | 55825947 | Result Group Id | 55825948 | Result Group Id | 55825947 | Result Group Id | 55825948 | Result Group Id | 55825947 | Result Group Id | 55825948 | Result Group Id | 55825947 | Result Group Id | 55825948 | Result Group Id | 55825947 | Result Group Id | 55825948 | Result Group Id | 55825947 | Result Group Id | 55825948 | Result Group Id | 55825947 | Result Group Id | 55825948 | Result Group Id | 55825947 | Result Group Id | 55825948 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 |
Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure |
Units | Participants | Units | Participants | Units | side of forehead (either left or right) | Units | side of forehead (either left or right) | Units | Participants | Units | Participants | Units | side of forehead (either left or right) | Units | side of forehead (either left or right) | Units | Participants | Units | Participants | Units | side of forehead (either left or right) | Units | side of forehead (either left or right) | Units | Participants | Units | Participants | Units | side of forehead (either left or right) | Units | side of forehead (either left or right) | Units | Participants | Units | Participants | Units | side of forehead (either left or right) | Units | side of forehead (either left or right) | Units | Participants | Units | Participants | Units | side of forehead (either left or right) | Units | side of forehead (either left or right) | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants |
Count | 14 | Count | 14 | Count | 14 | Count | 14 | Count | 14 | Count | 14 | Count | 14 | Count | 14 | Count | 14 | Count | 14 | Count | 14 | Count | 14 | Count | 14 | Count | 14 | Count | 14 | Count | 14 | Count | 14 | Count | 14 | Count | 14 | Count | 14 | Count | 14 | Count | 14 | Count | 14 | Count | 14 | Count | 14 | Count | 14 | Count | 14 | Count | 14 | Count | 14 | Count | 14 | Count | 14 | Count | 14 | Count | 14 | Count | 14 | Count | 14 | Count | 14 |
Provided Documents
Sequence: | 2565770 |
Document Type | Study Protocol and Statistical Analysis Plan |
Has Protocol | True |
Has Icf | False |
Has Sap | True |
Document Date | 2018-11-30 |
Url | https://ClinicalTrials.gov/ProvidedDocs/84/NCT03799484/Prot_SAP_000.pdf |
Reported Event Totals
Sequence: | 27770422 | Sequence: | 27770423 | Sequence: | 27770424 | Sequence: | 27770425 | Sequence: | 27770426 | Sequence: | 27770427 |
Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG001 | Ctgov Group Code | EG001 |
Event Type | serious | Event Type | other | Event Type | deaths | Event Type | serious | Event Type | other | Event Type | deaths |
Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality | Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality |
Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 |
Subjects At Risk | 14 | Subjects At Risk | 14 | Subjects At Risk | 14 | Subjects At Risk | 14 | Subjects At Risk | 14 | Subjects At Risk | 14 |
Created At | 2023-08-06 14:23:58.045603 | Created At | 2023-08-06 14:23:58.045603 | Created At | 2023-08-06 14:23:58.045603 | Created At | 2023-08-06 14:23:58.045603 | Created At | 2023-08-06 14:23:58.045603 | Created At | 2023-08-06 14:23:58.045603 |
Updated At | 2023-08-06 14:23:58.045603 | Updated At | 2023-08-06 14:23:58.045603 | Updated At | 2023-08-06 14:23:58.045603 | Updated At | 2023-08-06 14:23:58.045603 | Updated At | 2023-08-06 14:23:58.045603 | Updated At | 2023-08-06 14:23:58.045603 |
Responsible Parties
Sequence: | 28655291 |
Responsible Party Type | Principal Investigator |
Name | Karina Richani-Reverol |
Title | Clinical Assistant Professor |
Affiliation | The University of Texas Health Science Center, Houston |
Result Agreements
Sequence: | 3828473 |
Pi Employee | Yes |
Result Contacts
Sequence: | 3828438 |
Organization | The University of Texas Health Science Center at Houston |
Name | Karina Richani-Reverol, MD |
Phone | (713) 559-5200 |
Karina.RichaniReverol@uth.tmc.edu | |
Outcomes
Sequence: | 30603528 | Sequence: | 30603527 | Sequence: | 30603529 | Sequence: | 30603530 | Sequence: | 30603531 | Sequence: | 30603532 | Sequence: | 30603533 | Sequence: | 30603534 | Sequence: | 30603535 | Sequence: | 30603536 | Sequence: | 30603537 | Sequence: | 30603538 | Sequence: | 30603539 | Sequence: | 30603540 | Sequence: | 30603541 | Sequence: | 30603542 | Sequence: | 30603543 | Sequence: | 30603544 |
Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary |
Title | Eyebrow Excursion | Title | Eyebrow Excursion | Title | Eyebrow Excursion | Title | Eyebrow Excursion | Title | Duration of Botulinum Toxin Type A Effect | Title | Perception of Pain Immediately After Injection as Assessed by a Visual Analogue Scale | Title | Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey | Title | Number of Participants Who Perceive a Difference in Efficacy Between the 2 Sides of Their Face | Title | Number of Participants Who Perceive a Difference in Efficacy Between the 2 Sides of Their Face | Title | Number of Participants Who Perceive a Difference in Efficacy Between the 2 Sides of Their Face |
Description | Participants will be asked to raise the brows, and the excursion of the brow from resting position to maximum elevation will be measured in millimeters. | Description | Participants will be asked to raise the brows, and the excursion of the brow from resting position to maximum elevation will be measured in millimeters. | Description | Participants will be asked to raise the brows, and the excursion of the brow from resting position to maximum elevation will be measured in millimeters. | Description | Loss of Botulinum Toxin Type A effect is defined as return of baseline frontalis muscle function (function prior to injection) as indicated by eyebrow excursion measurement within 2 millimeters of baseline value. | Description | A visual analogue scale will be used to assess pain. The scale ranges from 0 (no pain) to 10 (the worse pain possible), with lower scores indicating a better outcome. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | Participants will be asked if there is a noticeable difference between the 2 sides of their face. | Description | Participants will be asked if there is a noticeable difference between the 2 sides of their face. | Description | Participants will be asked if there is a noticeable difference between the 2 sides of their face. | ||
Time Frame | Week 2 | Time Frame | Baseline | Time Frame | Week 6 | Time Frame | week 16 | Time Frame | week 16 | Time Frame | Immediately after botox injection | Time Frame | Week 2 | Time Frame | Week 6 | Time Frame | Week 16 | Time Frame | Week 2 | Time Frame | Week 6 | Time Frame | Week 16 | Time Frame | Week 2 | Time Frame | Week 6 | Time Frame | Week 16 | Time Frame | Week 2 | Time Frame | Week 6 | Time Frame | Week 16 |
Units | millimeters | Units | millimeters | Units | millimeters | Units | millimeters | Units | weeks | Units | units on a scale | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants |
Units Analyzed | side of forehead (either left or right) | Units Analyzed | side of forehead (either left or right) | Units Analyzed | side of forehead (either left or right) | Units Analyzed | side of forehead (either left or right) | Units Analyzed | side of forehead (either left or right) | Units Analyzed | side of forehead (either left or right) | ||||||||||||||||||||||||
Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Error | Dispersion Type | Standard Deviation | ||||||||||||||||||||||||
Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants |
Outcome Measurements
Sequence: | 234047580 | Sequence: | 234047581 | Sequence: | 234047582 | Sequence: | 234047583 | Sequence: | 234047584 | Sequence: | 234047585 | Sequence: | 234047586 | Sequence: | 234047587 | Sequence: | 234047588 | Sequence: | 234047589 | Sequence: | 234047590 | Sequence: | 234047591 | Sequence: | 234047592 | Sequence: | 234047593 | Sequence: | 234047594 | Sequence: | 234047595 | Sequence: | 234047596 | Sequence: | 234047597 | Sequence: | 234047598 | Sequence: | 234047599 | Sequence: | 234047600 | Sequence: | 234047601 | Sequence: | 234047602 | Sequence: | 234047603 | Sequence: | 234047604 | Sequence: | 234047605 | Sequence: | 234047606 | Sequence: | 234047607 | Sequence: | 234047608 | Sequence: | 234047609 | Sequence: | 234047610 | Sequence: | 234047611 | Sequence: | 234047612 | Sequence: | 234047613 | Sequence: | 234047614 | Sequence: | 234047615 | Sequence: | 234047616 | Sequence: | 234047617 | Sequence: | 234047618 | Sequence: | 234047619 | Sequence: | 234047620 | Sequence: | 234047621 | Sequence: | 234047622 | Sequence: | 234047623 | Sequence: | 234047624 | Sequence: | 234047625 | Sequence: | 234047626 | Sequence: | 234047627 | Sequence: | 234047628 | Sequence: | 234047629 | Sequence: | 234047630 | Sequence: | 234047631 | Sequence: | 234047632 | Sequence: | 234047633 | Sequence: | 234047634 | Sequence: | 234047635 | Sequence: | 234047636 | Sequence: | 234047637 | Sequence: | 234047638 | Sequence: | 234047639 |
Outcome Id | 30603527 | Outcome Id | 30603527 | Outcome Id | 30603528 | Outcome Id | 30603528 | Outcome Id | 30603529 | Outcome Id | 30603529 | Outcome Id | 30603530 | Outcome Id | 30603530 | Outcome Id | 30603531 | Outcome Id | 30603531 | Outcome Id | 30603532 | Outcome Id | 30603532 | Outcome Id | 30603533 | Outcome Id | 30603533 | Outcome Id | 30603533 | Outcome Id | 30603533 | Outcome Id | 30603533 | Outcome Id | 30603534 | Outcome Id | 30603534 | Outcome Id | 30603534 | Outcome Id | 30603534 | Outcome Id | 30603534 | Outcome Id | 30603535 | Outcome Id | 30603535 | Outcome Id | 30603535 | Outcome Id | 30603535 | Outcome Id | 30603535 | Outcome Id | 30603536 | Outcome Id | 30603536 | Outcome Id | 30603536 | Outcome Id | 30603536 | Outcome Id | 30603536 | Outcome Id | 30603537 | Outcome Id | 30603537 | Outcome Id | 30603537 | Outcome Id | 30603537 | Outcome Id | 30603537 | Outcome Id | 30603538 | Outcome Id | 30603538 | Outcome Id | 30603538 | Outcome Id | 30603538 | Outcome Id | 30603538 | Outcome Id | 30603539 | Outcome Id | 30603539 | Outcome Id | 30603539 | Outcome Id | 30603539 | Outcome Id | 30603539 | Outcome Id | 30603540 | Outcome Id | 30603540 | Outcome Id | 30603540 | Outcome Id | 30603540 | Outcome Id | 30603540 | Outcome Id | 30603541 | Outcome Id | 30603541 | Outcome Id | 30603541 | Outcome Id | 30603541 | Outcome Id | 30603541 | Outcome Id | 30603542 | Outcome Id | 30603543 | Outcome Id | 30603544 |
Result Group Id | 55825947 | Result Group Id | 55825948 | Result Group Id | 55825947 | Result Group Id | 55825948 | Result Group Id | 55825947 | Result Group Id | 55825948 | Result Group Id | 55825947 | Result Group Id | 55825948 | Result Group Id | 55825947 | Result Group Id | 55825948 | Result Group Id | 55825947 | Result Group Id | 55825948 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 |
Category | very satisfied | Category | satisfied | Category | neutral | Category | dissatisfied | Category | very dissatisfied | Category | very satisfied | Category | satisfied | Category | neutral | Category | dissatisfied | Category | very dissatisfied | Category | very satisfied | Category | satisfied | Category | neutral | Category | dissatisfied | Category | very dissatisfied | Category | very satisfied | Category | satisfied | Category | neutral | Category | dissatisfied | Category | very dissatisfied | Category | very satisfied | Category | satisfied | Category | neutral | Category | dissatisfied | Category | very dissatisfied | Category | very satisfied | Category | satisfied | Category | neutral | Category | dissatisfied | Category | very dissatisfied | Category | very satisfied | Category | satisfied | Category | neutral | Category | dissatisfied | Category | very dissatisfied | Category | very satisfied | Category | satisfied | Category | neutral | Category | dissatisfied | Category | very dissatisfied | Category | very satisfied | Category | satisfied | Category | neutral | Category | dissatisfied | Category | very dissatisfied | ||||||||||||||||||||||||||||||
Title | Eyebrow Excursion | Title | Eyebrow Excursion | Title | Eyebrow Excursion | Title | Eyebrow Excursion | Title | Eyebrow Excursion | Title | Eyebrow Excursion | Title | Eyebrow Excursion | Title | Eyebrow Excursion | Title | Duration of Botulinum Toxin Type A Effect | Title | Duration of Botulinum Toxin Type A Effect | Title | Perception of Pain Immediately After Injection as Assessed by a Visual Analogue Scale | Title | Perception of Pain Immediately After Injection as Assessed by a Visual Analogue Scale | Title | Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey | Title | Number of Participants Who Perceive a Difference in Efficacy Between the 2 Sides of Their Face | Title | Number of Participants Who Perceive a Difference in Efficacy Between the 2 Sides of Their Face | Title | Number of Participants Who Perceive a Difference in Efficacy Between the 2 Sides of Their Face |
Description | Participants will be asked to raise the brows, and the excursion of the brow from resting position to maximum elevation will be measured in millimeters. | Description | Participants will be asked to raise the brows, and the excursion of the brow from resting position to maximum elevation will be measured in millimeters. | Description | Participants will be asked to raise the brows, and the excursion of the brow from resting position to maximum elevation will be measured in millimeters. | Description | Participants will be asked to raise the brows, and the excursion of the brow from resting position to maximum elevation will be measured in millimeters. | Description | Participants will be asked to raise the brows, and the excursion of the brow from resting position to maximum elevation will be measured in millimeters. | Description | Participants will be asked to raise the brows, and the excursion of the brow from resting position to maximum elevation will be measured in millimeters. | Description | Loss of Botulinum Toxin Type A effect is defined as return of baseline frontalis muscle function (function prior to injection) as indicated by eyebrow excursion measurement within 2 millimeters of baseline value. | Description | Loss of Botulinum Toxin Type A effect is defined as return of baseline frontalis muscle function (function prior to injection) as indicated by eyebrow excursion measurement within 2 millimeters of baseline value. | Description | A visual analogue scale will be used to assess pain. The scale ranges from 0 (no pain) to 10 (the worse pain possible), with lower scores indicating a better outcome. | Description | A visual analogue scale will be used to assess pain. The scale ranges from 0 (no pain) to 10 (the worse pain possible), with lower scores indicating a better outcome. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | Participants will be asked if there is a noticeable difference between the 2 sides of their face. | Description | Participants will be asked if there is a noticeable difference between the 2 sides of their face. | Description | Participants will be asked if there is a noticeable difference between the 2 sides of their face. | ||||
Units | millimeters | Units | millimeters | Units | millimeters | Units | millimeters | Units | millimeters | Units | millimeters | Units | millimeters | Units | millimeters | Units | weeks | Units | weeks | Units | units on a scale | Units | units on a scale | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants |
Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants |
Param Value | 10.57 | Param Value | 10.57 | Param Value | 3.46 | Param Value | 3.43 | Param Value | 5.96 | Param Value | 5.68 | Param Value | 8.21 | Param Value | 8.07 | Param Value | 14.2857 | Param Value | 15.2857 | Param Value | 2.43 | Param Value | 3.96 | Param Value | 8 | Param Value | 6 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 7 | Param Value | 6 | Param Value | 1 | Param Value | 0 | Param Value | 0 | Param Value | 8 | Param Value | 2 | Param Value | 1 | Param Value | 3 | Param Value | 0 | Param Value | 8 | Param Value | 6 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 7 | Param Value | 5 | Param Value | 2 | Param Value | 0 | Param Value | 0 | Param Value | 8 | Param Value | 2 | Param Value | 1 | Param Value | 3 | Param Value | 0 | Param Value | 8 | Param Value | 6 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 6 | Param Value | 7 | Param Value | 1 | Param Value | 0 | Param Value | 0 | Param Value | 8 | Param Value | 2 | Param Value | 1 | Param Value | 3 | Param Value | 0 | Param Value | 3 | Param Value | 2 | Param Value | 0 |
Param Value Num | 10.57 | Param Value Num | 10.57 | Param Value Num | 3.46 | Param Value Num | 3.43 | Param Value Num | 5.96 | Param Value Num | 5.68 | Param Value Num | 8.21 | Param Value Num | 8.07 | Param Value Num | 14.2857 | Param Value Num | 15.2857 | Param Value Num | 2.43 | Param Value Num | 3.96 | Param Value Num | 8.0 | Param Value Num | 6.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 7.0 | Param Value Num | 6.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 8.0 | Param Value Num | 2.0 | Param Value Num | 1.0 | Param Value Num | 3.0 | Param Value Num | 0.0 | Param Value Num | 8.0 | Param Value Num | 6.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 7.0 | Param Value Num | 5.0 | Param Value Num | 2.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 8.0 | Param Value Num | 2.0 | Param Value Num | 1.0 | Param Value Num | 3.0 | Param Value Num | 0.0 | Param Value Num | 8.0 | Param Value Num | 6.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 6.0 | Param Value Num | 7.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 8.0 | Param Value Num | 2.0 | Param Value Num | 1.0 | Param Value Num | 3.0 | Param Value Num | 0.0 | Param Value Num | 3.0 | Param Value Num | 2.0 | Param Value Num | 0.0 |
Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Error | Dispersion Type | Standard Error | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dispersion Value | 3.3 | Dispersion Value | 3.16 | Dispersion Value | 2.76 | Dispersion Value | 2.93 | Dispersion Value | 2.62 | Dispersion Value | 2.55 | Dispersion Value | 2.89 | Dispersion Value | 2.97 | Dispersion Value | 1.2317 | Dispersion Value | 0.7301 | Dispersion Value | 1.55 | Dispersion Value | 1.74 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dispersion Value Num | 3.3 | Dispersion Value Num | 3.16 | Dispersion Value Num | 2.76 | Dispersion Value Num | 2.93 | Dispersion Value Num | 2.62 | Dispersion Value Num | 2.55 | Dispersion Value Num | 2.89 | Dispersion Value Num | 2.97 | Dispersion Value Num | 1.2317 | Dispersion Value Num | 0.7301 | Dispersion Value Num | 1.55 | Dispersion Value Num | 1.74 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Study References
Sequence: | 51655904 | Sequence: | 51655905 | Sequence: | 51655906 | Sequence: | 51655907 | Sequence: | 51655908 | Sequence: | 51655909 | Sequence: | 51655910 | Sequence: | 51655911 | Sequence: | 51655912 | Sequence: | 51655913 | Sequence: | 51655914 | Sequence: | 51655915 | Sequence: | 51655916 | Sequence: | 51655917 | Sequence: | 51655918 | Sequence: | 51655919 |
Pmid | 7365644 | Pmid | 9834738 | Pmid | 9279643 | Pmid | 15598005 | Pmid | 7824641 | Pmid | 2748749 | Pmid | 17117100 | Pmid | 24699554 | Pmid | 29016544 | Pmid | 27617615 | Pmid | 21120257 | Pmid | 19454924 | Pmid | 25705950 | Pmid | 15507786 | Pmid | 17376126 | Pmid | 15710113 |
Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background |
Citation | Scott AB. Botulinum toxin injection into extraocular muscles as an alternative to strabismus surgery. J Pediatr Ophthalmol Strabismus. 1980 Jan-Feb;17(1):21-5. doi: 10.3928/0191-3913-19800101-06. | Citation | Carruthers A, Carruthers J. Clinical indications and injection technique for the cosmetic use of botulinum A exotoxin. Dermatol Surg. 1998 Nov;24(11):1189-94. doi: 10.1111/j.1524-4725.1998.tb04097.x. | Citation | Carter SR, Seiff SR. Cosmetic botulinum toxin injections. Int Ophthalmol Clin. 1997 Summer;37(3):69-79. doi: 10.1097/00004397-199703730-00006. No abstract available. | Citation | Charles PD. Botulinum neurotoxin serotype A: a clinical update on non-cosmetic uses. Am J Health Syst Pharm. 2004 Nov 15;61(22 Suppl 6):S11-23. doi: 10.1093/ajhp/61.suppl_6.S11. | Citation | Carruthers A, Carruthers J. Aesthetic indications for botulinum toxin injections. Plast Reconstr Surg. 1995 Feb;95(2):427-8. doi: 10.1097/00006534-199502000-00049. No abstract available. | Citation | Clark RP, Berris CE. Botulinum toxin: a treatment for facial asymmetry caused by facial nerve paralysis. Plast Reconstr Surg. 1989 Aug;84(2):353-5. | Citation | Sami MS, Soparkar CN, Patrinely JR, Hollier LM, Hollier LH. Efficacy of botulinum toxin type a after topical anesthesia. Ophthalmic Plast Reconstr Surg. 2006 Nov-Dec;22(6):448-52. doi: 10.1097/01.iop.0000248989.33572.3c. | Citation | Gordin EA, Luginbuhl AL, Ortlip T, Heffelfinger RN, Krein H. Subcutaneous vs intramuscular botulinum toxin: split-face randomized study. JAMA Facial Plast Surg. 2014 May-Jun;16(3):193-8. doi: 10.1001/jamafacial.2013.2458. | Citation | Li Y, Dong W, Wang M, Xu N. Investigation of the Efficacy and Safety of Topical Vibration Anesthesia to Reduce Pain From Cosmetic Botulinum Toxin A Injections in Chinese Patients: A Multicenter, Randomized, Self-Controlled Study. Dermatol Surg. 2017 Dec;43 Suppl 3:S329-S335. doi: 10.1097/DSS.0000000000001349. | Citation | Shi LL, Sargen MR, Chen SC, Arbiser JL, Pollack BP. Effective local anesthesia for onabotulinumtoxin A injections to treat hyperhidrosis associated with traumatic amputation. Dermatol Online J. 2016 Jun 15;22(6):13030/qt38b203d0. | Citation | Baumann LS, Grunebaum L, Elsaie ML, Murdock J, Jablonka E, Figueras K, Bell M. Safety and efficacy of a rapid-acting topical 4% lidocaine gel in a unique drug delivery system. J Drugs Dermatol. 2010 Dec;9(12):1500-4. | Citation | Weiss RA, Lavin PT. Reduction of pain and anxiety prior to botulinum toxin injections with a new topical anesthetic method. Ophthalmic Plast Reconstr Surg. 2009 May-Jun;25(3):173-7. doi: 10.1097/IOP.0b013e3181a145ca. | Citation | Alam M, Bolotin D, Carruthers J, Hexsel D, Lawrence N, Minkis K, Ross EV. Consensus statement regarding storage and reuse of previously reconstituted neuromodulators. Dermatol Surg. 2015 Mar;41(3):321-6. doi: 10.1097/DSS.0000000000000303. | Citation | Carruthers J, Fagien S, Matarasso SL; Botox Consensus Group. Consensus recommendations on the use of botulinum toxin type a in facial aesthetics. Plast Reconstr Surg. 2004 Nov;114(6 Suppl):1S-22S. doi: 10.1097/01.PRS.0000144795.76040.D3. | Citation | Ito H, Ito H, Nakano S, Kusaka H. Low-dose subcutaneous injection of botulinum toxin type A for facial synkinesis and hyperlacrimation. Acta Neurol Scand. 2007 Apr;115(4):271-4. doi: 10.1111/j.1600-0404.2006.00746.x. | Citation | Tzou CH, Giovanoli P, Ploner M, Frey M. Are there ethnic differences of facial movements between Europeans and Asians? Br J Plast Surg. 2005 Mar;58(2):183-95. doi: 10.1016/j.bjps.2004.10.014. |
Baseline Counts
Sequence: | 11314641 |
Result Group Id | 55825945 |
Ctgov Group Code | BG000 |
Units | Participants |
Scope | overall |
Count | 14 |
Result Groups
Sequence: | 55825945 | Sequence: | 55825946 | Sequence: | 55825947 | Sequence: | 55825948 | Sequence: | 55825949 | Sequence: | 55825950 | Sequence: | 55825951 |
Ctgov Group Code | BG000 | Ctgov Group Code | FG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 |
Result Type | Baseline | Result Type | Participant Flow | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Reported Event | Result Type | Reported Event |
Title | All Participants | Title | All Participants | Title | Topical Anesthesia | Title | Petrolatum | Title | All Participants | Title | Topical Anesthesia | Title | Petrolatum |
Description | 2.5% Lidocaine/2.5% Prilocaine Cream will be applied to one side of the forehead and Petrolatum Ointment to the other side of the forehead prior to administration of Botulinum Toxin Type A Injection. | Description | 2.5% Lidocaine/2.5% Prilocaine Cream will be applied to one side of the forehead and Petrolatum Ointment to the other side of the forehead prior to administration of Botulinum Toxin Type A Injection. | Description | 2.5% Lidocaine/2.5% Prilocaine Cream will be applied to one side of the forehead and Petrolatum Ointment to the other prior to administration of Botulinum Toxin Type A Injection
Botulinum toxin type A: Botulinum toxin type A will be administered to both sides 2.5% lidocaine/2.5% prilocaine: 2.5% lidocaine/2.5% prilocaine will be applied to one side of the forehead |
Description | Petrolatum Ointment will be applied to one side of the forehead and 2.5% Lidocaine/2.5% Prilocaine Cream to the other side prior to administration of Botulinum Toxin Type A Injection
Botulinum toxin type A: Botulinum toxin type A will be administered to both sides petrolatum ointment: petrolatum ointment will be applied to one side of the forehead |
Description | 2.5% Lidocaine/2.5% Prilocaine Cream will be applied to one side of the forehead and Petrolatum Ointment to the other side of the forehead prior to administration of Botulinum Toxin Type A Injection. | Description | 2.5% Lidocaine/2.5% Prilocaine Cream will be applied to one side of the forehead and Petrolatum Ointment to the other prior to administration of Botulinum Toxin Type A Injection
Botulinum toxin type A: Botulinum toxin type A will be administered to both sides 2.5% lidocaine/2.5% prilocaine: 2.5% lidocaine/2.5% prilocaine will be applied to one side of the forehead |
Description | Petrolatum Ointment will be applied to one side of the forehead and 2.5% Lidocaine/2.5% Prilocaine Cream to the other side prior to administration of Botulinum Toxin Type A Injection
Botulinum toxin type A: Botulinum toxin type A will be administered to both sides petrolatum ointment: petrolatum ointment will be applied to one side of the forehead |
Baseline Measurements
Sequence: | 124852627 | Sequence: | 124852628 | Sequence: | 124852629 | Sequence: | 124852630 | Sequence: | 124852631 | Sequence: | 124852632 | Sequence: | 124852633 | Sequence: | 124852634 |
Result Group Id | 55825945 | Result Group Id | 55825945 | Result Group Id | 55825945 | Result Group Id | 55825945 | Result Group Id | 55825945 | Result Group Id | 55825945 | Result Group Id | 55825945 | Result Group Id | 55825945 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 |
Classification | Asian | Classification | Hispanic | Classification | White | Classification | United States | ||||||||
Category | Female | Category | Male | ||||||||||||
Title | Age, Continuous | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Region of Enrollment | Title | Distance between both lateral canthi |
Units | years | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | millimeters |
Param Type | Mean | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Mean |
Param Value | 35.5 | Param Value | 9 | Param Value | 5 | Param Value | 1 | Param Value | 6 | Param Value | 7 | Param Value | 14 | Param Value | 98.29 |
Param Value Num | 35.5 | Param Value Num | 9.0 | Param Value Num | 5.0 | Param Value Num | 1.0 | Param Value Num | 6.0 | Param Value Num | 7.0 | Param Value Num | 14.0 | Param Value Num | 98.29 |
Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | ||||||||||||
Dispersion Value | 6.7 | Dispersion Value | 3.43 | ||||||||||||
Dispersion Value Num | 6.7 | Dispersion Value Num | 3.43 | ||||||||||||
Number Analyzed | 14 | Number Analyzed | 14 | Number Analyzed | 14 | Number Analyzed | 14 | Number Analyzed | 14 | Number Analyzed | 14 | Number Analyzed | 14 | Number Analyzed | 14 |
]]>
https://zephyrnet.com/NCT03799471
2019-02-26
https://zephyrnet.com/?p=NCT03799471
NCT03799471https://www.clinicaltrials.gov/study/NCT03799471?tab=tableNANANAThis study evaluates nervous system hypersensitivity in individuals with inflammatory bowel disease (IBD) and experiences of ongoing musculoskeletal (MSK) pain. Previous results and current literature suggest that MSK pain in IBD may be influenced by hypersensitivity of the central nervous system, termed central sensitization. However, specific mechanisms contributing to pain experiences are unknown. Therefore, primary aims are to explore aspects of central sensitization through sensory testing in this population, and to investigate association of psychological and IBD features to sensory profiles. This study hypothesizes that IBD patients with MSK pain will demonstrate altered sensory function, and IBD/psychosocial features will be associated with altered sensory functioning and worse pain experiences.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-06 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2019-08-28 |
Start Month Year | February 26, 2019 |
Primary Completion Month Year | July 19, 2019 |
Verification Month Year | August 2019 |
Verification Date | 2019-08-31 |
Last Update Posted Date | 2019-08-28 |
Facilities
Sequence: | 200594632 |
Name | Dartmouth-Hitchcock Medical Center |
City | Lebanon |
State | New Hampshire |
Zip | 03756-0001 |
Country | United States |
Conditions
Sequence: | 52321373 | Sequence: | 52321374 | Sequence: | 52321375 |
Name | Inflammatory Bowel Diseases | Name | Chronic Pain | Name | Central Sensitization |
Downcase Name | inflammatory bowel diseases | Downcase Name | chronic pain | Downcase Name | central sensitization |
Id Information
Sequence: | 40266105 |
Id Source | org_study_id |
Id Value | W19040 |
Countries
Sequence: | 42685623 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55760298 | Sequence: | 55760299 | Sequence: | 55760300 |
Title | IBD with MSK pain | Title | IBD without MSK pain | Title | Healthy Controls |
Description | IBD patients with self-reported MSK pain. No intervention. Participants will be assessed once regarding: somatosensory functioning, psychological features, MSK pain features, co-morbidity, and IBD features | Description | IBD patients without self-reported MSK pain. No intervention. Participants will be assessed once regarding: somatosensory functioning, psychological features, co-morbidity, and IBD features | Description | Healthy controls. No intervention. Participants will be assessed once regarding: somatosensory functioning, psychological features, and co-morbidity. |
Keywords
Sequence: | 80075943 | Sequence: | 80075944 |
Name | chronic musculoskeletal pain | Name | central hypersensitivity |
Downcase Name | chronic musculoskeletal pain | Downcase Name | central hypersensitivity |
Design Outcomes
Sequence: | 177934246 | Sequence: | 177934247 | Sequence: | 177934248 | Sequence: | 177934249 | Sequence: | 177934250 | Sequence: | 177934251 | Sequence: | 177934252 | Sequence: | 177934253 | Sequence: | 177934254 | Sequence: | 177934255 | Sequence: | 177934256 | Sequence: | 177934257 | Sequence: | 177934258 | Sequence: | 177934259 | Sequence: | 177934260 | Sequence: | 177934261 | Sequence: | 177934262 | Sequence: | 177934263 | Sequence: | 177934264 | Sequence: | 177934265 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | other | Outcome Type | other |
Measure | Pain pressure threshold (PPT) | Measure | Conditioned pain modulation (CPM) | Measure | Temporal summation (TS) | Measure | Central sensitization inventory (CSI) | Measure | Abdominal pain: Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference 4a short form | Measure | Abdominal pain intensity: numeric rating scale | Measure | Health-related quality of life (HRQOL) – EQ-5D | Measure | Situational Catastrophizing Questionnaire (SCQ) | Measure | Positive and Negative Affective Schedule (PANAS) | Measure | 10-item Perceived Stress Scale (PSS-10) | Measure | Hospital Anxiety and Depression Scale (HADS) | Measure | Total comorbidity score | Measure | MSK pain location | Measure | MSK pain – PROMIS Pain Interference 4a | Measure | MSK pain intensity – numeric rating scale | Measure | Health-related quality of life (EQ-5D) | Measure | IBD type | Measure | IBD duration | Measure | Vibration detection threshold (VDT) | Measure | Semmes-Weinstein monofilament examination (SWME) |
Time Frame | Baseline | Time Frame | Baseline | Time Frame | Baseline | Time Frame | Baseline | Time Frame | Baseline | Time Frame | Baseline | Time Frame | Baseline | Time Frame | Baseline | Time Frame | Baseline | Time Frame | Baseline | Time Frame | Baseline | Time Frame | Baseline | Time Frame | Baseline | Time Frame | Baseline | Time Frame | Baseline | Time Frame | Baseline | Time Frame | Baseline | Time Frame | Baseline | Time Frame | Baseline | Time Frame | Baseline |
Description | PPT will be assessed using an electronic handheld algometer (Wagner Force One™ FDIX) in: 1) low back (local), and 2) contralateral tibialis anterior. Individuals in "IBD with MSK pain" group will undergo an additional PPT assessment related to the region identified as their "main" area of MSK pain.
PPT will be assessed by a series of 3 ascending stimulus intensities given as a slowly increasing ramp (50 kilopascal (kPa/s)) from 0 to a maximum pressure of 1000 kPa. Pressure corresponding to the moment when participants identify that the sensation of pressure alone changing to one of pressure and pain, will be recorded for each trial. PPT for each region will be described as the mean of three trials in kPa. Decreased values indicates hypersensitivity of the nervous system. |
Description | CPM in the present study includes: PPT of tibialis anterior (test stimulus) and cold pressor test (CPT) to the contralateral hand (conditioning stimulus).
PPT will be performed and recorded as descried above prior to and immediately following CPT. CPT: Hand will be submerged in an ice bath with the temperature maintained below 3°C for a maximum of 2 minutes. Participants will withdraw their hand when the pain perceived becomes intolerable or 2 minute maximum is reached. Participants will give a numeric pain rating (0-100) at the time of hand removal. Total immersion time (minutes:seconds) and pain rating will be recorded for CPT. CPM (primary outcome) will be defined as the absolute numerical difference of PPT after minus before the CPT, with positive values indicating successful pain modulation. |
Description | Mechanical TS in the present study will be assessed by a wind-up-ratio (WUR) of the volar aspect of the non-dominant arm using a Semmes-Weinstein monofilament (no. 6.45). The perceived intensity of a single stimulus will be compared with that of a series of 10 repetitive stimuli of the same physical intensity. Participants will be asked to give a pain rating for the single stimulus and a pain rating for the series of 10 stimuli as a whole, using a '0-100' numerical rating scale. This procedure will be repeated for three trials, with 1 minute between trials, and performed at different areas of the volar forearm for each trial. The mean pain rating of the 10 series divided by the mean pain rating of the single stimuli will be calculated as WUR. Higher scores indicate greater mechanical TS, indicating an increase in central sensitivity or facilitation. | Description | CSI is a self-report questionnaire indicating the presence of symptoms related to central sensitization syndromes. CSI consists of 25 statements where each statement is evaluated using a 5 point like scale with Never (0), Rarely (1), Sometimes (2), Often (3), and Always (4). This results in a cumulative score of 100. Scores equal to or greater than 40 indicate the likelihood of central sensitization. | Description | Positive findings for abdominal pain interference, include: mild (50-59), moderate (60-69), or severe (≥70). | Description | Numeric rating scales recorded for worst, average, and current pain levels, with positive findings as mild (1-4), moderate (5-6), or severe (7-10). | Description | The EQ-5D questionnaire descriptive system comprises five domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each one with five possible levels: no problems (level 1), slight problems (level 2), moderate problems (level 3), severe problems (level 4), and extreme problems (level 5); as well as a visual analogue scale ranging from 0 to 100 with higher scores indicating 'best health'. | Description | SCQ asks participants to reflect on any pain experienced during CPM testing, and to indicate the degree to which they experienced each of 13 thoughts or feelings during this experience, on 5-point Likert scales ranging from (0) not at all to (4) all the time. Total scores range from 0 to 24, with higher score representing greater pain catastrophizing. | Description | This questionnaire includes words describing 10 positive and 10 negative emotions, and requires participants to indicate on a Likert scale (1-5) the extent for which they felt each emotion during the previous week, with higher sub-scores represent greater negative or positive affect styles, respectively. | Description | The PSS-10 evaluates the degree to which individuals believe their life has been unpredictable, uncontrollable, and overloaded during the previous month, using a Likert scale (0-4) for each item, with higher scores representing greater perceived stress. | Description | Scores for each subscale range from 0 to 21, with scores categorized as follows: normal 0-7, mild 8-10, moderate 11-14, and severe 15-21. Scores for the entire scale (emotional distress) range from 0 to 42, with higher scores indicating more distress. | Description | Total comorbidity scores will be calculated as numerical disease counts using health conditions identified on the Self-Administered Comorbidity Questionnaire, a 20-item extraintestinal manifestation (EIM) checklist developed from multiple EIM investigations, and conditions identified on the central sensitization inventory (CSI) (part B). Scores range from 0 to 39 with higher scores indicating greater comorbidity. | Description | Pain location will be recorded regionally (n=47) using a body diagram. Individuals with generalized pain will be categorically (yes/no) distinguished from those with regional pain using the modified widespread pain criterion which requires having pain in 4 out of 5 pain regions (4 quadrants plus axial pain). | Description | Positive findings for the PROMIS Pain Interference 4a, include: mild (50-59), moderate (60-69), or severe (≥70). | Description | Numeric rating scales for pain intensity will be recorded for worst, average, and current pain levels, with positive findings as mild (1-4), moderate (5-6), or severe (7-10) | Description | EQ-5D is a standardized instrument for measuring of health-related quality of life. The EQ-5D consists of a descriptive system and the EQ VAS. The descriptive system comprises five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) each scored on a 5-point Likert scales ranging from (0) no problem to (4) severe. The EQ VAS records the patient's self-rated health on a 0 to 100 vertical visual analogue scale, with higher scores representing better health-related quality of life. | Description | IBD subtype recorded from medical charts as Crohn's disease, ulcerative colitis, or unspecified IBD. | Description | Time from initial IBD diagnosis – recorded from medical charts in years. | Description | VDT will be assessed using a Rydel-Seiffer graded tuning fork (64 Hz, 8/8 scale) placed over bony prominences (styloid process of the ulna and medial malleolus), bilaterally. Participants will verbally indicate the moment they can no longer feel the sensation of vibration, and the value (1-8) will be recorded. VDT of each site will be described as the mean of three trials. Lower scores indicate decreased thresholds and possible peripheral neuropathy. | Description | SWME of the upper limb will be performed using a 4.56 (4 g) monofilament at six locations divided over the palm and fingers, bilaterally. SWME of the lower limb will be performed using a 5.07 (10 g) monofilament at the pulp of the great toe, as well as the first, third, and fifth metatarsal heads, bilaterally. Participants will confirm (recorded as yes/no) application of the stimulus at each location. Incorrect response at any location indicates possible peripheral neuropathy. |
Browse Conditions
Sequence: | 194058662 | Sequence: | 194058663 | Sequence: | 194058664 | Sequence: | 194058665 | Sequence: | 194058666 | Sequence: | 194058670 | Sequence: | 194058671 | Sequence: | 194058672 | Sequence: | 194058667 | Sequence: | 194058668 | Sequence: | 194058669 |
Mesh Term | Musculoskeletal Pain | Mesh Term | Intestinal Diseases | Mesh Term | Inflammatory Bowel Diseases | Mesh Term | Chronic Pain | Mesh Term | Pain | Mesh Term | Gastroenteritis | Mesh Term | Muscular Diseases | Mesh Term | Musculoskeletal Diseases | Mesh Term | Neurologic Manifestations | Mesh Term | Gastrointestinal Diseases | Mesh Term | Digestive System Diseases |
Downcase Mesh Term | musculoskeletal pain | Downcase Mesh Term | intestinal diseases | Downcase Mesh Term | inflammatory bowel diseases | Downcase Mesh Term | chronic pain | Downcase Mesh Term | pain | Downcase Mesh Term | gastroenteritis | Downcase Mesh Term | muscular diseases | Downcase Mesh Term | musculoskeletal diseases | Downcase Mesh Term | neurologic manifestations | Downcase Mesh Term | gastrointestinal diseases | Downcase Mesh Term | digestive system diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48459975 | Sequence: | 48459976 |
Agency Class | OTHER | Agency Class | OTHER |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | Dartmouth-Hitchcock Medical Center | Name | University of Otago |
Overall Officials
Sequence: | 29365316 |
Role | Principal Investigator |
Name | Corey A Siegel, MD |
Affiliation | Dartmouth-Hitchcock Medical Center |
Eligibilities
Sequence: | 30852310 |
Sampling Method | Probability Sample |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | Accepts Healthy Volunteers |
Population | Dartmouth-Hitchcock Medical Center – IBD Center patient database. |
Criteria | Inclusion Criteria:
Adults (18 years of age or older) Exclusion Criteria: Participants with IBD (with and without MSK pain) will be excluded if they report any of the following: pregnancy |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254271951 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 4 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 3 |
Number Of Secondary Outcomes To Measure | 15 |
Number Of Other Outcomes To Measure | 2 |
Designs
Sequence: | 30598162 |
Observational Model | Case-Control |
Time Perspective | Cross-Sectional |
Responsible Parties
Sequence: | 28964651 |
Responsible Party Type | Principal Investigator |
Name | Corey Siegel |
Title | Section Chief, Gastroenterology and Hepatology |
Affiliation | Dartmouth-Hitchcock Medical Center |
Study References
Sequence: | 52225797 | Sequence: | 52225780 | Sequence: | 52225810 | Sequence: | 52225781 | Sequence: | 52225782 | Sequence: | 52225783 | Sequence: | 52225784 | Sequence: | 52225785 | Sequence: | 52225786 | Sequence: | 52225787 | Sequence: | 52225811 | Sequence: | 52225788 | Sequence: | 52225789 | Sequence: | 52225790 | Sequence: | 52225791 | Sequence: | 52225792 | Sequence: | 52225793 | Sequence: | 52225794 | Sequence: | 52225795 | Sequence: | 52225796 | Sequence: | 52225798 | Sequence: | 52225799 | Sequence: | 52225800 | Sequence: | 52225801 | Sequence: | 52225802 | Sequence: | 52225803 | Sequence: | 52225804 | Sequence: | 52225805 | Sequence: | 52225806 | Sequence: | 52225807 | Sequence: | 52225808 | Sequence: | 52225809 | Sequence: | 52225812 | Sequence: | 52225813 | Sequence: | 52225814 | Sequence: | 52225815 | Sequence: | 52225816 | Sequence: | 52225817 | Sequence: | 52225818 | Sequence: | 52225819 | Sequence: | 52225820 | Sequence: | 52225821 | Sequence: | 52225822 | Sequence: | 52225823 | Sequence: | 52225824 | Sequence: | 52225825 | Sequence: | 52225826 | Sequence: | 52225827 | Sequence: | 52225828 | Sequence: | 52225829 | Sequence: | 52225830 | Sequence: | 52225831 | Sequence: | 52225832 | Sequence: | 52225833 | Sequence: | 52225834 | Sequence: | 52225835 | Sequence: | 52225836 | Sequence: | 52225837 | Sequence: | 52225838 | Sequence: | 52225839 | Sequence: | 52225840 | Sequence: | 52225841 |
Pmid | 19380256 | Pmid | 17602990 | Pmid | 6668417 | Pmid | 25687629 | Pmid | 24833941 | Pmid | 26170832 | Pmid | 27332879 | Pmid | 26512134 | Pmid | 16142874 | Pmid | 25547976 | Pmid | 20372115 | Pmid | 21551189 | Pmid | 21857821 | Pmid | 26614685 | Pmid | 20961685 | Pmid | 25952059 | Pmid | 27586831 | Pmid | 29105941 | Pmid | 19130619 | Pmid | 11289089 | Pmid | 11839418 | Pmid | 16159591 | Pmid | 17717610 | Pmid | 23697467 | Pmid | 18209518 | Pmid | 28052089 | Pmid | 26075963 | Pmid | 12687505 | Pmid | 23181971 | Pmid | 23265763 | Pmid | 11832252 | Pmid | 22884758 | Pmid | 25031113 | Pmid | 17101814 | Pmid | 3397865 | Pmid | 16988570 | Pmid | 29572719 | Pmid | 22398068 | Pmid | 27780886 | Pmid | 26071941 | Pmid | 27584819 | Pmid | 20847477 | Pmid | 16000093 | Pmid | 27916278 | Pmid | 23490634 | Pmid | 21951710 | Pmid | 15737809 | Pmid | 16697110 | Pmid | 19595541 | Pmid | 11640995 | Pmid | 18215749 | Pmid | 29350873 | Pmid | 20932788 | Pmid | 23759706 | Pmid | 26741741 | Pmid | 25330039 | Pmid | 24290446 | Pmid | 26222349 | Pmid | 20878051 | Pmid | 26379077 | Pmid | 28328574 | ||
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https://zephyrnet.com/NCT03799458
2018-07-11
https://zephyrnet.com/?p=NCT03799458
NCT03799458https://www.clinicaltrials.gov/study/NCT03799458?tab=tableNANANAAim 1: To use magnetoencephalography (MEG) and magnetic resonance imaging (MRI) in Veterans and civilians with mild traumatic brain injury (mTBI) and sensory postconcussive symptoms (PCS) to demonstrate the mechanism of therapeutic benefit of HD-tDCS for sensory symptoms, as shown by reliable changes in the activity of the cognitive control network (CCN) and sensory system network (SSN) following stimulation; Aim 2: this intervention will result in long-term improvements in measures of executive function, depression/anxiety, and quality of life.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-12 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2023-06-05 |
Start Month Year | July 11, 2018 |
Primary Completion Month Year | April 30, 2023 |
Verification Month Year | June 2023 |
Verification Date | 2023-06-30 |
Last Update Posted Date | 2023-06-05 |
Detailed Descriptions
Sequence: | 20701809 |
Description | Experimental Design and Methods Participants: 120 subjects will be recruited for this study from the NM VA Health Care System and community, 40 healthy controls subjects for an imaging-only group, and 80 mTBI subjects for the stimulation arm who have suffered injury at least 3 months prior to study enrollment, but not more than 15 years prior to enrollment. All participants will be 18-59 years of age.
Recruitment: Human participants (ages 18-59) will be invited to come to the University of New Mexico (UNM) to ask questions prior to providing consent. They will be provided with consent forms that describe the study procedures and potential risks. Once informed consent is obtained and the appropriate forms signed, the participant will be assigned a unique research subject identifier (URSI) number, and from that point forward all research data will only be labeled with the URSI number. The key linking identifiers of participants to the URSI will be maintained on a separate database that will be stored behind locked doors, in a locked filing cabinet in a secure area. All participants may then undergo demographic data collection, neuropsychological assessments sensory evaluation, at UNM. They may also undergo MEG and MRI at the Mind Research Network (MRN), located in the same building. Demographic Data: As part of the initial assessment, basic demographic data regarding the subject may be noted down, including age, gender, socioeconomic status, educational attainment, handedness, use of common stimulants such as caffeine, and brain injury severity. They may also be asked if they are willing to allow their medical record to be accessed, for the purposes of confirming details about any traumatic brain injury (TBI) as well as obtaining results of neuroimaging studies done at the time of injury or afterward. This will include medical, surgical, neurological and psychiatric history, results of lab tests, brain scans, electroencephalography tests, medication lists, information from doctor's visits and hospital visits. Neuropsychological testing procedures: All neuropsychological testing will be administered in the Center for Brain Recovery and Repair Core by trained study personnel under direct supervision of core directors. The following domains and tests will be administered: Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research (Examiner); Digit Span; Delis-Kaplan Executive Function Systems (DKEFS) Trail-making Test Conditions 2 and 4; Hopkins Verbal Learning Test (HVLT); Frontal Systems Behavior Scale (FrSBe); Test of Memory Malingering (TOMM); Wechsler Test of Adult Reading (WTAR); Digit Symbol Coding; Handedness; Socioeconomic Status (SES); Patient's Global Impression of Change (PGIC); Glasgow Outcome Scale-Extended (GOSE). Sensory Assessment: Hearing, balance, and vision will be assessed using Common Data Element (CDE) instruments, including the Hearing Handicap Assessment, the Test for Visual Discomfort, the modified Balance Error Scoring System. Oculomotor control will be assessed using virtual reality goggles (Oculus) with implanted eye trackers (iScan). Magnetoencephalography: Magnetoencephalography (MEG) may be done after neuropsychological testing. The participant will sit in the MEG scanner to record brain magnetic fields. MEG setup takes between 10 and 30 minutes, and subsequent recording takes one hour. During MEG assessments participants will complete numerous tasks. Each task is designed to parse different cognitive mechanisms that contribute to sensory performance. In perceptual tasks, participants will discriminate tone pitches amongst novel distracting tones (Auditory Orienting Task; AOT). For eye movement tasks, participants are asked look either towards or away from a visual stimulus (Pro- and Anti-saccades). Magnetic resonance imaging (MRI): MRI scan(s) will be obtained for integration with MEG, as needed for analyses. Total scan time, including participant setup and removal, is expected to take 1 hour. Participants may lie down on a table and be placed into a long donut-shaped magnet. During the scan, participants will be asked to rest quietly or to fixate on a dot on a screen in front of them, or to perform a memory task. No contrast will be used. Any female over 18 who thinks she may be pregnant will complete a urine pregnancy screen before the MRI scan. Following initial testing, the participants in the stimulation arm of the study will receive 10 consecutive weekday sessions of high-definition transcranial direct current stimulation. 2 milliamperes active or sham anodal current will be delivered to the left dorsolateral prefrontal cortex for 30 minutes. During this time, participants will perform vision therapy tasks through a virtual reality headset, or a computer-based working memory task. Skin sensations will be assessed every 10 minutes. Post stimulation testing: the next available weekday following completion of the study protocol, subjects will return to UNM to repeat the demographic, neuropsychological, sensory, and imaging assessments. Long term followup: At 1 month, 3 months and 6 months after stimulation, subjects will be contacted via telephone or meet in person, and will be administered the Beck Depression Inventory (BDI-II), Posttraumatic Stress Disorder Checklist-Military (PCL-M), the Neurobehavioral Symptom Inventory (NSI), and Patient Global Impression of Change (PGIC) quality of life assessment tools utilized before and immediately after, after stimulation. Veterans will undergo these study followup visits at NMVAHCS, and civilians at UNM. |
Facilities
Sequence: | 199846146 |
Name | University of New Mexico Health Sciences Center |
City | Albuquerque |
State | New Mexico |
Zip | 87106 |
Country | United States |
Conditions
Sequence: | 52116838 |
Name | Mild Traumatic Brain Injury |
Downcase Name | mild traumatic brain injury |
Id Information
Sequence: | 40116755 |
Id Source | org_study_id |
Id Value | CDMRP-PT160096 |
Countries
Sequence: | 42520729 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55534787 | Sequence: | 55534788 | Sequence: | 55534789 |
Group Type | Active Comparator | Group Type | Sham Comparator | Group Type | No Intervention |
Title | Active Stimulation | Title | Sham Stimulation | Title | Imaging Only |
Description | Active HD-tDCS will be delivered while subjects perform sensory training tasks. | Description | Sham HD-tDCS will be delivered while subjects perform sensory training tasks. | Description | 40 subjects will undergo initial testing only as a healthy control group. |
Interventions
Sequence: | 52431833 | Sequence: | 52431834 |
Intervention Type | Device | Intervention Type | Device |
Name | Active High-definition transcranial direct current stimulation (HD-tDCS) | Name | Sham High-definition transcranial direct current stimulation (HD-tDCS) |
Description | Active HD-tDCS delivers active current through 2-10 electrodes held against the scalp with a lycra cap at specified 10-20 electroencephalography (EEG) coordinates. | Description | Sham HD-tDCS delivers sham current through 2-10 electrodes held against the scalp with a lycra cap at specified 10-20 electroencephalography (EEG) coordinates |
Design Outcomes
Sequence: | 177188508 | Sequence: | 177188509 |
Outcome Type | primary | Outcome Type | secondary |
Measure | Postconcussive sensory symptoms | Measure | Magnetoencephalography peak activation |
Time Frame | 2 week visit | Time Frame | 2 week visit |
Description | Somatic sub scale score from the Neurobehavioral Symptom Inventory (NSI) (range 0-48; 0-12 mild; 13-24 moderate; 25-36 severe; 37-48 very severe) | Description | Peak activation during the Auditory Orienting Task (AOT) performed during magnetoencephalography |
Browse Conditions
Sequence: | 193275585 | Sequence: | 193275586 | Sequence: | 193275587 | Sequence: | 193275588 | Sequence: | 193275589 | Sequence: | 193275590 | Sequence: | 193275591 | Sequence: | 193275592 | Sequence: | 193275593 | Sequence: | 193275594 | Sequence: | 193275584 |
Mesh Term | Brain Injuries, Traumatic | Mesh Term | Brain Concussion | Mesh Term | Wounds and Injuries | Mesh Term | Brain Diseases | Mesh Term | Central Nervous System Diseases | Mesh Term | Nervous System Diseases | Mesh Term | Craniocerebral Trauma | Mesh Term | Trauma, Nervous System | Mesh Term | Head Injuries, Closed | Mesh Term | Wounds, Nonpenetrating | Mesh Term | Brain Injuries |
Downcase Mesh Term | brain injuries, traumatic | Downcase Mesh Term | brain concussion | Downcase Mesh Term | wounds and injuries | Downcase Mesh Term | brain diseases | Downcase Mesh Term | central nervous system diseases | Downcase Mesh Term | nervous system diseases | Downcase Mesh Term | craniocerebral trauma | Downcase Mesh Term | trauma, nervous system | Downcase Mesh Term | head injuries, closed | Downcase Mesh Term | wounds, nonpenetrating | Downcase Mesh Term | brain injuries |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-list |
Sponsors
Sequence: | 48269942 | Sequence: | 48269943 | Sequence: | 48269944 | Sequence: | 48269945 | Sequence: | 48269946 | Sequence: | 48269947 |
Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator |
Name | University of New Mexico | Name | Biomedical Research Institute of New Mexico | Name | New Jersey Institute of Technology | Name | University of Miami | Name | The Mind Research Network | Name | The City College of New York |
Design Group Interventions
Sequence: | 68077502 | Sequence: | 68077503 |
Design Group Id | 55534787 | Design Group Id | 55534788 |
Intervention Id | 52431833 | Intervention Id | 52431834 |
Eligibilities
Sequence: | 30734726 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 59 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
are US Veteran or Active Duty Military personnel aged 18-59, Exclusion Criteria: any history of moderate or severe TBI; 10) any significant blindness, to screen out peripheral sensory damage; 11) any significant deafness beyond mild hearing loss, to screen out peripheral sensory damage; 12) any ongoing litigation related to TBI, to prevent interference with legal proceedings; 13) any contraindication to MRI; 14) membership in an identified vulnerable population, including minors, pregnant women, and prisoners, so as to prevent coercion. |
Adult | True |
Child | False |
Older Adult | False |
Calculated Values
Sequence: | 254011363 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 58 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 59 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 1 |
Designs
Sequence: | 30481094 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Triple |
Masking Description | Active and sham HD-tDCS will be delivered with the same device, and participants and research technician are blinded to the condition. |
Intervention Model Description | 120 subjects will be recruited for this study: 40 healthy controls subjects for the imaging-only group, and 80 mTBI subjects for the stimulation arm who have suffered mild TBI at least 3 months prior to study enrollment, but not more than 15 years prior to enrollment. The 80 mTBI subjects will be randomized to either active stimulation (40) or sham stimulation (40). |
Subject Masked | True |
Caregiver Masked | True |
Outcomes Assessor Masked | True |
Responsible Parties
Sequence: | 28847447 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03799445
2019-07-25
https://zephyrnet.com/?p=NCT03799445
NCT03799445https://www.clinicaltrials.gov/study/NCT03799445?tab=tableMaura Gillisonmgillison@mdanderson.org713-792-6363This phase II trial studies the side effects and best dose of ipilimumab, nivolumab, and radiation therapy and how well they work in treating patients with advanced human papillomavirus (HPV) positive oropharyngeal squamous cell carcinoma. Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving ipilimumab, nivolumab, and radiation therapy may work better in treating patients with HPV positive oropharyngeal squamous cell carcinoma.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-13 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2023-04-20 |
Start Month Year | July 25, 2019 |
Primary Completion Month Year | December 31, 2023 |
Verification Month Year | April 2023 |
Verification Date | 2023-04-30 |
Last Update Posted Date | 2023-04-20 |
Detailed Descriptions
Sequence: | 20839691 |
Description | PRIMARY OBJECTIVES:
I. To evaluate the safety, tolerability and feasibility of ipilimumab and nivolumab when administered concurrently with reduced-field radiotherapy (intensity-modulated radiation therapy [IMRT]). II. To evaluate the clinical complete response rate to ipilimumab, nivolumab and IMRT with reduced field at six months as indicated by fluorodeoxyglucose – positron emission tomography/computed tomography (FDG-PET/CT) post completion of radiation therapy (RT). III. To evaluate the 2-year progression-free survival (PFS) rate of subjects with low-intermediate volume, local-regionally advanced, human papilloma virus (HPV)-positive squamous cell carcinoma of the head and neck (SCCHN) treated with ipilimumab, nivolumab and reduced-field IMRT. SECONDARY OBJECTIVES: I. To evaluate overall response rate to six weeks of induction immunotherapy (IO). II. To evaluate the frequency of pharyngeal dysphasia as measured by Dynamic Imaging (Dynamic Imaging Grade of Swallowing Toxicity [DIGEST]) grade on modified barium swallow (MBS) and patient-reported symptoms (MD Anderson Dysphagia Inventory [MDADI]) at 6 month, 1 and 2 years after radiotherapy ([IMRT]. III. To measure acute and chronic toxicities per Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (CTCAE PRO). IV. To measure acute toxicity profiles at the end of radiation therapy and IO and at 6 months. V. To measure late toxicity profiles at 1 and 2 years. VI. To determine local and regional control at 6 and 12 months. VII. To determine patterns of failure (local-regional relapse vs. distant) at 1 and 2 years. VIII. To determine overall survival (OS) at 1 and 2 years. CORRELATIVE OBJECTIVES: I. To evaluate associations between total mutational load, interferon (INF) gamma score, T cell clonality at diagnosis with clinical response to induction, combination CTLA-4 PD-1 checkpoint blockade. II. To evaluate changes in the tumor immune microenvironment (CD8 + INF gamma score, T cell clonality, in tumor biopsy specimens pre and post induction immunotherapy (IO). III. To evaluate dynamic changes in and clearance of oral HPV and cell-free deoxyribonucleic acid (cfDNA) viral load during therapy and to investigate associations with PFS and OS. EXPLORATORY OBJECTIVES: I. To evaluate changes in peripheral blood lymphocyte phenotypes and serum cytokine profiles before and after induction IO. II. To evaluate changes in the T cell receptor repertoire in tumor-infiltrating lymphocyte (TIL) and the peripheral blood in tumor biopsy specimens pre and post induction IO. III. To determine the negative and positive predictive values (NPV and PPV) of FDG-PET/CT 12-14 weeks after end of RT for 1 year and 2 year PFS and OS. OUTLINE: Patients receive nivolumab intravenously (IV) over 30 minutes on days 1, 15, and 29 and ipilimumab IV over 30 minutes on day 1. Treatment repeats every for 6 weeks for 2 cycles in the absence of disease progression or unacceptable toxicity. Beginning on day 1 of cycle 2, patients also undergo IMRT 5 days a week (Monday-Friday) for 6 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 2 weeks, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. |
Facilities
Sequence: | 201189730 |
Status | Recruiting |
Name | M D Anderson Cancer Center |
City | Houston |
State | Texas |
Zip | 77030 |
Country | United States |
Facility Contacts
Sequence: | 28265827 |
Facility Id | 201189730 |
Contact Type | primary |
Name | Maura L. Gillison |
Phone | 713-792-6363 |
Facility Investigators
Sequence: | 18429847 |
Facility Id | 201189730 |
Role | Principal Investigator |
Name | Maura L. Gillison |
Browse Interventions
Sequence: | 96542851 | Sequence: | 96542852 | Sequence: | 96542853 | Sequence: | 96542854 | Sequence: | 96542855 | Sequence: | 96542856 |
Mesh Term | Nivolumab | Mesh Term | Ipilimumab | Mesh Term | Antineoplastic Agents, Immunological | Mesh Term | Antineoplastic Agents | Mesh Term | Immune Checkpoint Inhibitors | Mesh Term | Molecular Mechanisms of Pharmacological Action |
Downcase Mesh Term | nivolumab | Downcase Mesh Term | ipilimumab | Downcase Mesh Term | antineoplastic agents, immunological | Downcase Mesh Term | antineoplastic agents | Downcase Mesh Term | immune checkpoint inhibitors | Downcase Mesh Term | molecular mechanisms of pharmacological action |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52473688 | Sequence: | 52473689 | Sequence: | 52473690 | Sequence: | 52473691 | Sequence: | 52473692 | Sequence: | 52473693 | Sequence: | 52473694 | Sequence: | 52473695 | Sequence: | 52473696 | Sequence: | 52473697 | Sequence: | 52473698 |
Name | Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 | Name | Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 | Name | Human Papillomavirus Positive Oropharyngeal Squamous Cell Carcinoma | Name | Oropharyngeal Basaloid Carcinoma | Name | Pathologic Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 | Name | Pathologic Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 | Name | Posterior Tongue Squamous Cell Carcinoma | Name | Soft Palate Squamous Cell Carcinoma | Name | Stage III Oropharyngeal Squamous Cell Carcinoma AJCC v7 | Name | Stage IVA Oropharyngeal Squamous Cell Carcinoma AJCC v7 | Name | Tonsillar Squamous Cell Carcinoma |
Downcase Name | clinical stage i hpv-mediated (p16-positive) oropharyngeal carcinoma ajcc v8 | Downcase Name | clinical stage ii hpv-mediated (p16-positive) oropharyngeal carcinoma ajcc v8 | Downcase Name | human papillomavirus positive oropharyngeal squamous cell carcinoma | Downcase Name | oropharyngeal basaloid carcinoma | Downcase Name | pathologic stage i hpv-mediated (p16-positive) oropharyngeal carcinoma ajcc v8 | Downcase Name | pathologic stage ii hpv-mediated (p16-positive) oropharyngeal carcinoma ajcc v8 | Downcase Name | posterior tongue squamous cell carcinoma | Downcase Name | soft palate squamous cell carcinoma | Downcase Name | stage iii oropharyngeal squamous cell carcinoma ajcc v7 | Downcase Name | stage iva oropharyngeal squamous cell carcinoma ajcc v7 | Downcase Name | tonsillar squamous cell carcinoma |
Id Information
Sequence: | 40375496 | Sequence: | 40375497 | Sequence: | 40375498 |
Id Source | org_study_id | Id Source | secondary_id | Id Source | secondary_id |
Id Value | 2018-0381 | Id Value | NCI-2018-03260 | Id Value | 2018-0381 |
Id Type | Registry Identifier | Id Type | Other Identifier | ||
Id Type Description | CTRP (Clinical Trial Reporting Program) | Id Type Description | M D Anderson Cancer Center | ||
Countries
Sequence: | 42811279 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55929314 |
Group Type | Experimental |
Title | Treatment (nivolumab, ipilimumab, IMRT) |
Description | Patients receive nivolumab IV over 30 minutes on days 1, 15, and 29 and ipilimumab IV over 30 minutes on day 1. Treatment repeats every for 6 weeks for 2 cycles in the absence of disease progression or unacceptable toxicity. Beginning on day 1 of cycle 2, patients also undergo IMRT 5 days a week (Monday-Friday) for 6 weeks in the absence of disease progression or unacceptable toxicity. |
Interventions
Sequence: | 52783865 | Sequence: | 52783866 | Sequence: | 52783867 | Sequence: | 52783868 | Sequence: | 52783869 |
Intervention Type | Radiation | Intervention Type | Biological | Intervention Type | Biological | Intervention Type | Other | Intervention Type | Other |
Name | Intensity-Modulated Radiation Therapy | Name | Ipilimumab | Name | Nivolumab | Name | Quality-of-Life Assessment | Name | Questionnaire Administration |
Description | Undergo IMRT | Description | Given IV | Description | Given IV | Description | Ancillary studies | Description | Ancillary studies |
Design Outcomes
Sequence: | 178513931 | Sequence: | 178513932 | Sequence: | 178513933 | Sequence: | 178513934 | Sequence: | 178513935 | Sequence: | 178513936 | Sequence: | 178513937 | Sequence: | 178513938 | Sequence: | 178513939 | Sequence: | 178513940 | Sequence: | 178513941 | Sequence: | 178513942 | Sequence: | 178513943 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Dose limiting toxicity (DLT) (safety lead-in) | Measure | Complete response rate (Phase II) | Measure | Progression-free survival (PFS) (Phase II) | Measure | Number of patients who experience a >= grade 3 treatment-related adverse event (safety lead-in) | Measure | Number of patients who tolerated protocol therapy (safety lead-in) | Measure | Number of patients who achieve a clinical complete response (safety lead-in) | Measure | Incidence of acute and chronic adverse events (Phase II) | Measure | Acute toxicity profiles (Phase II) | Measure | Number of patients who experience >= grade 3 treatment-related adverse event (Phase II) | Measure | Late toxicity profiles (Phase II) | Measure | Patient-reported swallowing outcomes (Phase II) | Measure | Patterns of failure (local-regional relapse versus [vs] distant) (Phase II) | Measure | Overall survival (Phase II) |
Time Frame | Up to 28 days post-completion of radiation therapy | Time Frame | At 6 months | Time Frame | From start of therapy to progression or disease or death from any cause, assessed up to 2 years | Time Frame | Up to 28 days post-completion of radiation therapy | Time Frame | Up to 12 weeks (end of cycle 2) | Time Frame | Up to 28 weeks after radiation therapy | Time Frame | Up to 3 months from the end of intensity-modulated radiation therapy (IMRT) | Time Frame | At the end of radiation therapy, end of IO, and 6 months | Time Frame | At the end of radiation therapy, end of IO, and 6 months | Time Frame | At 1 and 2 years | Time Frame | At 1 and 2 years | Time Frame | At 1 and 2 years | Time Frame | At 1 and 2 years |
Description | Defined as any >= grade 3 adverse event (Common Terminology Criteria for Adverse Events [CTCAE], version [v.] 4) that is related to immunotherapy (IO) that does not resolve to grade 1 or less within 28 days. | Description | The number of patients who tolerated protocol therapy, including completion of radiotherapy without a treatment break and who were administered immunotherapy (IO) will be assessed. | Description | Incidence of adverse events (acute and chronic toxicities) will be assessed per CTCAE Patient Reported Outcome (PRO). | Description | Will be assessed by CTCAE v 4. | Description | Will be assessed per CTCAE v 4. |
Browse Conditions
Sequence: | 194642944 | Sequence: | 194642945 | Sequence: | 194642946 | Sequence: | 194642947 | Sequence: | 194642948 | Sequence: | 194642949 | Sequence: | 194642950 | Sequence: | 194642951 | Sequence: | 194642952 | Sequence: | 194642953 | Sequence: | 194642954 | Sequence: | 194642955 | Sequence: | 194642956 | Sequence: | 194642957 | Sequence: | 194642958 |
Mesh Term | Carcinoma | Mesh Term | Carcinoma, Squamous Cell | Mesh Term | Squamous Cell Carcinoma of Head and Neck | Mesh Term | Oropharyngeal Neoplasms | Mesh Term | Neoplasms, Glandular and Epithelial | Mesh Term | Neoplasms by Histologic Type | Mesh Term | Neoplasms | Mesh Term | Neoplasms, Squamous Cell | Mesh Term | Head and Neck Neoplasms | Mesh Term | Neoplasms by Site | Mesh Term | Pharyngeal Neoplasms | Mesh Term | Otorhinolaryngologic Neoplasms | Mesh Term | Pharyngeal Diseases | Mesh Term | Stomatognathic Diseases | Mesh Term | Otorhinolaryngologic Diseases |
Downcase Mesh Term | carcinoma | Downcase Mesh Term | carcinoma, squamous cell | Downcase Mesh Term | squamous cell carcinoma of head and neck | Downcase Mesh Term | oropharyngeal neoplasms | Downcase Mesh Term | neoplasms, glandular and epithelial | Downcase Mesh Term | neoplasms by histologic type | Downcase Mesh Term | neoplasms | Downcase Mesh Term | neoplasms, squamous cell | Downcase Mesh Term | head and neck neoplasms | Downcase Mesh Term | neoplasms by site | Downcase Mesh Term | pharyngeal neoplasms | Downcase Mesh Term | otorhinolaryngologic neoplasms | Downcase Mesh Term | pharyngeal diseases | Downcase Mesh Term | stomatognathic diseases | Downcase Mesh Term | otorhinolaryngologic diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48600519 | Sequence: | 48600520 |
Agency Class | OTHER | Agency Class | NIH |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | M.D. Anderson Cancer Center | Name | National Cancer Institute (NCI) |
Overall Officials
Sequence: | 29444061 |
Role | Principal Investigator |
Name | Maura L Gillison |
Affiliation | M.D. Anderson Cancer Center |
Central Contacts
Sequence: | 12086171 |
Contact Type | primary |
Name | Maura Gillison |
Phone | 713-792-6363 |
mgillison@mdanderson.org | |
Role | Contact |
Design Group Interventions
Sequence: | 68564033 | Sequence: | 68564034 | Sequence: | 68564035 | Sequence: | 68564036 | Sequence: | 68564037 |
Design Group Id | 55929314 | Design Group Id | 55929314 | Design Group Id | 55929314 | Design Group Id | 55929314 | Design Group Id | 55929314 |
Intervention Id | 52783865 | Intervention Id | 52783866 | Intervention Id | 52783867 | Intervention Id | 52783868 | Intervention Id | 52783869 |
Eligibilities
Sequence: | 30938913 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Histologically or cytologically newly confirmed diagnosis of squamous cell carcinoma (including the histological variants of papillary or basaloid) of the oropharynx (tonsil, base of tongue, soft palate, or oropharyngeal walls) Exclusion Criteria: Cancers of the oral cavity (oral tongue, floor mouth, alveolar ridge, buccal or lip), or the nasopharynx, hypopharynx, or larynx, even if p16 positive |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254254490 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 3 |
Number Of Secondary Outcomes To Measure | 10 |
Designs
Sequence: | 30684531 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Intervention Other Names
Sequence: | 26823847 | Sequence: | 26823848 | Sequence: | 26823849 | Sequence: | 26823850 | Sequence: | 26823851 | Sequence: | 26823852 | Sequence: | 26823853 | Sequence: | 26823854 | Sequence: | 26823855 | Sequence: | 26823856 | Sequence: | 26823857 | Sequence: | 26823858 | Sequence: | 26823859 | Sequence: | 26823860 |
Intervention Id | 52783865 | Intervention Id | 52783865 | Intervention Id | 52783865 | Intervention Id | 52783866 | Intervention Id | 52783866 | Intervention Id | 52783866 | Intervention Id | 52783866 | Intervention Id | 52783866 | Intervention Id | 52783867 | Intervention Id | 52783867 | Intervention Id | 52783867 | Intervention Id | 52783867 | Intervention Id | 52783867 | Intervention Id | 52783868 |
Name | IMRT | Name | Intensity Modulated RT | Name | Intensity-Modulated Radiotherapy | Name | Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody | Name | BMS-734016 | Name | MDX-010 | Name | MDX-CTLA4 | Name | Yervoy | Name | BMS-936558 | Name | MDX-1106 | Name | NIVO | Name | ONO-4538 | Name | Opdivo | Name | Quality of Life Assessment |
Links
Sequence: | 4411106 |
Url | http://www.mdanderson.org |
Description | MD Anderson Cancer Center Website |
Responsible Parties
Sequence: | 29051261 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03799432
2019-07-08
https://zephyrnet.com/?p=NCT03799432
NCT03799432https://www.clinicaltrials.gov/study/NCT03799432?tab=tableNANANAThe purpose of this study is to partner with the North Carolina Child Treatment Program (NC CTP) and the SAMHSA-funded National Child Traumatic Stress Network (NCTSN) to develop and pilot the Collaborative Organizational Approach to Selecting and Tailoring Implementation Strategies (COAST-IS). The COAST-IS intervention will involve coaching organizational leaders and therapists to use Intervention Mapping to select and tailor strategies. Intervention Mapping is a multistep process that is inherently ecological and incorporates theory, evidence, and stakeholder perspectives to ensure that intervention components effectively address key determinants of change. After collaboratively developing COAST-IS in Year 1, the investigators will conduct a randomized pilot trial of the intervention within an NC CTP learning collaborative, randomly assigning eight organizations to the learning collaborative-only condition or the learning collaborative plus COAST-IS condition. Participants will include organizational leaders (e.g., CEOs/Directors, Clinical Directors, Supervisors) and therapists (e.g., Licensed Clinical Social Workers, Licensed Psychologists, Licensed Professional Counselors). The investigators will evaluate COAST-IS in the following aims: 1) to assess the acceptability, appropriateness, feasibility, and utility of COAST-IS; 2) to evaluate organizational stakeholders’ fidelity to the core elements of Intervention Mapping; and 3) to demonstrate the feasibility of testing COAST-IS in a larger effectiveness trial. This work is significant because it will yield a systematic method that integrates theory, evidence, and stakeholder perspectives to improve the effectiveness and precision of implementation strategies. Ultimately, COAST-IS may have the potential to improve implementation and sustainment of a wide-range of EBPs in mental health and other health sectors.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-09 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2022-04-27 |
Start Month Year | July 8, 2019 |
Primary Completion Month Year | December 31, 2020 |
Verification Month Year | April 2022 |
Verification Date | 2022-04-30 |
Last Update Posted Date | 2022-04-27 |
Facilities
Sequence: | 201296264 |
Name | North Carolina Child Treatment Program |
City | Durham |
State | North Carolina |
Zip | 27701 |
Country | United States |
Conditions
Sequence: | 52511142 | Sequence: | 52511143 |
Name | Psychological Trauma | Name | Mental Health |
Downcase Name | psychological trauma | Downcase Name | mental health |
Id Information
Sequence: | 40401616 | Sequence: | 40401617 |
Id Source | org_study_id | Id Source | secondary_id |
Id Value | 17-0978 | Id Value | 1K01MH113806-01 |
Id Type | U.S. NIH Grant/Contract | ||
Id Link | https://reporter.nih.gov/quickSearch/1K01MH113806-01 |
Countries
Sequence: | 42837787 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55967529 | Sequence: | 55967530 |
Group Type | Experimental | Group Type | Active Comparator |
Title | TF-CBT Learning collaborative + COAST-IS | Title | TF-CBT Learning collaborative |
Description | In addition to participating in a learning collaborative for implementing trauma-focused cognitive behavioral therapy (TF-CBT) with periodic coaching calls, organizations will receive additional training and tailored implementation support. | Description | Organizations will participate in a learning collaborative for implementing trauma-focused cognitive behavioral therapy (TF-CBT) with periodic coaching calls. |
Interventions
Sequence: | 52818778 | Sequence: | 52818779 |
Intervention Type | Other | Intervention Type | Other |
Name | COAST-IS | Name | TF-CBT Learning Collaborative |
Description | COAST-IS has been designed to equip organizations with the knowledge, motivation, and skill needed to thoughtfully match implementation strategies to identified determinants by applying intervention mapping. The COAST-IS intervention will include four different modes of delivery: 1) dissemination of educational materials; 2) five web-based interactive education sessions on the need for tailoring implementation strategies and the application of intervention mapping; 3) site visits to discuss change objectives necessary to successfully implement trauma-focused cognitive behavioral therapy; and 4) organizational coaching related to using an intervention mapping approach. | Description | The learning collaborative model was adapted from the Breakthrough Series Collaborative model. Leadership of the collaboratives includes experts in evidence-based practices, implementation, and quality improvement. Main components include: 1) three face-to-face learning sessions (2-days each) that provide clinical training; 2) post-learning session action periods structured to facilitate therapists' application of learned skills; 3) a secure website to facilitate faculty-to-participant and peer-to-peer learning and document use of quality improvement methods; 4) fidelity monitoring and coaching; 5) a senior leader track supporting organizational change; 6) monthly outcomes monitoring; and 7) sustainability planning. |
Keywords
Sequence: | 80329878 | Sequence: | 80329879 | Sequence: | 80329880 | Sequence: | 80329881 |
Name | Implementation Science | Name | Cognitive Behavioral Therapy | Name | Children | Name | Youth |
Downcase Name | implementation science | Downcase Name | cognitive behavioral therapy | Downcase Name | children | Downcase Name | youth |
Design Outcomes
Sequence: | 178643283 | Sequence: | 178643284 | Sequence: | 178643285 | Sequence: | 178643286 | Sequence: | 178643287 | Sequence: | 178643288 | Sequence: | 178643289 | Sequence: | 178643290 | Sequence: | 178643291 | Sequence: | 178643292 | Sequence: | 178643293 | Sequence: | 178643294 | Sequence: | 178643295 | Sequence: | 178643296 | Sequence: | 178643297 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other |
Measure | Evaluate the acceptability of COAST-IS | Measure | Evaluate the appropriateness of COAST-IS | Measure | Evaluate the feasibility of COAST-IS | Measure | Evaluate the perceived utility of COAST-IS | Measure | Fidelity to COAST-IS | Measure | Fidelity to TF-CBT | Measure | Fidelity to TF-CBT | Measure | Organizational Readiness for Implementing Change (ORIC) | Measure | Evidence-based Practice Attitudes Scales (EBPAS) | Measure | Inner Setting of the Consolidated Framework for Implementation Research | Measure | Scale for Implementation Climate | Measure | Psychological Safety Scale (PSS) | Measure | Implementation Leadership Scale (ILS) | Measure | Implementation Citizenship Behavior Scale (ICBS) | Measure | Prior Experiences with Implementation |
Time Frame | 1 year | Time Frame | 1 year | Time Frame | 1 year | Time Frame | 1 year | Time Frame | 1 year | Time Frame | 6 months | Time Frame | 1 year | Time Frame | Baseline, 1 year | Time Frame | Baseline, 1 year | Time Frame | Baseline, 1 year | Time Frame | Baseline, 1 year | Time Frame | Baseline, 1 year | Time Frame | Baseline, 1 year | Time Frame | Baseline, 1 year | Time Frame | Baseline, 1 year |
Description | This will be assessed with the 4-item measure: Acceptability of Intervention. This measure is rated on a 5 point scale (completely disagree, disagree, neither agree nor disagree, agree, completely agree), with completely disagree having a score of 1 and completely agree having a score of 5. Higher scores indicate greater acceptability. | Description | This will be assessed with the 4-item measure: Intervention Appropriateness.This measure is rated on a 5 point scale (completely disagree, disagree, neither agree nor disagree, agree, completely agree), with completely disagree having a score of 1 and completely agree having a score of 5. Higher scores indicate greater appropriateness. | Description | This will be assessed with the 4-item measure: Feasibility of Intervention.This measure is rated on a 5 point scale (completely disagree, disagree, neither agree nor disagree, agree, completely agree), with completely disagree having a score of 1 and completely agree having a score of 5. Higher scores indicate greater feasibility. | Description | Semi-structured interview will focus on the perceived utility of COAST-IS. | Description | Fidelity to COAST-IS will be measured with a fidelity assessment tool adapted from the Stages of Implementation Completion measure, which assesses organizations' progression through eight stages of implementation (engagement through competency [conceptualized as the start of sustainment]). | Description | Therapist fidelity and adherence to TF-CBT will be assessed with the TF-CBT Fidelity Metric. This instrument consists of 12 scales (e.g., gradual exposure, cognitive processing) that allow a trainer to rate (on a 4-point scale) each TF-CBT component applied by a therapist within a session. | Description | Therapist fidelity and adherence to TF-CBT will be assessed with the TF-CBT Fidelity Metric. This instrument consists of 12 scales (e.g., gradual exposure, cognitive processing) that allow a trainer to rate (on a 4-point scale) each TF-CBT component applied by a therapist within a session. | Description | The 12 items comprising the ORIC measure will be included in an organizational barrier assessment that will be administered to all enrolled participants and will guide implementation support provided through COAST-IS. This measure assesses whether members of an organization, collectively, are (1) committed to implementing a new practice or process and (2) believe that they have the capacity to do so. For these two subscales and the overall ORIC scale, organizations receive scores between 1 and 5 (higher scores are considered more positive). | Description | The 15 items comprising the EBPAS measure will be included in an organizational barrier assessment that will be administered to all enrolled participants and will guide implementation support provided through COAST-IS. This measure articulates practitioner willingness to adopt new interventions as a function of four factors: (1) appeal of the new intervention, (2) organizational requirements, (3) practitioner openness, and (4) divergence (perceived incompatibility with practice or limited usefulness of research-based interventions). For these four subscales and the overall EBPAS scale, organizations receive scores between 0 and 4 (higher scores are considered more positive). | Description | This questionnaire assesses factors related to the inner setting of organizations that are believed to be important in influencing the implementation of interventions. Thirty items from this questionnaire will be included in an organizational barrier assessment that will be administered to all enrolled participants and will guide implementation support provided through COAST-IS. These items measure three factors: (1) culture, (2) learning climate, and (3) available resources. Organizations receive scores between 1 and 5 for each of these factors (higher scores are considered more positive). | Description | The six items comprising this measure will be included in an organizational barrier assessment that will be administered to all enrolled participants and will guide implementation support provided through COAST-IS. This measure assesses whether organizations are primed for implementation via three factors: the extent to which employees believe implementation is (1) expected, (2) supported, and (3) rewarded. For these three subscales and the overall ICS scale, organizations receive scores between 1 and 5 (higher scores are considered more positive). | Description | The seven items comprising the PSS measure will be included in an organizational barrier assessment that will be administered to all enrolled participants and will guide implementation support provided through COAST-IS. This measure assesses how much the environment of a work team makes members feel they can safely engage in learning behavior (e.g., seeking feedback, discussing errors, asking questions, experimenting) without great risk of losing face. Organizations receive a score between 1 and 7 for this scale (higher scores are considered more positive). | Description | The 12 items comprising the ILS measure will be included in an organizational barrier assessment that will be administered to all enrolled participants and will guide implementation support provided through COAST-IS. This measure assesses whether leadership is proactive, knowledgeable, supportive, and perseverant based on specific actions leaders take in promoting implementation. For these four subscales and the overall ILS scale, organizations receive scores between 0 and 4 (higher scores are considered more positive). | Description | The six items comprising the ICBS measure will be included in an organizational barrier assessment that will be administered to all enrolled participants and will guide implementation support provided through COAST-IS. This measure assesses two critical employee behaviors that go beyond what is required to support the implementation of evidence-based practices: (1) helping their peers with implementation-related activities and (2) keeping informed about issues related to evidence-based practice and implementation efforts. For these two subscales and the overall ICBS scale, organizations receive scores between 0 and 4 (higher scores are considered more positive). | Description | This questionnaire assesses employees' experiences and judgments toward previous innovation implementation, which may affect their implementation behavior regarding future innovations. Sixteen items from this questionnaire will be included in an organizational barrier assessment that will be administered to all enrolled participants and will guide implementation support provided through COAST-IS. These items measure four subscales: (1) perceived intensity of previous innovations, (2) perceived failure of previous innovations, (3) innovation-targeted helplessness, and (4) innovation fatigue. Organizations receive scores between 1 and 5 for each of these subscales (higher scores are considered more negative). |
Browse Conditions
Sequence: | 194782684 | Sequence: | 194782685 | Sequence: | 194782686 | Sequence: | 194782687 |
Mesh Term | Psychological Trauma | Mesh Term | Stress Disorders, Traumatic | Mesh Term | Trauma and Stressor Related Disorders | Mesh Term | Mental Disorders |
Downcase Mesh Term | psychological trauma | Downcase Mesh Term | stress disorders, traumatic | Downcase Mesh Term | trauma and stressor related disorders | Downcase Mesh Term | mental disorders |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48633725 | Sequence: | 48633726 | Sequence: | 48633727 | Sequence: | 48633728 | Sequence: | 48633729 |
Agency Class | OTHER | Agency Class | NIH | Agency Class | UNKNOWN | Agency Class | NETWORK | Agency Class | UNKNOWN |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator |
Name | Washington University School of Medicine | Name | National Institute of Mental Health (NIMH) | Name | North Carolina Child Treatment Program | Name | National Child Traumatic Stress Network | Name | UCLA-Duke National Center for Child Traumatic Stress |
Overall Officials
Sequence: | 29462751 |
Role | Principal Investigator |
Name | Byron J Powell, PhD |
Affiliation | Washington University School of Medicine |
Design Group Interventions
Sequence: | 68611695 | Sequence: | 68611696 | Sequence: | 68611697 |
Design Group Id | 55967529 | Design Group Id | 55967530 | Design Group Id | 55967529 |
Intervention Id | 52818778 | Intervention Id | 52818779 | Intervention Id | 52818779 |
Eligibilities
Sequence: | 30958980 |
Gender | All |
Minimum Age | N/A |
Maximum Age | N/A |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Employed at an organization participating in a North Carolina Child Treatment Program TF-CBT learning collaborative Working as an organizational leader (e.g., senior leaders and clinical supervisors) or therapist Direct involvement in the organization's implementation of TF-CBT |
Adult | True |
Child | True |
Older Adult | True |
Calculated Values
Sequence: | 253975780 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 18 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Number Of Primary Outcomes To Measure | 5 |
Number Of Secondary Outcomes To Measure | 2 |
Number Of Other Outcomes To Measure | 8 |
Designs
Sequence: | 30704547 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Health Services Research |
Time Perspective | |
Masking | None (Open Label) |
Responsible Parties
Sequence: | 29071273 |
Responsible Party Type | Sponsor |
Study References
Sequence: | 52416722 |
Pmid | 32391524 |
Reference Type | derived |
Citation | Powell BJ, Haley AD, Patel SV, Amaya-Jackson L, Glienke B, Blythe M, Lengnick-Hall R, McCrary S, Beidas RS, Lewis CC, Aarons GA, Wells KB, Saldana L, McKay MM, Weinberger M. Improving the implementation and sustainment of evidence-based practices in community mental health organizations: a study protocol for a matched-pair cluster randomized pilot study of the Collaborative Organizational Approach to Selecting and Tailoring Implementation Strategies (COAST-IS). Implement Sci Commun. 2020;1:9. doi: 10.1186/s43058-020-00009-5. Epub 2020 Feb 25. |
]]>
https://zephyrnet.com/NCT03799419
2019-04-01
https://zephyrnet.com/?p=NCT03799419
NCT03799419https://www.clinicaltrials.gov/study/NCT03799419?tab=tableMartha Falkensteinmfalkenstein@mclean.harvard.edu617-855-4424This study will conduct the development and preliminary evaluation of Cognitive Bias Modification for Interpretation (CBM-I) and Approach Avoidance Training (AAT) as augmentations to treatment as usual for OCD and related disorders. CBM-I refers to computerized interventions designed to directly manipulate interpretation bias through repeated practice on a training task, thereby inducing cognitive changes in a relatively automatic or implicit manner. In AAT, automatic approach tendencies toward feared stimuli are re-trained. Specifically, this study will examine the feasibility, acceptability, and clinical outcomes associated with CBM-I and AAT.
Adults with obsessive compulsive disorder (OCD) and related disorders will be recruited from a treatment program for these disorders and participants will be randomly assigned to either receive: 1) eight sessions of CBM-I or eight sessions of psychoeducation as a control condition, or 2) AAT or eight sessions of an inactive (sham) version of the AAT training.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-02 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2023-03-15 |
Start Month Year | April 1, 2019 |
Primary Completion Month Year | September 2024 |
Verification Month Year | March 2023 |
Verification Date | 2023-03-31 |
Last Update Posted Date | 2023-03-15 |
Facilities
Sequence: | 198942328 |
Status | Recruiting |
Name | McLean Hospital |
City | Belmont |
State | Massachusetts |
Zip | 02478 |
Country | United States |
Facility Contacts
Sequence: | 27982637 |
Facility Id | 198942328 |
Contact Type | primary |
Name | Martha Falkenstein |
mfalkenstein@mclean.harvard.edu | |
Phone | 617-855-4424 |
Conditions
Sequence: | 51881526 | Sequence: | 51881527 |
Name | Obsessive-Compulsive Disorder | Name | Obsessive-compulsive Disorders and Symptoms |
Downcase Name | obsessive-compulsive disorder | Downcase Name | obsessive-compulsive disorders and symptoms |
Id Information
Sequence: | 39929117 |
Id Source | org_study_id |
Id Value | 2017P002864 |
Countries
Sequence: | 42322966 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55301063 | Sequence: | 55301064 | Sequence: | 55301065 | Sequence: | 55301066 |
Group Type | Experimental | Group Type | Sham Comparator | Group Type | Experimental | Group Type | Sham Comparator |
Title | Cognitive bias modification with treatment as usual | Title | Psychoeducation with treatment as usual | Title | Approach avoidance training with treatment as usual | Title | Inactive sham approach avoidance training |
Description | Participants in this group will receive usual treatment in the program and 8 sessions of a computerized cognitive training targeting interpretation bias | Description | Participants in this group will receive usual treatment in the program and 8 sessions of psychoeducation | Description | Participants in this group will receive usual treatment in the program and 8 sessions of a computerized cognitive training targeting automatic approach tendencies | Description | Participants in this group will receive usual treatment in the program and 8 sessions of a sham approach avoidance training |
Interventions
Sequence: | 52199460 | Sequence: | 52199461 | Sequence: | 52199462 | Sequence: | 52199463 |
Intervention Type | Behavioral | Intervention Type | Behavioral | Intervention Type | Behavioral | Intervention Type | Behavioral |
Name | Cognitive bias modification for interpretation bias | Name | Psychoeducation | Name | Approach avoidance training | Name | Inactive sham approach avoidance training |
Description | Eight sessions of scenario-based CBM-I training for OCD will be administered, based on the widely-used paradigm of ambiguous scenario training developed by Mathews and Mackintosh (2000), in which participants are presented with scenarios that are ambiguous in whether or not they are threatening. Participants will complete a computer task consisting of a series of written scenarios designed to improve interpretation and attributional biases; these scenarios conclude with word fragments, which participants must fill in to resolve the ambiguity. | Description | Eight sessions of psychoeducation will be administered, which will describe symptoms of anxiety, the nature of biased thinking in anxiety, and summarize common psychosocial as well as pharmacological treatments for anxiety. The sessions will provide relevant information but will not provide training in changing thinking styles. | Description | Eight sessions of this computerized training program will be used to train approach tendencies, following previously validated procedures (Najmi, Kuckertz, & Amir, 2010). During the training program, participants will view a series of these images and be prompted to push or pull a joystick according to prompts on the screen, instead of the content of the picture. Avoidance will be stimulated through both pushing away (images on the screen will decrease in size upon the joystick being pushed), and approach will be stimulated through pulling towards pictures (images will increase in size to simulate approach). | Description | Eight sessions of the approach avoidance training will be administered, however the percentage of push vs pull trials will be altered in this sham version of the training. |
Keywords
Sequence: | 79401306 | Sequence: | 79401307 | Sequence: | 79401308 |
Name | cognitive bias modification | Name | interpretation bias | Name | approach avoidance |
Downcase Name | cognitive bias modification | Downcase Name | interpretation bias | Downcase Name | approach avoidance |
Design Outcomes
Sequence: | 176414902 | Sequence: | 176414899 | Sequence: | 176414900 | Sequence: | 176414901 | Sequence: | 176414903 | Sequence: | 176414904 | Sequence: | 176414905 | Sequence: | 176414906 | Sequence: | 176414907 | Sequence: | 176414908 |
Outcome Type | secondary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Change in Suicide Implicit Association Test | Measure | Change in Average Score on Obsessive Beliefs Questionnaire | Measure | Change in Average Score on Yale-Brown Obsessive Compulsive Scale | Measure | Change in Columbia-Suicide Severity Rating Scale | Measure | Change in Average Score on Depressive Symptom Index Suicidality Subscale. There are 4 items scored from 0-3 with greater numbers indicating greater severity. | Measure | Credibility/Expectancy Questionnaire | Measure | Exit Interview | Measure | Change in Behavioral Approach Test | Measure | Change in Average Score on Behavioral Inhibition/Behavioral Activation Scales | Measure | Dimensional Obsessive-Compulsive Scale |
Time Frame | Weeks 0, 2, and 4 | Time Frame | Weeks 0, 2, 4, and 8 | Time Frame | Weeks 0, 4, and 8 | Time Frame | Weeks 0, 4, and 8 | Time Frame | Weeks 0, 1, 2, 3, and 4 | Time Frame | Week 0 | Time Frame | Week 4 | Time Frame | Weeks 0, 2, and 4 | Time Frame | Weeks 0, 2, 4, and 8 | Time Frame | Weeks 0, 2, 4, and 8 |
Description | Computerized task which assesses implicit thoughts about self-injury, death, and suicide. | Description | Measure of interpretation biases, specifically: Inflated Responsibility/Overestimation of Threat, Perfectionism/Intolerance of Uncertainty, and Importance/Control of Thoughts. 44-item self-report measure, items scored 1-7 and summed; greater scores indicate greater severity. | Description | Interviewer-rated measure of OCD symptoms. It is 19 items, with only items 1-10 scored (from 0-4). Total scores range from 0-40, with higher scores reflecting greater severity. | Description | An interviewer-rated assessment of retrospective suicidality as well as recent suicidal ideation and behavior. Minimum total score 0, maximum total score 5, higher total scores indicate more suicidal ideation and/or behavior. | Description | Self-report measure of suicidality | Description | Measure of treatment expectancy and rationale credibility in our study. The items are rated on 9-point scales, with a total score range of 3 to 27. Greater scores indicate greater expectations and perceptions of treatment credibility. | Description | This interview will be conducted by a member of the study staff to obtain participant feedback on satisfaction and how the intervention might be improved. | Description | Behavioral Approach Test (BAT) will be administered as a measure of OCD-related avoidance, based on previously validated procedures (Cougle et al., 2007; Amir, Kuckertz, & Najmi, 2013). Participants rate peak anxiety 0-100 for each step of approaching feared stimuli.
Three different types of BAT will be implemented in order to measure avoidance with multiple types of contaminants, each with six steps on a hierarchy to be completed sequentially, providing a rating of anxiety 0-100 for each step. |
Description | 24-item measure of behavioral approach and behavioral avoidance, rated 1-4 and summed. | Description | (DOCS; Abramowitz et al., 2010) participants with contamination fears will be identified by their DOCS contamination subscale score; the DOCS is part of the admission measures in the OCD Institute's main study protocol. Additionally, we will examine these scores as an outcome measure for contamination-related obsessions and compulsions. It includes 20 items and is rated 0-4. |
Browse Conditions
Sequence: | 192315455 | Sequence: | 192315456 | Sequence: | 192315457 | Sequence: | 192315458 | Sequence: | 192315459 |
Mesh Term | Compulsive Personality Disorder | Mesh Term | Obsessive-Compulsive Disorder | Mesh Term | Personality Disorders | Mesh Term | Mental Disorders | Mesh Term | Anxiety Disorders |
Downcase Mesh Term | compulsive personality disorder | Downcase Mesh Term | obsessive-compulsive disorder | Downcase Mesh Term | personality disorders | Downcase Mesh Term | mental disorders | Downcase Mesh Term | anxiety disorders |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48048244 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Mclean Hospital |
Central Contacts
Sequence: | 11947809 |
Contact Type | primary |
Name | Martha Falkenstein |
Phone | 617-855-4424 |
mfalkenstein@mclean.harvard.edu | |
Role | Contact |
Design Group Interventions
Sequence: | 67795305 | Sequence: | 67795306 | Sequence: | 67795307 | Sequence: | 67795308 |
Design Group Id | 55301063 | Design Group Id | 55301064 | Design Group Id | 55301065 | Design Group Id | 55301066 |
Intervention Id | 52199460 | Intervention Id | 52199461 | Intervention Id | 52199462 | Intervention Id | 52199463 |
Eligibilities
Sequence: | 30594239 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Currently receiving treatment at the McLean Hospital OCD Institute Exclusion Criteria: Currently undergoing electroconvulsive therapy (ECT) |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253885480 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 9 |
Designs
Sequence: | 30341874 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Basic Science |
Time Perspective | |
Masking | Triple |
Subject Masked | True |
Investigator Masked | True |
Outcomes Assessor Masked | True |
Responsible Parties
Sequence: | 28718372 |
Responsible Party Type | Principal Investigator |
Name | Martha J Falkenstein |
Title | Staff Psychologist |
Affiliation | Mclean Hospital |
]]>
https://zephyrnet.com/NCT03799406
2016-10-01
https://zephyrnet.com/?p=NCT03799406
NCT03799406https://www.clinicaltrials.gov/study/NCT03799406?tab=tableNANANAThis study was conducted to evaluate the effect of oral vitamin D supplementation on the clinical course of acute bronchiolitis, and to investigate whether vitamin D deficiency among infants who required hospital-based care for bronchiolitis is associated with the severity of the acute episode.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-29 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2019-01-11 |
Start Month Year | October 1, 2016 |
Primary Completion Month Year | March 1, 2017 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-11 |
Detailed Descriptions
Sequence: | 20716264 |
Description | This is a double blind randomized controlled trial which was conducted on 60 infants who required hospital-based care for acute bronchiolitis. The patients were recruited in the period from October 2018 to January 2019. Informed consents were obtained from all caregivers, and approved by Institutional Research Board of our University.
The diagnosis of acute bronchiolitis was based on a first episode of respiratory distress with wheezing and/ or crackles, preceded by an infection of the upper airways (rhinorrhea, coryza, cough, fever). Disease severity was evaluated using Modified-Tal scoring systems for bronchiolitis, since it is repeatable and can reliably be used in research and clinical practice Sample size: Our hospital data have shown that the mean LOS for cases admitted with acute bronchiolitis was 3 ± 2 days. Assuming a reduction in length of hospital stay by 50% and study power of 80% to detect a clinical significance (α error) of 0.05 between interventional groups, we calculated a sample size of 30 patients in each treatment group. Randomization and Enrollment: Patients were randomized to receive vitamin D3 treatment [100 IU/Kg/day in acute bronchiolitis] (vitamin D group) or placebo (placebo group) all through the period of admission as a previous cohort observational study has postulated that vitamin D daily dose close to 100 IU/kg body weight is favorable for infants up to age 12 months. Both groups were equal in number. Both vitamin D3 and placebo were in drop form and were identical in shape and nearly the same taste and color. The assignments were kept in sealed envelopes till data analysis. The randomization and allocation process were done by a higher nursing staff blinded to the study. Throughout the study, the medical staff, and parents were blind to assignments. All patients were hospitalized and received treatment. The treatment consisted of intravenous fluids, oxygenation, and antipyretics if needed, and nebulized hypertonic saline. Nebulized adrenaline or salbutamol was added in severe cases according to the decision of a senior pediatrician. The validated clinical score for acute bronchiolitis were taken after a period of adjustment of at least 5 min and with the child quiet, not crying, without fever, and breathing room air. Respiratory rate were determined by observation of the thoracic movement over a full minute. The degree of accessory muscle use was based on the degree of intercostal or subcostal retraction. Physical examination as well as clinical severity score was recorded for each case at admission and every 12 hours, and at discharge. On discharge, all caregivers of breastfed, partially breastfed and bottle fed infants were advised to continue vitamin D supplementation at dose 400 IU per day All patients were submitted to careful history taking, complete clinical examination and the following laboratory investigations. Complete blood count Venous blood samples were collected from every subject by sterile venipuncture using disposable syringes. Each sample was then distributed as follows: One ml of blood was disposed into a plastic tube containing EDTA solution for performing complete blood count using electronic cell counter (sysmex kx-21,Japon). |
Facilities
Sequence: | 200053145 |
Name | Mansoura University Children's Hospital |
City | Mansourah |
Country | Egypt |
Browse Interventions
Sequence: | 96027720 | Sequence: | 96027721 | Sequence: | 96027722 | Sequence: | 96027723 | Sequence: | 96027724 | Sequence: | 96027725 | Sequence: | 96027726 |
Mesh Term | Vitamin D | Mesh Term | Cholecalciferol | Mesh Term | Vitamins | Mesh Term | Micronutrients | Mesh Term | Physiological Effects of Drugs | Mesh Term | Bone Density Conservation Agents | Mesh Term | Calcium-Regulating Hormones and Agents |
Downcase Mesh Term | vitamin d | Downcase Mesh Term | cholecalciferol | Downcase Mesh Term | vitamins | Downcase Mesh Term | micronutrients | Downcase Mesh Term | physiological effects of drugs | Downcase Mesh Term | bone density conservation agents | Downcase Mesh Term | calcium-regulating hormones and agents |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52156391 |
Name | Bronchiolitis |
Downcase Name | bronchiolitis |
Id Information
Sequence: | 40148157 |
Id Source | org_study_id |
Id Value | MS/16.01.38 |
Countries
Sequence: | 42557682 |
Name | Egypt |
Removed | False |
Design Groups
Sequence: | 55577820 | Sequence: | 55577821 |
Group Type | Active Comparator | Group Type | Placebo Comparator |
Title | Intervention group | Title | Placebo group |
Description | cholecalciferol at dose of 100 IU/Kg/day | Description | placebo |
Interventions
Sequence: | 52471929 | Sequence: | 52471930 |
Intervention Type | Drug | Intervention Type | Other |
Name | Cholecalciferol | Name | Placebo |
Description | Therapeutic trial of vitamin D supplementation during acute episode of bronchiolitis | Description | Placebo supplementation during acute episode of bronchiolitis |
Keywords
Sequence: | 79847977 | Sequence: | 79847978 | Sequence: | 79847979 | Sequence: | 79847980 | Sequence: | 79847981 |
Name | Acute bronchiolitis | Name | Vitamin D | Name | Modified Tal score | Name | Randomized | Name | Controlled trial |
Downcase Name | acute bronchiolitis | Downcase Name | vitamin d | Downcase Name | modified tal score | Downcase Name | randomized | Downcase Name | controlled trial |
Design Outcomes
Sequence: | 177327651 |
Outcome Type | primary |
Measure | length of hospital stay |
Time Frame | 3 to 5 days |
Description | Length of hospital stay in days |
Browse Conditions
Sequence: | 193431809 | Sequence: | 193431802 | Sequence: | 193431803 | Sequence: | 193431804 | Sequence: | 193431805 | Sequence: | 193431806 | Sequence: | 193431807 | Sequence: | 193431808 |
Mesh Term | Lung Diseases | Mesh Term | Bronchiolitis | Mesh Term | Bronchitis | Mesh Term | Respiratory Tract Infections | Mesh Term | Infections | Mesh Term | Bronchial Diseases | Mesh Term | Respiratory Tract Diseases | Mesh Term | Lung Diseases, Obstructive |
Downcase Mesh Term | lung diseases | Downcase Mesh Term | bronchiolitis | Downcase Mesh Term | bronchitis | Downcase Mesh Term | respiratory tract infections | Downcase Mesh Term | infections | Downcase Mesh Term | bronchial diseases | Downcase Mesh Term | respiratory tract diseases | Downcase Mesh Term | lung diseases, obstructive |
Mesh Type | mesh-ancestor | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48305984 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Mansoura University |
Overall Officials
Sequence: | 29277890 |
Role | Principal Investigator |
Name | amal osman, M.D. |
Affiliation | Mansoura University |
Design Group Interventions
Sequence: | 68130769 | Sequence: | 68130770 |
Design Group Id | 55577820 | Design Group Id | 55577821 |
Intervention Id | 52471929 | Intervention Id | 52471930 |
Eligibilities
Sequence: | 30757308 |
Gender | All |
Minimum Age | 1 Month |
Maximum Age | 24 Months |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Infants aged 1-24 months of age, diagnosed clinically as acute bronchiolitis and presented with any of the following: Persistent resting oxygen saturation below 92% in room air. Exclusion Criteria: Infants with history of prematurity (< 37 weeks), chronic cardiopulmonary disease, immunodeficiency, neuromuscular disease, and any other chronic medical condition. |
Adult | False |
Child | True |
Older Adult | False |
Calculated Values
Sequence: | 254226290 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 5 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 1 |
Maximum Age Num | 24 |
Minimum Age Unit | Month |
Maximum Age Unit | Months |
Number Of Primary Outcomes To Measure | 1 |
Designs
Sequence: | 30503533 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Quadruple |
Subject Masked | True |
Caregiver Masked | True |
Investigator Masked | True |
Outcomes Assessor Masked | True |
Intervention Other Names
Sequence: | 26665860 |
Intervention Id | 52471929 |
Name | Vitamin D |
Responsible Parties
Sequence: | 28869811 |
Responsible Party Type | Principal Investigator |
Name | Amal Osman |
Title | Lecturer of Pediatrics, Mansoura University |
Affiliation | Mansoura University |
Study References
Sequence: | 52049362 |
Pmid | 33305842 |
Reference Type | derived |
Citation | Huey SL, Acharya N, Silver A, Sheni R, Yu EA, Pena-Rosas JP, Mehta S. Effects of oral vitamin D supplementation on linear growth and other health outcomes among children under five years of age. Cochrane Database Syst Rev. 2020 Dec 8;12(12):CD012875. doi: 10.1002/14651858.CD012875.pub2. |
]]>
https://zephyrnet.com/NCT03799393
2017-08-01
https://zephyrnet.com/?p=NCT03799393
NCT03799393https://www.clinicaltrials.gov/study/NCT03799393?tab=tableNANANAThis study explores the utility of a tablet computer-based, individually-tailored application called Computer Intervention Authoring Software (CIAS) in the Emergency Department for discharge education on proper child car restraint safety. The investigators hypothesize that tablet-based, individually-tailored discharge instructions are more effective than current standard, one-size-fits-all, printed discharge instructions. This is a randomized, controlled, non-blinded trial of of children age 0-21 years old in the Emergency Department. Patients will be randomized to receive either (a) a brief tablet-based questionnaire followed by standard, paper discharge instructions or (b) a brief tablet-based questionnaire followed by the intervention – CIAS, a tablet-based computer program. One week after discharge, participants in both groups will receive an automatic text message and/or email message with a link to a web-based survey that will assess: knowledge of appropriate car restraints and whether the parent/patient engaged in any behavioral changes regarding child car restraint. These variables will be compared between the control and intervention groups.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-24 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2021-12-09 |
Start Month Year | August 1, 2017 |
Primary Completion Month Year | February 28, 2019 |
Verification Month Year | December 2021 |
Verification Date | 2021-12-31 |
Last Update Posted Date | 2021-12-09 |
Detailed Descriptions
Sequence: | 20792333 |
Description | This study explores the utility of a tablet computer-based, individually-tailored technology called Computer Intervention Authoring Software (CIAS) in the Emergency Department for discharge education on proper child car restraint safety. The investigators hypothesize that tablet-based, individually-tailored discharge instructions are more effective than current standard, one-size-fits-all, printed discharge instructions. This is a randomized, controlled, non-blinded trial of a convenience sample of 200 children age 0-21 years old who present to the Hasbro Children's Hospital Emergency Department by car and have access to a smartphone and/or email. Patients will be randomized to receive either (a) a brief tablet-based questionnaire followed by standard, paper discharge instructions or (b) a brief tablet-based questionnaire followed by the intervention – CIAS, a computer program that allows families to interact with a tablet computer to receive educational information customized to the patient. Children 13 years old and above will answer questions themselves instead of having their parent/guardian answer for them. Both group will be offered information for the Lifespan Injury Prevention Center's Kohl's Car Seat Program. Both groups will complete a questionnaire on the usefulness of their discharge education. One week after discharge, participants in both groups will receive an automatic text message and/or email message with a link to a web-based survey that will assess: knowledge of appropriate car restraints and whether the parent/patient engaged in any behavioral changes regarding child car restraint. These variables will be compared between the control and intervention groups. |
Facilities
Sequence: | 200729942 |
Name | Hasbro Children's Hospital Emergency Department |
City | Providence |
State | Rhode Island |
Zip | 02903 |
Country | United States |
Conditions
Sequence: | 52352795 | Sequence: | 52352796 | Sequence: | 52352797 |
Name | Safety Issues | Name | Injuries | Name | Car Accident |
Downcase Name | safety issues | Downcase Name | injuries | Downcase Name | car accident |
Id Information
Sequence: | 40288731 |
Id Source | org_study_id |
Id Value | 2012-17 |
Countries
Sequence: | 42710615 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55795171 | Sequence: | 55795172 |
Group Type | Active Comparator | Group Type | Experimental |
Title | Control Group | Title | Experimental/CIAS Group |
Description | The control group will receive a brief tablet-based questionnaire followed by standard, paper discharge instructions on car safety. Children ≥13 years old and above will answer questions themselves. They will complete a questionnaire on the usefulness of their discharge education.
One week after discharge, participants will receive an automatic text message and/or email message with a link to a web-based survey that will assess: knowledge of appropriate car restraints and whether the parent/patient engaged in any behavioral changes regarding child car restraint. |
Description | The Experimental/CIAS Group will receive a brief tablet-based questionnaire followed by the intervention – CIAS, an interactive tablet computer program that gives educational information customized to the patient's age and size. Children ≥13 years old will answer questions and interact with the program themselves. They will complete a questionnaire on the usefulness of their discharge education.
One week after discharge, participants will receive an automatic text message and/or email message with a link to a web-based survey that will assess: knowledge of appropriate car restraints and whether the parent/patient engaged in any behavioral changes regarding child car restraint. |
Interventions
Sequence: | 52663852 | Sequence: | 52663851 |
Intervention Type | Behavioral | Intervention Type | Behavioral |
Name | Standard Printed Discharge Instructions | Name | CIAS (Computer Intervention Authoring Software) |
Description | Patients/families will receive standard, printed discharge instructions. This is a 5 page general document from our Injury Prevention Center that describes appropriate car restraint safety for all age groups, not specific to the child enrolled. | Description | This is a digital application that allows families to interact with a tablet computer to receive educational information customized to the patient's age and size. allows authors to develop screening, assessment, and intervention tools for patients without requiring new programming. The CIAS intervention is programmed using tailored branching logic to allow a custom path through the intervention based on the respondent's answers. Delivery of the intervention uses a two-dimensional avatar narrator character that mimics the conversational structure of person-delivered brief interventions. |
Keywords
Sequence: | 80118423 | Sequence: | 80118424 | Sequence: | 80118425 | Sequence: | 80118426 | Sequence: | 80118427 |
Name | injury prevention | Name | car safety | Name | car seats | Name | booster seats | Name | car restraints |
Downcase Name | injury prevention | Downcase Name | car safety | Downcase Name | car seats | Downcase Name | booster seats | Downcase Name | car restraints |
Design Outcomes
Sequence: | 178048746 | Sequence: | 178048747 | Sequence: | 178048748 | Sequence: | 178048749 | Sequence: | 178048750 | Sequence: | 178048751 | Sequence: | 178048752 | Sequence: | 178048753 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Demonstration of age-appropriate car restraint knowledge | Measure | Change in car restraint knowledge | Measure | Actions taken related to car restraints | Measure | Rate of difference types of actions taken related to car restraints | Measure | Satisfaction with discharge education – CIAS | Measure | Parental confidence in type of car restraint | Measure | Parental confidence in car restraint installation | Measure | Parental confidence in buckling the car restraint |
Time Frame | one week after enrollment | Time Frame | one week after enrollment | Time Frame | one week after enrollment | Time Frame | one week after enrollment | Time Frame | during intervention/enrollment | Time Frame | one week after enrollment | Time Frame | one week after enrollment | Time Frame | one week after enrollment |
Description | Rate of correct response to a post-intervention follow-up survey question regarding age appropriate car restraint for child in control group vs. intervention group. | Description | Change in rate of correct response pre-intervention vs. post-intervention compared between control group vs. intervention | Description | Rate of parental self-report of actions taken related to changing use of car restraints on post-intervention follow-up survey. This will be a binary variable (NO action taken vs. YES action taken). | Description | Rates of each specific type of actions taken will also be compared between control and intervention groups (e.g. percentage of subjects who purchased a new car restraint device in each group, percentage of patients that had car seat installation checked at a fire department in each group, etc). | Description | For intervention group only – parent/patient satisfaction with education given on discharge based on score on Technology Posttrial Impressions Questionnaire. We will examine 13 individual components scored on an ordinal scale 1 to 5 (poor, fair, good, very good, excellent). Mean total score will be calculated. | Description | Change in parental confidence that child is in the correct type of car restraint, comparing pre- and post-intervention response according to the 1 to 5 ordinal scale:
How confident are you that your child is in the right type of car restraint? 1- not at all confident 2- 3- 4- 5- very confident |
Description | Change in parental confidence that car restraint is correctly installed, comparing pre- and post-intervention response according to the 1 to 5 ordinal scale:
How confident are you that your car restraint is installed correctly? 1- not at all confident 2- 3- 4- 5- very confident |
Description | Change in parental confidence that the child is correctly buckled in the car restraint, comparing pre- and post-intervention response according to the 1 to 5 ordinal scale:
How confident are you that your child is correctly buckled into the car restraint? 1- not at all confident 2- 3- 4- 5- very confident |
Browse Conditions
Sequence: | 194177447 | Sequence: | 194177448 | Sequence: | 194177449 |
Mesh Term | Emergencies | Mesh Term | Disease Attributes | Mesh Term | Pathologic Processes |
Downcase Mesh Term | emergencies | Downcase Mesh Term | disease attributes | Downcase Mesh Term | pathologic processes |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48488244 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Lifespan |
Overall Officials
Sequence: | 29381423 |
Role | Study Director |
Name | Susan Duffy, MD, MPH |
Affiliation | Associate Professor |
Design Group Interventions
Sequence: | 68396841 | Sequence: | 68396842 |
Design Group Id | 55795172 | Design Group Id | 55795171 |
Intervention Id | 52663851 | Intervention Id | 52663852 |
Eligibilities
Sequence: | 30870131 |
Gender | All |
Minimum Age | N/A |
Maximum Age | 21 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
– Children age 0-21 years presenting to the children's emergency department for any chief complaint whose parent/guardian owns or has access to a car that the child rides in (or for adolescents 16 years or older, have access to a car themselves). Exclusion Criteria: No access to email or a smart phone |
Adult | True |
Child | True |
Older Adult | False |
Calculated Values
Sequence: | 254027863 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 19 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Maximum Age Num | 21 |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 2 |
Number Of Secondary Outcomes To Measure | 6 |
Designs
Sequence: | 30615929 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Other |
Time Perspective | |
Masking | Single |
Outcomes Assessor Masked | True |
Responsible Parties
Sequence: | 28982467 |
Responsible Party Type | Principal Investigator |
Name | Almaz Dessie |
Title | Principal Investigator |
Affiliation | Lifespan |
]]>
https://zephyrnet.com/NCT03799380
2019-11-05
https://zephyrnet.com/?p=NCT03799380
NCT03799380https://www.clinicaltrials.gov/study/NCT03799380?tab=tableNANANAThe purpose of this study is to decrease the rate of visits to the Emergency Department (ED) and Acute Care Clinics (ACC) for dehydration for head & neck (H&N) and esophageal cancer patients that are given Gatorade while receiving radiation therapy with or without chemotherapy.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-08 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2021-11-03 |
Start Month Year | November 5, 2019 |
Primary Completion Month Year | May 5, 2021 |
Verification Month Year | November 2021 |
Verification Date | 2021-11-30 |
Last Update Posted Date | 2021-11-03 |
Detailed Descriptions
Sequence: | 20837991 |
Description | Among patients with cancer of the H&N or esophagus, complications related to dehydration are fairly common, and can result in requiring IV fluid support in an ACC setting, ED or even inpatient admission. By instructing participants to drink a reasonable amount of a common electrolyte-rich energy drink from the initiation of treatment through its completion, the hypothesis will be tested that this inexpensive and easily administered preventative strategy can significantly decrease the rate of ACC and ED visits.
The objectives of this study are to decrease the frequency of ACC visits during the course of radiation therapy and decrease the frequency of ED visits during the course of radiation therapy. The study team also seeks to decrease the incidence of orthostatic vital signs during the course of radiation therapy and decrease the number of days of missed treatments due to radiation toxicity during the course of radiation therapy. In the pilot cohort, participants will be given Gatorade G2 to drink daily during the course of radiation, along with standard of care nutritional support from dietitians. The randomized Phase 2 cohort has two study groups. Group 1 will receive standard of care nutritional support. Group 2 will receive standard of care nutritional support plus the study agent, Gatorade G2. |
Facilities
Sequence: | 201176072 |
Name | Cleveland Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center |
City | Cleveland |
State | Ohio |
Zip | 44106 |
Country | United States |
Conditions
Sequence: | 52469404 | Sequence: | 52469405 | Sequence: | 52469406 |
Name | Dehydration | Name | Head & Neck Cancer | Name | Esophageal Cancer |
Downcase Name | dehydration | Downcase Name | head & neck cancer | Downcase Name | esophageal cancer |
Id Information
Sequence: | 40372466 |
Id Source | org_study_id |
Id Value | CASE8318 |
Countries
Sequence: | 42807918 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55924638 | Sequence: | 55924639 |
Group Type | Active Comparator | Group Type | Experimental |
Title | Control – Standard of Care | Title | Experimental – Gatorade |
Description | Standard of care nutritional support | Description | Standard of care nutritional support with the addition of daily Gatorade G2 |
Interventions
Sequence: | 52779740 | Sequence: | 52779741 |
Intervention Type | Dietary Supplement | Intervention Type | Dietary Supplement |
Name | Gatorade G2 | Name | Standard of care nutritional support |
Description | Gatorade (G2), 20 oz. bottle, daily through the entire course of radiation therapy (approximately 5-7 weeks) | Description | Standard of care nutritional support |
Design Outcomes
Sequence: | 178498165 | Sequence: | 178498166 | Sequence: | 178498163 | Sequence: | 178498164 |
Outcome Type | secondary | Outcome Type | secondary | Outcome Type | primary | Outcome Type | primary |
Measure | Incidence of orthostatic vital signs | Measure | Missed days of radiation +/- chemotherapy/immunotherapy treatment | Measure | ACC visits | Measure | ED visits |
Time Frame | Up to 11 weeks after start of treatment | Time Frame | Up to 7 weeks after start of treatment | Time Frame | Up to 11 weeks after start of treatment | Time Frame | Up to 11 weeks after start of treatment |
Description | Number of orthostatic vital signs during the course of radiation therapy assessed at weekly visits. | Description | Number of missed days of radiation treatment among H&N and esophageal cancer patients undergoing radiation +/- chemotherapy/immunotherapy during the course of treatment. | Description | ACC visits during the course of radiation (7 weeks). Participants are followed for 4 weeks after completion of radiation. | Description | Number of ED visits during the course of radiation (7 weeks). Participants are followed for 4 weeks after completion of radiation. |
Browse Conditions
Sequence: | 194626385 | Sequence: | 194626386 | Sequence: | 194626387 | Sequence: | 194626388 | Sequence: | 194626389 | Sequence: | 194626390 | Sequence: | 194626391 | Sequence: | 194626392 | Sequence: | 194626393 | Sequence: | 194626394 | Sequence: | 194626395 | Sequence: | 194626396 | Sequence: | 194626397 |
Mesh Term | Head and Neck Neoplasms | Mesh Term | Esophageal Neoplasms | Mesh Term | Dehydration | Mesh Term | Neoplasms by Site | Mesh Term | Neoplasms | Mesh Term | Gastrointestinal Neoplasms | Mesh Term | Digestive System Neoplasms | Mesh Term | Digestive System Diseases | Mesh Term | Esophageal Diseases | Mesh Term | Gastrointestinal Diseases | Mesh Term | Water-Electrolyte Imbalance | Mesh Term | Metabolic Diseases | Mesh Term | Pathologic Processes |
Downcase Mesh Term | head and neck neoplasms | Downcase Mesh Term | esophageal neoplasms | Downcase Mesh Term | dehydration | Downcase Mesh Term | neoplasms by site | Downcase Mesh Term | neoplasms | Downcase Mesh Term | gastrointestinal neoplasms | Downcase Mesh Term | digestive system neoplasms | Downcase Mesh Term | digestive system diseases | Downcase Mesh Term | esophageal diseases | Downcase Mesh Term | gastrointestinal diseases | Downcase Mesh Term | water-electrolyte imbalance | Downcase Mesh Term | metabolic diseases | Downcase Mesh Term | pathologic processes |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48596466 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Case Comprehensive Cancer Center |
Overall Officials
Sequence: | 29441657 |
Role | Principal Investigator |
Name | Elisha Fredman, MD |
Affiliation | University Hospitals Cleveland Medical Center |
Design Group Interventions
Sequence: | 68558422 | Sequence: | 68558423 |
Design Group Id | 55924639 | Design Group Id | 55924638 |
Intervention Id | 52779740 | Intervention Id | 52779741 |
Eligibilities
Sequence: | 30936492 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
– Subjects must have histologically confirmed primary invasive cancer of the H&N (Nasopharynx/Nasal Cavity, Oral cavity, Oropharynx, Larynx, Hypopharynx) or Esophagus. Histologies: squamous cell carcinoma, adenocarcinoma, adenoid cystic carcinoma, sinonasal undifferentiated carcinoma Stages: Any stage that necessitates radiation therapy (either definitive, neoadjuvant or adjuvant) as per standard practice guidelines (NCCN, ASTRO) Subjects must have received no prior radiation therapy to the head, neck, thorax or abdomen in the last 1 year (with the exception of scalp squamous cell or basal cell carcinoma. Exclusion Criteria: The presence of any of the following will exclude a subject from study enrollment. Prior radiation therapy to the head, neck, thorax or abdomen in the last year, with the exception of scalp squamous cell or basal cell carcinoma. |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254222790 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 18 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 2 |
Number Of Secondary Outcomes To Measure | 2 |
Designs
Sequence: | 30682117 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Supportive Care |
Time Perspective | |
Masking | None (Open Label) |
Responsible Parties
Sequence: | 29048843 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03799367
2018-07-09
https://zephyrnet.com/?p=NCT03799367
NCT03799367https://www.clinicaltrials.gov/study/NCT03799367?tab=tableNANANAParents commonly find giving medicines to babies, using oral syringes or spoons, difficult and emotionally stressful. In developing countries, additional stress arises due to hygiene difficulties and the lack of clean water. To overcome these challenges and encourage breastfeeding, we have developed the concept of a Therapeutic Nipple Shield, a delivery system that makes it possible to give medicine and nutrients to babies during breastfeeding. It consists of a silicone nipple shield that allows the release of medicine/nutrients into human milk during the feed. Presentations of a prototype to parents and staff at the Rosie Hospital was very positive, and encouraged this clinical study. This study aims to give a vitamin B12 supplement to babies during breastfeeding. The supplement will be placed into a nipple shield, both of which are commercially available, and the mother will breastfeed her baby as usual. Before and after the feed, we will 1) collect a small blood sample from the baby to see whether the vitamin levels in the infant have increased, 2) ask the mother to participate in two short interviews about her expectations and experiences using the Therapeutic Nipple Shield.
<![CDATA[
Studies
Study First Submitted Date | 2018-07-08 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2019-01-10 |
Start Month Year | July 9, 2018 |
Primary Completion Month Year | December 31, 2018 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-10 |
Facilities
Sequence: | 200617878 |
Name | addenbrookes Hospital |
City | Cambridge |
Country | United Kingdom |
Conditions
Sequence: | 52328196 | Sequence: | 52328197 | Sequence: | 52328198 | Sequence: | 52328199 |
Name | Medication Systems | Name | Breast Feeding | Name | Milk, Human | Name | Infant, Newborn |
Downcase Name | medication systems | Downcase Name | breast feeding | Downcase Name | milk, human | Downcase Name | infant, newborn |
Id Information
Sequence: | 40271016 |
Id Source | org_study_id |
Id Value | 18/LO/0551 |
Countries
Sequence: | 42691058 |
Name | United Kingdom |
Removed | False |
Interventions
Sequence: | 52639205 |
Intervention Type | Device |
Name | Drug delivery during breastfeeding |
Description | This study aims to give a vitamin B12 supplement to babies during breastfeeding. 30 mother-infant pairs will be recruited. The supplement will be placed into a nipple shield, both of which are commercially available, and the mother will breastfeed her baby as usual. Before and after the feed, we will 1) collect a small blood sample from the baby to see whether the vitamin levels in the infant have increased, 2) ask the mother to participate in two short interviews about her expectations and experiences using the Therapeutic Nipple Shield. |
Design Outcomes
Sequence: | 177959668 | Sequence: | 177959669 |
Outcome Type | primary | Outcome Type | secondary |
Measure | Detection of the change in vitamin B12 concentration in the infants' blood 6-8 hours following vitamin B12 delivery from a nipple shield device during breastfeeding | Measure | Qualitative assessment of impact on maternal expectation, experience and acceptability |
Time Frame | Blood sampling base line and 6-8 hours post feed | Time Frame | Interviews will be conducted prior to and post interventional feed and will last about 30-50 min. |
Description | Two infant blood samples will be taken – one base line and one post intervention | Description | Semi-structured interviews will be conducted before and after vitamin B12 delivery during breastfeeding |
Sponsors
Sequence: | 48466339 | Sequence: | 48466340 |
Agency Class | OTHER | Agency Class | OTHER |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | Cambridge University Hospitals NHS Foundation Trust | Name | University of Cambridge |
Eligibilities
Sequence: | 30856276 |
Gender | All |
Minimum Age | 7 Days |
Maximum Age | 12 Months |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
No known allergy or hypersensitivity against any ingredient used in the study Infant aged up to 12 months Confident breastfeeder (exclusively or non-exclusively) Exclusion Criteria: The participant may not enter the study if ANY of the following apply: Not confident at breastfeeding |
Adult | False |
Child | True |
Older Adult | False |
Calculated Values
Sequence: | 254312995 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 5 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 7 |
Maximum Age Num | 12 |
Minimum Age Unit | Days |
Maximum Age Unit | Months |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 1 |
Designs
Sequence: | 30602115 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Device Feasibility |
Time Perspective | |
Masking | None (Open Label) |
Responsible Parties
Sequence: | 28968630 |
Responsible Party Type | Principal Investigator |
Name | Kathryn Beardsall |
Title | University Lecturer, University of Cambridge |
Affiliation | Cambridge University Hospitals NHS Foundation Trust |
Study References
Sequence: | 52232544 |
Pmid | 35245341 |
Reference Type | derived |
Citation | Maier T, Peirce P, Baird L, Whitehouse SL, Slater NKH, Beardsall K. Drug delivery from a solid formulation during breastfeeding-A feasibility study with mothers and infants. PLoS One. 2022 Mar 4;17(3):e0264747. doi: 10.1371/journal.pone.0264747. eCollection 2022. |
]]>
https://zephyrnet.com/NCT03799354
2019-09-18
https://zephyrnet.com/?p=NCT03799354
NCT03799354https://www.clinicaltrials.gov/study/NCT03799354?tab=tablePaola Baiardi, Mathpaola.baiardi@icsmaugeri.it0039+0382+592In the context of pulmonary rehabilitation of COPD patients, recent guidelines and metanalysis describe that Resistance Training (RT) can be successfully performed alone or in conjunction with Endurance Training (ET) without evidence of adverse events.
Maximal Strength Training (MST) is a kind of RT typically performed at ~85-90% of 1RM with maximal velocity to be developed in the concentric phase. Recent literature indicates a significant amelioration on the Rate of Force Development (RFD) after MST in healthy subjects, post-menopausal woman and older populations.
When comparing to the conventional ET, MST generates a little change in muscle mass (no hypertrophy), but a much greater improvement in the RFD. It has been described that neural adjustments play a major role in the MST-induced adaptations. MST is also well documented to improve aerobic endurance by improving walking work efficiency.
Only a small cohort study of COPD patients was conducted, describing that MST can meaningfully improve strength and RFD, with an increase of around 32% for mechanical efficiency and a decrease of the perceived effort during submaximal job. This improvement could determine best performances in daily activities and a best quality of life. The main aims of this physiological pilot randomized controlled trail will be to evaluate feasibility and efficacy of the MST compared to standard ET on strength, effort tolerance, fatigue, economy of walking, dyspnea and risk of falls in a populations of COPD patients, in a short and middle term (6 months).
<![CDATA[
Studies
Study First Submitted Date | 2018-12-04 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2022-08-11 |
Start Month Year | September 18, 2019 |
Primary Completion Month Year | June 15, 2023 |
Verification Month Year | December 2021 |
Verification Date | 2021-12-31 |
Last Update Posted Date | 2022-08-11 |
Detailed Descriptions
Sequence: | 20822172 |
Description | Exercise intolerance is a cardinal problem existing in patients with Chronic Obstructive Pulmonary Disease (COPD). Moreover, skeletal muscle dysfunction is a common extra-pulmonary manifestation, leading to fatigue, decrease in activity of daily living (ADL) performance and quality of life and increase of risk of falls, mainly in older patients. In the context of pulmonary rehabilitation, recent guidelines and metanalysis describe that Resistance Training (RT) can be successfully performed alone or in conjunction with Endurance Training (ET) without evidence of adverse events.
As concern the RT programs, metanalysis in COPD describe that training have been mainly performed with the lower limbs and the training intensities are heterogeneous, generally ranging from 40% to 70% of 1-Repetition Maximum (1-RM). Maximal Strength Training (MST) is a RT typically performed at ~85-90% of 1RM with maximal velocity to be developed in the concentric phase. Recent literature indicates a significant amelioration on the Rate of Force Development (RFD) after MST in healthy subjects, post-menopausal woman and older populations. When comparing to the conventional ET, MST generates a little change in muscle mass (no hypertrophy), but a much greater improvement in the RFD. It has been described that neural adjustments play a major role in the MST-induced adaptations. MST is also well documented to improve aerobic endurance by improving walking work efficiency. Although the mechanisms at the base of MST effect on the mechanical efficiency have not been completely clarified, there is evidence that changes in the relationships between power and speed bring to a longer relaxation phase inside the cycle of job, improving the recovery between contractions. In this field, only a small cohort study of COPD patients was conducted describing that MST can meaningfully improve the strength and the RFD, with an increase of around 32% for mechanical efficiency and a decrease of the perceived effort during submaximal job. This improvement could determine best performances in daily activities and a best quality of life. Nevertheless, this study has been conducted only in a small cohort (twelve patients) of patients with COPD and further studies are necessary to define the impact on the different components that determine the effort intolerance. The main aim of this physiological pilot randomized controlled trail will be to test the feasibility and the efficacy of the MST compared to standard ET on strength, effort tolerance, fatigue, economy of walking, dyspnea and risk of falls in a populations of COPD patients, in a short and middle term (6 months). |
Facilities
Sequence: | 201025529 |
Status | Recruiting |
Name | ICS Maugeri IRCCS, Respiratory Rehabilitation of the Institute of Lumezzane |
City | Lumezzane |
State | Brescia |
Zip | 25065 |
Country | Italy |
Facility Contacts
Sequence: | 28249728 | Sequence: | 28249729 |
Facility Id | 201025529 | Facility Id | 201025529 |
Contact Type | primary | Contact Type | backup |
Name | Mara Paneroni, MSc, PT | Name | Michele Vitacca, MD |
mara.paneroni@icsmaugeri.it | michele.vitacca@icsmaugeri.it | ||
Phone | 0039+030+8253 | Phone | 0039+030+8253 |
Phone Extension | 122 | Phone Extension | 182 |
Conditions
Sequence: | 52429186 |
Name | Chronic Obstructive Pulmonary Disease |
Downcase Name | chronic obstructive pulmonary disease |
Id Information
Sequence: | 40342075 |
Id Source | org_study_id |
Id Value | ICS Maugeri CE 2241 |
Countries
Sequence: | 42773619 |
Name | Italy |
Removed | False |
Design Groups
Sequence: | 55879528 | Sequence: | 55879529 |
Group Type | Experimental | Group Type | Active Comparator |
Title | Treatment Group | Title | Control group |
Description | Maximal strenght training (MST) plus endurance training (ET) | Description | Endurance training (ET) |
Interventions
Sequence: | 52738550 | Sequence: | 52738551 |
Intervention Type | Other | Intervention Type | Other |
Name | Maximal strenght training (MST) plus endurance training (ET) | Name | Endurance training (ET) |
Description | Patients will perform an addictive out-patients rehabilitative treatment of 8 weeks (3 times/week, ≥20 training sessions) consisting of:
MST- It will consist of four sets of five repetitions on a leg-press with a focus on the rate of force development during the concentric contraction of the quadriceps from a 90° to legs complete extension. The load will be 85-90% of 1RM. When a patient will be able to perform more than five repetitions in a set, the load will be increased. All strength training will be performed on a seated horizontal leg press. |
Description | Patients will perform a usual out-patients rehabilitative treatment of 8 weeks (3 times/week, ≥20 training sessions). They will perform ET by cycling sessions that will last 40 minutes/each at constant-load, starting from a load intensity corresponding to patient specific AT, assessed during the baseline incremental test. The intensity will be gradually increased during the sessions with a symptom-based progression, according to the protocol by Maltais and coworkers. A 3-min warm-up and cool-down will be provided. Heart rate (HR), blood pressure, oxygen pulsoxymetry, and symptoms by Borg CR10 scale will be monitored at the beginning and end of each session.
Out of the training-days, both groups will continue their normal daily living with modest regular activity, as recommended by their physician. |
Keywords
Sequence: | 80217494 | Sequence: | 80217495 | Sequence: | 80217496 |
Name | rehabilitation | Name | resistive training | Name | exercise |
Downcase Name | rehabilitation | Downcase Name | resistive training | Downcase Name | exercise |
Design Outcomes
Sequence: | 178349218 | Sequence: | 178349219 | Sequence: | 178349220 | Sequence: | 178349221 | Sequence: | 178349222 | Sequence: | 178349223 | Sequence: | 178349224 | Sequence: | 178349225 | Sequence: | 178349226 | Sequence: | 178349227 | Sequence: | 178349228 | Sequence: | 178349229 | Sequence: | 178349230 | Sequence: | 178349231 | Sequence: | 178349232 | Sequence: | 178349233 | Sequence: | 178349234 | Sequence: | 178349235 | Sequence: | 178349236 | Sequence: | 178349237 | Sequence: | 178349238 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Change in walking efficiency | Measure | Change in Leg Strength by 1-Repetition Maximum on leg press | Measure | Change in maximal Rate of Force Development (RFD) | Measure | Change in maximal effort tolerance | Measure | Change in Constant Load Effort tolerance | Measure | Change in Fatigue (physiological evaluation) | Measure | Change in Fatigue (qualitative evaluation) | Measure | Change in Muscle volume | Measure | Change in Dyspnea | Measure | Concentration of CRP | Measure | Change in Low grade Inflammation | Measure | Concentration of Tumor necrosis factor alpha | Measure | Concentration of Interleukin-6 | Measure | Muscular proteolyses by 3-MeH concentration | Measure | Change in Balance (qualitative measure) | Measure | Change in quality of life | Measure | Patient Satisfaction: Likert Scale | Measure | Change in Falls | Measure | Hospitalizations | Measure | Mortality | Measure | Change in Balance (quantitative measure) |
Time Frame | baseline and 8 weeks | Time Frame | baseline and 8 weeks | Time Frame | baseline and 8 weeks | Time Frame | baseline and 8 weeks | Time Frame | baseline and 8 weeks | Time Frame | baseline and 8 weeks | Time Frame | baseline and 8 weeks | Time Frame | baseline and 8 weeks | Time Frame | baseline and 8 weeks | Time Frame | baseline and 8 weeks | Time Frame | baseline and 8 weeks | Time Frame | baseline and 8 weeks | Time Frame | baseline and 8 weeks | Time Frame | baseline and 8 weeks | Time Frame | baseline and 8 weeks | Time Frame | baseline and 8 weeks | Time Frame | at 8 weeks | Time Frame | baseline and 8 months | Time Frame | baseline and 8 months | Time Frame | baseline and 8 months | Time Frame | baseline and 8 weeks |
Description | The text will be executed using a portable metabolimeter detecting oxygen consumption (VO2).
After a 10 min of warm up on a treadmill, the patient will walk 5 min at submaximal steady state walking at 4.5 km/h at 5% incline. Using the average of VO2 of the last minute of walking, the walking efficiency will be defined as percentage of change as follows: external work accomplished/ energy expenditure x 100. |
Description | 1-Repetition Maximum (1RM) will be evaluated. 1RM will be measured on a horizontal leg press at a knee angle of 90°. 1RM will be recorded as the heaviest lifted load achieved, applying rest periods of ~4 min between test lifts and increments of 5 kg between each trial until failure. | Description | Immediately after the maximal test 1-RM (see above), using the same apparatus, maximal rate of Force Development (RFD) will be assessed using a force platform and applying a load corresponding to 75% of the participant's pre-test 1RM. The subjects will be instructed to execute the lift as rapidly as possible in the concentric phase. RFD will be analyzed as the time difference between 10% and 90% of Peak force. | Description | It will be evaluated by VO2 consumption on maximal cardiopulmonary exercise test (CPET) on cycloergometer | Description | It will be evaluated by evaluated by time of execution of Cardiopulmonary Constant-Load Endurance Test | Description | To define peripheral and central component of fatigue, before and after CLET, the investigators will test the difference on force produced during a single twitch superimposed on the Maximal Voluntary Contraction (MVC) and the force produced by the electrically evoked Resting Twitch (RT) produced, at rest, 5 seconds after the MVC. | Description | Fatigue Severity Scale (scale measuring fatigue, 9-item scale ranging from 7 = absence of fatigue to 63= maximal presence of fatigue) | Description | Sagittal ultrasound images of the Vastus Lateralis (VL) muscle will be recorded with an 8-12 MHz linear transducer. Images will be obtained with a 90° flexion of hip and knee, at 50% of femur length. The pennation angle (hp) of the VL fascicles will be measured as the angle between the VL muscle fascicles and the deep aponeurosis of the insertion. | Description | Barthel Index Dyspnea (scale measuring dyspnea during basal ADL, 10-item scale ranging from 0 = absence of dyspnea to 100 = maximal dyspnea) | Description | C reactive protein [CRP] (mg/dl) | Description | Evaluation of neutrophils/ lymphocytes ratio | Description | TNF-alpha (pg/ml) | Description | IL6 (pg/ml) | Description | Evaluation of urinary 3 Methyl-Histine (3-MeH) (micromol/ml) | Description | BERG scale ( scale measuring balance, composed by 14 balance related tasks, ranging from 0 = worse balance to 56= best balance) | Description | EuroQol 5-D (scale measuring quality of life, composed by 2 sessions: one of 5 questions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) with multiple choice ranging from 0 = no problem to 25= very low quality of life and one using Visual Analogic Scale (VAS) to quantify the health status ranging from 0 = worst health condition to 100 = best health condition. The two scale sessions are considered separately. | Description | Likert Scale 0-4 ( 0=completely unsatisfied, 4= very satisfied). | Description | Evaluation of the rate of falls | Description | Evaluation of the rate of hospitalizations | Description | Evaluation of deaths (number) | Description | The fall risk (FR) assessment will be evaluated by Balance Board. |
Browse Conditions
Sequence: | 194467913 | Sequence: | 194467914 | Sequence: | 194467915 | Sequence: | 194467916 | Sequence: | 194467917 | Sequence: | 194467918 | Sequence: | 194467919 |
Mesh Term | Lung Diseases, Obstructive | Mesh Term | Pulmonary Disease, Chronic Obstructive | Mesh Term | Lung Diseases | Mesh Term | Respiratory Tract Diseases | Mesh Term | Chronic Disease | Mesh Term | Disease Attributes | Mesh Term | Pathologic Processes |
Downcase Mesh Term | lung diseases, obstructive | Downcase Mesh Term | pulmonary disease, chronic obstructive | Downcase Mesh Term | lung diseases | Downcase Mesh Term | respiratory tract diseases | Downcase Mesh Term | chronic disease | Downcase Mesh Term | disease attributes | Downcase Mesh Term | pathologic processes |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48558168 | Sequence: | 48558169 |
Agency Class | OTHER | Agency Class | OTHER |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | Istituti Clinici Scientifici Maugeri SpA | Name | Universita di Verona |
Overall Officials
Sequence: | 29419480 |
Role | Principal Investigator |
Name | Mara Paneroni, MSc, PT |
Affiliation | Istituti Clinici Scientifici Maugeri |
Central Contacts
Sequence: | 12076270 | Sequence: | 12076271 |
Contact Type | primary | Contact Type | backup |
Name | Mara Paneroni, MSc, PT | Name | Paola Baiardi, Math |
Phone | 0039+030+8253 | Phone | 0039+0382+592 |
mara.paneroni@icsmaugeri.it | paola.baiardi@icsmaugeri.it | ||
Phone Extension | 122 | Phone Extension | 599 |
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 68501762 | Sequence: | 68501763 |
Design Group Id | 55879528 | Design Group Id | 55879529 |
Intervention Id | 52738550 | Intervention Id | 52738551 |
Eligibilities
Sequence: | 30913340 |
Gender | All |
Minimum Age | 50 Years |
Maximum Age | 80 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
COPD clinical definition according to GOLD guidelines with forced expiratory volume (FEV1)/ forced vital capacity (FVC) < 70%, and FEV1 < 50% of predicted Exclusion Criteria: pulmonary diseases other than COPD |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254176376 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 50 |
Maximum Age Num | 80 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 20 |
Designs
Sequence: | 30659035 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Other |
Time Perspective | |
Masking | None (Open Label) |
Intervention Model Description | Pilot randomized controlled trial |
Responsible Parties
Sequence: | 29025709 |
Responsible Party Type | Sponsor |
Study References
Sequence: | 52339669 | Sequence: | 52339670 | Sequence: | 52339671 | Sequence: | 52339672 |
Pmid | 24787074 | Pmid | 10378915 | Pmid | 17277584 | Pmid | 19804581 |
Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background |
Citation | Maltais F, Decramer M, Casaburi R, Barreiro E, Burelle Y, Debigare R, Dekhuijzen PN, Franssen F, Gayan-Ramirez G, Gea J, Gosker HR, Gosselink R, Hayot M, Hussain SN, Janssens W, Polkey MI, Roca J, Saey D, Schols AM, Spruit MA, Steiner M, Taivassalo T, Troosters T, Vogiatzis I, Wagner PD; ATS/ERS Ad Hoc Committee on Limb Muscle Dysfunction in COPD. An official American Thoracic Society/European Respiratory Society statement: update on limb muscle dysfunction in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2014 May 1;189(9):e15-62. doi: 10.1164/rccm.201402-0373ST. | Citation | Hoff J, Helgerud J, Wisloff U. Maximal strength training improves work economy in trained female cross-country skiers. Med Sci Sports Exerc. 1999 Jun;31(6):870-7. doi: 10.1097/00005768-199906000-00016. | Citation | Hoff J, Tjonna AE, Steinshamn S, Hoydal M, Richardson RS, Helgerud J. Maximal strength training of the legs in COPD: a therapy for mechanical inefficiency. Med Sci Sports Exerc. 2007 Feb;39(2):220-6. doi: 10.1249/01.mss.0000246989.48729.39. | Citation | Wang E, Helgerud J, Loe H, Indseth K, Kaehler N, Hoff J. Maximal strength training improves walking performance in peripheral arterial disease patients. Scand J Med Sci Sports. 2010 Oct;20(5):764-70. doi: 10.1111/j.1600-0838.2009.01014.x. |
]]>
https://zephyrnet.com/NCT03799341
2019-11-13
https://zephyrnet.com/?p=NCT03799341
NCT03799341https://www.clinicaltrials.gov/study/NCT03799341?tab=tableStuart R Steinhauer, PhDStuart.Steinhauer@va.gov(412) 360-2397The proposed work will investigate changes in brain signaling and cognitive functioning that support recovery from addiction, as well as use of pretreatment neurocognitive functioning to inform substance use treatment planning. Substance use disorders are prevalent amongst Veterans. Cocaine addiction, in particular, has been shown to complicate treatment of other high priority behavioral health problems in the Veteran population (e.g., PTSD, opioid addiction). While there are currently no approved medications to support recovery from cocaine addiction, research indicates that Contingency Management (CM) – a behavioral intervention for cocaine users – can be effective. However, individual responses are variable and long-term benefits are limited. This CDA will test a new model of how CM works by examining brain-based predictors and indicators of treatment response. Results will have immediate implications for measurement-based implementation of existing CM variants within the VA, supporting access to the version of CM that is best aligned with each Veteran’s needs.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-07 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2023-03-06 |
Start Month Year | November 13, 2019 |
Primary Completion Month Year | December 31, 2023 |
Verification Month Year | March 2023 |
Verification Date | 2023-03-31 |
Last Update Posted Date | 2023-03-06 |
Detailed Descriptions
Sequence: | 20685817 |
Description | Electrophysiological methods, including event-related potential and functional connectivity approaches, have potential to clarify mechanisms of substance use treatment response and characterize individual differences therein. Veterans are disproportionately affected by disorders of addiction, of which cocaine use disorder (CUD) is particularly problematic due to high relapse rates and the absence of approved pharmacotherapy options. Behavioral interventions for CUD have therefore become an important focus and Contingency Management (CM) has emerged as the best-supported approach. CM involves reinforcing cocaine abstinence (established through objective testing) with reliable, short-term reward, such as chances to win prizes (i.e., Prize-Based CM or PBCM). Given robust empirical support, nationwide dissemination of PBCM has been supported by a VHA initiative since 2011. However, PBCM response rates are variable and long-term benefits are limited – problems magnified by the cost of implementation with respect to staffing and prizes. Measurement-based approaches to PBCM implementation have promise to improve the effectiveness and efficiency of CM programming but have not yet been investigated within the VA or considered in relation to promising neuromarkers. Importantly, two versions of PBCM are already utilized at VA sites and may differentially benefit individuals with distinct neurocognitive profiles. Specifically, VA PBCM programs employ either abstract (voucher prize) or concrete (tangible prize) incentives, the latter of which may more effectively incentivize abstinence in Veterans with poor future-oriented thinking and planning ability. While selection between existing PBCM variants currently reflects practical considerations only, pretreatment neurocognitive functioning could meaningfully and realistically inform clinical decision-making in this regard.
This project aims to advance measurement-based implementation of CM by testing a novel neurocognitive model with immediate implications for the use of abstract versus concrete PBCM incentives within the VA. Specifically, the future-minded decision-making (FMDM) model posits that CM scaffolds future-oriented goal representation and self-control to support abstinence during in the moment use-related decision-making. For individuals with greater FMDM impairment, concrete, readily-accessible incentives may be more effective than abstract voucher-based rewards (which require future-oriented thinking and planning to acquire value). To test this model, neurocognitive substrates of FMDM will be examined as predictors of differential treatment response in voucher (VoucherPBCM) versus tangible prize (TangiblePBCM) versions of PBCM. Treatment-related change in neural and cognitive-behavioral correlates of FMDM will also be evaluated in PBCM-adherent versus non-adherent subgroups. Veterans with CUD will be allocated to VoucherPBCM or TangiblePBCM conditions and followed for a 12-week treatment interval. Pre- and post-treatment electroencephalography (EEG) and cognitive-behavioral assessments will be used to measure FMDM-related constructs (working memory, self-control, future-oriented decision-making, future reward representation) and related neuromarkers. These measures will be investigated as predictors of differential treatment response in VoucherPBCM versus TangiblePBCM, as well as maintenance of gains during a post-treatment follow-up period. Change in FMDM-related neural and cognitive measures over the course of treatment will also be evaluated for evidence of neuroadaptation (e.g., changes in functional connectivity) and enhancement of FMDM function through PBCM. Taken together, results of the current research project will represent a first step toward precision implementation of CM within the VA. |
Facilities
Sequence: | 199669286 |
Status | Recruiting |
Name | VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA |
City | Pittsburgh |
State | Pennsylvania |
Zip | 15240 |
Country | United States |
Facility Contacts
Sequence: | 28064311 | Sequence: | 28064312 |
Facility Id | 199669286 | Facility Id | 199669286 |
Contact Type | primary | Contact Type | backup |
Name | Sarah E Forster, PhD | Name | Stuart R Steinhauer, PhD |
Sarah.Forster2@va.gov | Stuart.Steinhauer@va.gov | ||
Phone | 412-360-2365 | Phone | (412) 360-2397 |
Facility Investigators
Sequence: | 18305269 |
Facility Id | 199669286 |
Role | Principal Investigator |
Name | Sarah E. Forster, PhD |
Conditions
Sequence: | 52075941 |
Name | Cocaine Use Disorder |
Downcase Name | cocaine use disorder |
Id Information
Sequence: | 40082978 | Sequence: | 40082979 |
Id Source | org_study_id | Id Source | secondary_id |
Id Value | NURA-002-18S | Id Value | CX001807-01A1 |
Id Type | Other Grant/Funding Number | ||
Id Type Description | VA CSR&D | ||
Countries
Sequence: | 42482393 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55489107 | Sequence: | 55489108 |
Group Type | Experimental | Group Type | Experimental |
Title | Tangible Prize-Based Contingency Management (TangiblePBCM) | Title | Voucher Prize-Based Contingency Management (VoucherPBCM) |
Description | For participants assigned to TangiblePBCM, prize draws resulting in one or more small, large, or jumbo wins will result in access to a prize cabinet stocked with small, medium, large, and jumbo financial incentive items. Medium incentive items are included for selection in the event that a patient draws several small prize slips on the same day and are considered equivalent to 4 small prizes. Selection of specific prize items will be informed by patient preference and items will be restocked at least every 2 weeks. The prize cabinet will be open during TangiblePBCM sessions such that prize items are readily visible. Selection of prizes, maintenance of the prize cabinet, and policies regarding prize redemption will follow published guidance on administration of TangiblePBCM within the context of research protocols. | Description | For participants assigned to VoucherPBCM, prize draws resulting in one or more small, large, or jumbo wins will be reinforced with VA Canteen vouchers in the specified incentive range (i.e., small, large, or jumbo). |
Interventions
Sequence: | 52388954 | Sequence: | 52388955 |
Intervention Type | Behavioral | Intervention Type | Behavioral |
Name | Prize-Based Contingency Management | Name | Treatment As Usual Outpatient Substance Use Treatment |
Description | Participants assigned to Prize-based Contingency
Management (PBCM) conditions will receive PBCM as an adjunct to TAU. PBCM will involve twice weekly one-on-one sessions with a provider for 12-weeks. During each session, a urine specimen provided by the patient will be tested for cocaine using a point-of-care dip-test. Results of point-of-care testing will be shared with the patient and negative results will be reinforced with draws from a fish bowl containing 500 paper slips, 250 of which award small, large, or jumbo prizes (remaining slips deliver words of encouragement). Patients will be reinforced with a single prize draw for their first negative specimen; an additional prize draw will be added for each consecutive negative result (up to 8 prize draws per session). Abstinence-contingent prize draws will be reset to one upon either a positive test result or unexcused, missed appointment. |
Description | All participants will receive treatment as usual outpatient substance use services during the 12-week treatment interval. TAU will specifically entail recommended participation in at least two outpatient group and/or individual psychotherapy encounters per week within the Center for Treatment of Addictive Disorders (CTAD) at VA Pittsburgh Healthcare System. Participants will additionally continue any previously prescribed pharmacotherapy for substance use and/or other mental health conditions, if applicable. |
Keywords
Sequence: | 79711704 | Sequence: | 79711705 | Sequence: | 79711706 | Sequence: | 79711707 | Sequence: | 79711708 | Sequence: | 79711709 | Sequence: | 79711710 | Sequence: | 79711711 | Sequence: | 79711712 | Sequence: | 79711713 | Sequence: | 79711714 |
Name | Cocaine-Related Disorders | Name | Contingency Management | Name | Reward | Name | Choice Behavior | Name | Executive Function | Name | Precision Medicine | Name | Evidence-Based Practice | Name | Prospective Thinking | Name | Electroencephalography | Name | Event-Related Potentials | Name | Functional Connectivity |
Downcase Name | cocaine-related disorders | Downcase Name | contingency management | Downcase Name | reward | Downcase Name | choice behavior | Downcase Name | executive function | Downcase Name | precision medicine | Downcase Name | evidence-based practice | Downcase Name | prospective thinking | Downcase Name | electroencephalography | Downcase Name | event-related potentials | Downcase Name | functional connectivity |
Design Outcomes
Sequence: | 177054177 | Sequence: | 177054178 | Sequence: | 177054179 | Sequence: | 177054180 | Sequence: | 177054181 | Sequence: | 177054182 | Sequence: | 177054183 | Sequence: | 177054184 | Sequence: | 177054185 | Sequence: | 177054186 | Sequence: | 177054187 | Sequence: | 177054188 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other |
Measure | % Cocaine-Negative Urine Specimens | Measure | Longest Duration of Cocaine Abstinence | Measure | % Contingency Management (CM) Sessions Attended (CM Groups Only) | Measure | Total Non-CM Treatment Encounters | Measure | % Self-Reported Cocaine-Abstinent Days During Treatment | Measure | % Self-Reported Drug- and Alcohol-Abstinent Days During Treatment | Measure | % Self-Reported Stimulant-Abstinent Days at Post-Treatment (CM Groups Only) | Measure | % Self-Reported Drug- and Alcohol-Abstinent Days at Post-Treatment (CM Groups Only) | Measure | Pre- to Post-Treatment Change in Theta Synchronization | Measure | Pre- to Post-Treatment Change in Executive Working Memory | Measure | Pre- to Post-Treatment Change in Episodic Future Thinking Effect (Delay Discounting) | Measure | Pre- to Post-Treatment Change Spontaneous Eyeblink Rate |
Time Frame | 12-Week Treatment Interval | Time Frame | 12-Week Treatment Interval | Time Frame | 12-Week Treatment Interval | Time Frame | 12-Week Treatment Interval | Time Frame | 12-Week Treatment Interval | Time Frame | 12-Week Treatment Interval | Time Frame | 6 Month Post-Treatment Interval | Time Frame | 6 Month Post-Treatment Interval | Time Frame | 12-Week Treatment Interval | Time Frame | 12-Week Treatment Interval | Time Frame | 12-Week Treatment Interval | Time Frame | 12-Week Treatment Interval |
Description | Proportion of urine specimens provided during the 12-week treatment interval that test negative for cocaine. | Description | Longest period of objectively verified abstinence from cocaine during treatment. | Description | Proportion of CM treatment sessions attended. | Description | Number of non-CM treatment encounters during treatment (documented in chart and/or self-reported) | Description | Proportion of self-reported cocaine-abstinent days during the 12-week treatment interval. | Description | Proportion of self-reported drug- and alcohol-abstinent days during the 12-week treatment interval. | Description | Proportion of self-reported stimulant-abstinent days during the 6 month post-treatment interval. | Description | Proportion of self-reported drug- and alcohol-abstinent days during the 6 month post-treatment interval. | Description | Treatment-related change in theta synchronization between anterior cingulate cortex and lateral prefrontal cortex during high conflict events in the Parametric Conflict Flankers task. | Description | Treatment-related change in Brown-Peterson working memory scores. We will specifically use a modified Brown-Peterson test (Auditory Consonant Trigrams) for which both age- and Veteran-specific norms exist. Summary scores for this measure (including 9-, 18-, and 36-second delay conditions) can range from 0-45, with higher scores indicating improved executive working memory performance. | Description | Treatment-related change in the difference in delay discounting slopes (ln(k)) estimated for discounting conditions with and without personally meaningful event tags. | Description | Treatment-related change in spontaneous eyeblink rate at rest. |
Sponsors
Sequence: | 48231043 |
Agency Class | FED |
Lead Or Collaborator | lead |
Name | VA Office of Research and Development |
Overall Officials
Sequence: | 29229791 |
Role | Principal Investigator |
Name | Sarah E. Forster, PhD |
Affiliation | VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA |
Central Contacts
Sequence: | 11988926 | Sequence: | 11988927 |
Contact Type | primary | Contact Type | backup |
Name | Sarah E Forster, PhD | Name | Stuart R Steinhauer, PhD |
Phone | (412) 360-2365 | Phone | (412) 360-2397 |
Sarah.Forster2@va.gov | Stuart.Steinhauer@va.gov | ||
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 68022635 | Sequence: | 68022636 | Sequence: | 68022637 | Sequence: | 68022638 |
Design Group Id | 55489107 | Design Group Id | 55489108 | Design Group Id | 55489107 | Design Group Id | 55489108 |
Intervention Id | 52388954 | Intervention Id | 52388954 | Intervention Id | 52388955 | Intervention Id | 52388955 |
Eligibilities
Sequence: | 30709974 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 75 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Military Veterans Exclusion Criteria: History of Severe Traumatic Brain Injury, Seizure Disorder, or other Neurological Illness |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253935080 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 75 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 2 |
Number Of Secondary Outcomes To Measure | 6 |
Number Of Other Outcomes To Measure | 4 |
Designs
Sequence: | 30456565 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Intervention Model Description | Participants will be randomly assigned to receive: (1) 12 weeks of TangiblePBCM (n = 70) or (2) 12 weeks of VoucherPBCM (n = 70). CM recipients will also be followed for 6 months post treatment. The proposed design enables evaluation of CM outcome predictors within 140 CM recipients – both with respect to initial treatment response and longer term (6 month) outcomes. All participants will receive a Baseline Assessment prior to the 12 Week Treatment interval, as well as a Follow-up Assessment at the conclusion of this period. Data from Baseline and Follow-up Assessments will enable longitudinal analysis of treatment-related change in EEG and cognitive-behavioral measures in TangiblePBCM and VoucherPBCM in treatment adherent versus treatment non-adherent subgroups. |
Responsible Parties
Sequence: | 28823039 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03799328
2019-05-23
https://zephyrnet.com/?p=NCT03799328
NCT03799328https://www.clinicaltrials.gov/study/NCT03799328?tab=tableNANANAOral immunotherapy (OIT) is a food allergy treatment where small amounts of the food a child is allergic to is eaten and gradually increased over time with the aim to be able to eat a certain amount of the allergen without experiencing an allergic reaction. While this process works in many children there are concerns about safety, feasibility and drop-outs and how to adapt protocols for multiple allergies.
Many OIT trials have targeted approximately 4000mg of single food/day. In these trials up to 40% drop-out. There is evidence much lower doses can have beneficial effects.
The investigators will evaluate if low doses of foods can allow for OIT to multiple foods. This approach may have efficacy against accidental exposure and be able to demonstrate immune changes. This approach may have a low burden of treatment and a low rate of allergic reactions and
<![CDATA[
Studies
Study First Submitted Date | 2018-11-20 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2022-05-06 |
Start Month Year | May 23, 2019 |
Primary Completion Month Year | January 2025 |
Verification Month Year | May 2022 |
Verification Date | 2022-05-31 |
Last Update Posted Date | 2022-05-06 |
Detailed Descriptions
Sequence: | 20562430 |
Description | This is a single-arm, open label, study of the intervention of low dose multiple-nut OIT in nut allergic children.
After meeting eligibility criteria, participants will have a food challenge to 2-5 nuts. If the oral food challenge is positive, participants will be enrolled in the study to multiple nut OIT. A blood draw and quality of life (QOL) survey will occur at baseline. Participants will have dose escalation visits of the multiple nut OIT every 2 months to a target dose of 30mg of each nut protein. A blood draw and QOL survey will occur at 6 months. Participants will then continue with daily ingestion of the 30mg of each nut protein for 1 year with visits every 3 months. After 18 months from the start of the study, another oral food challenge will be given to participants to assess the change in the maximum tolerated dose of nuts. A blood draw will assess changes in the immune parameters. A QOL survey will occur at 18 months to assess changes in QOL. |
Facilities
Sequence: | 198524681 |
Name | Hospital for Sick Children |
City | Toronto |
State | Ontario |
Zip | M5G1X8 |
Country | Canada |
Conditions
Sequence: | 51761827 |
Name | Food Allergy |
Downcase Name | food allergy |
Id Information
Sequence: | 39831227 |
Id Source | org_study_id |
Id Value | 1000060633 |
Countries
Sequence: | 42230995 |
Name | Canada |
Removed | False |
Design Groups
Sequence: | 55182572 |
Group Type | Experimental |
Title | multi-OIT |
Description | Low dose OIT with multiple allergens |
Interventions
Sequence: | 52082940 |
Intervention Type | Other |
Name | multi-OIT |
Description | low dose OIT to multiple foods |
Design Outcomes
Sequence: | 176059986 | Sequence: | 176059987 | Sequence: | 176059988 | Sequence: | 176059989 | Sequence: | 176059990 | Sequence: | 176059991 | Sequence: | 176059992 | Sequence: | 176059993 | Sequence: | 176059994 | Sequence: | 176059995 | Sequence: | 176059996 | Sequence: | 176059997 | Sequence: | 176059998 | Sequence: | 176059999 | Sequence: | 176060000 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other |
Measure | Desensitization to allergic food as assessed by change in maximum tolerated dose in a dichotomous manner | Measure | Immunological change in IgG4 | Measure | Desensitization to allergic food as assessed by change in maximum tolerated dose on a linear scale | Measure | Immunological change in IgG4 | Measure | Desensitization to allergic food as assessed by maximum tolerated dose | Measure | Desensitization to allergic food as assessed by maximum tolerated dose | Measure | Feasibility analysis as assessed by can the patients achieve the maintenance dosing of the allergen mix for OIT | Measure | Feasibility analysis as assessed by drop-out rate | Measure | Incidence of Treatment-Emergent Adverse Events: Safety analysis as assessed by use of epinephrine | Measure | Quality of life scale | Measure | Change in allergen specific IgE, and components | Measure | Basophil activation test | Measure | Skin prick test (SPT) reactivity to the individual nut extracts | Measure | High content functional immune profiling via mass cytometry and single cell sorting | Measure | Number of participants with treatment related adverse effects |
Time Frame | month 0, month 18 | Time Frame | month 0, month 18 | Time Frame | month 0, month 18 | Time Frame | pre-study, month 18 | Time Frame | month 18 | Time Frame | month 0, month 18 | Time Frame | month 18 | Time Frame | month 18 | Time Frame | month 18 | Time Frame | month 0, month 18 | Time Frame | month 0, month 18 | Time Frame | month 0, month 18 | Time Frame | month 0, month 18 | Time Frame | pre-study, month 18 | Time Frame | month 0, month 18 |
Description | Change in how much nuts the participant can eat without an allergic reaction after the low dose OIT assessed as dichotomous did the participant reach 5 times the baseline eliciting dose | Description | Change in allergen specific immunoglobulin G4 (IgG4) from baseline to end | Description | A continuous variable amount tolerated at baseline vs at end | Description | Change in IgG4 from measures from historical data to 18 month of study. Some patients will have historical IgG4 values to compare | Description | Did they reach 300mg (cumulative) on the 18 month exit oral food challenge | Description | Did they reach 140mg (cumulative) on the 18 month exit oral food challenge | Description | Proportion who achieve maintenance doses of their allergen mix (descriptive) | Description | Proportion who drop-out of the study (descriptive) | Description | Administration of epinephrine; (descriptive); | Description | Change in quality of life at 18m of children compared to baseline assessment (using validated questionnaire: Food allergy quality of life questionnaires (FAQLQ) FAQLQ Parental form (PF) for ages 0-12 OR the FAQLQ-teenager form (TF) using total score. The FAQLQ total and domain scores range from 1-7 with higher scores indicative of worse health related quality of life with the total score being the average of the domain scores. The domains include Emotional Impact, Social and Dietary Restrictions, Food Anxiety, Allergen Avoidance, and Risk of Accidental Exposure. | Description | Change in allergen specific IgE, and components via microarray | Description | Basophil activation test | Description | The size of the skin prick test will be compared | Description | Compare the change in the immune pattern | Description | Diaries will be analyzed for allergic symptoms and tabulated |
Browse Conditions
Sequence: | 191834671 | Sequence: | 191834672 | Sequence: | 191834673 | Sequence: | 191834674 |
Mesh Term | Hypersensitivity | Mesh Term | Food Hypersensitivity | Mesh Term | Immune System Diseases | Mesh Term | Hypersensitivity, Immediate |
Downcase Mesh Term | hypersensitivity | Downcase Mesh Term | food hypersensitivity | Downcase Mesh Term | immune system diseases | Downcase Mesh Term | hypersensitivity, immediate |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 47938447 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | The Hospital for Sick Children |
Overall Officials
Sequence: | 29045136 |
Role | Principal Investigator |
Name | Julia Upton |
Affiliation | The Hospital for Sick Children |
Design Group Interventions
Sequence: | 67652690 |
Design Group Id | 55182572 |
Intervention Id | 52082940 |
Eligibilities
Sequence: | 30525763 |
Gender | All |
Minimum Age | 6 Months |
Maximum Age | 15 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Relevant allergy to 2-5 nuts Exclusion Criteria: History of frequent or repeated, severe or life-threatening episodes of anaphylactic shock |
Adult | False |
Child | True |
Older Adult | False |
Calculated Values
Sequence: | 254091700 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 6 |
Maximum Age Num | 15 |
Minimum Age Unit | Months |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 2 |
Number Of Secondary Outcomes To Measure | 4 |
Number Of Other Outcomes To Measure | 9 |
Designs
Sequence: | 30274672 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Provided Documents
Sequence: | 2565148 |
Document Type | Study Protocol and Statistical Analysis Plan |
Has Protocol | True |
Has Icf | False |
Has Sap | True |
Document Date | 2018-11-13 |
Url | https://ClinicalTrials.gov/ProvidedDocs/28/NCT03799328/Prot_SAP_000.pdf |
Responsible Parties
Sequence: | 28654595 |
Responsible Party Type | Principal Investigator |
Name | Julia Upton |
Title | Principal Investigator |
Affiliation | The Hospital for Sick Children |
]]>
https://zephyrnet.com/NCT03799315
2019-01-14
https://zephyrnet.com/?p=NCT03799315
NCT03799315https://www.clinicaltrials.gov/study/NCT03799315?tab=tableNANANASmoking rates remain above 60% for individuals involved in the criminal justice system and contribute to elevated mortality rates in this population. Addressing smoking disparities among justice-involved individuals is a critical public health issue in Minnesota, one of a few states with rising incarceration rates. People who are incarcerated represent the intersection of multiple high-priority populations (disproportionately African-American, Native American, low-income, homeless, on Medicaid, and suffering from mental illness and substance use disorders). This study examines the impact of a smoking cessation intervention for individuals discharged from jail to the community on smoking abstinence. Participants will be randomized to either 1) guideline-based, in-person smoking cessation counseling during incarceration, telephone counseling after incarceration, and nicotine replacement, or 2) enhanced treatment as usual. This study’s findings will be used to develop a larger, multi-site study that is fully powered to measure longer-term health and smoking cessation outcomes.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-04 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2020-09-14 |
Start Month Year | January 14, 2019 |
Primary Completion Month Year | March 16, 2020 |
Verification Month Year | September 2020 |
Verification Date | 2020-09-30 |
Last Update Posted Date | 2020-09-14 |
Detailed Descriptions
Sequence: | 20735760 |
Description | Outcome assessments will be conducted for both arms at 1 week, 3 weeks, and 12 weeks post discharge from jail. During these assessments, seven-day point prevalence abstinence will be bio-verified with exhaled carbon monoxide, and self-reported general health, physical health, mental health, and substance use measures will also be obtained. The analysis is fully powered (i.e., power > .8) to detect significant between group effects on the primary outcome (i.e., the longitudinal, between group effect on bio-verified seven-day point prevalence abstinence over the 3 weeks post discharge). All analyses will be conducted on the intent to treat sample and will utilize pre-specified logistic and linear regression models. |
Facilities
Sequence: | 200244169 |
Name | Hennepin Healthcare Research Institute |
City | Minneapolis |
State | Minnesota |
Zip | 55415 |
Country | United States |
Browse Interventions
Sequence: | 96113049 | Sequence: | 96113050 | Sequence: | 96113051 | Sequence: | 96113052 | Sequence: | 96113053 | Sequence: | 96113054 | Sequence: | 96113055 | Sequence: | 96113056 | Sequence: | 96113057 | Sequence: | 96113058 |
Mesh Term | Nicotine | Mesh Term | Ganglionic Stimulants | Mesh Term | Autonomic Agents | Mesh Term | Peripheral Nervous System Agents | Mesh Term | Physiological Effects of Drugs | Mesh Term | Nicotinic Agonists | Mesh Term | Cholinergic Agonists | Mesh Term | Cholinergic Agents | Mesh Term | Neurotransmitter Agents | Mesh Term | Molecular Mechanisms of Pharmacological Action |
Downcase Mesh Term | nicotine | Downcase Mesh Term | ganglionic stimulants | Downcase Mesh Term | autonomic agents | Downcase Mesh Term | peripheral nervous system agents | Downcase Mesh Term | physiological effects of drugs | Downcase Mesh Term | nicotinic agonists | Downcase Mesh Term | cholinergic agonists | Downcase Mesh Term | cholinergic agents | Downcase Mesh Term | neurotransmitter agents | Downcase Mesh Term | molecular mechanisms of pharmacological action |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52208079 |
Name | Tobacco Use |
Downcase Name | tobacco use |
Id Information
Sequence: | 40186125 |
Id Source | org_study_id |
Id Value | RC-2018-0013 |
Countries
Sequence: | 42599618 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55634631 | Sequence: | 55634632 |
Group Type | Experimental | Group Type | No Intervention |
Title | Jail-Based Use of Smoking Cessation Treatment (JUST) | Title | Enhanced Treatment As Usual (TAU) |
Description | Participants will receive guidline-based smoking cessation counseling while in jail and phone-based smoking cessation counseling sessions and nicotine lozenges after release from jail. | Description | Participants will receive the usual, limited smoking cessation treatment while in jail, plus an additional health and wellness education session in jail. Nicotine lozenges will be offered at the end of the study to those who did not quit smoking. |
Interventions
Sequence: | 52522046 | Sequence: | 52522047 |
Intervention Type | Drug | Intervention Type | Behavioral |
Name | Nicotine Replacement Therapy | Name | Counseling |
Description | All participants randomized to the JUST group will receive training on proper use of nicotine lozenges to aid in smoking cessation. Upon release from jail, participants will receive 2mg nicotine lozenges. | Description | All participants randomized to the JUST group will receive one hour of in-person, individual, guideline-based smoking cessation counseling during their jail stay. Upon release from jail, they will receive four 30-minute counseling phone calls over 3 weeks. These phone calls will take place at 24 hours, day 7, day 14, and day 20. |
Keywords
Sequence: | 79922895 | Sequence: | 79922896 | Sequence: | 79922897 | Sequence: | 79922898 | Sequence: | 79922899 |
Name | Incarceration | Name | Smoking | Name | Counseling | Name | Nicotine Replacement | Name | Disparities |
Downcase Name | incarceration | Downcase Name | smoking | Downcase Name | counseling | Downcase Name | nicotine replacement | Downcase Name | disparities |
Design Outcomes
Sequence: | 177511092 | Sequence: | 177511093 | Sequence: | 177511094 | Sequence: | 177511095 | Sequence: | 177511096 | Sequence: | 177511097 | Sequence: | 177511098 | Sequence: | 177511099 | Sequence: | 177511100 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Bioverified 7-day point prevalence abstinence from smoking | Measure | Time to Lapse | Measure | Time to Relapse | Measure | Bio-verified 7-day point prevalence abstinence from smoking | Measure | Health-related quality of life | Measure | Depressive symptoms | Measure | Self-Reported Affect | Measure | Health care utilization | Measure | Substance abuse |
Time Frame | Over 3 weeks | Time Frame | 1 week, 3 weeks, 12 weeks | Time Frame | 3 weeks, 12 weeks | Time Frame | Over 12 weeks | Time Frame | 1 week, 3 weeks, 12 weeks | Time Frame | 1 week, 3 weeks, 12 weeks | Time Frame | 1 week, 3 weeks, 12 weeks | Time Frame | 1 week, 3 weeks, 12 weeks | Time Frame | 1 week, 3 weeks, 12 weeks |
Description | Bioverified 7-day point prevalence abstinence from smoking | Description | Days to first lapse (i.e., any cigarette use, even a puff) | Description | Days to first relapse | Description | Bioverified 7-day point prevalence abstinence from smoking | Description | Self-Reported health using the SF-12 total score and physical and mental health composite scores. Lower scores indicate worse health. | Description | The 10 item Center for Epidemiologic Studies Depression Scale (CESD-10) ranges from 0-30 with higher scores indicating higher depression symptoms. | Description | 10-item Positive and Negative Affect Scales (PANAS). The 5-item positive affect scale on the PANAS ranges from 5-25 with higher scores indicating greater positive affect. The 5-item negative affect scale on the PANAS ranges from 5-25 with higher scores indicating greater negative affect. | Description | Self-reported hospitalizations and use of the emergency department | Description | Self-reported substance abuse using the Drug Abuse Screening Test-10. Higher scores indicate more severe drug abuse. |
Sponsors
Sequence: | 48353668 | Sequence: | 48353669 | Sequence: | 48353670 |
Agency Class | OTHER | Agency Class | UNKNOWN | Agency Class | OTHER |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator |
Name | Hennepin Healthcare Research Institute | Name | Hennepin County Adult Detention Center | Name | Brown University |
Design Group Interventions
Sequence: | 68199155 | Sequence: | 68199156 |
Design Group Id | 55634631 | Design Group Id | 55634631 |
Intervention Id | 52522046 | Intervention Id | 52522047 |
Eligibilities
Sequence: | 30786852 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 64 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
Use of ≥ 1 cigarette per day prior to incarceration Exclusion Criteria: Active tuberculosis |
Adult | True |
Child | False |
Older Adult | False |
Calculated Values
Sequence: | 253989600 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 14 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 64 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 8 |
Designs
Sequence: | 30532922 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Single |
Outcomes Assessor Masked | True |
Responsible Parties
Sequence: | 28899216 |
Responsible Party Type | Principal Investigator |
Name | Tyler Winkelman |
Title | Clinician-Investigator |
Affiliation | Hennepin Healthcare Research Institute |
Study References
Sequence: | 52103034 | Sequence: | 52103035 | Sequence: | 52103036 | Sequence: | 52103037 | Sequence: | 52103038 | Sequence: | 52103039 | Sequence: | 52103040 | Sequence: | 52103041 | Sequence: | 52103042 | Sequence: | 52103043 | Sequence: | 52103044 | Sequence: | 52103045 | Sequence: | 52103046 | Sequence: | 52103047 | Sequence: | 52103048 | Sequence: | 52103049 | Sequence: | 52103050 | Sequence: | 52103051 | Sequence: | 52103052 | Sequence: | 52103053 | Sequence: | 52103054 | Sequence: | 52103055 | Sequence: | 52103056 | Sequence: | 52103057 |
Pmid | 27832052 | Pmid | 30635028 | Pmid | 28116579 | Pmid | 25097186 | Pmid | 27638837 | Pmid | 28323472 | Pmid | 29309230 | Pmid | 24817280 | Pmid | 21974746 | Pmid | 23567902 | Pmid | 11716663 | Pmid | 22160762 | Pmid | 12915172 | Pmid | 26069036 | Pmid | 28415979 | Pmid | 27798322 | Pmid | 21802731 | Pmid | 18381994 | Pmid | 20509891 | Pmid | 34228127 | ||||||||
Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | derived |
Citation | Jamal A, King BA, Neff LJ, Whitmill J, Babb SD, Graffunder CM. Current Cigarette Smoking Among Adults – United States, 2005-2015. MMWR Morb Mortal Wkly Rep. 2016 Nov 11;65(44):1205-1211. doi: 10.15585/mmwr.mm6544a2. | Citation | Winkelman TNA, Vickery KD, Busch AM. Tobacco use among non-elderly adults with and without criminal justice involvement in the past year: United States, 2008-2016. Addict Sci Clin Pract. 2019 Jan 11;14(1):2. doi: 10.1186/s13722-019-0131-y. | Citation | Puljevic C, Kinner SA, de Andrade D. Extending smoking abstinence after release from smoke-free prisons: protocol for a randomised controlled trial. Health Justice. 2017 Dec;5(1):1. doi: 10.1186/s40352-016-0046-6. Epub 2017 Jan 23. | Citation | Binswanger IA, Carson EA, Krueger PM, Mueller SR, Steiner JF, Sabol WJ. Prison tobacco control policies and deaths from smoking in United States prisons: population based retrospective analysis. BMJ. 2014 Aug 5;349:g4542. doi: 10.1136/bmj.g4542. | Citation | Travis J, Western B, Redburn S, eds. The Growth of Incarceration in the United States: Exploring Causes and Consequences. Washington, D.C.: The National Academies Press; 2014. doi:10.17226/18613. | Citation | Winkelman TN, Kieffer EC, Goold SD, Morenoff JD, Cross K, Ayanian JZ. Health Insurance Trends and Access to Behavioral Healthcare Among Justice-Involved Individuals-United States, 2008-2014. J Gen Intern Med. 2016 Dec;31(12):1523-1529. doi: 10.1007/s11606-016-3845-5. | Citation | Winkelman TN, Choi H, Davis MM. The Affordable Care Act, Insurance Coverage, and Health Care Utilization of Previously Incarcerated Young Men: 2008-2015. Am J Public Health. 2017 May;107(5):807-811. doi: 10.2105/AJPH.2017.303703. Epub 2017 Mar 21. | Citation | Vickery KD, Bodurtha P, Winkelman TNA, Hougham C, Owen R, Legler MS, Erickson E, Davis MM. Cross-Sector Service Use Among High Health Care Utilizers In Minnesota After Medicaid Expansion. Health Aff (Millwood). 2018 Jan;37(1):62-69. doi: 10.1377/hlthaff.2017.0991. | Citation | Frank JW, Linder JA, Becker WC, Fiellin DA, Wang EA. Increased hospital and emergency department utilization by individuals with recent criminal justice involvement: results of a national survey. J Gen Intern Med. 2014 Sep;29(9):1226-33. doi: 10.1007/s11606-014-2877-y. Epub 2014 May 10. | Citation | Clarke JG, Martin RA, Stein L, Lopes CE, Mello J, Friedmann P, Bock B. Working Inside for Smoking Elimination (Project W.I.S.E.) study design and rationale to prevent return to smoking after release from a smoke free prison. BMC Public Health. 2011 Oct 5;11:767. doi: 10.1186/1471-2458-11-767. | Citation | Clarke JG, Stein LA, Martin RA, Martin SA, Parker D, Lopes CE, McGovern AR, Simon R, Roberts M, Friedman P, Bock B. Forced smoking abstinence: not enough for smoking cessation. JAMA Intern Med. 2013 May 13;173(9):789-94. doi: 10.1001/jamainternmed.2013.197. | Citation | Mulder I, Tijhuis M, Smit HA, Kromhout D. Smoking cessation and quality of life: the effect of amount of smoking and time since quitting. Prev Med. 2001 Dec;33(6):653-60. doi: 10.1006/pmed.2001.0941. | Citation | Piper ME, Kenford S, Fiore MC, Baker TB. Smoking cessation and quality of life: changes in life satisfaction over 3 years following a quit attempt. Ann Behav Med. 2012 Apr;43(2):262-70. doi: 10.1007/s12160-011-9329-2. | Citation | Lemon SC, Friedmann PD, Stein MD. The impact of smoking cessation on drug abuse treatment outcome. Addict Behav. 2003 Sep;28(7):1323-31. doi: 10.1016/s0306-4603(02)00259-9. | Citation | Thurgood SL, McNeill A, Clark-Carter D, Brose LS. A Systematic Review of Smoking Cessation Interventions for Adults in Substance Abuse Treatment or Recovery. Nicotine Tob Res. 2016 May;18(5):993-1001. doi: 10.1093/ntr/ntv127. Epub 2015 Jun 11. | Citation | Busch AM, Tooley EM, Dunsiger S, Chattillion EA, Srour JF, Pagoto SL, Kahler CW, Borrelli B. Behavioral activation for smoking cessation and mood management following a cardiac event: results of a pilot randomized controlled trial. BMC Public Health. 2017 Apr 17;17(1):323. doi: 10.1186/s12889-017-4250-7. | Citation | A randomised controlled study of the Health Intervention "SNAP" in Northern Territory prisons- where smoking is banned- to prevent relapse to smoking. Trial Review. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371923. Published October 10, 2017. Accessed December 29, 2017. | Citation | de Andrade D, Kinner SA. Systematic review of health and behavioural outcomes of smoking cessation interventions in prisons. Tob Control. 2016 Sep;26(5):495-501. doi: 10.1136/tobaccocontrol-2016-053297. Epub 2016 Oct 18. | Citation | Fiore MC, Jaen CR, Baker TB, et al. Treating Tobacco Use and Dependence: 2008 Update. Rockville, MD: U.S. Department of Health and Human Services. Public Health Service; 2008. https://bphc.hrsa.gov/buckets/treatingtobacco.pdf. Accessed October 17, 2017. | Citation | Prisoner Research FAQs. HHS.gov. https://www.hhs.gov/ohrp/regulations-andpolicy/ guidance/faq/prisoner-research/index.html. Accessed December 18, 2017. | Citation | Binswanger IA, Nowels C, Corsi KF, Long J, Booth RE, Kutner J, Steiner JF. "From the prison door right to the sidewalk, everything went downhill," a qualitative study of the health experiences of recently released inmates. Int J Law Psychiatry. 2011 Jul-Aug;34(4):249-55. doi: 10.1016/j.ijlp.2011.07.002. Epub 2011 Jul 29. | Citation | Wang EA, White MC, Jamison R, Goldenson J, Estes M, Tulsky JP. Discharge planning and continuity of health care: findings from the San Francisco County Jail. Am J Public Health. 2008 Dec;98(12):2182-4. doi: 10.2105/AJPH.2007.119669. Epub 2008 Apr 1. | Citation | Wang EA, Green J. Incarceration as a key variable in racial disparities of asthma prevalence. BMC Public Health. 2010 May 28;10:290. doi: 10.1186/1471-2458-10-290. | Citation | Winkelman TNA, Ford BR, Dunsiger S, Chrastek M, Cameron S, Strother E, Bock BC, Busch AM. Feasibility and Acceptability of a Smoking Cessation Program for Individuals Released From an Urban, Pretrial Jail: A Pilot Randomized Clinical Trial. JAMA Netw Open. 2021 Jul 1;4(7):e2115687. doi: 10.1001/jamanetworkopen.2021.15687. |
]]>
https://zephyrnet.com/NCT03799302
2018-08-01
https://zephyrnet.com/?p=NCT03799302
NCT03799302https://www.clinicaltrials.gov/study/NCT03799302?tab=tableTed Donahuetedd@oslc.org541-285-2711This study aims to test the impact of an empirically derived implementation strategy-under real-world conditions and across multiple child service systems-on successful adoption and sustainment of two evidence-based programs that address adolescent substance abuse: Treatment Foster Care Oregon (TFCO; formerly Multidimensional Treatment Foster Care) and Multidimensional Family Therapy (MDFT), both developed with funding from NIDA. Methods for this study utilize “technology-based approaches” for “implementing large-scale change.” Leveraging previous data focused on developing and testing the 8-staged Stages of Implementation Completion (SIC) tool, a randomized evaluation of a SIC Coaching Strategy (SIC-CS) is proposed. Study activities include extending the SIC into the Sustainment Phase and testing the SIC-CS to support the adoption of new evidence-based programs.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-13 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2022-07-22 |
Start Month Year | August 1, 2018 |
Primary Completion Month Year | January 2023 |
Verification Month Year | July 2022 |
Verification Date | 2022-07-31 |
Last Update Posted Date | 2022-07-22 |
Facilities
Sequence: | 199189122 |
Status | Recruiting |
Name | Oregon Social Learning Center |
City | Eugene |
State | Oregon |
Zip | 97401 |
Country | United States |
Facility Contacts
Sequence: | 28003923 | Sequence: | 28003924 |
Facility Id | 199189122 | Facility Id | 199189122 |
Contact Type | primary | Contact Type | backup |
Name | Courtenay Padgett | Name | Lisa Saldana, PhD |
courtp@oslc.org | lisas@oslc.org | ||
Phone | 541-485-2711 | Phone | 541-485-2711 |
Facility Investigators
Sequence: | 18267812 |
Facility Id | 199189122 |
Role | Principal Investigator |
Name | Lisa Saldana, PhD |
Conditions
Sequence: | 51953393 |
Name | Evidence Based Practice |
Downcase Name | evidence based practice |
Id Information
Sequence: | 39989609 |
Id Source | org_study_id |
Id Value | R01DA044745 |
Id Type | U.S. NIH Grant/Contract |
Id Link | https://reporter.nih.gov/quickSearch/R01DA044745 |
Countries
Sequence: | 42380514 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55353391 | Sequence: | 55353392 |
Group Type | No Intervention | Group Type | Experimental |
Title | Standard Consultation | Title | SIC Coaching Consultation |
Description | Sites in this arm will receive the standard consultation from the TFCO or MDFT purveyors | Description | In addition to the standard consultation from the TFCO or MDFT purveyors, sites in this arm will also receive feedback on how they are doing in terms of completing expected activities in their efforts to implement the designated EBP. |
Interventions
Sequence: | 52265626 |
Intervention Type | Behavioral |
Name | SIC Coaching |
Description | Sites receiving consultation to implement either TFCO or MDFT will also receive consultation on their implementation fidelity as measured and tracked by the SIC. |
Design Outcomes
Sequence: | 176606146 |
Outcome Type | primary |
Measure | Stages of Implementation Completion (SIC) |
Time Frame | Baseline through month 60 |
Description | The SIC is an 8-stage observational assessment tool recording organizational site completion of implementation activities that map onto the three phases of implementation (Pre-Implementation, Implementation, Sustainability). |
Sponsors
Sequence: | 48115544 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Oregon Social Learning Center |
Overall Officials
Sequence: | 29160890 |
Role | Principal Investigator |
Name | Lisa Saldana, PHD |
Affiliation | Oregon Social Learning Center |
Central Contacts
Sequence: | 11959552 | Sequence: | 11959553 |
Contact Type | primary | Contact Type | backup |
Name | Lisa Saldana | Name | Ted Donahue |
Phone | 541-485-2711 | Phone | 541-285-2711 |
lisas@oslc.org | tedd@oslc.org | ||
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 67857640 |
Design Group Id | 55353392 |
Intervention Id | 52265626 |
Eligibilities
Sequence: | 30637058 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 70 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
Senior leadership staff from teams that either currently are sustaining or who achieve 1-year sustainment post certification during the first year of the project Exclusion Criteria: none |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254132236 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 70 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Designs
Sequence: | 30383992 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Other |
Time Perspective | |
Masking | None (Open Label) |
Responsible Parties
Sequence: | 28750727 |
Responsible Party Type | Principal Investigator |
Name | Lisa Saldana |
Title | Principal Investigator |
Affiliation | Oregon Social Learning Center |
]]>
https://zephyrnet.com/NCT03799289
2019-01-03
https://zephyrnet.com/?p=NCT03799289
NCT03799289https://www.clinicaltrials.gov/study/NCT03799289?tab=tableNANANAThe purpose of this study is to examine two approaches for improving long-term weight loss success. All participants will receive a 12-week, in-person standard behavioral weight loss program followed by either 12 weeks of yoga instruction or 12 weeks of cooking/dietary education instruction (determined via randomization procedures). Assessments of weight, physical activity, dietary behaviors, and psychosocial factors will occur at baseline, 3, and 6 months.
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Studies
Study First Submitted Date | 2018-12-05 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2021-10-28 |
Start Month Year | January 3, 2019 |
Primary Completion Month Year | June 18, 2020 |
Verification Month Year | June 2021 |
Verification Date | 2021-06-30 |
Last Update Posted Date | 2021-10-28 |
Results First Posted Date | 2021-10-28 |
Detailed Descriptions
Sequence: | 20559316 |
Description | Behavioral weight loss (WL) programs result in clinically significant weight losses; however rates of long-term WL maintenance are poor. Previous studies suggest that long-term WL success may require an enhanced ability to overcome physiological and hedonic urges to eat and an improved capacity for dealing with life stressors, negative mood states, and food cravings. Thus interventions which target stress reduction and reduce the tendency to use food as a coping strategy for aversive experiences may offer a protective effect against dietary lapses; thereby improving long-term WL outcomes. Yoga is a mind-body intervention which reduces stress and improves overall physical and psychological well-being and offers promise for strengthening the psychological skill set needed for maintaining important weight-related behaviors long-term. The physical and cognitive skills practiced within yoga target multiple underlying psychological processes (e.g., mindfulness, distress tolerance) which could reduce emotional eating, improve dietary choices, and enhance one's ability to tolerate food cravings or hedonic urges to eat. While yoga is an effective treatment approach for other chronic health conditions, it has not been examined as a potential intervention for improving long-term WL outcomes. Within the context of the obesity field, yoga has been viewed as a mode of exercise and not necessarily as a mind-body intervention approach (as is the case in other fields). Thus, given the lower caloric expenditure of yoga in comparison to many forms of aerobic exercise, the effect of yoga on important weight- related processes and behaviors has not been examined.
The primary aims of this study are to examine the feasibility and acceptability of implementing yoga within a weight management program. Secondary aims focus on examining the impact of yoga, relative to a cooking/dietary education intervention (matched for contact time) on important psychological constructs (perceived stress, mindfulness, and distress tolerance) and weight. Sixty women with overweight or obesity will be randomly assigned to a 12-week standard behavioral WL program, followed by either 12 weeks of group-based yoga or 12 weeks of cooking/dietary information classes. Both groups will be instructed to self-monitor and achieve the dietary and aerobic exercise goals throughout the 24-week program. Primary assessments will occur at baseline and weeks 12 and 24. |
Facilities
Sequence: | 198498215 |
Name | Weight Control and Diabetes Research Center |
City | Providence |
State | Rhode Island |
Zip | 02903 |
Country | United States |
Conditions
Sequence: | 51754237 |
Name | Obesity |
Downcase Name | obesity |
Id Information
Sequence: | 39825469 | Sequence: | 39825470 |
Id Source | org_study_id | Id Source | secondary_id |
Id Value | 2096-18 | Id Value | R03DK115978-01A1 |
Id Type | U.S. NIH Grant/Contract | ||
Id Link | https://reporter.nih.gov/quickSearch/R03DK115978-01A1 |
Countries
Sequence: | 42225517 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55175384 | Sequence: | 55175385 |
Group Type | Experimental | Group Type | Active Comparator |
Title | Iyengar Yoga | Title | Cooking/dietary education |
Description | Participants randomized to the yoga intervention arm will receive 12 weeks of group-based yoga instruction, following a 12-week standard behavioral weight loss program. Group-based yoga instruction will occur twice per week and classes will be 60 minutes in duration. The yoga program will consist of breathing, postural, and meditation practices and home-based yoga practice will also be prescribed. | Description | Participants randomized to the cooking/dietary education intervention arm will receive 12 weeks of group-based, cooking/dietary education instruction, following a 12-week standard behavioral weight loss program. This group-based instruction will occur twice per week and classes will be 60 minutes in duration. Classes will focus on providing basic nutrition knowledge and culinary skills, and will include cooking demonstrations. |
Interventions
Sequence: | 52075617 | Sequence: | 52075618 |
Intervention Type | Behavioral | Intervention Type | Behavioral |
Name | Behavioral weight loss followed by yoga instruction | Name | Behavioral weight loss followed by cooking/dietary education instruction |
Description | 12-week standard behavioral weight loss program followed by a 12-week yoga intervention | Description | 12-week standard behavioral weight loss program followed by a 12-week cooking/dietary education intervention |
Keywords
Sequence: | 79182957 | Sequence: | 79182958 | Sequence: | 79182959 | Sequence: | 79182960 | Sequence: | 79182961 |
Name | Obesity | Name | Weight loss | Name | physical activity | Name | yoga | Name | exercise |
Downcase Name | obesity | Downcase Name | weight loss | Downcase Name | physical activity | Downcase Name | yoga | Downcase Name | exercise |
Design Outcomes
Sequence: | 176033855 | Sequence: | 176033856 | Sequence: | 176033857 | Sequence: | 176033858 | Sequence: | 176033859 | Sequence: | 176033860 | Sequence: | 176033861 | Sequence: | 176033862 | Sequence: | 176033863 | Sequence: | 176033864 | Sequence: | 176033865 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Program Satisfaction Ratings | Measure | Intervention Session Attendance | Measure | Feasibility of the Intervention (Retention) | Measure | Changes in Perceived Stress (Measured Via the Perceived Stress Scale) | Measure | Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) – Observing Subscale | Measure | Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) – Describing Subscale | Measure | Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) – Acting With Awareness Subscale | Measure | Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) – Non-judgmental Inner Critic Subscale | Measure | Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) – Non-reactivity Subscale | Measure | Change in Distress Tolerance (Assessed Via the Distress Tolerance Scale) | Measure | Change in Weight |
Time Frame | 6 months | Time Frame | 6 months | Time Frame | 6 months | Time Frame | Change from 12 to 24 weeks | Time Frame | Change from 12 to 24 weeks | Time Frame | Change from 12 to 24 weeks | Time Frame | Change from 12 to 24 weeks | Time Frame | Change from 12 to 24 weeks | Time Frame | Change from 12 to 24 weeks | Time Frame | Change from 12 to 24 weeks | Time Frame | Change from 12 to 24 weeks |
Description | Participants were asked, 'How satisfied were you with the yoga or cooking/dietary education intervention that you received over the past 3 months' on a 1-10 scale (1=very dissatisfied, 10=very satisfied) | Description | Yoga or control intervention sessions attended, expressed as a percentage (# of sessions completed/# of sessions possible x 100). | Description | Number of participants completing the 6-month assessment visit. Percentage of total participants can be computed as follows: the number of participants completing the 6-month assessment divided by the total number of participants who completed the 3-month weight loss program and learned of their randomization assignment | Description | Perceived stress scores range from 0-40, with higher scores indicating higher perceived stress. Change in perceived stress was calculated as follows: 24-week perceived stress score minus 12-week perceived stress score. Negative change scores indicate that perceived stress was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that perceived stress increased. | Description | The observation subscale assesses the ways we use our sensory awareness. It involves how we see, feel, and perceive the internal and external world around us and select the stimuli that require our attention and focus. Mindfulness subscale scores range from 8-40, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased. | Description | The describing subscale evaluates the way we label our experiences and express them in words to ourselves and others. Subscale scores range from 8-40, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased. | Description | This subscale examines whether we can act out of quick judgment and get out of the autopilot mode before responding to a situation. Subscale scores range from 8-40, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased. | Description | This subscale assesses the degree of self-acceptance and unconditional empathy for oneself and others. Subscale scores range from 8-40, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased. | Description | This subscale assesses active detachment from negative thoughts and emotions so that we can accept their existence and choose not to react to them. Subscale scores range from 7-35, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased. | Description | The Distress Tolerance Scale is a 15-item measure designed to assess one's perceived ability to tolerate emotional distress. Total scores range from 15-75 with higher scores on the scale indicate greater levels of distress tolerance. Change in distress tolerance was calculated as follows: 24-week distress tolerance score minus 12-week distress tolerance score. Negative change scores indicate that distress tolerance decreased as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that distress tolerance increased. | Description | Calculated as the percentage of weight lost from 12 to 24 weeks, as a result of the yoga or cooking/dietary education interventions. It was calculated as follows: (24-week weight minus 12-week weight) / 12-week weight x 100. Positive numbers indicate weight gain whereas negative numbers indicate weight loss. |
Browse Conditions
Sequence: | 191805387 | Sequence: | 191805388 | Sequence: | 191805389 |
Mesh Term | Weight Loss | Mesh Term | Body Weight | Mesh Term | Body Weight Changes |
Downcase Mesh Term | weight loss | Downcase Mesh Term | body weight | Downcase Mesh Term | body weight changes |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 47931499 | Sequence: | 47931500 |
Agency Class | OTHER | Agency Class | NIH |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | The Miriam Hospital | Name | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
Overall Officials
Sequence: | 29041257 |
Role | Principal Investigator |
Name | Jessica Unick, PhD |
Affiliation | The Miriam Hospital's Weight Control & Diabetes Research Center |
Design Group Interventions
Sequence: | 67643575 | Sequence: | 67643576 |
Design Group Id | 55175384 | Design Group Id | 55175385 |
Intervention Id | 52075617 | Intervention Id | 52075618 |
Eligibilities
Sequence: | 30521601 |
Gender | Female |
Minimum Age | 18 Years |
Maximum Age | 60 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
BMI 25-40 kg/m2 Exclusion Criteria: Presence of any condition that would limit one's ability to exercise or lose weight safely |
Adult | True |
Child | False |
Older Adult | False |
Calculated Values
Sequence: | 254081799 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 17 |
Were Results Reported | True |
Months To Report Results | 14 |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 60 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 3 |
Number Of Secondary Outcomes To Measure | 8 |
Designs
Sequence: | 30270614 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Milestones
Sequence: | 40739741 | Sequence: | 40739742 | Sequence: | 40739743 | Sequence: | 40739744 | Sequence: | 40739745 | Sequence: | 40739746 | Sequence: | 40739747 | Sequence: | 40739748 | Sequence: | 40739749 | Sequence: | 40739750 | Sequence: | 40739751 | Sequence: | 40739752 |
Result Group Id | 55809366 | Result Group Id | 55809367 | Result Group Id | 55809366 | Result Group Id | 55809367 | Result Group Id | 55809366 | Result Group Id | 55809367 | Result Group Id | 55809366 | Result Group Id | 55809367 | Result Group Id | 55809366 | Result Group Id | 55809367 | Result Group Id | 55809366 | Result Group Id | 55809367 |
Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 |
Title | STARTED | Title | STARTED | Title | COMPLETED | Title | COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | STARTED | Title | STARTED | Title | COMPLETED | Title | COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED |
Period | Initial Weight Loss Program (Weeks 1-12) | Period | Initial Weight Loss Program (Weeks 1-12) | Period | Initial Weight Loss Program (Weeks 1-12) | Period | Initial Weight Loss Program (Weeks 1-12) | Period | Initial Weight Loss Program (Weeks 1-12) | Period | Initial Weight Loss Program (Weeks 1-12) | Period | Maintenance Intervention (Weeks 13-24) | Period | Maintenance Intervention (Weeks 13-24) | Period | Maintenance Intervention (Weeks 13-24) | Period | Maintenance Intervention (Weeks 13-24) | Period | Maintenance Intervention (Weeks 13-24) | Period | Maintenance Intervention (Weeks 13-24) |
Count | 30 | Count | 30 | Count | 24 | Count | 27 | Count | 6 | Count | 3 | Count | 24 | Count | 27 | Count | 24 | Count | 27 | Count | 0 | Count | 0 |
Participant Flows
Sequence: | 3896129 |
Outcome Counts
Sequence: | 73491903 | Sequence: | 73491904 | Sequence: | 73491905 | Sequence: | 73491906 | Sequence: | 73491907 | Sequence: | 73491908 | Sequence: | 73491909 | Sequence: | 73491910 | Sequence: | 73491911 | Sequence: | 73491912 | Sequence: | 73491913 | Sequence: | 73491914 | Sequence: | 73491915 | Sequence: | 73491916 | Sequence: | 73491917 | Sequence: | 73491918 | Sequence: | 73491919 | Sequence: | 73491920 | Sequence: | 73491921 | Sequence: | 73491922 | Sequence: | 73491923 | Sequence: | 73491924 |
Outcome Id | 30592640 | Outcome Id | 30592640 | Outcome Id | 30592641 | Outcome Id | 30592641 | Outcome Id | 30592642 | Outcome Id | 30592642 | Outcome Id | 30592643 | Outcome Id | 30592643 | Outcome Id | 30592644 | Outcome Id | 30592644 | Outcome Id | 30592645 | Outcome Id | 30592645 | Outcome Id | 30592646 | Outcome Id | 30592646 | Outcome Id | 30592647 | Outcome Id | 30592647 | Outcome Id | 30592648 | Outcome Id | 30592648 | Outcome Id | 30592649 | Outcome Id | 30592649 | Outcome Id | 30592650 | Outcome Id | 30592650 |
Result Group Id | 55809368 | Result Group Id | 55809369 | Result Group Id | 55809368 | Result Group Id | 55809369 | Result Group Id | 55809368 | Result Group Id | 55809369 | Result Group Id | 55809368 | Result Group Id | 55809369 | Result Group Id | 55809368 | Result Group Id | 55809369 | Result Group Id | 55809368 | Result Group Id | 55809369 | Result Group Id | 55809368 | Result Group Id | 55809369 | Result Group Id | 55809368 | Result Group Id | 55809369 | Result Group Id | 55809368 | Result Group Id | 55809369 | Result Group Id | 55809368 | Result Group Id | 55809369 | Result Group Id | 55809368 | Result Group Id | 55809369 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 |
Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure |
Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants |
Count | 24 | Count | 27 | Count | 24 | Count | 27 | Count | 24 | Count | 27 | Count | 24 | Count | 27 | Count | 24 | Count | 27 | Count | 24 | Count | 27 | Count | 24 | Count | 27 | Count | 24 | Count | 27 | Count | 24 | Count | 27 | Count | 24 | Count | 27 | Count | 24 | Count | 27 |
Provided Documents
Sequence: | 2564033 | Sequence: | 2564034 |
Document Type | Study Protocol and Statistical Analysis Plan | Document Type | Informed Consent Form |
Has Protocol | True | Has Protocol | False |
Has Icf | False | Has Icf | True |
Has Sap | True | Has Sap | False |
Document Date | 2020-05-16 | Document Date | 2019-05-03 |
Url | https://ClinicalTrials.gov/ProvidedDocs/89/NCT03799289/Prot_SAP_002.pdf | Url | https://ClinicalTrials.gov/ProvidedDocs/89/NCT03799289/ICF_000.pdf |
Reported Event Totals
Sequence: | 27759742 | Sequence: | 27759743 | Sequence: | 27759744 | Sequence: | 27759745 | Sequence: | 27759746 | Sequence: | 27759747 |
Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG001 | Ctgov Group Code | EG001 |
Event Type | serious | Event Type | other | Event Type | deaths | Event Type | serious | Event Type | other | Event Type | deaths |
Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality | Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality |
Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 |
Subjects At Risk | 24 | Subjects At Risk | 24 | Subjects At Risk | 24 | Subjects At Risk | 27 | Subjects At Risk | 27 | Subjects At Risk | 27 |
Created At | 2023-08-06 13:09:20.552364 | Created At | 2023-08-06 13:09:20.552364 | Created At | 2023-08-06 13:09:20.552364 | Created At | 2023-08-06 13:09:20.552364 | Created At | 2023-08-06 13:09:20.552364 | Created At | 2023-08-06 13:09:20.552364 |
Updated At | 2023-08-06 13:09:20.552364 | Updated At | 2023-08-06 13:09:20.552364 | Updated At | 2023-08-06 13:09:20.552364 | Updated At | 2023-08-06 13:09:20.552364 | Updated At | 2023-08-06 13:09:20.552364 | Updated At | 2023-08-06 13:09:20.552364 |
Responsible Parties
Sequence: | 28650760 |
Responsible Party Type | Sponsor |
Result Agreements
Sequence: | 3826873 |
Pi Employee | No |
Result Contacts
Sequence: | 3826838 |
Organization | The Miriam Hospital |
Name | Jessica Unick, PD (Principal Investigator) |
Phone | 401-793-8966 |
junick@lifespan.org | |
Outcomes
Sequence: | 30592640 | Sequence: | 30592641 | Sequence: | 30592642 | Sequence: | 30592643 | Sequence: | 30592644 | Sequence: | 30592645 | Sequence: | 30592646 | Sequence: | 30592647 | Sequence: | 30592648 | Sequence: | 30592649 | Sequence: | 30592650 |
Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary |
Title | Program Satisfaction Ratings | Title | Intervention Session Attendance | Title | Feasibility of the Intervention (Retention) | Title | Changes in Perceived Stress (Measured Via the Perceived Stress Scale) | Title | Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) – Observing Subscale | Title | Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) – Describing Subscale | Title | Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) – Acting With Awareness Subscale | Title | Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) – Non-judgmental Inner Critic Subscale | Title | Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) – Non-reactivity Subscale | Title | Change in Distress Tolerance (Assessed Via the Distress Tolerance Scale) | Title | Change in Weight |
Description | Participants were asked, 'How satisfied were you with the yoga or cooking/dietary education intervention that you received over the past 3 months' on a 1-10 scale (1=very dissatisfied, 10=very satisfied) | Description | Yoga or control intervention sessions attended, expressed as a percentage (# of sessions completed/# of sessions possible x 100). | Description | Number of participants completing the 6-month assessment visit. Percentage of total participants can be computed as follows: the number of participants completing the 6-month assessment divided by the total number of participants who completed the 3-month weight loss program and learned of their randomization assignment | Description | Perceived stress scores range from 0-40, with higher scores indicating higher perceived stress. Change in perceived stress was calculated as follows: 24-week perceived stress score minus 12-week perceived stress score. Negative change scores indicate that perceived stress was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that perceived stress increased. | Description | The observation subscale assesses the ways we use our sensory awareness. It involves how we see, feel, and perceive the internal and external world around us and select the stimuli that require our attention and focus. Mindfulness subscale scores range from 8-40, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased. | Description | The describing subscale evaluates the way we label our experiences and express them in words to ourselves and others. Subscale scores range from 8-40, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased. | Description | This subscale examines whether we can act out of quick judgment and get out of the autopilot mode before responding to a situation. Subscale scores range from 8-40, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased. | Description | This subscale assesses the degree of self-acceptance and unconditional empathy for oneself and others. Subscale scores range from 8-40, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased. | Description | This subscale assesses active detachment from negative thoughts and emotions so that we can accept their existence and choose not to react to them. Subscale scores range from 7-35, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased. | Description | The Distress Tolerance Scale is a 15-item measure designed to assess one's perceived ability to tolerate emotional distress. Total scores range from 15-75 with higher scores on the scale indicate greater levels of distress tolerance. Change in distress tolerance was calculated as follows: 24-week distress tolerance score minus 12-week distress tolerance score. Negative change scores indicate that distress tolerance decreased as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that distress tolerance increased. | Description | Calculated as the percentage of weight lost from 12 to 24 weeks, as a result of the yoga or cooking/dietary education interventions. It was calculated as follows: (24-week weight minus 12-week weight) / 12-week weight x 100. Positive numbers indicate weight gain whereas negative numbers indicate weight loss. |
Time Frame | 6 months | Time Frame | 6 months | Time Frame | 6 months | Time Frame | Change from 12 to 24 weeks | Time Frame | Change from 12 to 24 weeks | Time Frame | Change from 12 to 24 weeks | Time Frame | Change from 12 to 24 weeks | Time Frame | Change from 12 to 24 weeks | Time Frame | Change from 12 to 24 weeks | Time Frame | Change from 12 to 24 weeks | Time Frame | Change from 12 to 24 weeks |
Units | units on a scale | Units | percentage of sessions attended | Units | Participants | Units | units on a scale | Units | units on a scale | Units | Change on a scale | Units | units on a scale | Units | Change on a scale | Units | units on a scale | Units | units on a scale | Units | Percent weight change |
Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | ||
Param Type | Mean | Param Type | Mean | Param Type | Count of Participants | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean |
Outcome Measurements
Sequence: | 233985906 | Sequence: | 233985907 | Sequence: | 233985908 | Sequence: | 233985909 | Sequence: | 233985910 | Sequence: | 233985911 | Sequence: | 233985912 | Sequence: | 233985913 | Sequence: | 233985924 | Sequence: | 233985914 | Sequence: | 233985915 | Sequence: | 233985916 | Sequence: | 233985917 | Sequence: | 233985918 | Sequence: | 233985919 | Sequence: | 233985920 | Sequence: | 233985921 | Sequence: | 233985922 | Sequence: | 233985923 | Sequence: | 233985925 | Sequence: | 233985926 | Sequence: | 233985927 |
Outcome Id | 30592640 | Outcome Id | 30592640 | Outcome Id | 30592641 | Outcome Id | 30592641 | Outcome Id | 30592642 | Outcome Id | 30592642 | Outcome Id | 30592643 | Outcome Id | 30592643 | Outcome Id | 30592649 | Outcome Id | 30592644 | Outcome Id | 30592644 | Outcome Id | 30592645 | Outcome Id | 30592645 | Outcome Id | 30592646 | Outcome Id | 30592646 | Outcome Id | 30592647 | Outcome Id | 30592647 | Outcome Id | 30592648 | Outcome Id | 30592648 | Outcome Id | 30592649 | Outcome Id | 30592650 | Outcome Id | 30592650 |
Result Group Id | 55809368 | Result Group Id | 55809369 | Result Group Id | 55809368 | Result Group Id | 55809369 | Result Group Id | 55809368 | Result Group Id | 55809369 | Result Group Id | 55809368 | Result Group Id | 55809369 | Result Group Id | 55809368 | Result Group Id | 55809368 | Result Group Id | 55809369 | Result Group Id | 55809368 | Result Group Id | 55809369 | Result Group Id | 55809368 | Result Group Id | 55809369 | Result Group Id | 55809368 | Result Group Id | 55809369 | Result Group Id | 55809368 | Result Group Id | 55809369 | Result Group Id | 55809369 | Result Group Id | 55809368 | Result Group Id | 55809369 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 |
Title | Program Satisfaction Ratings | Title | Program Satisfaction Ratings | Title | Intervention Session Attendance | Title | Intervention Session Attendance | Title | Feasibility of the Intervention (Retention) | Title | Feasibility of the Intervention (Retention) | Title | Changes in Perceived Stress (Measured Via the Perceived Stress Scale) | Title | Changes in Perceived Stress (Measured Via the Perceived Stress Scale) | Title | Change in Distress Tolerance (Assessed Via the Distress Tolerance Scale) | Title | Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) – Observing Subscale | Title | Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) – Observing Subscale | Title | Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) – Describing Subscale | Title | Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) – Describing Subscale | Title | Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) – Acting With Awareness Subscale | Title | Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) – Acting With Awareness Subscale | Title | Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) – Non-judgmental Inner Critic Subscale | Title | Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) – Non-judgmental Inner Critic Subscale | Title | Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) – Non-reactivity Subscale | Title | Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) – Non-reactivity Subscale | Title | Change in Distress Tolerance (Assessed Via the Distress Tolerance Scale) | Title | Change in Weight | Title | Change in Weight |
Description | Participants were asked, 'How satisfied were you with the yoga or cooking/dietary education intervention that you received over the past 3 months' on a 1-10 scale (1=very dissatisfied, 10=very satisfied) | Description | Participants were asked, 'How satisfied were you with the yoga or cooking/dietary education intervention that you received over the past 3 months' on a 1-10 scale (1=very dissatisfied, 10=very satisfied) | Description | Yoga or control intervention sessions attended, expressed as a percentage (# of sessions completed/# of sessions possible x 100). | Description | Yoga or control intervention sessions attended, expressed as a percentage (# of sessions completed/# of sessions possible x 100). | Description | Number of participants completing the 6-month assessment visit. Percentage of total participants can be computed as follows: the number of participants completing the 6-month assessment divided by the total number of participants who completed the 3-month weight loss program and learned of their randomization assignment | Description | Number of participants completing the 6-month assessment visit. Percentage of total participants can be computed as follows: the number of participants completing the 6-month assessment divided by the total number of participants who completed the 3-month weight loss program and learned of their randomization assignment | Description | Perceived stress scores range from 0-40, with higher scores indicating higher perceived stress. Change in perceived stress was calculated as follows: 24-week perceived stress score minus 12-week perceived stress score. Negative change scores indicate that perceived stress was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that perceived stress increased. | Description | Perceived stress scores range from 0-40, with higher scores indicating higher perceived stress. Change in perceived stress was calculated as follows: 24-week perceived stress score minus 12-week perceived stress score. Negative change scores indicate that perceived stress was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that perceived stress increased. | Description | The Distress Tolerance Scale is a 15-item measure designed to assess one's perceived ability to tolerate emotional distress. Total scores range from 15-75 with higher scores on the scale indicate greater levels of distress tolerance. Change in distress tolerance was calculated as follows: 24-week distress tolerance score minus 12-week distress tolerance score. Negative change scores indicate that distress tolerance decreased as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that distress tolerance increased. | Description | The observation subscale assesses the ways we use our sensory awareness. It involves how we see, feel, and perceive the internal and external world around us and select the stimuli that require our attention and focus. Mindfulness subscale scores range from 8-40, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased. | Description | The observation subscale assesses the ways we use our sensory awareness. It involves how we see, feel, and perceive the internal and external world around us and select the stimuli that require our attention and focus. Mindfulness subscale scores range from 8-40, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased. | Description | The describing subscale evaluates the way we label our experiences and express them in words to ourselves and others. Subscale scores range from 8-40, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased. | Description | The describing subscale evaluates the way we label our experiences and express them in words to ourselves and others. Subscale scores range from 8-40, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased. | Description | This subscale examines whether we can act out of quick judgment and get out of the autopilot mode before responding to a situation. Subscale scores range from 8-40, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased. | Description | This subscale examines whether we can act out of quick judgment and get out of the autopilot mode before responding to a situation. Subscale scores range from 8-40, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased. | Description | This subscale assesses the degree of self-acceptance and unconditional empathy for oneself and others. Subscale scores range from 8-40, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased. | Description | This subscale assesses the degree of self-acceptance and unconditional empathy for oneself and others. Subscale scores range from 8-40, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased. | Description | This subscale assesses active detachment from negative thoughts and emotions so that we can accept their existence and choose not to react to them. Subscale scores range from 7-35, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased. | Description | This subscale assesses active detachment from negative thoughts and emotions so that we can accept their existence and choose not to react to them. Subscale scores range from 7-35, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased. | Description | The Distress Tolerance Scale is a 15-item measure designed to assess one's perceived ability to tolerate emotional distress. Total scores range from 15-75 with higher scores on the scale indicate greater levels of distress tolerance. Change in distress tolerance was calculated as follows: 24-week distress tolerance score minus 12-week distress tolerance score. Negative change scores indicate that distress tolerance decreased as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that distress tolerance increased. | Description | Calculated as the percentage of weight lost from 12 to 24 weeks, as a result of the yoga or cooking/dietary education interventions. It was calculated as follows: (24-week weight minus 12-week weight) / 12-week weight x 100. Positive numbers indicate weight gain whereas negative numbers indicate weight loss. | Description | Calculated as the percentage of weight lost from 12 to 24 weeks, as a result of the yoga or cooking/dietary education interventions. It was calculated as follows: (24-week weight minus 12-week weight) / 12-week weight x 100. Positive numbers indicate weight gain whereas negative numbers indicate weight loss. |
Units | units on a scale | Units | units on a scale | Units | percentage of sessions attended | Units | percentage of sessions attended | Units | Participants | Units | Participants | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | Change on a scale | Units | Change on a scale | Units | units on a scale | Units | units on a scale | Units | Change on a scale | Units | Change on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | Percent weight change | Units | Percent weight change |
Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean |
Param Value | 7.6 | Param Value | 8.3 | Param Value | 75.4 | Param Value | 75.9 | Param Value | 24 | Param Value | 27 | Param Value | 0.01 | Param Value | -0.06 | Param Value | 0.02 | Param Value | 1.7 | Param Value | 0.9 | Param Value | -0.17 | Param Value | -0.9 | Param Value | -0.29 | Param Value | 0.04 | Param Value | 0.46 | Param Value | 0.74 | Param Value | 0.33 | Param Value | -1.67 | Param Value | -0.06 | Param Value | -0.33 | Param Value | -0.38 |
Param Value Num | 7.6 | Param Value Num | 8.3 | Param Value Num | 75.4 | Param Value Num | 75.9 | Param Value Num | 24.0 | Param Value Num | 27.0 | Param Value Num | 0.01 | Param Value Num | -0.06 | Param Value Num | 0.02 | Param Value Num | 1.7 | Param Value Num | 0.9 | Param Value Num | -0.17 | Param Value Num | -0.9 | Param Value Num | -0.29 | Param Value Num | 0.04 | Param Value Num | 0.46 | Param Value Num | 0.74 | Param Value Num | 0.33 | Param Value Num | -1.67 | Param Value Num | -0.06 | Param Value Num | -0.33 | Param Value Num | -0.38 |
Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | ||||
Dispersion Value | 2.9 | Dispersion Value | 2.4 | Dispersion Value | 24.6 | Dispersion Value | 27.1 | Dispersion Value | 0.51 | Dispersion Value | 0.60 | Dispersion Value | 0.51 | Dispersion Value | 5.9 | Dispersion Value | 3.7 | Dispersion Value | 5.1 | Dispersion Value | 3.9 | Dispersion Value | 3.06 | Dispersion Value | 5.03 | Dispersion Value | 4.34 | Dispersion Value | 4.59 | Dispersion Value | 3.17 | Dispersion Value | 3.82 | Dispersion Value | 0.60 | Dispersion Value | 2.91 | Dispersion Value | 4.03 | ||||
Dispersion Value Num | 2.9 | Dispersion Value Num | 2.4 | Dispersion Value Num | 24.6 | Dispersion Value Num | 27.1 | Dispersion Value Num | 0.51 | Dispersion Value Num | 0.6 | Dispersion Value Num | 0.51 | Dispersion Value Num | 5.9 | Dispersion Value Num | 3.7 | Dispersion Value Num | 5.1 | Dispersion Value Num | 3.9 | Dispersion Value Num | 3.06 | Dispersion Value Num | 5.03 | Dispersion Value Num | 4.34 | Dispersion Value Num | 4.59 | Dispersion Value Num | 3.17 | Dispersion Value Num | 3.82 | Dispersion Value Num | 0.6 | Dispersion Value Num | 2.91 | Dispersion Value Num | 4.03 | ||||
Baseline Counts
Sequence: | 11310350 | Sequence: | 11310351 | Sequence: | 11310352 |
Result Group Id | 55809363 | Result Group Id | 55809364 | Result Group Id | 55809365 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 |
Units | Participants | Units | Participants | Units | Participants |
Scope | overall | Scope | overall | Scope | overall |
Count | 24 | Count | 27 | Count | 51 |
Result Groups
Sequence: | 55809363 | Sequence: | 55809364 | Sequence: | 55809365 | Sequence: | 55809366 | Sequence: | 55809367 | Sequence: | 55809368 | Sequence: | 55809369 | Sequence: | 55809370 | Sequence: | 55809371 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 |
Result Type | Baseline | Result Type | Baseline | Result Type | Baseline | Result Type | Participant Flow | Result Type | Participant Flow | Result Type | Outcome | Result Type | Outcome | Result Type | Reported Event | Result Type | Reported Event |
Title | Iyengar Yoga | Title | Cooking/Dietary Education | Title | Total | Title | Iyengar Yoga | Title | Cooking/Dietary Education | Title | Iyengar Yoga | Title | Cooking/Dietary Education | Title | Iyengar Yoga | Title | Cooking/Dietary Education |
Description | Participants randomized to the yoga intervention arm will receive 12 weeks of group-based yoga instruction, following a 12-week standard behavioral weight loss program. Group-based yoga instruction will occur twice per week and classes will be 60 minutes in duration. The yoga program will consist of breathing, postural, and meditation practices and home-based yoga practice will also be prescribed.
Behavioral weight loss followed by yoga instruction: 12-week standard behavioral weight loss program followed by a 12-week yoga intervention |
Description | Participants randomized to the cooking/dietary education intervention arm will receive 12 weeks of group-based, cooking/dietary education instruction, following a 12-week standard behavioral weight loss program. This group-based instruction will occur twice per week and classes will be 60 minutes in duration. Classes will focus on providing basic nutrition knowledge and culinary skills, and will include cooking demonstrations.
Behavioral weight loss followed by cooking/dietary education instruction: 12-week standard behavioral weight loss program followed by a 12-week cooking/dietary education intervention |
Description | Total of all reporting groups | Description | Participants randomized to the yoga intervention arm will receive 12 weeks of group-based yoga instruction, following a 12-week standard behavioral weight loss program. Group-based yoga instruction will occur twice per week and classes will be 60 minutes in duration. The yoga program will consist of breathing, postural, and meditation practices and home-based yoga practice will also be prescribed.
Behavioral weight loss followed by yoga instruction: 12-week standard behavioral weight loss program followed by a 12-week yoga intervention |
Description | Participants randomized to the cooking/dietary education intervention arm will receive 12 weeks of group-based, cooking/dietary education instruction, following a 12-week standard behavioral weight loss program. This group-based instruction will occur twice per week and classes will be 60 minutes in duration. Classes will focus on providing basic nutrition knowledge and culinary skills, and will include cooking demonstrations.
Behavioral weight loss followed by cooking/dietary education instruction: 12-week standard behavioral weight loss program followed by a 12-week cooking/dietary education intervention |
Description | Participants randomized to the yoga intervention arm will receive 12 weeks of group-based yoga instruction, following a 12-week standard behavioral weight loss program. Group-based yoga instruction will occur twice per week and classes will be 60 minutes in duration. The yoga program will consist of breathing, postural, and meditation practices and home-based yoga practice will also be prescribed.
Behavioral weight loss followed by yoga instruction: 12-week standard behavioral weight loss program followed by a 12-week yoga intervention |
Description | Participants randomized to the cooking/dietary education intervention arm will receive 12 weeks of group-based, cooking/dietary education instruction, following a 12-week standard behavioral weight loss program. This group-based instruction will occur twice per week and classes will be 60 minutes in duration. Classes will focus on providing basic nutrition knowledge and culinary skills, and will include cooking demonstrations.
Behavioral weight loss followed by cooking/dietary education instruction: 12-week standard behavioral weight loss program followed by a 12-week cooking/dietary education intervention |
Description | Participants randomized to the yoga intervention arm will receive 12 weeks of group-based yoga instruction, following a 12-week standard behavioral weight loss program. Group-based yoga instruction will occur twice per week and classes will be 60 minutes in duration. The yoga program will consist of breathing, postural, and meditation practices and home-based yoga practice will also be prescribed.
Behavioral weight loss followed by yoga instruction: 12-week standard behavioral weight loss program followed by a 12-week yoga intervention |
Description | Participants randomized to the cooking/dietary education intervention arm will receive 12 weeks of group-based, cooking/dietary education instruction, following a 12-week standard behavioral weight loss program. This group-based instruction will occur twice per week and classes will be 60 minutes in duration. Classes will focus on providing basic nutrition knowledge and culinary skills, and will include cooking demonstrations.
Behavioral weight loss followed by cooking/dietary education instruction: 12-week standard behavioral weight loss program followed by a 12-week cooking/dietary education intervention |
Baseline Measurements
Sequence: | 124801200 | Sequence: | 124801201 | Sequence: | 124801202 | Sequence: | 124801173 | Sequence: | 124801174 | Sequence: | 124801175 | Sequence: | 124801176 | Sequence: | 124801177 | Sequence: | 124801178 | Sequence: | 124801179 | Sequence: | 124801180 | Sequence: | 124801181 | Sequence: | 124801182 | Sequence: | 124801183 | Sequence: | 124801184 | Sequence: | 124801185 | Sequence: | 124801186 | Sequence: | 124801187 | Sequence: | 124801188 | Sequence: | 124801189 | Sequence: | 124801190 | Sequence: | 124801191 | Sequence: | 124801192 | Sequence: | 124801193 | Sequence: | 124801194 | Sequence: | 124801195 | Sequence: | 124801196 | Sequence: | 124801197 | Sequence: | 124801198 | Sequence: | 124801199 | Sequence: | 124801203 | Sequence: | 124801204 | Sequence: | 124801205 | Sequence: | 124801206 | Sequence: | 124801207 | Sequence: | 124801208 | Sequence: | 124801209 | Sequence: | 124801210 | Sequence: | 124801211 | Sequence: | 124801212 | Sequence: | 124801213 | Sequence: | 124801214 | Sequence: | 124801215 | Sequence: | 124801216 | Sequence: | 124801217 | Sequence: | 124801218 | Sequence: | 124801219 | Sequence: | 124801220 |
Result Group Id | 55809363 | Result Group Id | 55809364 | Result Group Id | 55809365 | Result Group Id | 55809363 | Result Group Id | 55809364 | Result Group Id | 55809365 | Result Group Id | 55809363 | Result Group Id | 55809364 | Result Group Id | 55809365 | Result Group Id | 55809363 | Result Group Id | 55809364 | Result Group Id | 55809365 | Result Group Id | 55809363 | Result Group Id | 55809364 | Result Group Id | 55809365 | Result Group Id | 55809363 | Result Group Id | 55809364 | Result Group Id | 55809365 | Result Group Id | 55809363 | Result Group Id | 55809364 | Result Group Id | 55809365 | Result Group Id | 55809363 | Result Group Id | 55809364 | Result Group Id | 55809365 | Result Group Id | 55809363 | Result Group Id | 55809364 | Result Group Id | 55809365 | Result Group Id | 55809363 | Result Group Id | 55809364 | Result Group Id | 55809365 | Result Group Id | 55809363 | Result Group Id | 55809364 | Result Group Id | 55809365 | Result Group Id | 55809363 | Result Group Id | 55809364 | Result Group Id | 55809365 | Result Group Id | 55809363 | Result Group Id | 55809364 | Result Group Id | 55809365 | Result Group Id | 55809363 | Result Group Id | 55809364 | Result Group Id | 55809365 | Result Group Id | 55809363 | Result Group Id | 55809364 | Result Group Id | 55809365 | Result Group Id | 55809363 | Result Group Id | 55809364 | Result Group Id | 55809365 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 |
Classification | United States | Classification | United States | Classification | United States | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Category | Black or African American | Category | Black or African American | Category | Black or African American | Category | Female | Category | Female | Category | Female | Category | Male | Category | Male | Category | Male | Category | Hispanic or Latino | Category | Hispanic or Latino | Category | Hispanic or Latino | Category | Not Hispanic or Latino | Category | Not Hispanic or Latino | Category | Not Hispanic or Latino | Category | Unknown or Not Reported | Category | Unknown or Not Reported | Category | Unknown or Not Reported | Category | American Indian or Alaska Native | Category | American Indian or Alaska Native | Category | American Indian or Alaska Native | Category | Asian | Category | Asian | Category | Asian | Category | Native Hawaiian or Other Pacific Islander | Category | Native Hawaiian or Other Pacific Islander | Category | Native Hawaiian or Other Pacific Islander | Category | White | Category | White | Category | White | Category | More than one race | Category | More than one race | Category | More than one race | Category | Unknown or Not Reported | Category | Unknown or Not Reported | Category | Unknown or Not Reported | ||||||||||||||||||||||||
Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Age, Continuous | Title | Age, Continuous | Title | Age, Continuous | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Ethnicity (NIH/OMB) | Title | Ethnicity (NIH/OMB) | Title | Ethnicity (NIH/OMB) | Title | Ethnicity (NIH/OMB) | Title | Ethnicity (NIH/OMB) | Title | Ethnicity (NIH/OMB) | Title | Ethnicity (NIH/OMB) | Title | Ethnicity (NIH/OMB) | Title | Ethnicity (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Region of Enrollment | Title | Region of Enrollment | Title | Region of Enrollment | Title | Body mass index (BMI) at baseline (pre weight loss) | Title | Body mass index (BMI) at baseline (pre weight loss) | Title | Body mass index (BMI) at baseline (pre weight loss) | Title | Body mass index (BMI) at 12 weeks (post weight loss intervention) | Title | Body mass index (BMI) at 12 weeks (post weight loss intervention) | Title | Body mass index (BMI) at 12 weeks (post weight loss intervention) |
Description | Post-12 week weight loss was considered the 'new baseline' for those receiving the the yoga and cooking interventions, as we were examining these as intervention approaches for improving long-term weight loss | Description | Post-12 week weight loss was considered the 'new baseline' for those receiving the the yoga and cooking interventions, as we were examining these as intervention approaches for improving long-term weight loss | Description | Post-12 week weight loss was considered the 'new baseline' for those receiving the the yoga and cooking interventions, as we were examining these as intervention approaches for improving long-term weight loss | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Units | Participants | Units | Participants | Units | Participants | Units | years | Units | years | Units | years | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | participants | Units | participants | Units | participants | Units | kg /m^2 | Units | kg /m^2 | Units | kg /m^2 | Units | kg/m^2 | Units | kg/m^2 | Units | kg/m^2 |
Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean |
Param Value | 1 | Param Value | 1 | Param Value | 2 | Param Value | 48.7 | Param Value | 49.1 | Param Value | 48.7 | Param Value | 24 | Param Value | 27 | Param Value | 51 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 4 | Param Value | 2 | Param Value | 6 | Param Value | 20 | Param Value | 25 | Param Value | 45 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 1 | Param Value | 0 | Param Value | 1 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 19 | Param Value | 23 | Param Value | 42 | Param Value | 3 | Param Value | 3 | Param Value | 6 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 24 | Param Value | 27 | Param Value | 51 | Param Value | 34.6 | Param Value | 34.5 | Param Value | 34.6 | Param Value | 33.1 | Param Value | 31.8 | Param Value | 32.4 |
Param Value Num | 1.0 | Param Value Num | 1.0 | Param Value Num | 2.0 | Param Value Num | 48.7 | Param Value Num | 49.1 | Param Value Num | 48.7 | Param Value Num | 24.0 | Param Value Num | 27.0 | Param Value Num | 51.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 4.0 | Param Value Num | 2.0 | Param Value Num | 6.0 | Param Value Num | 20.0 | Param Value Num | 25.0 | Param Value Num | 45.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 19.0 | Param Value Num | 23.0 | Param Value Num | 42.0 | Param Value Num | 3.0 | Param Value Num | 3.0 | Param Value Num | 6.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 24.0 | Param Value Num | 27.0 | Param Value Num | 51.0 | Param Value Num | 34.6 | Param Value Num | 34.5 | Param Value Num | 34.6 | Param Value Num | 33.1 | Param Value Num | 31.8 | Param Value Num | 32.4 |
Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dispersion Value | 9.9 | Dispersion Value | 9.5 | Dispersion Value | 9.6 | Dispersion Value | 4.1 | Dispersion Value | 3.5 | Dispersion Value | 3.8 | Dispersion Value | 4.5 | Dispersion Value | 3.7 | Dispersion Value | 4.1 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dispersion Value Num | 9.9 | Dispersion Value Num | 9.5 | Dispersion Value Num | 9.6 | Dispersion Value Num | 4.1 | Dispersion Value Num | 3.5 | Dispersion Value Num | 3.8 | Dispersion Value Num | 4.5 | Dispersion Value Num | 3.7 | Dispersion Value Num | 4.1 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Number Analyzed | 24 | Number Analyzed | 27 | Number Analyzed | 51 | Number Analyzed | 24 | Number Analyzed | 27 | Number Analyzed | 51 | Number Analyzed | 24 | Number Analyzed | 27 | Number Analyzed | 51 | Number Analyzed | 24 | Number Analyzed | 27 | Number Analyzed | 51 | Number Analyzed | 24 | Number Analyzed | 27 | Number Analyzed | 51 | Number Analyzed | 24 | Number Analyzed | 27 | Number Analyzed | 51 | Number Analyzed | 24 | Number Analyzed | 27 | Number Analyzed | 51 | Number Analyzed | 24 | Number Analyzed | 27 | Number Analyzed | 51 | Number Analyzed | 24 | Number Analyzed | 27 | Number Analyzed | 51 | Number Analyzed | 24 | Number Analyzed | 27 | Number Analyzed | 51 | Number Analyzed | 24 | Number Analyzed | 27 | Number Analyzed | 51 | Number Analyzed | 24 | Number Analyzed | 27 | Number Analyzed | 51 | Number Analyzed | 24 | Number Analyzed | 27 | Number Analyzed | 51 | Number Analyzed | 24 | Number Analyzed | 27 | Number Analyzed | 51 | Number Analyzed | 24 | Number Analyzed | 27 | Number Analyzed | 51 | Number Analyzed | 24 | Number Analyzed | 27 | Number Analyzed | 51 |
]]>
https://zephyrnet.com/NCT03799276
2019-01-15
https://zephyrnet.com/?p=NCT03799276
NCT03799276https://www.clinicaltrials.gov/study/NCT03799276?tab=tableSophie Seang, MDsophie.seang@aphp.fr33142164183Antiretroviral therapy is currently the only way to control HIV disease progression in HIV infected subjects and to prevent transmission. However a sustained virological control through antiretroviral therapy is requested for these objectives. There is currently 8-10% of patients who failed therapy for many reasons other than virological resistance including social unstability, psychiatric disorders, migrant status, drug or alcohol addictions. Because many of these vulnerabilities can be managed and patients helped for following adequately cares and treatments, study team designed the OPTICARE Program to help reduce impact of the patients’ vulnerabilities.
The OPTICARE study is designed as a prospective implementation interventional study which aims to improve retention in care among vulnerable HIV infected patients over 48 weeks.
The OPTICARE program is a support program dedicated to patients either lost to follow up or in highly fraility situation that will offer an individualized care management to fill their gaps towards optimized care and control of viral replication. Our aim is, in patients virally failing in relation with poor adherence to care and treatment to test first part whether tracking proactively lost to follow up patients or detecting frail individuals at risk of lost to care is effective and secondly to evaluate the efficacy, the feasibility and the acceptability of an intervention tailored to each individual to get them to treatment success with viral suppression. In our context, a randomized approach would not be seen as ethical or possible in an environment where investigators need to evaluate such intervention as a pilot approach. Investigators therefore enrolled patients in a cohort population study OPTICARE program aim to actively identify vulnerable HIV+ population and promote optimal access to health care to this population using retention in care program in order to enable long term HIV infection control.
The primary objective is to assess the feasability and the effectiveness of the OPTICARE program. The OPTICARE program aims to propose an individualized care to vulnerable HIV infected patients (UNAIDS/Second 90% goal) and to drive them to treatment success (UNAIDS/Third 90% goal) within a one-year period.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-08 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2023-05-12 |
Start Month Year | January 15, 2019 |
Primary Completion Month Year | June 15, 2022 |
Verification Month Year | May 2023 |
Verification Date | 2023-05-31 |
Last Update Posted Date | 2023-05-12 |
Detailed Descriptions
Sequence: | 20665983 |
Description | The OPTICARE program is an individualized program proposed to vulnerable HIV infected patients according to a baseline evaluation of the clinical, social, psychological and cultural aspects.
Once enrolled in the OPTICARE program, each patient will benefit of: A comprehensive and complete check up personal interview, through a daily visit, with a physician, an educational nurse, a social worker and a cultural mediator (if needed), in order to identify mains issues Regarding the specific needs, each patient may benefit of: a personal assistance to complete administrative procedures (update health insurance, assistance to fill administrative papers, provide a budget for photo ID, transport tickets) A multidisciplinary team (physician, educational nurse, psychotherapist, social worker and cultural mediator) will proactively assist the patient (home visits, recall) during a one year follow up. The program is initially proposed to the patient. In case of non-acceptance, the patient can further join the program after 3 months. Patients who do not accept the OPTICARE program will be followed up in standard of care according to French HIV management guidelines. (https://cns.sante.fr/actualites/prise-en-charge-du-vih-recommandations-du-groupe-dexperts/). All administratives and social procedures will be given to the social district. |
Facilities
Sequence: | 199484753 |
Status | Recruiting |
Name | Yasmine Dudoit |
City | Paris |
Zip | 75013 |
Country | France |
Facility Contacts
Sequence: | 28039724 | Sequence: | 28039725 |
Facility Id | 199484753 | Facility Id | 199484753 |
Contact Type | primary | Contact Type | backup |
Name | Yasmine Dudoit | Name | Sophie Seang, MD |
yasmine.dudoit@aphp.fr | sophie.seang@aphp.fr | ||
Phone | 330142164181 | Phone | 33142164183 |
Conditions
Sequence: | 52026073 |
Name | HIV Infections |
Downcase Name | hiv infections |
Id Information
Sequence: | 40044816 |
Id Source | org_study_id |
Id Value | CREPATS 08 |
Countries
Sequence: | 42442144 |
Name | France |
Removed | False |
Design Groups
Sequence: | 55433550 |
Group Type | Experimental |
Title | Opticare study |
Description | Phase I: Identification and Selection of study population The first step will include an active search by OPTICARE team for vulnerable and lost to follow up patients
Phase II: Implementation of the individualized follow-up program The patients who agree to participate to the program will be defined as the OPTICARE population. |
Interventions
Sequence: | 52338401 |
Intervention Type | Other |
Name | Opticare study |
Description | Each patient will be evaluated by
An HIV physician Following these interviews and visits, a multisciplinary team will define for each patient an individualized OPTICARE program based on the following items: clinical, psychological/psychiatric, social status and follow up visits will be planned with the patient. Regular (Day 15 and monthly) phone calls will be set up during the first six months of the OPTICARE program, to assess the clinical status and ART adherence. Patients will have their medical, biological and social status assessed through visits at W4, W12, W24, W36 (medical and social status only) and W 48 with all members of the OPTICARE team. |
Design Outcomes
Sequence: | 176876087 |
Outcome Type | primary |
Measure | Measure of plasma viral load to assess the effectiveness of the OPTICARE Program to attend HIV plasma viral load < 50 cp/ml at week 48 |
Time Frame | 12 months |
Description | Measure of plasma viral load assessed by RNA quantification using COBAS 6800 system (Roche) |
Browse Conditions
Sequence: | 192910405 | Sequence: | 192910406 | Sequence: | 192910407 | Sequence: | 192910408 | Sequence: | 192910409 | Sequence: | 192910410 | Sequence: | 192910411 | Sequence: | 192910412 | Sequence: | 192910413 | Sequence: | 192910414 | Sequence: | 192910415 | Sequence: | 192910416 | Sequence: | 192910417 | Sequence: | 192910418 |
Mesh Term | HIV Infections | Mesh Term | Blood-Borne Infections | Mesh Term | Communicable Diseases | Mesh Term | Infections | Mesh Term | Sexually Transmitted Diseases, Viral | Mesh Term | Sexually Transmitted Diseases | Mesh Term | Lentivirus Infections | Mesh Term | Retroviridae Infections | Mesh Term | RNA Virus Infections | Mesh Term | Virus Diseases | Mesh Term | Genital Diseases | Mesh Term | Urogenital Diseases | Mesh Term | Immunologic Deficiency Syndromes | Mesh Term | Immune System Diseases |
Downcase Mesh Term | hiv infections | Downcase Mesh Term | blood-borne infections | Downcase Mesh Term | communicable diseases | Downcase Mesh Term | infections | Downcase Mesh Term | sexually transmitted diseases, viral | Downcase Mesh Term | sexually transmitted diseases | Downcase Mesh Term | lentivirus infections | Downcase Mesh Term | retroviridae infections | Downcase Mesh Term | rna virus infections | Downcase Mesh Term | virus diseases | Downcase Mesh Term | genital diseases | Downcase Mesh Term | urogenital diseases | Downcase Mesh Term | immunologic deficiency syndromes | Downcase Mesh Term | immune system diseases |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48183685 | Sequence: | 48183686 | Sequence: | 48183687 |
Agency Class | OTHER | Agency Class | INDUSTRY | Agency Class | OTHER |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator |
Name | Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida | Name | ViiV Healthcare | Name | Institut de Sante Publique, d'Epidemiologie et de Developpement |
Overall Officials
Sequence: | 29201525 |
Role | Principal Investigator |
Name | Sophie Seang, MD |
Affiliation | Pitie Salpetriere Hospital |
Central Contacts
Sequence: | 11977103 | Sequence: | 11977104 |
Contact Type | primary | Contact Type | backup |
Name | Yasmine Dudoit | Name | Sophie Seang, MD |
Phone | 33142164181 | Phone | 33142164183 |
yasmine.dudoit@aphp.fr | sophie.seang@aphp.fr | ||
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 67955894 |
Design Group Id | 55433550 |
Intervention Id | 52338401 |
Eligibilities
Sequence: | 30680162 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Patients Lost to follow-up defined as a patient with no clinical visit: In the 12 months period for patients > 250/mm3 CD4 cells or AND with HIV plasma viral load > 400 cp/ml (following French HIV guidelines) HIV+ patients with virological failure defined as HIV plasma viral load (pVL) > 400 cp/ml (2 determinations with at least two weeks apart) HIV+ patients newly diagnosed with virological failure 6 months after ART initiation (virological failure defined by two HIV plasma viral load > 50cp/ml following French HIV guidelines *) and with one of the following vulnerable risk factors : Social frailty (lack of health insurance, homeless, accommodation by family/friends, post incarceration) A standard glass is defined by a quantity of pure alcohol of 10 grams, corresponding to approximately 10 cl of wine, 25 cl of beer at 5% vol, or 3 cl of alcohol at 40% vol. (https://www.sfalcoologie.asso.fr/download/RBP2014-SFA-Mesusage-AA.pdf) Exclusion Criteria: Patients unwilling to participate. https://cns.sante.fr/actualites/prise-en-charge-du-vih-recommandations-du-groupe-dexperts |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253878348 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 41 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Designs
Sequence: | 30426905 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Supportive Care |
Time Perspective | |
Masking | None (Open Label) |
Responsible Parties
Sequence: | 28793431 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03799263
2019-02-01
https://zephyrnet.com/?p=NCT03799263
NCT03799263https://www.clinicaltrials.gov/study/NCT03799263?tab=tableNANANAThe six minute walking test (6MWT) is a recognized clinical test to evaluate exercise capacity in different diseases and different conditions. The modalities of performance are described in International Guidelines. The usually reported measure is the distance in meters walked in 6 minutes. Despite the report of a single variable during the test is considered as a limit, changes in monitored variables are seldom analyzed together with the distance walked. In the past there have been some attempts of multifactorial evaluation of 6MWT, however up to date, there is no system considering together the changes of different variables. The investigators wonder whether a multidimensional index based on variables monitored during the 6MWT would better predict 24 month exacerbations and mortality in COPD patients.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-02 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2023-03-03 |
Start Month Year | February 1, 2019 |
Primary Completion Month Year | January 31, 2021 |
Verification Month Year | March 2023 |
Verification Date | 2023-03-31 |
Last Update Posted Date | 2023-03-03 |
Detailed Descriptions
Sequence: | 20685819 |
Description | Rationale: the six minute walking test (6MWT) is a recognized clinical test to evaluate exercise capacity in different diseases and different conditions. In COPD patients the 6MWT is a marker of severity, influenced by the severity of airway obstruction as well as of comorbidities. This test has been shown as a predictor of survival and need of hospitalization. The modalities of performance are described in International Guidelines. The usually reported measure is the distance in meters walked in 6 minutes. However, besides the pathological conditions, this result is influenced by the individual demographic and anthropometrics characteristics. The Minimal Clinically Important Difference in COPD subjects is reported to be 30 meters (m.). A decrease greater than 30 m., as compared to the previous year, is a predictor of death risk. During the test some physiological variables should be monitored such as heart rate (HR), and pulse oxymetry (SpO2). An oxyhemoglobin desaturation >4% or a SpO2 <90% during the test, are also predictors of increased risk of death or hospitalization. In addition, also the difference between the HR at baseline and that after one minute after the end of the test (recovery heart rate: HRR) seems to be a predictor of survival and COPD exacerbation rates. Despite the report of a single variable during the test is considered as a limit, changes in monitored variables are seldom analyzed together with the distance walked. In the past there have been some attempts of multifactorial evaluation of 6MWT, however up to date, there is no system considering together the changes of different variables. We wonder whether a multidimensional index based on variables monitored during the 6MWT would better predict 24 month exacerbations and mortality in COPD patients.
Objectives: Primary Objective: To develop and validate a multidimensional index in COPD subjects with different grades of severity as assessed by the Global Initiative for Chronic Obstructive Lung disease as a predictor of 24 month exacerbation rate. Secondary Objectives: To evaluate the predictive value of 24 month mortality. To evaluate the relationship of this index and other accepted clinical predictors. |
Facilities
Sequence: | 199669288 |
Name | Maugeri Foundation |
City | Tradate |
State | VA |
Zip | 21049 |
Country | Italy |
Conditions
Sequence: | 52075944 | Sequence: | 52075945 | Sequence: | 52075946 | Sequence: | 52075947 |
Name | COPD | Name | Mortality | Name | Disease Exacerbation | Name | Exercise Capacity |
Downcase Name | copd | Downcase Name | mortality | Downcase Name | disease exacerbation | Downcase Name | exercise capacity |
Id Information
Sequence: | 40082981 |
Id Source | org_study_id |
Id Value | 2019001 |
Countries
Sequence: | 42482395 |
Name | Italy |
Removed | False |
Interventions
Sequence: | 52388957 |
Intervention Type | Procedure |
Name | evaluation group |
Description | Recordings Pneumologic assessment Severity grades (I-IV: old GOLD and A-D: new GOLD) Smoke History Drug therapy Comorbidities 6MWT performed within previous 10-14 months, if available. Measurements Standard exams usually performed at Rehab Center Lung Function tests and diffusing capacity of the lung for carbon monoxide Arterial Blood Gases Dyspnoea Health Status and Health Related Quality of Life Daily activity Lower limb muscle strength Exercise capacity |
Design Outcomes
Sequence: | 177054200 | Sequence: | 177054201 | Sequence: | 177054202 | Sequence: | 177054203 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary |
Measure | COPD Exacerbation | Measure | Mortality | Measure | hospitalizations | Measure | symptoms and anthropometrics characteristics correlation |
Time Frame | 24 month | Time Frame | 24 month | Time Frame | 24 month | Time Frame | 24 month |
Description | number of patients with acute exacerbations (treated with antibiotics or steroids) | Description | number of patients died | Description | number of patients hospitalized for COPD | Description | Index correlation capacity with dyspnoea (Medical Research Council questionnaire, Barthel Dyspnoea), body weight (kilogram), heart frequency (HR), distance walked (6MWT) |
Browse Conditions
Sequence: | 193107893 | Sequence: | 193107894 | Sequence: | 193107895 |
Mesh Term | Disease Progression | Mesh Term | Disease Attributes | Mesh Term | Pathologic Processes |
Downcase Mesh Term | disease progression | Downcase Mesh Term | disease attributes | Downcase Mesh Term | pathologic processes |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48231045 | Sequence: | 48231046 |
Agency Class | OTHER | Agency Class | OTHER |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | Maugeri Foundation | Name | Università degli Studi di Sassari |
Overall Officials
Sequence: | 29229793 |
Role | Study Director |
Name | Antonio Spanevello, Prof |
Affiliation | Maugeri Foundation |
Eligibilities
Sequence: | 30709976 |
Sampling Method | Non-Probability Sample |
Gender | All |
Minimum Age | 45 Years |
Maximum Age | 85 Years |
Population | Stable COPD patients assessed for Pulmonary Rehabilitation |
Criteria | Inclusion Criteria:
COPD diagnosis and grades of severity as assessed by the "old" (I to IV) and "new" (A to D) GOLD guidelines (23) Exclusion Criteria: Associated Comorbidities with short term severe prognosis |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253935084 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 24 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 45 |
Maximum Age Num | 85 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 2 |
Number Of Secondary Outcomes To Measure | 2 |
Designs
Sequence: | 30456567 |
Observational Model | Cohort |
Time Perspective | Prospective |
Responsible Parties
Sequence: | 28823041 |
Responsible Party Type | Principal Investigator |
Name | elisabetta zampogna |
Title | Dr |
Affiliation | Maugeri Foundation |
Study References
Sequence: | 51971733 | Sequence: | 51971734 | Sequence: | 51971735 | Sequence: | 51971736 | Sequence: | 51971737 | Sequence: | 51971738 |
Pmid | 6805625 | Pmid | 20471236 | Pmid | 12091180 | Pmid | 12917227 | Pmid | 28624883 | Pmid | 18550610 |
Reference Type | result | Reference Type | result | Reference Type | result | Reference Type | result | Reference Type | result | Reference Type | result |
Citation | Butland RJ, Pang J, Gross ER, Woodcock AA, Geddes DM. Two-, six-, and 12-minute walking tests in respiratory disease. Br Med J (Clin Res Ed). 1982 May 29;284(6329):1607-8. doi: 10.1136/bmj.284.6329.1607. No abstract available. | Citation | Spruit MA, Watkins ML, Edwards LD, Vestbo J, Calverley PM, Pinto-Plata V, Celli BR, Tal-Singer R, Wouters EF; Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints (ECLIPSE) study investigators. Determinants of poor 6-min walking distance in patients with COPD: the ECLIPSE cohort. Respir Med. 2010 Jun;104(6):849-57. doi: 10.1016/j.rmed.2009.12.007. Epub 2010 May 14. | Citation | ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available. Erratum In: Am J Respir Crit Care Med. 2016 May 15;193(10):1185. | Citation | Lama VN, Flaherty KR, Toews GB, Colby TV, Travis WD, Long Q, Murray S, Kazerooni EA, Gross BH, Lynch JP 3rd, Martinez FJ. Prognostic value of desaturation during a 6-minute walk test in idiopathic interstitial pneumonia. Am J Respir Crit Care Med. 2003 Nov 1;168(9):1084-90. doi: 10.1164/rccm.200302-219OC. Epub 2003 Aug 13. | Citation | Rodriguez DA, Kortianou EA, Alison JA, Casas A, Giavedoni S, Barberan-Garcia A, Arbillaga A, Vilaro J, Gimeno-Santos E, Vogiatzis I, Rabinovich R, Roca J. Heart Rate Recovery After 6-min Walking Test Predicts Acute Exacerbation in COPD. Lung. 2017 Aug;195(4):463-467. doi: 10.1007/s00408-017-0027-0. Epub 2017 Jun 17. | Citation | Puhan MA, Mador MJ, Held U, Goldstein R, Guyatt GH, Schunemann HJ. Interpretation of treatment changes in 6-minute walk distance in patients with COPD. Eur Respir J. 2008 Sep;32(3):637-43. doi: 10.1183/09031936.00140507. Epub 2008 Jun 11. |
]]>
https://zephyrnet.com/NCT03799250
2019-06-30
https://zephyrnet.com/?p=NCT03799250
NCT03799250https://www.clinicaltrials.gov/study/NCT03799250?tab=tableBinyamin Zeribibenjzr@gmail.comNAFluid therapy is a cornerstone in patient therapy perioperatively. Many studies have addressed the amount of fluid administered (restrictive vs liberal strategies). Other studies focused on the type of fluids (colloid vs crystalloids), and in the last twenty years a more common subject of research was- the correct evaluation of the dynamic fluid status of patients.Bolus driven fluid therapy has been investigated in many goal-directed hemodynamic therapy (GDHT) trials and has become a widely used approach in intraoperative fluid management.
While there are numerous studies on the intraoperative outcome of GDHT, research on the immediate postoperative outcome of GDHT therapy use is scarce.
In this study the investigators aim to evaluate the efficacy of bolus-based fluid management guided by common clinical parameters in postoperative period in post-anesthesia care unit.
In this randomized clinical trial all patients will be randomized to one of the following groups:
The control group will receive standard care which includes fluid maintenance program as dictated by the operating room anesthesiologist and as needed boluses through the PACU stay.
The GDT group will not receive any maintenance fluid. Fluid boluses will be given according to the flowchart attached.
Measurements of hemodynamic variables including heart rate and automatic non-invasive blood pressure measurements as well pulse oximetry as routine procedures will be recorded and stored by Metavision system (iMDsoft company) at regular intervals, all according to standard clinical practice.
Blood gases measurement will be performed upon admission and at discharge. Urine output will be measured and recorded every hour.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-08 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2019-09-25 |
Start Month Year | June 30, 2019 |
Primary Completion Month Year | December 2020 |
Verification Month Year | December 2018 |
Verification Date | 2018-12-31 |
Last Update Posted Date | 2019-09-25 |
Detailed Descriptions
Sequence: | 20716267 |
Description | Methods Prior to surgery the patient will be assessed in the pre-anesthesia clinic, study protocol will be explained, questions answered and informed consent form will be signed by one of the investigating physicians. In case of an urgent case with no pre-anesthetic clinic visit, the process will take place in the entrance to the surgery room. Following surgery, patients will be assessed for eligibility and randomized to one of the study arms.
The control group will receive standard care which includes fluid maintenance program as dictated by the operating room anesthesiologist and as needed boluses through the PACU stay. Study Arm: The GDT group will not receive any maintenance fluid. Fluid boluses will be given according to the flowchart attached. Baseline MAP and HR will be measured in the pre-anesthetic clinic or if not available will be recorded according to community medical record. Blood products will be administered according to departmental guidelines and clinician decision unrelated to participation in the study. Patients will be extubated, either in the operating room or postoperatively, when they fulfilled standard clinical criteria (adequate protective reflexes, adequate oxygenation, and stable hemodynamics), according to clinical indication unrelated to the participation in the study. Measurements of hemodynamic variables including heart rate and automatic non-invasive blood pressure measurements as well pulse oximetry as routine procedures will be recorded and stored by Metavision system (iMDsoft company) at regular intervals, all according to standard clinical practice. Blood gases measurement will be performed upon admission and at discharge. Urine output will be measured and recorded every hour. Other laboratory exams will be taken based on the physician discretion unrelated to the participation in the study. Data Collection: For each participating patient the following data will be collected and recorded: Demographic data |
Facilities
Sequence: | 200053165 |
Status | Recruiting |
Name | Rabin Medical Center |
City | Petah tikva |
Country | Israel |
Facility Contacts
Sequence: | 28097472 |
Facility Id | 200053165 |
Contact Type | primary |
Name | nadav sheffy, md |
nadavs1@gmail.com | |
Phone | 972522246447 |
Facility Investigators
Sequence: | 18326398 |
Facility Id | 200053165 |
Role | Principal Investigator |
Name | nadav sheffy, md |
Conditions
Sequence: | 52156396 |
Name | Ringer's Lactate |
Downcase Name | ringer's lactate |
Id Information
Sequence: | 40148163 |
Id Source | org_study_id |
Id Value | 824-18 |
Countries
Sequence: | 42557689 |
Name | Israel |
Removed | False |
Design Groups
Sequence: | 55577830 | Sequence: | 55577831 |
Group Type | Experimental | Group Type | Active Comparator |
Title | Goal Directed Hemodynamic Therapy | Title | Control Group |
Description | The GDT (Goal Directed Therapy) group will not receive any maintenance fluid. Fluid boluses will be given according to the flowchart attached.
Baseline MAP and HR will be measured in the pre-anesthetic clinic or if not available will be recorded according to community medical record. Measurements of hemodynamic variables including heart rate and automatic non-invasive blood pressure measurements as well pulse oximetry as routine procedures will be recorded and stored by Metavision system (iMDsoft company) at regular intervals, all according to standard clinical practice. Blood gases measurement will be performed upon admission and at discharge. Urine output will be measured and recorded every hour. Other laboratory exams will be taken based on the physician discretion unrelated to the participation in the study. |
Description | The control group will receive standard care which includes fluid maintenance program as dictated by the operating room anesthesiologist and as needed boluses through the PACU (Post Anesthesia Care Unit) stay. |
Interventions
Sequence: | 52471939 | Sequence: | 52471940 |
Intervention Type | Drug | Intervention Type | Other |
Name | Ringer lactate | Name | standard care |
Description | Comparison between fluid maintenance in PACU compared to a bolus based goal directed hemodynamic therapy in the PACU | Description | standard care |
Design Outcomes
Sequence: | 177327660 | Sequence: | 177327661 | Sequence: | 177327662 | Sequence: | 177327663 | Sequence: | 177327664 | Sequence: | 177327665 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | The rate of postoperative complications measured according to the European Perioperative Clinical Outcome definitions and Clavien-Dindo Classification in the week following the intervention | Measure | The total amount of fluid infused. | Measure | Length of stay in PACU | Measure | Length of stay in hospital | Measure | Post-operative pulmonary complications | Measure | Acute kidney injury |
Time Frame | 1 week post surgery | Time Frame | 1 week post operative | Time Frame | 8 hours after surgery | Time Frame | 1 month after surgery | Time Frame | 1 week after surgery | Time Frame | 1 week after surgery |
Description | Postoperative complication rates according to the EPCO classification |
Sponsors
Sequence: | 48305990 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Rabin Medical Center |
Overall Officials
Sequence: | 29277893 | Sequence: | 29277894 |
Role | Principal Investigator | Role | Study Chair |
Name | Nadav O Sheffy, MD | Name | Leonid O Eidelman, MD |
Affiliation | Rabin Medical Center | Affiliation | Rabin Medical Center |
Central Contacts
Sequence: | 12004724 | Sequence: | 12004725 |
Contact Type | primary | Contact Type | backup |
Name | Nadav Sheffy, MD | Name | Binyamin Zeribi |
Phone | 972522246447 | ||
nadavs1@gmail.com | benjzr@gmail.com | ||
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 68130780 | Sequence: | 68130781 |
Design Group Id | 55577830 | Design Group Id | 55577831 |
Intervention Id | 52471939 | Intervention Id | 52471940 |
Eligibilities
Sequence: | 30757313 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Patient undergoing general surgery, vascular surgery or urological surgery and who are expected to stay in the PACU for more than 8 hours. Exclusion Criteria: – Pregnancy |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254226389 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 5 |
Designs
Sequence: | 30503538 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Responsible Parties
Sequence: | 28869816 |
Responsible Party Type | Sponsor |
Study References
Sequence: | 52049364 | Sequence: | 52049365 | Sequence: | 52049366 | Sequence: | 52049367 | Sequence: | 52049368 | Sequence: | 52049369 | Sequence: | 52049370 | Sequence: | 52049371 | Sequence: | 52049372 | Sequence: | 52049373 | Sequence: | 52049374 | Sequence: | 52049375 | Sequence: | 52049376 | Sequence: | 52049377 | Sequence: | 52049378 |
Pmid | 23672779 | Pmid | 16356219 | Pmid | 25104915 | Pmid | 28558654 | Pmid | 12357146 | Pmid | 26829494 | Pmid | 29576114 | Pmid | 29742967 | Pmid | 17115398 | Pmid | 28880931 | Pmid | 21873370 | Pmid | 20613538 | Pmid | 9510275 | Pmid | 25058504 | Pmid | 15273542 |
Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background |
Citation | Cecconi M, Corredor C, Arulkumaran N, Abuella G, Ball J, Grounds RM, Hamilton M, Rhodes A. Clinical review: Goal-directed therapy-what is the evidence in surgical patients? The effect on different risk groups. Crit Care. 2013 Mar 5;17(2):209. doi: 10.1186/cc11823. | Citation | Pearse R, Dawson D, Fawcett J, Rhodes A, Grounds RM, Bennett ED. Early goal-directed therapy after major surgery reduces complications and duration of hospital stay. A randomised, controlled trial [ISRCTN38797445]. Crit Care. 2005;9(6):R687-93. doi: 10.1186/cc3887. Epub 2005 Nov 8. | Citation | Della Rocca G, Vetrugno L, Tripi G, Deana C, Barbariol F, Pompei L. Liberal or restricted fluid administration: are we ready for a proposal of a restricted intraoperative approach? BMC Anesthesiol. 2014 Aug 1;14:62. doi: 10.1186/1471-2253-14-62. eCollection 2014. | Citation | Malbouisson LMS, Silva JM Jr, Carmona MJC, Lopes MR, Assuncao MS, Valiatti JLDS, Simoes CM, Auler JOC Jr. A pragmatic multi-center trial of goal-directed fluid management based on pulse pressure variation monitoring during high-risk surgery. BMC Anesthesiol. 2017 May 30;17(1):70. doi: 10.1186/s12871-017-0356-9. | Citation | Gan TJ, Soppitt A, Maroof M, el-Moalem H, Robertson KM, Moretti E, Dwane P, Glass PS. Goal-directed intraoperative fluid administration reduces length of hospital stay after major surgery. Anesthesiology. 2002 Oct;97(4):820-6. doi: 10.1097/00000542-200210000-00012. | Citation | Hand WR, Stoll WD, McEvoy MD, McSwain JR, Sealy CD, Skoner JM, Hornig JD, Tennant PA, Wolf B, Day TA. Intraoperative goal-directed hemodynamic management in free tissue transfer for head and neck cancer. Head Neck. 2016 Apr;38 Suppl 1(Suppl 1):E1974-80. doi: 10.1002/hed.24362. Epub 2016 Feb 1. | Citation | Calvo-Vecino JM, Ripolles-Melchor J, Mythen MG, Casans-Frances R, Balik A, Artacho JP, Martinez-Hurtado E, Serrano Romero A, Fernandez Perez C, Asuero de Lis S; FEDORA Trial Investigators Group. Effect of goal-directed haemodynamic therapy on postoperative complications in low-moderate risk surgical patients: a multicentre randomised controlled trial (FEDORA trial). Br J Anaesth. 2018 Apr;120(4):734-744. doi: 10.1016/j.bja.2017.12.018. Epub 2018 Feb 3. | Citation | Myles PS, Bellomo R, Corcoran T, Forbes A, Peyton P, Story D, Christophi C, Leslie K, McGuinness S, Parke R, Serpell J, Chan MTV, Painter T, McCluskey S, Minto G, Wallace S; Australian and New Zealand College of Anaesthetists Clinical Trials Network and the Australian and New Zealand Intensive Care Society Clinical Trials Group. Restrictive versus Liberal Fluid Therapy for Major Abdominal Surgery. N Engl J Med. 2018 Jun 14;378(24):2263-2274. doi: 10.1056/NEJMoa1801601. Epub 2018 May 9. | Citation | Sanders GM. Randomized clinical trial assessing the effect of Doppler-optimized fluid management on outcome after elective colorectal resection (Br J Surg) 2006; 93; 1069-1076. Br J Surg. 2006 Dec;93(12):1563. doi: 10.1002/bjs.5683. No abstract available. | Citation | Weinberg L, Ianno D, Churilov L, Chao I, Scurrah N, Rachbuch C, Banting J, Muralidharan V, Story D, Bellomo R, Christophi C, Nikfarjam M. Restrictive intraoperative fluid optimisation algorithm improves outcomes in patients undergoing pancreaticoduodenectomy: A prospective multicentre randomized controlled trial. PLoS One. 2017 Sep 7;12(9):e0183313. doi: 10.1371/journal.pone.0183313. eCollection 2017. | Citation | Challand C, Struthers R, Sneyd JR, Erasmus PD, Mellor N, Hosie KB, Minto G. Randomized controlled trial of intraoperative goal-directed fluid therapy in aerobically fit and unfit patients having major colorectal surgery. Br J Anaesth. 2012 Jan;108(1):53-62. doi: 10.1093/bja/aer273. Epub 2011 Aug 26. | Citation | Van der Linden PJ, Dierick A, Wilmin S, Bellens B, De Hert SG. A randomized controlled trial comparing an intraoperative goal-directed strategy with routine clinical practice in patients undergoing peripheral arterial surgery. Eur J Anaesthesiol. 2010 Sep;27(9):788-93. doi: 10.1097/EJA.0b013e32833cb2dd. | Citation | Valentine RJ, Duke ML, Inman MH, Grayburn PA, Hagino RT, Kakish HB, Clagett GP. Effectiveness of pulmonary artery catheters in aortic surgery: a randomized trial. J Vasc Surg. 1998 Feb;27(2):203-11; discussion 211-2. doi: 10.1016/s0741-5214(98)70351-9. | Citation | Jammer I, Wickboldt N, Sander M, Smith A, Schultz MJ, Pelosi P, Leva B, Rhodes A, Hoeft A, Walder B, Chew MS, Pearse RM; European Society of Anaesthesiology (ESA) and the European Society of Intensive Care Medicine (ESICM); European Society of Anaesthesiology; European Society of Intensive Care Medicine. Standards for definitions and use of outcome measures for clinical effectiveness research in perioperative medicine: European Perioperative Clinical Outcome (EPCO) definitions: a statement from the ESA-ESICM joint taskforce on perioperative outcome measures. Eur J Anaesthesiol. 2015 Feb;32(2):88-105. doi: 10.1097/EJA.0000000000000118. | Citation | Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae. |
]]>
https://zephyrnet.com/NCT03799237
2018-10-01
https://zephyrnet.com/?p=NCT03799237
NCT03799237https://www.clinicaltrials.gov/study/NCT03799237?tab=tableSivaneswari Selvarajoo, BScsivaneswariselvarajoo@gmail.com+60108968645During dengue outbreaks, the Ministry of Health Malaysia employs various methods to control the spread of disease, including killing the larvae of Aedes mosquitoes, fogging, together with educating and disseminating information about the dengue outbreak, to the community. However, this is too late. Research has shown that when an outbreak has occurred, the viral infection has already spread among the community. Therefore, this current trial aims to educate the public (via questionnaire survey and interactions with the residential managements, mainly), detect dengue-infected mosquitoes, inform the communities of the presence of dengue-infected mosquitoes, followed by approaching and educating them to take precautionary measures before the outbreak happens. Trapping (using gravid oviposition sticky (GOS) traps) and detecting dengue virus non-structural 1 (NS1) antigen (using dengue NS1 kit) in the Aedes mosquitoes will be a more reliable way to alert the community before a potential dengue outbreak in their housing area. The community will receive information of presence of infected mosquitoes and probable dengue infections before dengue cases are reported. This will be an ideal time for clean-ups and for search and destroy activities. With this shift in approach and the use of newer techniques, it is hoped that deaths and epidemics due to dengue will be reduced.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-02 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2019-01-10 |
Start Month Year | October 1, 2018 |
Primary Completion Month Year | March 31, 2020 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-10 |
Detailed Descriptions
Sequence: | 20735757 |
Description | This cluster randomised controlled trial will be conducted to provide evidence on the efficacy of an integrated active vector surveillance and preventive strategy in the community. It aims to demonstrate effectiveness of a new proactive paradigm in reducing dengue epidemics. The main hypotheses are 1) This new paradigm (GOS trap and dengue NS1 kit for detection of dengue in Aedes) will reduce dengue epidemics compared to the usual current vector surveillance/control carried out by the Ministry of Health. 2) Community will be more receptive to this new surveillance activity as they will receive information of dengue transmissions before dengue cases are reported.
The study sites at PJU10, Damansara Damai, Petaling Jaya, Selangor, Malaysia are Intervention arm: Harmoni Apartment, Impian Apartment, Park Avenue Condominium, and Suria Shop Apartment Activities to be carried out include: A. Questionnaire survey and blood taking for dengue seroprevalence among residents from both arms When people in the community are gathered at an identified, suitable area, the Knowledge, Attitude and Practice (KAP) questionnaires will be distributed for them to answer. After the questionnaire survey, about 3 ml of venous blood would be taken by trained personnel for dengue IgG and IgM serology. B. Placement of the GOS mosquito trap in the intervention arm The GOS mosquito traps will be placed in the intervention arm and serviced weekly. The trapped Aedes mosquitoes would be checked for dengue virus via dengue NS1 rapid diagnostic test kit. The GOS mosquito traps will also be placed randomly in the control arm once per month for entomological survey. C. If a dengue-positive mosquito is found, flyers and banners will be distributed and hung to inform the residents of the presence of dengue transmission in the apartment block/apartment. Alternatively, the residents may also be approached house-to-house or an educational booth set up at strategic locations in the apartment to warn and educate the residents. D. The KAP questionnaire survey will be carried out again 3 months before the completion of the trial in the intervention arm to gauge the communities' perception of this intervention. |
Facilities
Sequence: | 200244156 |
Status | Recruiting |
Name | Petaling Jaya City Council |
City | Petaling Jaya |
State | Selangor |
Country | Malaysia |
Facility Contacts
Sequence: | 28127966 |
Facility Id | 200244156 |
Contact Type | primary |
Name | Poo Soon Ong, Master |
Conditions
Sequence: | 52208074 |
Name | Dengue |
Downcase Name | dengue |
Id Information
Sequence: | 40186121 | Sequence: | 40186122 |
Id Source | org_study_id | Id Source | secondary_id |
Id Value | GOSNS1-1 | Id Value | MO013-2017 |
Id Type | Other Grant/Funding Number | ||
Id Type Description | Malaysia Ministry of Education | ||
Countries
Sequence: | 42599613 |
Name | Malaysia |
Removed | False |
Design Groups
Sequence: | 55634627 | Sequence: | 55634628 |
Group Type | Experimental | Group Type | No Intervention |
Title | GOS trap and dengue NS1 antigen kit | Title | Control |
Description | Gravid Oviposition Sticky (GOS) traps will be placed to trap adult Aedes mosquitoes and changed weekly. NS1 will be used to detect dengue in trapped Aedes mosquitoes. When dengue NS1 positive mosquitoes are found, community will be alerted via flyers, banners and other means. Routine Aedes/dengue control and surveillance will be carried out as usual as per the current Ministry of Health guidelines. | Description | The GOS traps will be placed randomly in the control arm once per month for entomological survey. Routine Aedes control and surveillance will be carried out as per the current Ministry of Health guidelines. Dengue control measure will be initiated by the health authorities when human cases are reported from this arm. |
Interventions
Sequence: | 52522043 |
Intervention Type | Other |
Name | GOS trap and dengue NS1 antigen kit |
Description | The GOS trap lure and sticky surfaces to trap gravid Aedes mosquitoes. Three GOS traps will be placed on every 3 floors of the residential blocks. The traps will be changed weekly. Trapped Aedes mosquitoes will be identified to species. The mosquitoes will then be dissected, to remove the abdomen from the thorax. Five to seven abdomens of the same mosquito species will be pooled and tested for dengue NS1 antigen using the SD Biosensor Standard Q dengue NS1 antigen test kit. If the pool is tested positive for dengue NS1, the head and thorax of the respective abdomens will be subjected to the same procedure for dengue NS1 antigen test, individually. This may allow us to identify a focus where there could be dengue-infected individuals. Flyers/Posters will be disseminated besides, house-to-house approach to inform the residents of the findings and apartment blocks where these mosquitoes were found. The apartment management will also make use of social media disseminate this information. |
Keywords
Sequence: | 79922882 | Sequence: | 79922883 | Sequence: | 79922884 | Sequence: | 79922885 | Sequence: | 79922886 |
Name | Dengue | Name | Adult Aedes | Name | GOS trap | Name | Dengue NS1 antigen test | Name | Early dengue detection and surveillance |
Downcase Name | dengue | Downcase Name | adult aedes | Downcase Name | gos trap | Downcase Name | dengue ns1 antigen test | Downcase Name | early dengue detection and surveillance |
Design Outcomes
Sequence: | 177511066 | Sequence: | 177511067 | Sequence: | 177511068 | Sequence: | 177511069 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Change in number of weekly notified dengue cases in intervention arm | Measure | Change in the duration of dengue outbreaks in intervention arm | Measure | Change in adult Aedes density in the intervention arm | Measure | Change in level of dengue Knowledge, Attitude and Practice in the intervention arm |
Time Frame | Assess weekly, through study completion, 1 and a half years | Time Frame | Through study completion, an average of 1 and a half years | Time Frame | Assess weekly, through study completion, within 1 and half years. | Time Frame | 6 months after recruitment for pre-trial questionnaire survey. 3 months after recruitment for post-trial questionnaire survey, through study completion, 1 and a half years |
Description | The number of notified dengue cases in the study sites will be obtained from the District Health Office | Description | The duration of dengue outbreaks in the study sites will be obtained from the District Health Office. | Description | Based on the weekly trap index | Description | The mean of the percentage score of the population for each domain (knowledge & attitude/practises) will be determined for the pre- and post-test. Then, paired t-test will be performed to determine the presence of significant changes in both means (An increase in score percentage indicate a better outcome). Additionally, an individual percentage score of 80% and above indicates indicates good knowledge/attitude/practice. |
Browse Conditions
Sequence: | 193626881 | Sequence: | 193626882 | Sequence: | 193626883 | Sequence: | 193626884 | Sequence: | 193626885 | Sequence: | 193626886 | Sequence: | 193626887 | Sequence: | 193626888 | Sequence: | 193626889 |
Mesh Term | Dengue | Mesh Term | Arbovirus Infections | Mesh Term | Vector Borne Diseases | Mesh Term | Infections | Mesh Term | Virus Diseases | Mesh Term | Flavivirus Infections | Mesh Term | Flaviviridae Infections | Mesh Term | RNA Virus Infections | Mesh Term | Hemorrhagic Fevers, Viral |
Downcase Mesh Term | dengue | Downcase Mesh Term | arbovirus infections | Downcase Mesh Term | vector borne diseases | Downcase Mesh Term | infections | Downcase Mesh Term | virus diseases | Downcase Mesh Term | flavivirus infections | Downcase Mesh Term | flaviviridae infections | Downcase Mesh Term | rna virus infections | Downcase Mesh Term | hemorrhagic fevers, viral |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48353659 | Sequence: | 48353660 | Sequence: | 48353661 |
Agency Class | OTHER | Agency Class | UNKNOWN | Agency Class | UNKNOWN |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator |
Name | Jonathan Liew Wee Kent | Name | Petaling Jaya City Council, Malaysia | Name | Selangor State Health Department, Malaysia |
Overall Officials
Sequence: | 29305961 | Sequence: | 29305962 |
Role | Principal Investigator | Role | Study Director |
Name | Jonathan WK Liew, PhD | Name | Indra Vythilingam, PhD |
Affiliation | University of Malaya | Affiliation | University of Malaya |
Central Contacts
Sequence: | 12017205 | Sequence: | 12017206 |
Contact Type | primary | Contact Type | backup |
Name | Jonathan WK Liew, PhD | Name | Sivaneswari Selvarajoo, BSc |
Phone | +60178858375 | Phone | +60108968645 |
jonathanliew@um.edu.my | sivaneswariselvarajoo@gmail.com | ||
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 68199152 |
Design Group Id | 55634627 |
Intervention Id | 52522043 |
Eligibilities
Sequence: | 30786849 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
Age 18 years and above, including pregnant women and healthy individuals Exclusion Criteria: Age below 18 years |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253989595 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 2 |
Number Of Secondary Outcomes To Measure | 2 |
Designs
Sequence: | 30532919 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Prevention |
Time Perspective | |
Masking | None (Open Label) |
Intervention Model Description | Cluster Randomized Controlled Trial |
Provided Documents
Sequence: | 2582458 | Sequence: | 2582459 |
Document Type | Informed Consent Form | Document Type | Study Protocol and Statistical Analysis Plan |
Has Protocol | False | Has Protocol | True |
Has Icf | True | Has Icf | False |
Has Sap | False | Has Sap | True |
Document Date | 2019-01-02 | Document Date | 2019-01-04 |
Url | https://ClinicalTrials.gov/ProvidedDocs/37/NCT03799237/ICF_000.pdf | Url | https://ClinicalTrials.gov/ProvidedDocs/37/NCT03799237/Prot_SAP_001.pdf |
Responsible Parties
Sequence: | 28899213 |
Responsible Party Type | Sponsor-Investigator |
Name | Jonathan Liew Wee Kent |
Title | Postdoctoral Research Fellow |
Affiliation | University of Malaya |
Study References
Sequence: | 52103019 | Sequence: | 52103020 | Sequence: | 52103021 | Sequence: | 52103022 | Sequence: | 52103023 | Sequence: | 52103024 | Sequence: | 52103025 | Sequence: | 52103026 |
Pmid | 28327173 | Pmid | 25600599 | Pmid | 29125255 | Pmid | 21175947 | Pmid | 17607465 | Pmid | 23478581 | Pmid | 26094839 | Pmid | 31477185 |
Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | derived |
Citation | Lau SM, Chua TH, Sulaiman WY, Joanne S, Lim YA, Sekaran SD, Chinna K, Venugopalan B, Vythilingam I. A new paradigm for Aedes spp. surveillance using gravid ovipositing sticky trap and NS1 antigen test kit. Parasit Vectors. 2017 Mar 21;10(1):151. doi: 10.1186/s13071-017-2091-y. | Citation | Klungthong C, Manasatienkij W, Phonpakobsin T, Chinnawirotpisan P, Rodpradit P, Hussem K, Thaisomboonsuk B, Ong-ajchaowlerd P, Nisalak A, Kalayanarooj S, Buddhari D, Gibbons RV, Jarman RG, Yoon IK, Fernandez S. Monitoring and improving the sensitivity of dengue nested RT-PCR used in longitudinal surveillance in Thailand. J Clin Virol. 2015 Feb;63:25-31. doi: 10.1016/j.jcv.2014.12.009. Epub 2014 Dec 12. | Citation | Roslan MA, Ngui R, Vythilingam I, Sulaiman WYW. Evaluation of sticky traps for adult Aedes mosquitoes in Malaysia: a potential monitoring and surveillance tool for the efficacy of control strategies. J Vector Ecol. 2017 Dec;42(2):298-307. doi: 10.1111/jvec.12270. | Citation | Chadee DD, Ritchie SA. Efficacy of sticky and standard ovitraps for Aedes aegypti in Trinidad, West Indies. J Vector Ecol. 2010 Dec;35(2):395-400. doi: 10.1111/j.1948-7134.2010.00098.x. | Citation | Gama RA, Silva EM, Silva IM, Resende MC, Eiras AE. Evaluation of the sticky MosquiTRAP for detecting Aedes (Stegomyia) aegypti (L.) (Diptera: Culicidae) during the dry season in Belo Horizonte, Minas Gerais, Brazil. Neotrop Entomol. 2007 Mar-Apr;36(2):294-302. doi: 10.1590/s1519-566×2007000200018. | Citation | Lee C, Vythilingam I, Chong CS, Abdul Razak MA, Tan CH, Liew C, Pok KY, Ng LC. Gravitraps for management of dengue clusters in Singapore. Am J Trop Med Hyg. 2013 May;88(5):888-892. doi: 10.4269/ajtmh.12-0329. Epub 2013 Mar 11. | Citation | Lau SM, Vythilingam I, Doss JI, Sekaran SD, Chua TH, Wan Sulaiman WY, Chinna K, Lim YA, Venugopalan B. Surveillance of adult Aedes mosquitoes in Selangor, Malaysia. Trop Med Int Health. 2015 Oct;20(10):1271-80. doi: 10.1111/tmi.12555. Epub 2015 Jul 14. | Citation | Liew JWK, Selvarajoo S, Tan W, Ahmad Zaki R, Vythilingam I. Gravid oviposition sticky trap and dengue non-structural 1 antigen test for early surveillance of dengue in multi-storey dwellings: study protocol of a cluster randomized controlled trial. Infect Dis Poverty. 2019 Sep 3;8(1):71. doi: 10.1186/s40249-019-0584-y. |
]]>
https://zephyrnet.com/NCT03799224
2018-12-01
https://zephyrnet.com/?p=NCT03799224
NCT03799224https://www.clinicaltrials.gov/study/NCT03799224?tab=tableChen-Hua Yanyanchenhua@vip.sina.com+86 010 88326666Allogeneic haematopoietic stem cell transplantation (allo-HSCT) remains one of the currently available curative therapies for acute leukemia (AL). Leukemia relapse is one of the mainly causes of transplant failure. We reported previously that patients with relapse or refractory AL were at very high risk of relapse post allo-HSCT, with cumulative relapse rate of 50-80%. Decitabine has been demonstrated efficacy in the treatment of patients with recurrent or refractory leukemia and myelodysplastic syndrome. It was reported that the combination of decitabine, with busulfan and cyclophosphamide as a preparative regimen for allo-HSCT using HLA-matching donors was safe and effective. In this prospective, single-arm clinical trial, we aimed to examine the efficacy of combining decitabine with modified busulfan and cyclophosphamide (mBU/CY) as a preparative regimen for allo-HSCT in recurrent and refractory AL patients.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-08 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2019-05-29 |
Start Month Year | December 1, 2018 |
Primary Completion Month Year | December 31, 2021 |
Verification Month Year | May 2019 |
Verification Date | 2019-05-31 |
Last Update Posted Date | 2019-05-29 |
Detailed Descriptions
Sequence: | 20721625 |
Description | Patients enrolled in this study would receive decitabine 200mg·m-2·d-1 on day -12 and -11 pre-HSCT. The conditioning therapy for human leukocyte antigen (HLA)-mismatched HSCT patients was modified BU/CY plus ATG (thymoglobulin; Sang Stat, France) consisting of cytarabine (Ara-C 4 g·m-2·d-1) intravenously on days -10 to -9, busulfan (BU 3.2 mg·kg-1·d-1) intravenously on days -8 to -6, cyclophosphamide (CY 1.8 g·m-2·d-1), intravenously on days -5 to -4, semustine (Me-CCNU, 250 mg·m-2), orally once on day -3, and ATG (2.5 mg·kg-1·d-1) intravenously on days -5 to -2. In matched sibling transplantations, patients received hydroxycarbamide (80 mg·kg-1) orally on day -10 and a lower dose of Ara-C (2 g·m-2·d-1) on day -9, but otherwise an identical regimen to the HLA-mismatched patients without ATG.
BM(bone marrow) samples from patients were obtained to assess leukemia status after HSCT. The time points that we monitored BM samples included at time of allo-HSCT; 1 month, 2 months, 3 months, 4.5 months, 6 months, 9 months, and 12 months after allo-HSCT; and every 6 months thereafter to the defined endpoints or for at least until 5 years after transplantation. |
Facilities
Sequence: | 200108113 |
Status | Recruiting |
Name | Peking University Institute of Hematology,Beijing |
City | Beijing |
State | Beijing |
Zip | 100044 |
Country | China |
Facility Contacts
Sequence: | 28106410 | Sequence: | 28106411 |
Facility Id | 200108113 | Facility Id | 200108113 |
Contact Type | primary | Contact Type | backup |
Name | Chen-hua Yan, MD | Name | Jing Liu, MD |
yanchenhua@vip.sina.com | liujing0245@bjmu.edu.cn | ||
Phone | 86 010 88326666 | Phone | 86 010 88326666 |
Facility Investigators
Sequence: | 18332492 |
Facility Id | 200108113 |
Role | Principal Investigator |
Name | Xiao-Jun Huang, MD |
Browse Interventions
Sequence: | 96050229 | Sequence: | 96050230 | Sequence: | 96050231 | Sequence: | 96050232 | Sequence: | 96050233 | Sequence: | 96050234 |
Mesh Term | Decitabine | Mesh Term | Antimetabolites, Antineoplastic | Mesh Term | Antimetabolites | Mesh Term | Molecular Mechanisms of Pharmacological Action | Mesh Term | Antineoplastic Agents | Mesh Term | Enzyme Inhibitors |
Downcase Mesh Term | decitabine | Downcase Mesh Term | antimetabolites, antineoplastic | Downcase Mesh Term | antimetabolites | Downcase Mesh Term | molecular mechanisms of pharmacological action | Downcase Mesh Term | antineoplastic agents | Downcase Mesh Term | enzyme inhibitors |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52171218 | Sequence: | 52171219 | Sequence: | 52171220 |
Name | Stem Cell Transplant Complications | Name | Relapse Leukemia | Name | Refractory Leukemia |
Downcase Name | stem cell transplant complications | Downcase Name | relapse leukemia | Downcase Name | refractory leukemia |
Id Information
Sequence: | 40158622 |
Id Source | org_study_id |
Id Value | decitabine pre-HSCT for R/R AL |
Countries
Sequence: | 42568933 |
Name | China |
Removed | False |
Design Groups
Sequence: | 55593155 | Sequence: | 55593156 |
Group Type | Experimental | Group Type | Experimental |
Title | Decitabine plus mBU/CY for HLA-mismatched HSCT | Title | Decitabine plus mBU/CY for matched sibling transplant |
Description | Decitabine plus mBU/CY as precondition regimen for recurrent and refractory acute leukemia at the time of HLA-mismatched HSCT
Details: The conditioning therapy for human leukocyte antigen (HLA)-mismatched HSCT patients was decitabine plus modified BU/CY and ATG,consisting of decitabine 100mg·m-2·d-1 q12h on days-12 and -11,cytarabine (Ara-C 4 g·m-2·d-1) intravenously on days -10 to -9, busulfan (BU 3.2 mg·kg-1·d-1) intravenously on days -8 to -6, cyclophosphamide (CY 1.8 g·m-2·d-1), intravenously on days -5 to -4, semustine (Me-CCNU, 250 mg/m2), orally once on day -3, and ATG (2.5 mg·kg-1·d-1) intravenously on days -5 to -2 |
Description | Decitabine plus mBU/CY as precondition regimen for High Risk Acute Leukemia With MRD (minimal residual disease) at the time of matched sibling transplant.
Details: In matched sibling transplantations, patients received decitabine 100mg·m-2·d-1 q12h on days-12 and -11,hydroxycarbamide (80 mg/kg) orally on day -10 and a lower dose of Ara-C (2 g·m-2·d-1) on day -9, busulfan (BU 3.2 mg·kg-1·d-1) intravenously on days -8 to -6, cyclophosphamide (CY 1.8 g·m-2·d-1), intravenously on days -5 to -4, semustine (Me-CCNU, 250 mg/m2), orally once on day -3. |
Interventions
Sequence: | 52485463 | Sequence: | 52485464 | Sequence: | 52485465 |
Intervention Type | Drug | Intervention Type | Drug | Intervention Type | Drug |
Name | Decitabine | Name | mBU/CY and ATG | Name | mBU/CY |
Description | Decitabine 200mg.m-2.d-1 intravenously on days -12 and -11 | Description | Ara-C 4 g·m-2·d-1 intravenously on days -10 to -9 Busulfan (BU 3.2 mg·kg-1·d-1) intravenously on days -8 to -6, Cyclophosphamide (CY 1.8 g·m-2·d-1) intravenously on days -5 to -4 Semustine (Me-CCNU, 250 mg·m-2) orally once on day -3 ATG (2.5 mg·kg-1·d-1) intravenously on days -5 to -2 | Description | hydroxycarbamide (80 mg·kg-1) orally on day -10 Ara-C (2 g·m-2·d-1) on day -9 Busulfan (BU 3.2 mg·kg-1·d-1) intravenously on days -8 to -6, Cyclophosphamide (CY 1.8 g·m-2·d-1) intravenously on days -5 to -4 Semustine (Me-CCNU, 250 mg·m-2) orally once on day -3 |
Keywords
Sequence: | 79868505 | Sequence: | 79868506 | Sequence: | 79868507 | Sequence: | 79868508 |
Name | recurrent acute leukemia | Name | refractory acute leukemia | Name | preconditioning regimen | Name | allogeneic stem cell transplantation |
Downcase Name | recurrent acute leukemia | Downcase Name | refractory acute leukemia | Downcase Name | preconditioning regimen | Downcase Name | allogeneic stem cell transplantation |
Design Outcomes
Sequence: | 177378813 | Sequence: | 177378814 | Sequence: | 177378815 | Sequence: | 177378816 | Sequence: | 177378817 | Sequence: | 177378818 | Sequence: | 177378819 | Sequence: | 177378820 | Sequence: | 177378821 | Sequence: | 177378822 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | 1 year cumulative incidence of relapse | Measure | 2 year cumulative incidence of relapse | Measure | Non-relapse mortality | Measure | 1 year overall survival | Measure | 5 years overall survival | Measure | 1 year leukemia free survival | Measure | 5 years leukemia free survival | Measure | engraftment | Measure | Acute graft versus host disease | Measure | Chronic graft versus host disease |
Time Frame | 1 year post allo-HSCT | Time Frame | 2 years post allo-HSCT | Time Frame | 1 year post allo-HSCT | Time Frame | 1 year post allo-HSCT | Time Frame | 5 years post allo-HSCT] 1 year leukemia free survival | Time Frame | 1 year post allo-HSCT | Time Frame | 5 years post allo-HSCT | Time Frame | 100 days post allo-HSCT | Time Frame | 100 days post allo-HSCT | Time Frame | 1 years post allo-HSCT |
Description | The cumulative incidence of relapse at 1 year post allo-HSCT | Description | The cumulative incidence of relapse at 2 years post allo-HSCT | Description | The cumulative incidence of non-relapse mortality at 1 year post allo-HSCT | Description | The overall survival at 1 year post allo-HSCT | Description | The overall survival at 5 years post allo-HSCT | Description | The leukemia free survival at 1 years post allo-HSCT | Description | The leukemia free survival at 5 years post allo-HSCT | Description | The total neutrophil and platelet engraftment rate | Description | The cumulative incidence of grade II-IV acute graft versus host disease | Description | The cumulative incidence of intermediate to severe chronic graft versus host disease |
Browse Conditions
Sequence: | 193486661 | Sequence: | 193486662 | Sequence: | 193486663 | Sequence: | 193486664 | Sequence: | 193486665 | Sequence: | 193486666 |
Mesh Term | Leukemia | Mesh Term | Recurrence | Mesh Term | Neoplasms by Histologic Type | Mesh Term | Neoplasms | Mesh Term | Disease Attributes | Mesh Term | Pathologic Processes |
Downcase Mesh Term | leukemia | Downcase Mesh Term | recurrence | Downcase Mesh Term | neoplasms by histologic type | Downcase Mesh Term | neoplasms | Downcase Mesh Term | disease attributes | Downcase Mesh Term | pathologic processes |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48319267 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Peking University People's Hospital |
Overall Officials
Sequence: | 29285342 |
Role | Study Chair |
Name | Xiao-Jun Huang |
Affiliation | Peking University People's Hospital |
Central Contacts
Sequence: | 12008870 | Sequence: | 12008871 |
Contact Type | primary | Contact Type | backup |
Name | Xiao-Jun Huang | Name | Chen-Hua Yan |
Phone | +86 010 88326666 | Phone | +86 010 88326666 |
yanchenhua@vip.sina.com | yanchenhua@vip.sina.com | ||
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 68149111 | Sequence: | 68149112 | Sequence: | 68149113 | Sequence: | 68149114 |
Design Group Id | 55593155 | Design Group Id | 55593156 | Design Group Id | 55593155 | Design Group Id | 55593156 |
Intervention Id | 52485463 | Intervention Id | 52485463 | Intervention Id | 52485464 | Intervention Id | 52485465 |
Eligibilities
Sequence: | 30765341 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 55 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
patients with relapsed acute leukemia Exclusion Criteria: pregnancy women |
Adult | True |
Child | False |
Older Adult | False |
Calculated Values
Sequence: | 253883255 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 55 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 2 |
Number Of Secondary Outcomes To Measure | 8 |
Designs
Sequence: | 30511508 |
Allocation | Non-Randomized |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Intervention Model Description | Patients enrolled in this study would receive decitabine 200mg·m-2·d-1 on day -12 and -11 pre-HSCT. The conditioning therapy for human leukocyte antigen (HLA)-mismatched HSCT patients was modified BU/CY plus ATG. In matched sibling transplantations, patients received hydroxycarbamide (80 mg·kg-1) orally on day -10 and a lower dose of Ara-C (2 g·m-2·d-1) on day -9, but otherwise an identical regimen to the HLA-mismatched patients without ATG.BM samples from patients would be obtained to assess leukemia status after HSCT. The time points that we monitored BM samples included at time of allo-HSCT; 1 month, 2 months, 3 months, 4.5 months, 6 months, 9 months, and 12 months after allo-HSCT; and every 6 months thereafter to the defined endpoints or for at least until 5 year after transplantation. |
Responsible Parties
Sequence: | 28877802 |
Responsible Party Type | Principal Investigator |
Name | Xiaojun Huang,MD |
Title | Director of the Hematology Department |
Affiliation | Peking University People's Hospital |
]]>
https://zephyrnet.com/NCT03799211
2018-06-04
https://zephyrnet.com/?p=NCT03799211
NCT03799211https://www.clinicaltrials.gov/study/NCT03799211?tab=tableNANANAMigraine patients are oftentimes referred for evidence based behavioral therapies to prevent migraine. Yet, at follow-up visits, they report not seeing the behavioral therapist. This is a pilot feasibility acceptability study to assess whether motivational interviewing (MI) can be implemented in the headache center setting to help improve initiation and adherence to behavioral therapy for migraine. We will also assess patients’ reasons for making/not making the appointment.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-31 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2020-07-23 |
Start Month Year | June 4, 2018 |
Primary Completion Month Year | January 1, 2019 |
Verification Month Year | July 2020 |
Verification Date | 2020-07-31 |
Last Update Posted Date | 2020-07-23 |
Results First Posted Date | 2020-07-23 |
Facilities
Sequence: | 200233720 |
Name | NYU Langone |
City | New York |
State | New York |
Zip | 10016 |
Country | United States |
Conditions
Sequence: | 52204174 |
Name | Migraine |
Downcase Name | migraine |
Id Information
Sequence: | 40183286 |
Id Source | org_study_id |
Id Value | 16-00937 |
Countries
Sequence: | 42596886 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55630429 | Sequence: | 55630430 |
Group Type | Experimental | Group Type | Active Comparator |
Title | Motivational Interviewing | Title | Usual Care |
Interventions
Sequence: | 52518367 | Sequence: | 52518368 |
Intervention Type | Behavioral | Intervention Type | Behavioral |
Name | Motivational Interviewing | Name | Treatment as Usual |
Description | Phone call using motivational interviewing technique | Description | will receive a regular study phone call after three months |
Design Outcomes
Sequence: | 177498710 | Sequence: | 177498711 | Sequence: | 177498712 | Sequence: | 177498713 | Sequence: | 177498714 | Sequence: | 177498715 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Percentage of Patients Who Made an Appointment for Behavioral Therapy | Measure | Percentage of Participants Who Attended Appointments | Measure | Percentage of Participants Who Initiated Appointments | Measure | Mean Reported Importance of Managing Migraine | Measure | Mean Reported Confidence in Managing Migraines | Measure | Mean Reported Confidence in Behavioral Therapy |
Time Frame | 3-6 Months | Time Frame | 3-6 Months | Time Frame | Month 3-4 post-recruitment | Time Frame | First Follow-up Call (1 month post baseline) conducted only for the Arm/Group "Motivational Interviewing" and Last Follow-up Call (3-4 months post baseline) | Time Frame | First Follow-up Call (1 month post baseline) conducted only for the Arm/Group "Motivational Interviewing" and Last Follow-up Call (3-4 months post baseline) | Time Frame | First Follow-up Call (1 month post baseline) conducted only for the Arm/Group "Motivational Interviewing" and Last Follow-up Call (3-4 months post baseline) |
Description | Of those who initiated behavioral therapy, percentage who attended appointments | Description | Reported the importance to participants of managing migraine. Importance was rated on a scale from 0 to 10, where the higher the score, the higher the importance. | Description | Reported confidence in participant's ability to manage migraine. Confidence was rated on a scale from 0 to 10, with the higher the score, the higher the confidence. | Description | Reported confidence in behavioral therapy to help participant manage migraine. Confidence was rated on a scale from 0 to 10, where the higher the score, the higher the confidence. |
Browse Conditions
Sequence: | 193612179 | Sequence: | 193612180 | Sequence: | 193612181 | Sequence: | 193612182 | Sequence: | 193612183 | Sequence: | 193612184 |
Mesh Term | Migraine Disorders | Mesh Term | Headache Disorders, Primary | Mesh Term | Headache Disorders | Mesh Term | Brain Diseases | Mesh Term | Central Nervous System Diseases | Mesh Term | Nervous System Diseases |
Downcase Mesh Term | migraine disorders | Downcase Mesh Term | headache disorders, primary | Downcase Mesh Term | headache disorders | Downcase Mesh Term | brain diseases | Downcase Mesh Term | central nervous system diseases | Downcase Mesh Term | nervous system diseases |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48350097 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | NYU Langone Health |
Overall Officials
Sequence: | 29303713 |
Role | Principal Investigator |
Name | Mia Minen, MD |
Affiliation | NYU Langone |
Design Group Interventions
Sequence: | 68194259 | Sequence: | 68194260 |
Design Group Id | 55630429 | Design Group Id | 55630430 |
Intervention Id | 52518367 | Intervention Id | 52518368 |
Eligibilities
Sequence: | 30784602 |
Gender | All |
Minimum Age | 16 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Migraine diagnosis age 16+ Exclusion Criteria: Unable to read the questionnaire, no phone number |
Adult | True |
Child | True |
Older Adult | True |
Calculated Values
Sequence: | 253985177 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 7 |
Were Results Reported | True |
Months To Report Results | 18 |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 16 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 5 |
Designs
Sequence: | 30530683 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Drop Withdrawals
Sequence: | 29007649 | Sequence: | 29007650 | Sequence: | 29007651 | Sequence: | 29007652 |
Result Group Id | 56116378 | Result Group Id | 56116379 | Result Group Id | 56116378 | Result Group Id | 56116379 |
Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 |
Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study |
Reason | Lost to Follow-up | Reason | Lost to Follow-up | Reason | Withdrawal by Subject | Reason | Withdrawal by Subject |
Count | 2 | Count | 13 | Count | 2 | Count | 0 |
Milestones
Sequence: | 41031649 | Sequence: | 41031650 | Sequence: | 41031651 | Sequence: | 41031652 | Sequence: | 41031653 | Sequence: | 41031654 |
Result Group Id | 56116378 | Result Group Id | 56116379 | Result Group Id | 56116378 | Result Group Id | 56116379 | Result Group Id | 56116378 | Result Group Id | 56116379 |
Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 |
Title | STARTED | Title | STARTED | Title | COMPLETED | Title | COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED |
Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study |
Count | 36 | Count | 40 | Count | 32 | Count | 27 | Count | 4 | Count | 13 |
Participant Flows
Sequence: | 3923169 |
Outcome Counts
Sequence: | 74046062 | Sequence: | 74046063 | Sequence: | 74046064 | Sequence: | 74046065 | Sequence: | 74046066 | Sequence: | 74046067 | Sequence: | 74046068 | Sequence: | 74046069 | Sequence: | 74046070 | Sequence: | 74046071 | Sequence: | 74046072 | Sequence: | 74046073 |
Outcome Id | 30823261 | Outcome Id | 30823261 | Outcome Id | 30823262 | Outcome Id | 30823262 | Outcome Id | 30823263 | Outcome Id | 30823263 | Outcome Id | 30823264 | Outcome Id | 30823264 | Outcome Id | 30823265 | Outcome Id | 30823265 | Outcome Id | 30823266 | Outcome Id | 30823266 |
Result Group Id | 56116380 | Result Group Id | 56116381 | Result Group Id | 56116382 | Result Group Id | 56116383 | Result Group Id | 56116382 | Result Group Id | 56116383 | Result Group Id | 56116382 | Result Group Id | 56116383 | Result Group Id | 56116382 | Result Group Id | 56116383 | Result Group Id | 56116382 | Result Group Id | 56116383 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 |
Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure |
Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants |
Count | 32 | Count | 27 | Count | 27 | Count | 32 | Count | 27 | Count | 32 | Count | 27 | Count | 32 | Count | 27 | Count | 32 | Count | 27 | Count | 32 |
Provided Documents
Sequence: | 2582162 |
Document Type | Study Protocol and Statistical Analysis Plan |
Has Protocol | True |
Has Icf | False |
Has Sap | True |
Document Date | 2019-12-23 |
Url | https://ClinicalTrials.gov/ProvidedDocs/11/NCT03799211/Prot_SAP_000.pdf |
Reported Event Totals
Sequence: | 27958312 | Sequence: | 27958313 | Sequence: | 27958314 | Sequence: | 27958315 | Sequence: | 27958316 | Sequence: | 27958317 |
Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG001 | Ctgov Group Code | EG001 |
Event Type | serious | Event Type | other | Event Type | deaths | Event Type | serious | Event Type | other | Event Type | deaths |
Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality | Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality |
Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 |
Subjects At Risk | 0 | Subjects At Risk | 0 | Subjects At Risk | 0 | Subjects At Risk | 0 | Subjects At Risk | 0 | Subjects At Risk | 0 |
Created At | 2023-08-09 06:44:03.854711 | Created At | 2023-08-09 06:44:03.854711 | Created At | 2023-08-09 06:44:03.854711 | Created At | 2023-08-09 06:44:03.854711 | Created At | 2023-08-09 06:44:03.854711 | Created At | 2023-08-09 06:44:03.854711 |
Updated At | 2023-08-09 06:44:03.854711 | Updated At | 2023-08-09 06:44:03.854711 | Updated At | 2023-08-09 06:44:03.854711 | Updated At | 2023-08-09 06:44:03.854711 | Updated At | 2023-08-09 06:44:03.854711 | Updated At | 2023-08-09 06:44:03.854711 |
Responsible Parties
Sequence: | 28896984 |
Responsible Party Type | Sponsor |
Result Agreements
Sequence: | 3853913 |
Pi Employee | Yes |
Result Contacts
Sequence: | 3853878 |
Organization | NYU Langone Health |
Name | Mia Minen, MD, MPH |
Phone | 212-263-7744 |
Mia.Minen@nyulangone.org | |
Outcomes
Sequence: | 30823261 | Sequence: | 30823262 | Sequence: | 30823263 | Sequence: | 30823264 | Sequence: | 30823265 | Sequence: | 30823266 |
Outcome Type | Primary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary |
Title | Percentage of Patients Who Made an Appointment for Behavioral Therapy | Title | Percentage of Participants Who Attended Appointments | Title | Percentage of Participants Who Initiated Appointments | Title | Mean Reported Importance of Managing Migraine | Title | Mean Reported Confidence in Managing Migraines | Title | Mean Reported Confidence in Behavioral Therapy |
Description | Of those who initiated behavioral therapy, percentage who attended appointments | Description | Reported the importance to participants of managing migraine. Importance was rated on a scale from 0 to 10, where the higher the score, the higher the importance. | Description | Reported confidence in participant's ability to manage migraine. Confidence was rated on a scale from 0 to 10, with the higher the score, the higher the confidence. | Description | Reported confidence in behavioral therapy to help participant manage migraine. Confidence was rated on a scale from 0 to 10, where the higher the score, the higher the confidence. | ||||
Time Frame | 3-6 Months | Time Frame | 3-6 Months | Time Frame | Month 3-4 post-recruitment | Time Frame | First Follow-up Call (1 month post baseline) conducted only for the Arm/Group "Motivational Interviewing" and Last Follow-up Call (3-4 months post baseline) | Time Frame | First Follow-up Call (1 month post baseline) conducted only for the Arm/Group "Motivational Interviewing" and Last Follow-up Call (3-4 months post baseline) | Time Frame | First Follow-up Call (1 month post baseline) conducted only for the Arm/Group "Motivational Interviewing" and Last Follow-up Call (3-4 months post baseline) |
Units | percentage of participants | Units | percentage of participants | Units | percentage of participants | Units | units on a scale | Units | score on a scale | Units | score on a scale |
Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | ||||||
Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Mean | Param Type | Mean | Param Type | Mean |
Outcome Measurements
Sequence: | 235818943 | Sequence: | 235818944 | Sequence: | 235818945 | Sequence: | 235818946 | Sequence: | 235818947 | Sequence: | 235818948 | Sequence: | 235818933 | Sequence: | 235818934 | Sequence: | 235818935 | Sequence: | 235818936 | Sequence: | 235818937 | Sequence: | 235818938 | Sequence: | 235818939 | Sequence: | 235818940 | Sequence: | 235818941 | Sequence: | 235818942 | Sequence: | 235818949 | Sequence: | 235818950 |
Outcome Id | 30823265 | Outcome Id | 30823265 | Outcome Id | 30823265 | Outcome Id | 30823265 | Outcome Id | 30823266 | Outcome Id | 30823266 | Outcome Id | 30823261 | Outcome Id | 30823261 | Outcome Id | 30823262 | Outcome Id | 30823262 | Outcome Id | 30823263 | Outcome Id | 30823263 | Outcome Id | 30823264 | Outcome Id | 30823264 | Outcome Id | 30823264 | Outcome Id | 30823264 | Outcome Id | 30823266 | Outcome Id | 30823266 |
Result Group Id | 56116382 | Result Group Id | 56116383 | Result Group Id | 56116382 | Result Group Id | 56116383 | Result Group Id | 56116382 | Result Group Id | 56116383 | Result Group Id | 56116380 | Result Group Id | 56116381 | Result Group Id | 56116382 | Result Group Id | 56116383 | Result Group Id | 56116382 | Result Group Id | 56116383 | Result Group Id | 56116382 | Result Group Id | 56116383 | Result Group Id | 56116382 | Result Group Id | 56116383 | Result Group Id | 56116382 | Result Group Id | 56116383 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 |
Classification | First Follow-Up Call | Classification | First Follow-Up Call | Classification | Last Follow-Up Call | Classification | Last Follow-Up Call | Classification | First Follow-Up Call | Classification | First Follow-Up Call | Classification | First Follow-Up Call | Classification | First Follow-Up Call | Classification | Last Follow-Up Call | Classification | Last Follow-Up Call | Classification | Last Follow-Up Call | Classification | Last Follow-Up Call | ||||||||||||
Title | Mean Reported Confidence in Managing Migraines | Title | Mean Reported Confidence in Managing Migraines | Title | Mean Reported Confidence in Managing Migraines | Title | Mean Reported Confidence in Managing Migraines | Title | Mean Reported Confidence in Behavioral Therapy | Title | Mean Reported Confidence in Behavioral Therapy | Title | Percentage of Patients Who Made an Appointment for Behavioral Therapy | Title | Percentage of Patients Who Made an Appointment for Behavioral Therapy | Title | Percentage of Participants Who Attended Appointments | Title | Percentage of Participants Who Attended Appointments | Title | Percentage of Participants Who Initiated Appointments | Title | Percentage of Participants Who Initiated Appointments | Title | Mean Reported Importance of Managing Migraine | Title | Mean Reported Importance of Managing Migraine | Title | Mean Reported Importance of Managing Migraine | Title | Mean Reported Importance of Managing Migraine | Title | Mean Reported Confidence in Behavioral Therapy | Title | Mean Reported Confidence in Behavioral Therapy |
Description | Reported confidence in participant's ability to manage migraine. Confidence was rated on a scale from 0 to 10, with the higher the score, the higher the confidence. | Description | Reported confidence in participant's ability to manage migraine. Confidence was rated on a scale from 0 to 10, with the higher the score, the higher the confidence. | Description | Reported confidence in participant's ability to manage migraine. Confidence was rated on a scale from 0 to 10, with the higher the score, the higher the confidence. | Description | Reported confidence in participant's ability to manage migraine. Confidence was rated on a scale from 0 to 10, with the higher the score, the higher the confidence. | Description | Reported confidence in behavioral therapy to help participant manage migraine. Confidence was rated on a scale from 0 to 10, where the higher the score, the higher the confidence. | Description | Reported confidence in behavioral therapy to help participant manage migraine. Confidence was rated on a scale from 0 to 10, where the higher the score, the higher the confidence. | Description | Of those who initiated behavioral therapy, percentage who attended appointments | Description | Of those who initiated behavioral therapy, percentage who attended appointments | Description | Reported the importance to participants of managing migraine. Importance was rated on a scale from 0 to 10, where the higher the score, the higher the importance. | Description | Reported the importance to participants of managing migraine. Importance was rated on a scale from 0 to 10, where the higher the score, the higher the importance. | Description | Reported the importance to participants of managing migraine. Importance was rated on a scale from 0 to 10, where the higher the score, the higher the importance. | Description | Reported the importance to participants of managing migraine. Importance was rated on a scale from 0 to 10, where the higher the score, the higher the importance. | Description | Reported confidence in behavioral therapy to help participant manage migraine. Confidence was rated on a scale from 0 to 10, where the higher the score, the higher the confidence. | Description | Reported confidence in behavioral therapy to help participant manage migraine. Confidence was rated on a scale from 0 to 10, where the higher the score, the higher the confidence. | ||||||||
Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | percentage of participants | Units | percentage of participants | Units | percentage of participants | Units | percentage of participants | Units | percentage of participants | Units | percentage of participants | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | score on a scale | Units | score on a scale |
Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean |
Param Value | NA | Param Value | 6.26 | Param Value | 6.59 | Param Value | 6.62 | Param Value | NA | Param Value | 4.83 | Param Value | 37.5 | Param Value | 22.2 | Param Value | 22.2 | Param Value | 21.9 | Param Value | 40.7 | Param Value | 68.8 | Param Value | NA | Param Value | 9.16 | Param Value | 9.19 | Param Value | 9.22 | Param Value | 5.35 | Param Value | 5.04 |
Param Value Num | 6.26 | Param Value Num | 6.59 | Param Value Num | 6.62 | Param Value Num | 4.83 | Param Value Num | 37.5 | Param Value Num | 22.2 | Param Value Num | 22.2 | Param Value Num | 21.9 | Param Value Num | 40.7 | Param Value Num | 68.8 | Param Value Num | 9.16 | Param Value Num | 9.19 | Param Value Num | 9.22 | Param Value Num | 5.35 | Param Value Num | 5.04 | ||||||
Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | ||||||||||||
Dispersion Value | NA | Dispersion Value | 2.27 | Dispersion Value | 2.26 | Dispersion Value | 2.50 | Dispersion Value | NA | Dispersion Value | 2.47 | Dispersion Value | NA | Dispersion Value | 1.27 | Dispersion Value | 1.3 | Dispersion Value | 1.18 | Dispersion Value | 2.59 | Dispersion Value | 1.95 | ||||||||||||
Dispersion Value Num | 2.27 | Dispersion Value Num | 2.26 | Dispersion Value Num | 2.5 | Dispersion Value Num | 2.47 | Dispersion Value Num | 1.27 | Dispersion Value Num | 1.3 | Dispersion Value Num | 1.18 | Dispersion Value Num | 2.59 | Dispersion Value Num | 1.95 | ||||||||||||||||||
Explanation Of Na | Only one follow-up call was conducted for this arm | Explanation Of Na | Only one follow-up call was conducted for this arm | Explanation Of Na | Only one follow-up call was conducted for this arm |
Baseline Counts
Sequence: | 11389330 | Sequence: | 11389331 | Sequence: | 11389332 |
Result Group Id | 56116375 | Result Group Id | 56116376 | Result Group Id | 56116377 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 |
Units | Participants | Units | Participants | Units | Participants |
Scope | overall | Scope | overall | Scope | overall |
Count | 36 | Count | 40 | Count | 76 |
Result Groups
Sequence: | 56116375 | Sequence: | 56116376 | Sequence: | 56116377 | Sequence: | 56116378 | Sequence: | 56116379 | Sequence: | 56116380 | Sequence: | 56116381 | Sequence: | 56116382 | Sequence: | 56116383 | Sequence: | 56116384 | Sequence: | 56116385 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 |
Result Type | Baseline | Result Type | Baseline | Result Type | Baseline | Result Type | Participant Flow | Result Type | Participant Flow | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Reported Event | Result Type | Reported Event |
Title | Motivational Interviewing | Title | Usual Care | Title | Total | Title | Motivational Interviewing | Title | Usual Care | Title | Motivational Interviewing | Title | Usual Care | Title | Usual Care | Title | Motivational Interviewing | Title | Motivational Interviewing | Title | Usual Care |
Description | Motivational Interviewing: Phone call using motivational interviewing technique | Description | Treatment as Usual: will receive a regular study phone call after three months | Description | Total of all reporting groups | Description | Motivational Interviewing: Phone call using motivational interviewing technique | Description | Treatment as Usual: will receive a regular study phone call after three months | Description | Motivational Interviewing: Phone call using motivational interviewing technique | Description | Treatment as Usual: will receive a regular study phone call after three months | Description | Treatment as Usual: will receive a regular study phone call after three months | Description | Motivational Interviewing: Phone call using motivational interviewing technique | Description | Motivational Interviewing: Phone call using motivational interviewing technique | Description | Treatment as Usual: will receive a regular study phone call after three months |
Baseline Measurements
Sequence: | 125670055 | Sequence: | 125670033 | Sequence: | 125670034 | Sequence: | 125670035 | Sequence: | 125670036 | Sequence: | 125670037 | Sequence: | 125670038 | Sequence: | 125670039 | Sequence: | 125670040 | Sequence: | 125670041 | Sequence: | 125670042 | Sequence: | 125670043 | Sequence: | 125670044 | Sequence: | 125670045 | Sequence: | 125670046 | Sequence: | 125670047 | Sequence: | 125670048 | Sequence: | 125670049 | Sequence: | 125670050 | Sequence: | 125670051 | Sequence: | 125670052 | Sequence: | 125670053 | Sequence: | 125670054 | Sequence: | 125670056 | Sequence: | 125670057 | Sequence: | 125670058 | Sequence: | 125670059 | Sequence: | 125670060 | Sequence: | 125670061 | Sequence: | 125670062 | Sequence: | 125670063 | Sequence: | 125670064 | Sequence: | 125670065 | Sequence: | 125670066 | Sequence: | 125670067 | Sequence: | 125670068 | Sequence: | 125670069 | Sequence: | 125670070 | Sequence: | 125670071 | Sequence: | 125670072 | Sequence: | 125670073 | Sequence: | 125670074 |
Result Group Id | 56116376 | Result Group Id | 56116375 | Result Group Id | 56116376 | Result Group Id | 56116377 | Result Group Id | 56116375 | Result Group Id | 56116376 | Result Group Id | 56116377 | Result Group Id | 56116375 | Result Group Id | 56116376 | Result Group Id | 56116377 | Result Group Id | 56116375 | Result Group Id | 56116376 | Result Group Id | 56116377 | Result Group Id | 56116375 | Result Group Id | 56116376 | Result Group Id | 56116377 | Result Group Id | 56116375 | Result Group Id | 56116376 | Result Group Id | 56116377 | Result Group Id | 56116375 | Result Group Id | 56116376 | Result Group Id | 56116377 | Result Group Id | 56116375 | Result Group Id | 56116377 | Result Group Id | 56116375 | Result Group Id | 56116376 | Result Group Id | 56116377 | Result Group Id | 56116375 | Result Group Id | 56116376 | Result Group Id | 56116377 | Result Group Id | 56116375 | Result Group Id | 56116376 | Result Group Id | 56116377 | Result Group Id | 56116375 | Result Group Id | 56116376 | Result Group Id | 56116377 | Result Group Id | 56116375 | Result Group Id | 56116376 | Result Group Id | 56116377 | Result Group Id | 56116375 | Result Group Id | 56116376 | Result Group Id | 56116377 |
Ctgov Group Code | BG001 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 |
Classification | United States | Classification | United States | Classification | United States | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Category | Asian | Category | Female | Category | Female | Category | Female | Category | Male | Category | Male | Category | Male | Category | Hispanic or Latino | Category | Hispanic or Latino | Category | Hispanic or Latino | Category | Not Hispanic or Latino | Category | Not Hispanic or Latino | Category | Not Hispanic or Latino | Category | Unknown or Not Reported | Category | Unknown or Not Reported | Category | Unknown or Not Reported | Category | American Indian or Alaska Native | Category | American Indian or Alaska Native | Category | American Indian or Alaska Native | Category | Asian | Category | Asian | Category | Native Hawaiian or Other Pacific Islander | Category | Native Hawaiian or Other Pacific Islander | Category | Native Hawaiian or Other Pacific Islander | Category | Black or African American | Category | Black or African American | Category | Black or African American | Category | White | Category | White | Category | White | Category | More than one race | Category | More than one race | Category | More than one race | Category | Unknown or Not Reported | Category | Unknown or Not Reported | Category | Unknown or Not Reported | ||||||||||||
Title | Race (NIH/OMB) | Title | Age, Continuous | Title | Age, Continuous | Title | Age, Continuous | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Ethnicity (NIH/OMB) | Title | Ethnicity (NIH/OMB) | Title | Ethnicity (NIH/OMB) | Title | Ethnicity (NIH/OMB) | Title | Ethnicity (NIH/OMB) | Title | Ethnicity (NIH/OMB) | Title | Ethnicity (NIH/OMB) | Title | Ethnicity (NIH/OMB) | Title | Ethnicity (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Region of Enrollment | Title | Region of Enrollment | Title | Region of Enrollment |
Units | Participants | Units | years | Units | years | Units | years | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | participants | Units | participants | Units | participants |
Param Type | Count of Participants | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Number | Param Type | Number | Param Type | Number |
Param Value | 0 | Param Value | 40.4 | Param Value | 38.1 | Param Value | 39.3 | Param Value | 32 | Param Value | 39 | Param Value | 71 | Param Value | 4 | Param Value | 1 | Param Value | 5 | Param Value | 6 | Param Value | 4 | Param Value | 10 | Param Value | 30 | Param Value | 36 | Param Value | 66 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 3 | Param Value | 3 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 2 | Param Value | 1 | Param Value | 3 | Param Value | 26 | Param Value | 33 | Param Value | 59 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 5 | Param Value | 6 | Param Value | 11 | Param Value | 36 | Param Value | 40 | Param Value | 76 |
Param Value Num | 0.0 | Param Value Num | 40.4 | Param Value Num | 38.1 | Param Value Num | 39.3 | Param Value Num | 32.0 | Param Value Num | 39.0 | Param Value Num | 71.0 | Param Value Num | 4.0 | Param Value Num | 1.0 | Param Value Num | 5.0 | Param Value Num | 6.0 | Param Value Num | 4.0 | Param Value Num | 10.0 | Param Value Num | 30.0 | Param Value Num | 36.0 | Param Value Num | 66.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 3.0 | Param Value Num | 3.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 2.0 | Param Value Num | 1.0 | Param Value Num | 3.0 | Param Value Num | 26.0 | Param Value Num | 33.0 | Param Value Num | 59.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 5.0 | Param Value Num | 6.0 | Param Value Num | 11.0 | Param Value Num | 36.0 | Param Value Num | 40.0 | Param Value Num | 76.0 |
Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dispersion Value | 12.3 | Dispersion Value | 12.1 | Dispersion Value | 12.2 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dispersion Value Num | 12.3 | Dispersion Value Num | 12.1 | Dispersion Value Num | 12.2 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Number Analyzed | 40 | Number Analyzed | 36 | Number Analyzed | 40 | Number Analyzed | 76 | Number Analyzed | 36 | Number Analyzed | 40 | Number Analyzed | 76 | Number Analyzed | 36 | Number Analyzed | 40 | Number Analyzed | 76 | Number Analyzed | 36 | Number Analyzed | 40 | Number Analyzed | 76 | Number Analyzed | 36 | Number Analyzed | 40 | Number Analyzed | 76 | Number Analyzed | 36 | Number Analyzed | 40 | Number Analyzed | 76 | Number Analyzed | 36 | Number Analyzed | 40 | Number Analyzed | 76 | Number Analyzed | 36 | Number Analyzed | 76 | Number Analyzed | 36 | Number Analyzed | 40 | Number Analyzed | 76 | Number Analyzed | 36 | Number Analyzed | 40 | Number Analyzed | 76 | Number Analyzed | 36 | Number Analyzed | 40 | Number Analyzed | 76 | Number Analyzed | 36 | Number Analyzed | 40 | Number Analyzed | 76 | Number Analyzed | 36 | Number Analyzed | 40 | Number Analyzed | 76 | Number Analyzed | 36 | Number Analyzed | 40 | Number Analyzed | 76 |
]]>
https://zephyrnet.com/NCT03799198
2019-01-07
https://zephyrnet.com/?p=NCT03799198
NCT03799198https://www.clinicaltrials.gov/study/NCT03799198?tab=tableNANANAResearchers are doing this study to compare the effects of drugs approved for long-term weight loss combined with an employer-based weight management program with the effects of the weight management program without drugs for weight loss. If participants agree to be in this study, they will join the Cleveland Clinic Integrated Medical Weight Management Program (WMP). Participants will be assigned by chance (like flipping a coin) to one of two treatment groups: A) Group 1: Cleveland Clinic Integrated Medical WMP + medication for long-term weight loss. B) Group 2: Cleveland Clinic Integrated Medical WMP without medication for weight loss. Participants have an equal chance of being in either of the treatment groups. The total study duration for the individual participants will be approximately one year.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-08 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2022-11-14 |
Start Month Year | January 7, 2019 |
Primary Completion Month Year | May 22, 2020 |
Verification Month Year | November 2022 |
Verification Date | 2022-11-30 |
Last Update Posted Date | 2022-11-14 |
Results First Posted Date | 2021-06-18 |
Facilities
Sequence: | 199947291 |
Name | Novo Nordisk Investigational Site |
City | Cleveland |
State | Ohio |
Zip | 44195 |
Country | United States |
Conditions
Sequence: | 52133459 |
Name | Obesity |
Downcase Name | obesity |
Id Information
Sequence: | 40130936 | Sequence: | 40130937 |
Id Source | org_study_id | Id Source | secondary_id |
Id Value | NN8022-4432 | Id Value | U1111-1218-8104 |
Id Type | Other Identifier | ||
Id Type Description | World Health Organization (WHO) | ||
Countries
Sequence: | 42538538 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55553236 | Sequence: | 55553237 |
Group Type | Experimental | Group Type | Active Comparator |
Title | WMP + Rx | Title | WMP alone |
Description | Participants will receive Cleveland Clinic's Integrated Medical WMP with medication for chronic weight management (Rx) for approximately one year. After discussing with the study doctor, participants will receive one of the following listed 5 drugs approved by the Food and Drug Administration (FDA) for long-term weight loss: 1) orlistat, 2) lorcaserin or lorcaserin extended-release, 3) phentermine/topiramate extended-release, 4) naltrexone/bupropion extended-release and 5) liraglutide 3.0 mg. | Description | Participants will receive Cleveland Clinic's Integrated Medical WMP alone for approximately one year. |
Interventions
Sequence: | 52449619 | Sequence: | 52449620 |
Intervention Type | Other | Intervention Type | Drug |
Name | Weight Management Program (WMP) | Name | Medication for chronic weight management (Rx) |
Description | As part of usual care, participants will: 1) Discuss and choose one of three diet options: protein-sparing modified fast, Mediterranean, or meal replacement. 2) Be referred to a nutritionist appointment. 3) Initiate a series of twelve monthly study visits in the context of shared medical appointments (SMAs) covering nutrition, physical activity, appetite control, sleep issues, and anxiety/depression/stress. 4) Be referred to an exercise physiologist for a personalized physical activity program. 5) If assessed relevant by the study clinician, be referred to a mental health specialist and/or sleep clinic. | Description | Following listed 5 drugs will be administered as prescribed by the study doctor:
1) Orlistat (Xenical® pills, per os [p.o.; by mouth]). 2) Lorcaserin or lorcaserin extended-release (Belviq®/Belviq XR® pills, p.o.). 3) Phentermine/topiramate extended-release (Qsymia® pills, p.o.). 4) Naltrexone/bupropion extended-release (Contrave® pills, p.o.). 5) Liraglutide 3.0 mg (Saxenda® injections, subcutaneously [under the skin]). |
Design Outcomes
Sequence: | 177246914 | Sequence: | 177246915 | Sequence: | 177246916 | Sequence: | 177246917 | Sequence: | 177246918 | Sequence: | 177246919 | Sequence: | 177246920 | Sequence: | 177246921 | Sequence: | 177246922 | Sequence: | 177246923 | Sequence: | 177246924 | Sequence: | 177246925 | Sequence: | 177246926 | Sequence: | 177246927 | Sequence: | 177246928 | Sequence: | 177246929 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Change in Body Weight | Measure | Participants Achieving 5% or More Reduction in Body Weight | Measure | Participants Achieving 10% or More Reduction in Body Weight | Measure | Number of Shared Medical Appointments (SMAs) Attended | Measure | Participants Attending 9 or More SMAs | Measure | Proportion of Days Covered by Prescription Claims for Medication for Chronic Weight Management | Measure | Participants Covered by Prescription Claims for Medication for Chronic Weight Management for at Least 80% of Days | Measure | Change in 'At-Work Productivity Loss Index' as Measured by Work Limitations Questionnaire Self-administered Short-Form (WLQ-8) | Measure | Change in 'Time Management' as Measured by WLQ-8 | Measure | Change in 'Physical Tasks' as Measured by WLQ-8 | Measure | Change in 'Mental/Interpersonal Tasks' as Measured by WLQ-8 | Measure | Change in 'Output Tasks' as Measured by WLQ-8 | Measure | Change in 'Absenteeism: Percent Work Time Missed Due to Excess Weight' as Measured by Work Productivity and Activity Impairment Questionnaire Specific Health Problem V2.0 (WPAI:SHP) | Measure | Change in 'Presenteeism: Percent Impairment While Working Due to Excess Weight' as Measured by WPAI:SHP | Measure | Change in 'Work Productivity Loss: Percent Overall Work Impairment Due to Excess Weight' as Measured by WPAI:SHP | Measure | Change in 'Percent Activity Impairment Due to Excess Weight' as Measured by WPAI:SHP |
Time Frame | Month 0, month 12 | Time Frame | Month 12 | Time Frame | Month 12 | Time Frame | Months 0-12 | Time Frame | Months 0-12 | Time Frame | Months 0-12 | Time Frame | Months 0-12 | Time Frame | Month 0, month 12 | Time Frame | Month 0, month 12 | Time Frame | Month 0, month 12 | Time Frame | Month 0, month 12 | Time Frame | Month 0, month 12 | Time Frame | Month 0, month 12 | Time Frame | Month 0, month 12 | Time Frame | Month 0, month 12 | Time Frame | Month 0, month 12 |
Description | Percentage change in body weight from baseline (month 0) to month 12 is presented. | Description | The percentage of participants achieving 5% or more reduction in body weight was analyzed using a logistic regression model with treatment as categorical effect and baseline weight (kg) as covariate. Percentage of participants who achieved 5% or more reduction in body weight from baseline at month 12 is presented. | Description | The percentage of participants achieving 10% or more reduction in body weight was analyzed using a logistic regression model with treatment as categorical effect and baseline weight (kg) as covariate. Percentage of participants who achieved 10% or more reduction in body weight from baseline at month 12 is presented. | Description | Shared medical appointments (SMAs) is a concept that combines group appointments for participants with clinical intervention, consisting of encounters with a nutritionist, exercise physiologist, and endocrinologist/obesity medicine specialist. The mean number of SMAs attended by the participants are presented. | Description | Shared medical appointment (SMA) is a concept that combines group appointments for participants with clinical intervention, consisting of encounters with a nutritionist, exercise physiologist, and endocrinologist/obesity medicine specialist. Number of participants who attended 9 or more SMAs is presented. | Description | Participants who enrolled in the WMP + Rx arm were provided a prescription for medication indicated for chronic weight management. Proportion of days covered by prescription claims for medication for chronic weight management is presented. This endpoint is applicable only for treatment arm, WMP + Rx. | Description | Participants who enrolled in the WMP + Rx arm were provided a prescription for medication indicated for chronic weight management. Number of participants covered by prescription claims for medication for chronic weight management for at least 80% of days is presented. This endpoint is applicable only for treatment arm, WMP + Rx. | Description | The WLQ-8 questionnaire assesses the degree to which participants have difficulty related to time management, physical tasks, mental/interpersonal tasks, and output tasks due to their physical and/or emotional health. The WLQ-8 produces subscale scores as well as an index of overall at-work productivity loss. WLQ-8 outcomes are expressed as proportion time with difficulty, with higher scores indicating greater limitations, i.e., worse outcomes. The score ranges from 1 to 5 where '1' represents none of the time and, '5' represents all of the time. Change in 'At-Work Productivity Loss Index' from month 0 to month 12 is presented. | Description | The WLQ-8 questionnaire assesses the degree to which participants have difficulty related to time management, physical tasks, mental/interpersonal tasks, and output tasks due to their physical and/or emotional health. WLQ-8 outcomes are expressed as proportion time with difficulty, with higher scores indicating greater limitations, i.e., worse outcomes. The score ranges from 1 to 5 where '1' represents none of the time and, '5' represents all of the time. Change in 'time management' from month 0 to month 12 is presented. | Description | The WLQ-8 questionnaire assesses the degree to which participants have difficulty related to time management, physical tasks, mental/interpersonal tasks, and output tasks due to their physical and/or emotional health. WLQ-8 outcomes are expressed as proportion time with difficulty, with higher scores indicating greater limitations, i.e., worse outcomes. The score ranges from 1 to 5 where '1' represents none of the time and, '5' represents all of the time. Change in 'physical tasks' from month 0 to month 12 is presented. | Description | The WLQ-8 questionnaire assesses the degree to which participants have difficulty related to time management, physical tasks, mental/interpersonal tasks, and output tasks due to their physical and/or emotional health. WLQ-8 outcomes are expressed as proportion time with difficulty, with higher scores indicating greater limitations, i.e., worse outcomes. The score ranges from 1 to 5 where '1' represents none of the time and, '5' represents all of the time. Change in 'mental/interpersonal tasks' from month 0 to month 12 is presented. | Description | The WLQ-8 questionnaire assesses the degree to which participants have difficulty related to time management, physical tasks, mental/interpersonal tasks, and output tasks due to their physical and/or emotional health. WLQ-8 outcomes are expressed as proportion time with difficulty, with higher scores indicating greater limitations, i.e., worse outcomes. The score ranges from 1 to 5 where '1' represents none of the time and, '5' represents all of the time. Change in 'output tasks' from month 0 to month 12 is presented. | Description | The WPAI:SHP questionnaire assesses both work productivity through absenteeism (i.e., work time missed), presenteeism (i.e., impairment at work or reduced on-the-job effectiveness), and work productivity loss, as well as daily activity impairment (e.g., work around the house, shopping, exercising, childcare, studying) attributable to excess weight. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Negative numbers indicate improvement from baseline. | Description | The WPAI:SHP questionnaire assesses both work productivity through absenteeism (i.e., work time missed), presenteeism (i.e., impairment at work or reduced on-the-job effectiveness), and work productivity loss, as well as daily activity impairment (e.g., work around the house, shopping, exercising, childcare, studying) attributable to excess weight. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Negative numbers indicate improvement from baseline. | Description | The WPAI:SHP questionnaire assesses both work productivity through absenteeism (i.e., work time missed), presenteeism (i.e., impairment at work or reduced on-the-job effectiveness), and work productivity loss, as well as daily activity impairment (e.g., work around the house, shopping, exercising, childcare, studying) attributable to excess weight. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Negative numbers indicate improvement from baseline. | Description | The WPAI:SHP questionnaire assesses both work productivity through absenteeism (i.e., work time missed), presenteeism (i.e., impairment at work or reduced on-the-job effectiveness), and work productivity loss, as well as daily activity impairment (e.g., work around the house, shopping, exercising, childcare, studying) attributable to excess weight. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Negative numbers indicate improvement from baseline. |
Browse Conditions
Sequence: | 193345553 | Sequence: | 193345554 | Sequence: | 193345555 | Sequence: | 193345556 | Sequence: | 193345557 |
Mesh Term | Obesity | Mesh Term | Overweight | Mesh Term | Overnutrition | Mesh Term | Nutrition Disorders | Mesh Term | Body Weight |
Downcase Mesh Term | obesity | Downcase Mesh Term | overweight | Downcase Mesh Term | overnutrition | Downcase Mesh Term | nutrition disorders | Downcase Mesh Term | body weight |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48285506 |
Agency Class | INDUSTRY |
Lead Or Collaborator | lead |
Name | Novo Nordisk A/S |
Overall Officials
Sequence: | 29265149 |
Role | Study Director |
Name | Clinical Reporting Anchor and Disclosure (1452) |
Affiliation | Novo Nordisk A/S |
Design Group Interventions
Sequence: | 68100615 | Sequence: | 68100616 | Sequence: | 68100617 |
Design Group Id | 55553236 | Design Group Id | 55553237 | Design Group Id | 55553236 |
Intervention Id | 52449619 | Intervention Id | 52449619 | Intervention Id | 52449620 |
Eligibilities
Sequence: | 30744449 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine eligibility for the study Exclusion Criteria: Contraindications to all of the medications approved by the FDA for chronic weight management according to the label |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254096827 |
Number Of Facilities | 1 |
Number Of Sae Subjects | 23 |
Registered In Calendar Year | 2019 |
Actual Duration | 16 |
Were Results Reported | True |
Months To Report Results | 11 |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 15 |
Designs
Sequence: | 30490746 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Drop Withdrawals
Sequence: | 28962950 | Sequence: | 28962951 | Sequence: | 28962952 | Sequence: | 28962953 |
Result Group Id | 56067797 | Result Group Id | 56067798 | Result Group Id | 56067797 | Result Group Id | 56067798 |
Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 |
Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study |
Reason | Lost to Follow-up | Reason | Lost to Follow-up | Reason | Death | Reason | Death |
Count | 4 | Count | 8 | Count | 0 | Count | 1 |
Milestones
Sequence: | 40980557 | Sequence: | 40980558 | Sequence: | 40980559 | Sequence: | 40980560 | Sequence: | 40980561 | Sequence: | 40980562 | Sequence: | 40980563 | Sequence: | 40980564 |
Result Group Id | 56067797 | Result Group Id | 56067798 | Result Group Id | 56067797 | Result Group Id | 56067798 | Result Group Id | 56067797 | Result Group Id | 56067798 | Result Group Id | 56067797 | Result Group Id | 56067798 |
Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 |
Title | STARTED | Title | STARTED | Title | Full Analysis Set (FAS) | Title | Full Analysis Set (FAS) | Title | COMPLETED | Title | COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED |
Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study |
Count | 100 | Count | 100 | Count | 100 | Count | 100 | Count | 96 | Count | 91 | Count | 4 | Count | 9 |
Outcome Analyses
Sequence: | 16556339 |
Outcome Id | 30783824 |
Non Inferiority Type | Superiority |
Param Type | Treatment Difference |
Param Value | -3.5 |
Dispersion Type | Standard Error of the Mean |
Dispersion Value | 1.02 |
P Value Modifier | < |
P Value | 0.001 |
Ci N Sides | 2-Sided |
Ci Percent | 95.0 |
Ci Lower Limit | -5.51 |
Ci Upper Limit | -1.5 |
Method | ANCOVA |
Groups Description | Analysis of in-trial data with missing observations for body weight at month 12 imputed from the WMP arm based on a jump to reference multiple (x=100) imputation approach. Percent change in body weight from baseline to month 12 was calculated for each study participant within the FAS and analyzed using an analysis of covariance model with randomized treatment as a factor and baseline body weight (kg) as a covariate. |
Outcome Analysis Groups
Sequence: | 32109410 | Sequence: | 32109411 |
Outcome Analysis Id | 16556339 | Outcome Analysis Id | 16556339 |
Result Group Id | 56067799 | Result Group Id | 56067800 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG001 |
Participant Flows
Sequence: | 3919108 |
Recruitment Details | The trial was conducted at a single site in the United States. |
Pre Assignment Details | Participants were randomized in a 1:1 manner to receive either Cleveland Clinic's Integrated Medical Weight Management Program (WMP) with medication for chronic weight management (WMP + Rx) or Cleveland Clinic's Integrated Medical WMP alone (WMP). |
Outcome Counts
Sequence: | 73950351 | Sequence: | 73950352 | Sequence: | 73950353 | Sequence: | 73950354 | Sequence: | 73950355 | Sequence: | 73950356 | Sequence: | 73950357 | Sequence: | 73950358 | Sequence: | 73950359 | Sequence: | 73950360 | Sequence: | 73950361 | Sequence: | 73950362 | Sequence: | 73950363 | Sequence: | 73950364 | Sequence: | 73950365 | Sequence: | 73950366 | Sequence: | 73950367 | Sequence: | 73950368 | Sequence: | 73950369 | Sequence: | 73950370 | Sequence: | 73950371 | Sequence: | 73950372 | Sequence: | 73950373 | Sequence: | 73950374 | Sequence: | 73950375 | Sequence: | 73950376 | Sequence: | 73950377 | Sequence: | 73950378 | Sequence: | 73950379 | Sequence: | 73950380 |
Outcome Id | 30783824 | Outcome Id | 30783824 | Outcome Id | 30783825 | Outcome Id | 30783825 | Outcome Id | 30783826 | Outcome Id | 30783826 | Outcome Id | 30783827 | Outcome Id | 30783827 | Outcome Id | 30783828 | Outcome Id | 30783828 | Outcome Id | 30783829 | Outcome Id | 30783830 | Outcome Id | 30783831 | Outcome Id | 30783831 | Outcome Id | 30783832 | Outcome Id | 30783832 | Outcome Id | 30783833 | Outcome Id | 30783833 | Outcome Id | 30783834 | Outcome Id | 30783834 | Outcome Id | 30783835 | Outcome Id | 30783835 | Outcome Id | 30783836 | Outcome Id | 30783836 | Outcome Id | 30783837 | Outcome Id | 30783837 | Outcome Id | 30783838 | Outcome Id | 30783838 | Outcome Id | 30783839 | Outcome Id | 30783839 |
Result Group Id | 56067799 | Result Group Id | 56067800 | Result Group Id | 56067799 | Result Group Id | 56067800 | Result Group Id | 56067799 | Result Group Id | 56067800 | Result Group Id | 56067799 | Result Group Id | 56067800 | Result Group Id | 56067799 | Result Group Id | 56067800 | Result Group Id | 56067799 | Result Group Id | 56067799 | Result Group Id | 56067799 | Result Group Id | 56067800 | Result Group Id | 56067799 | Result Group Id | 56067800 | Result Group Id | 56067799 | Result Group Id | 56067800 | Result Group Id | 56067799 | Result Group Id | 56067800 | Result Group Id | 56067799 | Result Group Id | 56067800 | Result Group Id | 56067799 | Result Group Id | 56067800 | Result Group Id | 56067799 | Result Group Id | 56067800 | Result Group Id | 56067799 | Result Group Id | 56067800 | Result Group Id | 56067799 | Result Group Id | 56067800 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 |
Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure |
Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants |
Count | 100 | Count | 100 | Count | 100 | Count | 100 | Count | 100 | Count | 100 | Count | 100 | Count | 100 | Count | 100 | Count | 100 | Count | 100 | Count | 100 | Count | 100 | Count | 98 | Count | 98 | Count | 95 | Count | 99 | Count | 98 | Count | 98 | Count | 97 | Count | 97 | Count | 98 | Count | 95 | Count | 95 | Count | 95 | Count | 95 | Count | 95 | Count | 95 | Count | 100 | Count | 100 |
Provided Documents
Sequence: | 2576849 | Sequence: | 2576850 |
Document Type | Study Protocol | Document Type | Statistical Analysis Plan |
Has Protocol | True | Has Protocol | False |
Has Icf | False | Has Icf | False |
Has Sap | False | Has Sap | True |
Document Date | 2018-10-10 | Document Date | 2020-05-18 |
Url | https://ClinicalTrials.gov/ProvidedDocs/98/NCT03799198/Prot_000.pdf | Url | https://ClinicalTrials.gov/ProvidedDocs/98/NCT03799198/SAP_001.pdf |
Reported Event Totals
Sequence: | 27926830 | Sequence: | 27926831 | Sequence: | 27926832 | Sequence: | 27926833 | Sequence: | 27926834 | Sequence: | 27926835 |
Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG001 | Ctgov Group Code | EG001 |
Event Type | serious | Event Type | other | Event Type | deaths | Event Type | serious | Event Type | other | Event Type | deaths |
Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality | Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality |
Subjects Affected | 8 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 11 | Subjects Affected | 0 | Subjects Affected | 1 |
Subjects At Risk | 100 | Subjects At Risk | 0 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 0 | Subjects At Risk | 100 |
Created At | 2023-08-08 19:39:46.931925 | Created At | 2023-08-08 19:39:46.931925 | Created At | 2023-08-08 19:39:46.931925 | Created At | 2023-08-08 19:39:46.931925 | Created At | 2023-08-08 19:39:46.931925 | Created At | 2023-08-08 19:39:46.931925 |
Updated At | 2023-08-08 19:39:46.931925 | Updated At | 2023-08-08 19:39:46.931925 | Updated At | 2023-08-08 19:39:46.931925 | Updated At | 2023-08-08 19:39:46.931925 | Updated At | 2023-08-08 19:39:46.931925 | Updated At | 2023-08-08 19:39:46.931925 |
Reported Events
Sequence: | 527811605 | Sequence: | 527811585 | Sequence: | 527811586 | Sequence: | 527811587 | Sequence: | 527811588 | Sequence: | 527811589 | Sequence: | 527811590 | Sequence: | 527811591 | Sequence: | 527811592 | Sequence: | 527811606 | Sequence: | 527811593 | Sequence: | 527811594 | Sequence: | 527811595 | Sequence: | 527811596 | Sequence: | 527811597 | Sequence: | 527811598 | Sequence: | 527811599 | Sequence: | 527811600 | Sequence: | 527811601 | Sequence: | 527811602 | Sequence: | 527811603 | Sequence: | 527811604 | Sequence: | 527811607 | Sequence: | 527811608 | Sequence: | 527811609 | Sequence: | 527811610 | Sequence: | 527811611 | Sequence: | 527811612 | Sequence: | 527811613 | Sequence: | 527811614 | Sequence: | 527811615 | Sequence: | 527811616 | Sequence: | 527811617 | Sequence: | 527811618 | Sequence: | 527811619 | Sequence: | 527811620 | Sequence: | 527811621 | Sequence: | 527811622 | Sequence: | 527811623 | Sequence: | 527811624 | Sequence: | 527811625 | Sequence: | 527811626 | Sequence: | 527811627 | Sequence: | 527811628 | Sequence: | 527811629 | Sequence: | 527811630 |
Result Group Id | 56067801 | Result Group Id | 56067801 | Result Group Id | 56067802 | Result Group Id | 56067801 | Result Group Id | 56067802 | Result Group Id | 56067801 | Result Group Id | 56067802 | Result Group Id | 56067801 | Result Group Id | 56067802 | Result Group Id | 56067802 | Result Group Id | 56067801 | Result Group Id | 56067802 | Result Group Id | 56067801 | Result Group Id | 56067802 | Result Group Id | 56067801 | Result Group Id | 56067802 | Result Group Id | 56067801 | Result Group Id | 56067802 | Result Group Id | 56067801 | Result Group Id | 56067802 | Result Group Id | 56067801 | Result Group Id | 56067802 | Result Group Id | 56067801 | Result Group Id | 56067802 | Result Group Id | 56067801 | Result Group Id | 56067802 | Result Group Id | 56067801 | Result Group Id | 56067802 | Result Group Id | 56067801 | Result Group Id | 56067802 | Result Group Id | 56067801 | Result Group Id | 56067802 | Result Group Id | 56067801 | Result Group Id | 56067802 | Result Group Id | 56067801 | Result Group Id | 56067802 | Result Group Id | 56067801 | Result Group Id | 56067802 | Result Group Id | 56067801 | Result Group Id | 56067802 | Result Group Id | 56067801 | Result Group Id | 56067802 | Result Group Id | 56067801 | Result Group Id | 56067802 | Result Group Id | 56067801 | Result Group Id | 56067802 |
Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 |
Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 |
Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious |
Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 1 | Subjects Affected | 0 |
Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 |
Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. |
Event Count | 0 | Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 1 | Event Count | 1 | Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 1 | Event Count | 1 | Event Count | 0 | Event Count | 0 | Event Count | 1 | Event Count | 1 | Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 1 | Event Count | 1 | Event Count | 0 | Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 1 | Event Count | 1 | Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 0 | Event Count | 1 | Event Count | 1 | Event Count | 0 |
Organ System | Blood and lymphatic system disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Blood and lymphatic system disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | General disorders | Organ System | General disorders | Organ System | Hepatobiliary disorders | Organ System | Hepatobiliary disorders | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Organ System | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Psychiatric disorders | Organ System | Psychiatric disorders | Organ System | Reproductive system and breast disorders | Organ System | Reproductive system and breast disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Social circumstances | Organ System | Social circumstances | Organ System | Surgical and medical procedures | Organ System | Surgical and medical procedures | Organ System | Vascular disorders | Organ System | Vascular disorders |
Adverse Event Term | Plasma Cell Myeloma | Adverse Event Term | Atrial Fibrillation | Adverse Event Term | Atrial Fibrillation | Adverse Event Term | Atrial Tachycardia | Adverse Event Term | Atrial Tachycardia | Adverse Event Term | Congestive Cardiomyopathy | Adverse Event Term | Congestive Cardiomyopathy | Adverse Event Term | Appendicitis | Adverse Event Term | Appendicitis | Adverse Event Term | Plasma Cell Myeloma | Adverse Event Term | Gastroenteritis Salmonella | Adverse Event Term | Gastroenteritis Salmonella | Adverse Event Term | Procedural Vomiting | Adverse Event Term | Procedural Vomiting | Adverse Event Term | Dehydration | Adverse Event Term | Dehydration | Adverse Event Term | Malnutrition | Adverse Event Term | Malnutrition | Adverse Event Term | Arthralgia | Adverse Event Term | Arthralgia | Adverse Event Term | Intervertebral Disc Protrusion | Adverse Event Term | Intervertebral Disc Protrusion | Adverse Event Term | Non-Cardiac Chest Pain | Adverse Event Term | Non-Cardiac Chest Pain | Adverse Event Term | Cholelithiasis | Adverse Event Term | Cholelithiasis | Adverse Event Term | Pyelonephritis | Adverse Event Term | Pyelonephritis | Adverse Event Term | Parathyroid Tumour Benign | Adverse Event Term | Parathyroid Tumour Benign | Adverse Event Term | Syncope | Adverse Event Term | Syncope | Adverse Event Term | Depression Suicidal | Adverse Event Term | Depression Suicidal | Adverse Event Term | Ovarian Mass | Adverse Event Term | Ovarian Mass | Adverse Event Term | Respiratory Failure | Adverse Event Term | Respiratory Failure | Adverse Event Term | Skin Lesion | Adverse Event Term | Skin Lesion | Adverse Event Term | Organ Donor | Adverse Event Term | Organ Donor | Adverse Event Term | Gastric Bypass | Adverse Event Term | Gastric Bypass | Adverse Event Term | Dizziness | Advers |