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<![CDATA[ Contributing Factors for Poor HIV Treatment Response in Children With TB/HIV Coinfection ]]>
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
Email kantwi@gmail.com Email 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
Email awewura.kwara@medicine.ufl.edu Email 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
Antiretroviral-naïve to efavirenz and meet criteria for initiation or switch to efavirenz-based ART
Are available for follow-up until achievement of a study endpoint like completion of study at 6 months or discontinuation of ART.

Exclusion Criteria:

Unable to obtain informed signed consent parent(s) or legal guardian
Have AIDS-related opportunistic infections other than TB
History of acute hepatitis within 30 days of study entry
Persistent vomiting or diarrhea at time of enrolment
Hemoglobin < 6 g/dl, white blood cells < 2500/mm3, serum creatinine > 1.5 mg/dl, aspartate transaminase (AST) and alanine transaminase (ALT) > 2 times upper limit of normal

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

]]>

<![CDATA[ Pharmacokinetics of Intracellular TFV-DP and FTC-TP in HIV-infected Adolescents ]]>
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
Email Kantwi@gmail.com Email 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
Email awewura.kwara@medicine.ufl.edu Email 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.
Pregnant or breast feeding.
Require therapy for other opportunistic infections other than tuberculosis (TB).

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

]]>

<![CDATA[ Adequacy of the New Pediatric Isoniazid/Rifampin/Pyrazinamide (HRZ) Tablet ]]>
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
Email antwisampson@yahoo.com Email 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
Email awewura.kwara@medicine.ufl.edu Email 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.
Available for follow-up until completion of TB treatment and/or achievement of a study endpoint like discontinuation of therapy, and/or pharmacokinetic sampling.

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.
Unable to obtain informed signed consent from parent(s) or legal guardian.
Have AIDS-related opportunistic infections other than TB, history of or proven acute hepatitis within 30 days of study entry, persistent vomiting, or diarrhea.
Hemoglobin < 6 g/dl, white blood cells < 2500/mm3, serum creatinine > 1.5 mg/dl, aspartate transaminase (AST) and alanine transaminase (ALT) > 2 times upper limit of normal.

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

]]>

<![CDATA[ Exercise and Overnight Motor Sequence Task ]]>
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
Based on the SCID diagnosed to have schizophrenia and related psychotic disorders
Ability to understand the nature of the study and to give written informed consent

Exclusion Criteria:

Severe physical illness (Myocardial Infarction, Hypertension, Fracture, Spinal problems in which exercise may be contraindicated), and seizure disorders
Comorbid substance dependence
Unstable psychotic symptoms
A history of brain trauma or organic brain disease
Known history of intellectual disability or special school attendance
Answered one or more "yes" in the PAR-Q and without doctors approval for exercise

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

]]>

<![CDATA[ Study on the Progress of Breast Cancer Cases in Males and the Assessment of Relapse Risk ]]>
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.
The enrollment of patients who died is allowed.

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

]]>

<![CDATA[ Recovery, Fatigability, and Proteomic Response to Aerobic Exercise Training in Healthy Individuals ]]>
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.
<![CDATA[

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
body mass index > 19 to <35 kg/m2
able to pedal leg cycle ergometer
able to comprehend and speak English

Exclusion Criteria:

diabetes mellitus
significant pulmonary dysfunction (eg. chronic obstructive lung disease; interstitial lung disease)
hypertension
anemia
stroke
cancer (other than melanoma)
cardiac, pulmonary, thyroid, autoimmune, musculoskeletal, neurological, metabolic bone, mitochondrial, hepatic, renal, and/or psychiatric disease
abnormal blood lipids
active substance abuse or cognitive impairment
chronic infection requiring antiviral or antibiotic treatment
taking any medications that may limit exercise capacity or the ability to adapt to aerobic exercise training
previously or currently on anticoagulant therapy or therapeutic hormone replacement/supplementation (excluding birth control)
pregnant
smoking

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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Am Heart J. 2009 Dec;158(6):1031-7. doi: 10.1016/j.ahj.2009.10.003. Citation Mora S, Cook N, Buring JE, Ridker PM, Lee IM. Physical activity and reduced risk of cardiovascular events: potential mediating mechanisms. Circulation. 2007 Nov 6;116(19):2110-8. doi: 10.1161/CIRCULATIONAHA.107.729939. Epub 2007 Oct 22. Citation Booth FW, Laye MJ. The future: genes, physical activity and health. Acta Physiol (Oxf). 2010 Aug;199(4):549-56. doi: 10.1111/j.1748-1716.2010.02117.x. Epub 2010 Mar 24. Citation Santos-Parker JR, Santos-Parker KS, McQueen MB, Martens CR, Seals DR. Habitual aerobic exercise and circulating proteomic patterns in healthy adults: relation to indicators of healthspan. J Appl Physiol (1985). 2018 Nov 1;125(5):1646-1659. doi: 10.1152/japplphysiol.00458.2018. Epub 2018 Sep 20. Citation Collins FS, Patrinos A, Jordan E, Chakravarti A, Gesteland R, Walters L. New goals for the U.S. Human Genome Project: 1998-2003. Science. 1998 Oct 23;282(5389):682-9. doi: 10.1126/science.282.5389.682. Citation Jameson JL, Longo DL. Precision medicine–personalized, problematic, and promising. N Engl J Med. 2015 Jun 4;372(23):2229-34. doi: 10.1056/NEJMsb1503104. Epub 2015 May 27. No abstract available. Citation Cornwall J, Elliott JM, Walton DM, Osmotherly PG. Clinical Genomics in Physical Therapy: Where to From Here? Phys Ther. 2018 Sep 1;98(9):733-736. doi: 10.1093/ptj/pzy069. No abstract available. Citation Buford TW, Roberts MD, Church TS. Toward exercise as personalized medicine. Sports Med. 2013 Mar;43(3):157-65. doi: 10.1007/s40279-013-0018-0. Citation Davidsen PK, Turan N, Egginton S, Falciani F. Multilevel functional genomics data integration as a tool for understanding physiology: a network biology perspective. J Appl Physiol (1985). 2016 Feb 1;120(3):297-309. doi: 10.1152/japplphysiol.01110.2014. Epub 2015 Nov 5. Citation Magni R, Espina BH, Liotta LA, Luchini A, Espina V. 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.

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<![CDATA[ Remote Monitoring to Improve Physician Monitoring, Patient Satisfaction, and Predict Readmissions Following Surgery ]]>
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
Must be undergoing the procedure at Mayo Clinic in Rochester, MN
Must be greater than or equal to 40 years of age

Exclusion Criteria:

Under 40 years of age
Concomitant additional surgical procedure (e.g., CABG + valve replacement)
Patients with implantable pacemakers/defibrillators
Patients that find the device too uncomfortable to wear for 48 hours

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

]]>

<![CDATA[ Synchronous Video (Telemedicine) Consulation in the Prehospital Setting ]]>
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
Hemodynamically unstable trauma patients requiring resuscitation and airway management
Trauma patients with altered mentation requiring airway management
Acute stroke patients
Medical patients that refuse transport for medical evaluation Pediatric Intensive Care Telemedicine Program
Complex clinical situations where paramedic teams need immediate management guidance
Critically ill pediatric patients requiring evaluation/stabilization for interfacility transport
Pediatric patients requiring intervention for respiratory failure
Pediatric patients with ongoing seizures and/or neurological abnormalities
Hemodynamically unstable patients
Complex clinical situations requiring medical control guidance

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

]]>

<![CDATA[ Integrated Treatment for Youth With Mood Disorders ]]>
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;
Diagnosed with a primary depressive or bipolar disorder;
Admitted to the Child and Adolescent Integrated Mood Program (CAIMP) at Mayo Clinic.

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

]]>

<![CDATA[ Human Beta-2 Adrenergic Stimulation and Muscle Glucose Uptake ]]>
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;
Male sex;
Age: 18-30
BMI: 18-25 kg/m2;
Normal physical activity levels;

Exclusion Criteria:

Not meeting all inclusion criteria
Cardiovascular diseases (determined by means of questionnaires, heart rate/blood pressure measurements)
Respiratory diseases (including asthma, bronchitis and COPD);
Unstable body weight (weight gain or loss > 5 kg in the last three months);
Intention to lose or gain body weight (e.g. with caloric restriction or physical activity)
Excessive alcohol and/or drug abuse;
Hypokalaemia;
Hb < 8.4 mmol/L;
Epilepsy;
Smoking;
Renal and/or liver insufficiency;
Participation in another biomedical study within 1 month before the first study visit, possibly interfering with the study results;
Medication use known to hamper subject's safety during the study procedures;
Subjects who do not want to be informed about unexpected medical findings;
Subjects who do not want that their treating physician to be informed;
Inability to participate and/or complete the required measurements;
Participation in organised or structured physical exercise;
Any condition, disease or abnormal laboratory test result that, in the opinion of the Investigator, would interfere with the study outcome, affect trial participation or put the subject at undue risk;
Hyperthyroidism

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

]]>

<![CDATA[ Effect of Cranberry and Agaves Extract on Microbiota and Intestinal Health ]]>
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)
fasting insulin over 60 pmol/L or fasting glucose 5.6 – 6.9 mmol/L
at least one of the following criteria: Tg ≥ 1.7 mmol/L; blood pressure ≥ 130/85 mmHg; HDL < 0,9 mmol/L; hsCRP 1-10 mg/L
non-smoking
eating fruits and vegetables less then 5 portions/day

Exclusion Criteria:

chronic disease
taking drugs or natural health products that could affect glucose or lipid metabolism
taking anti-inflammatory, antiacids
taking pre or probiotics
inflammatory bowel disease
antibiotics in the past 3 months
allergy or intolerance to cranberries or agaves
Major surgery in the past 3 months

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

]]>

<![CDATA[ Bisoprolol Versus Corticosteroid and Bisoprolol Combination for Prophylaxis Against Atrial Fibrillation After on Pump Coronary Artery Bypass Surgery ]]>
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,
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
chronic obstructive pulmonary disease were not included in the study.

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

]]>

<![CDATA[ Rate of Gastric Emptying in Term Parturients Undergoing Elective Cesarean Section ]]>
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
Email 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
Email ppopivanov@coombe.ie Email 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
18yrs
gestation >38 gestation weeks

Exclusion Criteria:

Multiple pregnancy
Previous upper GI surgery
Known disorder of gastric emptying
Hiatus Hernia
BMI >40
Diabetes Mellitus, Gestational Diabetes

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

]]>

<![CDATA[ Telehealth Powerful Tools for Caregivers Effectiveness Study ]]>
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
speak English
cognitive ability to participate in PTC classes
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

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.

]]>

<![CDATA[ Treatment of Anterior Ligament Rupture With Internal Brace Repair – A Prospective Randomised Controlled Study. ]]>
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
Rheumatoid arthritis
Other knee ligament instability
Obesity BMI >30
Morbus Bechterew

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

]]>

<![CDATA[ Survival and Description of Care for Patients With Degenerate Vaterian Ampulloma ]]>
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
Email david.tougeron@chu-poitiers.fr Email 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
Email 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.
Histologically-proven adenocarcinoma of the ampulla of Vater which is operable or with locoregional or metastatic recurrence after excision less than 6 months previously.

Exclusion Criteria:

Patients who cannot be followed up regularly for psychological, social, family or geographical reasons.
Non-ampullary tumours.
Non-adenocarcinomatous ampullary tumours.
Ampullary adenocarcinomas which are metastatic or locally advanced from the outset and inoperable.

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

]]>

<![CDATA[ The Validity and Reliability of the Turkish Version of the Combined Index of Severity of Fibromyalgia ]]>
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
Email balptug@eul.edu.tr Email 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.
Feeling Fibromyalgia symptoms last 3 mounts

Exclusion Criteria:

Having physical and functional problems with FMS
Having a diagnosis of chronic pain other than FMS,
Using medicine other than simple analgesics,
History of cardiovascular or pulmonary diseases
Can not read and write in Turkish language

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.

]]>

<![CDATA[ Influence of Age on Trauma Femoral Fractures ]]>
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

]]>

<![CDATA[ A Study to Evaluate the Single Dose Safety, Tolerability and Pharmacokinetics of IV BCX4430 ]]>
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.
Day 6 (+1 day), Day 8 (+1 day), Day 14 (± 1 day)
Day 21 (+2 days) or early termination.

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.
Day 6 (+1 day), Day 8 (+1 day), Day 14 (± 1 day)
Day 21 (+2 days) or early termination.

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
males and non-pregnant, non-lactating females
BMI 19.0-32.0
willing to abide by contraceptive requirements
normal vitals
willing to abide by study procedures and restrictions

Exclusion Criteria:

clinically significant medical condition or medical history or psychiatric condition or history of psychiatric condition
abnormal cardiac finding, or laboratory/urinalysis abnormality at screening
known family history of sudden death or long QT syndrome, family or personal history of QT prolongation, or arrhythmia that required medical intervention
current participation in any other investigational drug study or participation in an investigational drug study within 3 months of screening visit
use of prescription, OTC, or herbal medications during study or use of any specified medications within 30 days prior to study
Recent or current history of alcohol or drug abuse
Regular use of tobacco or nicotine products
Positive serology for HBV, HCV, or HIV
history of severe adverse reaction to or known sensitivity to any drug
pregnant, lactating, or planning to become pregnant within 30 days of the study. Male subjects with pregnant female partners are excluded

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
Email 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.
Day 6 (+1 day), Day 8 (+1 day), Day 14 (± 1 day)
Day 21 (+2 days) or early termination.

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.
Day 6 (+1 day), Day 8 (+1 day), Day 14 (± 1 day)
Day 21 (+2 days) or early termination.

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.
Day 6 (+1 day), Day 8 (+1 day), Day 14 (± 1 day)
Day 21 (+2 days) or early termination.

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.
Day 6 (+1 day), Day 8 (+1 day), Day 14 (± 1 day)
Day 21 (+2 days) or early termination.

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.
Day 6 (+1 day), Day 8 (+1 day), Day 14 (± 1 day)
Day 21 (+2 days) or early termination.

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.
Day 6 (+1 day), Day 8 (+1 day), Day 14 (± 1 day)
Day 21 (+2 days) or early termination.

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.
Day 6 (+1 day), Day 8 (+1 day), Day 14 (± 1 day)
Day 21 (+2 days) or early termination.

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.
Day 6 (+1 day), Day 8 (+1 day), Day 14 (± 1 day)
Day 21 (+2 days) or early termination.

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.
Day 6 (+1 day), Day 8 (+1 day), Day 14 (± 1 day)
Day 21 (+2 days) or early termination.

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.
Day 6 (+1 day), Day 8 (+1 day), Day 14 (± 1 day)
Day 21 (+2 days) or early termination.

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.
Day 6 (+1 day), Day 8 (+1 day), Day 14 (± 1 day)
Day 21 (+2 days) or early termination.

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.
Day 6 (+1 day), Day 8 (+1 day), Day 14 (± 1 day)
Day 21 (+2 days) or early termination.

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.
Day 6 (+1 day), Day 8 (+1 day), Day 14 (± 1 day)
Day 21 (+2 days) or early termination.

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.
Day 6 (+1 day), Day 8 (+1 day), Day 14 (± 1 day)
Day 21 (+2 days) or early termination.

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

]]>

<![CDATA[ Greater China Metabolic and Bariatric Surgery Database ]]>
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

]]>

<![CDATA[ Effects of Nutritional Fat on the Growth of Intestinal E. Coli ]]>
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.
Email 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
Email benjamin.misselwitz@usz.ch Email 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
Written informed consent
Age 18 – 85 years
Working at ETH Zurich or University of Zurich and trained and experienced in handling -80°C freezers at biosafety level 2.

Exclusion Criteria:

Previous history of gastrointestinal disease or surgery (excludes appendectomy, hernia repair and surgery for anorectal disorders)
Known diabetes mellitus, scleroderma, neurological impairment or other major diseases requiring ongoing management
Immunesuppression
Subjects with antibiotic therapy, proton pump inhibitors or laxatives within the last four weeks
Pregnancy beyond week 12. "Mutaflor" intake is safe during pregnancy; however, special regulations are required to gain access to the -80°C freezers. No pregnancy test will be performed.

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

]]>

<![CDATA[ A Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients With Resectable Non-small Cell Lung Cancer ]]>
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

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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
cisplatin/gemcitabine
pemetrexed/cisplatin
pemetrexed/carboplatin

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
cisplatin/gemcitabine
pemetrexed/cisplatin
pemetrexed/carboplatin

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
Newly diagnosed and previously untreated patients with histologically or cytologically documented NSCLC with resectable (Stage IIA to select [ie, N2] Stage IIIB) disease
World Health Organization (WHO)/ECOG PS of 0 or 1 at enrollment
At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 Target Lesion (TL) at baseline
No prior exposure to immune-mediated therapy including, but not limited to, other anti-CTLA-4, anti-PD-1, anti-PD-L1, and anti-PD-L2 antibodies, excluding therapeutic anticancer vaccines
Adequate organ and marrow function
Confirmation of a patient's tumour PD-L1 status
Provision of sufficient tumour biopsy sample for evaluation and confirmation of EGFR and ALK status
Planned surgery must comprise lobectomy, sleeve resection, or bilobectomy

Exclusion Criteria:

History of allogeneic organ transplantation
Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease, diverticulitis, systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome)
History of another primary malignancy
History of active primary immunodeficiency
Active infection including tuberculosis hepatitis B and C, or human immunodeficiency virus
Deemed unresectable NSCLC by multidisciplinary evaluation
Patients who have pre-operative radiotherapy treatment as part of their care plan
Patients who have brain metastases or spinal cord compression
Stage IIIB N3 and Stages IIIC, IVA, and IVB NSCLC
Known allergy or hypersensitivity to any of the study drugs or excipients
Existence of more than one primary tumour such as mixed small cell and NSCLC histology
Patients whose planned surgery at enrollment includes any of the following procedures: pneumonectomy, segmentectomies, or wedge resections
Patients with a documented test result confirming the presence of EGFRm or ALK translocation

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)

]]>

<![CDATA[ Study of Exosomes in Monitoring Patients With Sarcoma (EXOSARC) ]]>
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,
for which neoadjuvant chemotherapy is being considered
metastatic or locally advanced cancer before and after treatment with first-line chemotherapywhich may include neoadjuvant therapy

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.
Determine if the exosome concentration as well as the protein and RNA profile they contain varies after treatment.
Determine if the initial exosome concentration (at T0) is associated with a response to treatment.
Determine whether the change in exosome concentration before and after treatment is associated with a response to treatment.
Identify a protein marker or RNA associated with a treatment response (marker present at T0 or occurring during follow-up).

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
Email echaigneau@chu-besancon.fr Email ahervieu@cgfl.fr Email 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)
Then four blood samples of 32mL distributed over 6 months

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)
Then three blood samples of 32 mL distribuated over 3 months

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
Email ahervieu@cgfl.fr Email 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
Previous treatment of the disease with chemotherapy, radiotherapy or surgery is allowed if it has been completed for more than 12 months at the time of inclusion.
For metastatic or locally advanced (inoperable) sarcoma, patients for whom first-line metastatic chemotherapy is indicated.
Age ≥18 years
Affiliation to a social security scheme
Patients who signed informed consent to participate in the study

Exclusion Criteria:

Patients who meet at least one of the following criteria will not be eligible:

Patient with another synchronous tumor,
Patient with sarcoma in irradiated territory
Patient with a history of cancer other than sarcoma in the 5 years preceding the diagnosis of sarcoma
Patient unable to undergo medical follow-up for geographical, social or psychological reasons,
Person benefiting from a protection system for adults (including guardianship and trusteeship),
Serology HIV and / or HBV and / or HCV positive.
Pregnant or lactating woman.
Patients unable to understand, read and / or sign informed consent.

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

]]>

<![CDATA[ Stimulation Parameters and Non-motor Symptoms in PD Treated With DBS ]]>
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,
Ability to provide informed consent,
Clinical diagnosis of idiopathic Parkinson disease (PD) by a movement disorders neurologist,
Disease duration of at least 4 years,
Treated with bilateral STN DBS for at least 3 months prior to study enrollment.

Exclusion Criteria:

History of prior neurosurgical intervention for PD (e.g., DBS, thalamotomy, pallidotomy)
History of other central nervous system disease (excluding migraine),
Presence of active psychiatric symptoms meeting Diagnostic and Statistical Manual of Mental Disorders-4th Edition (DSM-IV) criteria for Axis-I disorder on formal psychiatric evaluation, with the exception of mild depression (Beck Depression Inventory-2 score below 19),
Cognitive impairment meeting Diagnostic and Statistical Manual of Mental Disorders-4th Edition (DSM-IV) criteria for dementia on formal neuropsychological evaluation,
Current alcohol or substance abuse,
Lack of fluency in English which would invalidate cognitive testing,

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

]]>

<![CDATA[ Early Palliative Care for Patients With Haematological Malignancies ]]>
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
Email 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
Email 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
Patients from being diagnosed with acute myeloid leukemia and high-risk myelodysplastic syndrome or after the third line of therapy for high-grade lymphoma.

Exclusion Criteria:

All patients with a curative project (induction chemotherapy ou allogenic transplantation)
All patients in a terminal palliative status
Patients who don't speak French,
Patients not able to read and write
Patients who don't agree to participate in the protocol
Patients with psychiatric troubles or cognitive disorders
Patients under guardianship or curatorship, deprived of freedom or under justice protection.

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

]]>

<![CDATA[ Development and Usability Testing of a Progressive WebApp for Women With Heart Disease ]]>
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
Email monica.parry@utoronto.ca Email 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
Email monica.parry@utoronto.ca Email 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
women will be required to speak and read English

Exclusion Criteria:

severe cognitive impairment assessed using the Six-Item Screener
major co-morbid medical or psychiatric illness that could preclude their ability to participate

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.

]]>

<![CDATA[ Validation of Point of Care Liver Function Tests ]]>
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)
18 years or older

Exclusion Criteria:

Inadequate blood sample obtained from finger stick
Inconclusive liver function testing
Not all 6 liver tests completed on the same sample
Liver tests not drawn for normal method at same time as 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

]]>

<![CDATA[ Characterization of the Fungal Origins in the Autoimmune Polyendocrinopathy of Type 1 Compared With the Autoimmune Polyendocrinopathies of Type 2 ]]>
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
Email 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.
a reasonable delay of 2 weeks after the resolution of an intercurrent infectious episode is to be observed.
assent of the patient after information adapted to his age and his degree of understanding.
informed, express and written consent of the patient or of each of the holders of parental authority.
Inclusion criteria specific to group 1: 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.
Inclusion criteria specific to group 2 : 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.

Exclusion Criteria:

impossibility to receive informed information for adults, or impossibility to receive enlightened information for the holders of parental authority if minor subject
inability to participate in the entire study, refusal to sign the consent.
people in an emergency situation.
persons deprived of their liberty.
pregnant or lactating woman (pregnant women will be offered to participate in the study after delivery).

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

]]>

<![CDATA[ Social Impact of Children’s Dental Appearance ]]>
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
sufficient compliance
dividable into the two groups (with or without caries experience)

Exclusion Criteria:

missing agreement to participate in the study
insufficient compliance

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

]]>

<![CDATA[ Effect of Cross Frequency tACS on Cognitive Control ]]>
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

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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
Able to provide informed consent
Willing to comply with all study procedures and be available for the duration of the study Speak and understand English

Exclusion Criteria:

Attention Deficit Hyperactivity Disorder (currently under treatment)
Neurological disorders and conditions, including, but not limited to:
History of epilepsy
Seizures (except childhood febrile seizures and electroconvulsive therapy induced seizures) Dementia
History of stroke
Parkinson's disease
Multiple sclerosis
Cerebral aneurysm
Brain tumors
Medical or neurological illness or treatment for a medical disorder that could interfere with study participation (e.g., unstable cardiac disease, malignancy)
Prior brain surgery
Any brain devices/implants, including cochlear implants and aneurysm clips
History or current traumatic brain injury
(For females) Pregnancy or breast feeding
Personal or family history of mental/psychiatric disorder (e.g., anxiety, major depressive disorder, schizophrenia, etc.)
Positive urine test for the following: Marijuana (THC), Cocaine (COC), Phencyclidine (PCP), Amphetamine (AMP), Ecstasy (MDMA), Methamphetamine (Mamp), Opiates (OPI), Oxycodone (OXY), Methadone (MTD), Barbiturates (BAR), Benzodiazepines (BZO), Buprenorphine (BUP), Tricyclic Antidepressants (TCA), Propoxyphene (PPX)
Anything that, in the opinion of the investigator, would place the participant at increased risk or preclude the participant's full compliance with or completion of the study

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

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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
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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
Email 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.

]]>

<![CDATA[ Skeletal Muscle Function in Interstitial Lung Disease ]]>
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.
<![CDATA[

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
Email yannick.molgat-seon@hli.ubc.ca Email 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)
A multidisciplinary diagnosis of idiopathic pulmonary fibrosis (IPF), idiopathic fibrotic nonspecific interstitial pneumonia (NSIP), chronic hypersensitivity pneumonitis (HP), or unclassifiable ILD with a differential diagnosis that consists of the above diagnoses
Fibrosis on high resolution computed tomography (HRCT): honeycombing, reticulation, or traction bronchiectasis
Appropriate candidate for pulmonary rehabilitation
6 minute walk distance 50m or more
Oxygen saturation ≥ 92% by pulse oximetry at rest while breathing room air
Clinically stable for the preceding 6 weeks
Can fluently read and write in English

Inclusion Criteria for Healthy Controls:

Age 40-80 (inclusive)
Normal pulmonary function (80-120% predicted)
No lung or cardiovascular disease
Can fluently read and write in English

Exclusion Criteria for the ILD patients:

Contraindication to exercise testing (e.g. significant cardiovascular, musculoskeletal, neurological disease)
Other significant extra-pulmonary disease that, based on clinical assessment, could impair exercise capacity and/or oxygenation
Forced vital capacity (FVC) less than 50% or Diffusion capacity for carbon monoxide (DLCO) less than 25%
Concurrent or recent participation (less than 6 months) in a pulmonary rehabilitation program
Use of prednisone greater than 10 mg/day for more than 2 weeks within 3 months of the first study visit
Significant emphysema (less than 10% volume on HRCT or FEV1/FVC less than 0.70)

Exclusion Criteria for Healthy Controls:

Currently smoking or previously smoked more than 10 pack-years
Any medical conditions that prevents them for exercising safely
Cardiac pacemaker or any metal or electronic inside the body

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

]]>

<![CDATA[ Bone Health in Patients With Atopic Dermatitis ]]>
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.
HR-pQCT data will be compared with current known data from other diseases
To correlate bone mineral density with eczema severity using Eczema area and severity index (EASI) and Scoring atopic dermatitis (SCORAD) scores.
To determine if bone mineral density in children with atopic dermatitis correlates with bone age and bone-health specific serum markers.

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
Email Nguyen.Henry@mayo.edu Email 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
Email Nguyen.Henry@mayo.edu Email 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
Duration of atopic dermatitis symptoms for a minimum of 6 months
Ability to cooperate with DXA and HR-pQCT procedure

Exclusion Criteria:

Those without a confirmed diagnosis of moderate to severe atopic dermatitis
Presence of concurrent disease that may also affect bone health, including rickets or other vitamin D deficiency, thyroid disease, renal disease, Paget's disease, osteogenesis imperfecta, inflammatory bowel disease, and other chronic inflammatory diseases
Current use of medications that may affect bone health, including bisphosphonate, Forteo, Tymlos, denosumab, thiazide, heparin, medroxyprogesterone acetate, cyclosporine, and oral tacrolimus. However, medications that are used for atopic dermatitis treatment are allowed
Pregnant or breast feeding females
Inability to cooperate with the blood draw

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.

]]>

<![CDATA[ Vestibular Therapy in Alzheimer’s Disease ]]>
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
Email 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).
Age ≥ 60 years.
Vestibular loss defined as bilaterally impaired vestibular responses (semicircular canal or otolith responses).
Able to participate in study procedures including vestibular physiologic testing, balance and gait assessment, neurocognitive testing, and VT or active control.
Able to give informed consent, as further detailed in the Human Subjects section. The investigators anticipate that individuals who are too impaired to provide informed consent would also not be able to effectively participate in VT or active control.
Presence of a caregiver, defined as an individual who spends at least 10 hours per week with the patient. The caregiver must be able to participate in study procedures, specifically the text-messaging system. Both the VT and active control involve 8 weeks of once weekly visits and daily home exercises, and the investigators believe a caregiver would increase the likelihood of successful completion of either therapy.

Exclusion Criteria:

Diagnosis of severe AD (CDR≥3).
Diagnosis of mild cognitive impairment or diagnosis of non-AD dementia, for example Parkinson's disease dementia, Dementia with Lewy Bodies, vascular dementia, fronto-temporal dementia, and primary progressive aphasia.
Deemed unable to participate in study procedures and VT or active control, (e.g. patients with significant medical comorbidities, excessive agitation, or use of mobility aids such as a cane or walker.)
Use of daily vestibular suppressant medications, specifically anti-histamines and benzodiazepines, as this can alter the response to VT.
Lack of availability to participate in 8 weeks of VT or active control.

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.

]]>

<![CDATA[ A Clinical Study to Investigate the Food Effect on the Pharmacokinetics of ACT-541468 in Healthy Male Subjects ]]>
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
Healthy male subjects aged between 18 and 45 years (inclusive) at Screening
Body mass index (BMI) of 18.0 to 28.0 kg/m2 (inclusive) at Screening
No clinically relevant findings on the physical examination at Screening

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)
Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol
Modified Swiss Narcolepsy Scale total score < 0 at screening or history of narcolepsy or cataplexy

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

]]>

<![CDATA[ The Effect of Advanced Improvement Program (ERAS) on Postoperative Outcomes in Patients Undergoing Open Heart Surgery ]]>
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
Email ipekyd@hotmail.com Email 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
Email ipekyd@hotmail.com Email 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;
Patients undergoing elective open heart surgery (cardiopulmonarybiasis, aortic and mitral valve replacement);
ASA III ;
Patients with informed consent for the study.

Exclusion Criteria:

Patients who refuse to participate in the study;
Patients under emergency conditions.

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

]]>

<![CDATA[ Zoomers for the Capital Region: A Peer-Led Exercise Program for Aging Adults ]]>
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.
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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
Can exercise with minimal supervision (cleared for physical activity)
Can commit to a 12-week exercise program (2 sessions/week)

Exclusion Criteria:

Under 50 years of age
Not cleared to perform physical activity

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
Email 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

]]>

<![CDATA[ Chimney Trial of Parastomal Hernia Prevention ]]>
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
Rectal adenocarcinoma with curative intent laparoscopic or robotic assisted abdominoperineal resection or low Hartmann´s operation and permanent colostomy
Patient has a life expectancy of at least 12 months.
Patient must sign Informed consent before any study procedures and agrees to attend all study visits

Exclusion Criteria:

Abdominoperineal resection or Hartmann's operation by laparotomy or conversion to laparotomy
Complication requiring laparotomy during post surgery treatment at surgical ward after APR
Patient with a comorbid illness or condition that would preclude the use of surgery (ASA 4-5).
Patients with concurrent or previous malignant tumors within 5 years before study enrollment
Patients with T4b tumors which impose a multi-organ resection
Rectal malignancy other than adenocarcinoma
Patient undergoing emergency procedures
Planned rectal surgery along with major concomitant procedures (e.g. hepatectomies, other intestinal resections).
Metastatic disease with no possibility of curative surgery
Pregnant or suspected pregnancy
Patients living geographically distant and/or unwilling to return for follow-ups or comply with all study requirements
Active abdominal infection at the time of surgery
Previous surgery at the colostomy site
Language barrier or other reasons why informed consent is not possible

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.

]]>

<![CDATA[ Exploratory Study of ZG-801 for the Treatment of Hyperkalemia ]]>
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
Informed consent given
Serum Potassium measurement at baseline is 5.1 to < 6.5 mEq/L (Non-dialysis patients or 5.5 to < 6.5 mEq/L (Dialysis patients)

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
Subjects with severe heart failure, defined as NYHA (New York Heart Association) class IV
Subjects with uncorrected hemodynamically significant primary vascular disease or uncontrolled or hemodynamically unstable arrhythmia
Subjects with coronary artery bypass graft, percutaneous intervention, or major surgery including thoracic and cardiac, within the previous 3 months or anticipated need during study participation
Subjects with heart, liver (only Dialysis patients), or kidney transplant recipient, or anticipated need for transplant during the study period
Subjects with any of the significant cardiovascular or cerebrovascular events within the previous 2 months
Subjects with a history of or current diagnosis of a severe swallowing disorder, moderate to severe gastroparesis, or history of bariatric surgery, bowel obstruction or severe gastrointestinal disorders or major gastrointestinal surgery
Subjects who cannot use the oral concomitant medication to be separate 3 hours from ZG-801 medication
Subjects suspected of transient high potassium levels, such as those caused only by dietary effects

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

]]>

<![CDATA[ MESO-CAR T Cells Therapy for Relapsed and Refractory Ovarian Cancer ]]>
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.
To determine in vivo dynamics and persistency of anti- MESO CAR-T cells.

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.
Email 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
Email 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;
Expected survival > 12 weeks;
Clinical performance status of ECOG score 0-2;
Patients who have previously been treated with second- line or more lines of standard treatment are not effective (No remission or recurrence after remission);
At least one measurable tumor foci according to RECIST standard 1.1 ;
Positive Mesothelin expression in tumor tissues;
Creatinine ≤ 1.5×ULN;
ALT and AST ≤ 3×ULN;
Total bilirubin ≤ 2×ULN;
Hemoglobin≥90g/L;
Absolute counting of neutrophils≥1000uL ;
Absolute counting of lymphocytes>0.7×10^9/L;
Counting of Platelet≥75000/uL;
The venous access required for collection can be established without contraindications for leukocyte collection;
Able to understand and sign the Informed Consent Document.

Exclusion Criteria:

Accompanied by other uncontrolled malignant tumors;
Active hepatitis B, hepatitis C, syphilis, HIV infection;
Suffering severe cardiovascular or respiratory disease;
Any other diseases could affect the outcome of this trial;
Any affairs could affect the safety of the subjects or outcome of this trial;
Pregnant or lactating women, or patients who plan to be pregnancy during or after treatment;
There are active or uncontrollable infections (except simple urinary tract infections or upper respiratory tract infections) that require systemic therapy 14 days or 14 days prior to assignment;
Patients who are accounted by researchers to be not appropriate for this test;
Received CAR-T treatment or other gene therapies before assignment;
Subject suffering disease affects the understanding of informed consent or comply with study protocol.

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

]]>

<![CDATA[ Assessment of Abuse Potential of Rapastinel in Humans ]]>
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
Have a supine systolic blood pressure (BP) ≥ 95 mm Hg and ≤ 145 mg Hg, or supine diastolic BP ≥ 50 mm Hg and ≤ 90 mm Hg at the Screening Visit.
Have negative test results for benzoylecgonine (cocaine), methadone, barbiturates, amphetamines, benzodiazepines, alcohol, oxycodone and other opioids, and phencyclidine at any admission
Able, as assessed by the investigator, and willing to follow study instructions and likely to complete all required study visits

Exclusion Criteria:

Evidence of drug or alcohol dependence (excluding nicotine and caffeine) within the past 2 years
Suicidal risk based on the opinion of the principal investigator (or appropriately trained designee)
History of violent or psychotic behavior when taking psychedelic drugs, or unwilling to take a drug that might alter perception in a controlled setting
Have taken or require concomitant treatment with any CNS depressants, or cannot safely discontinue these medications within 14 days (or 5 half-lives, whichever is longer) before study treatment administration
Previously participated in an investigational study of rapastinel.
Participation in any other clinical investigation using an experimental drug within 30 days, 5 half-lives or twice the duration of the biological effect of the study treatment (whichever is longer), prior to study treatment administration or is concurrently enrolled in any clinical trial, judged not to be scientifically or medically compatible with this study
Consumption of alcohol within 72 hours before administration of study treatment
Breastfeeding
Unable to refrain from consuming caffeine or xanthine-containing compounds such as tea, coffee, soft drinks, energy sports drinks or chocolate (more than 48 oz/day) from 48 hours before administration of study treatment.
Have consumed dietary supplements or other foods or beverages that may affect various drug metabolizing enzymes and transporters (eg, grapefruit, grapefruit juice, grapefruit-containing beverages), vegetables from the mustard green family (eg, kale, broccoli, watercress, collard greens, kohlrabi, Brussels sprouts, mustard), and charbroiled meats within 14 days prior to dosing or unable to refrain from consumption during the study.
The ability to tolerate IV ketamine as judged by the Investigator, based on available safety data, as well as pharmacodynamic data.

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

]]>

<![CDATA[ Effects of Different Percentages Body Weight Supported Treadmill Training on Gait, Balance, Quality of Life and Fatigue in Parkinson’s Disease ]]>
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.
Subjects had clinically moderate to advanced severity of disease (Hoehn and Yahr stage 2 – 4).
Subjects whose medical treatment had been on stable dosage of dopaminomimetics for at least 4 weeks before the study.
Subjects ability to walk with or without assistive device.

Exclusion Criteria:

Subjects had cardiovascular, inflammatory or musculoskeletal problems that could prevent them to participate in an exercise program.
Subjects whose mini mental status examination score was less than 26.

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

]]>

<![CDATA[ Safety and Efficacy Study of Inhaled Carbon Monoxide to Treat Acute Respiratory Distress Syndrome (ARDS) ]]>
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
Acute cerebrovascular accident (CVA) within 48 hours of study drug administration
New onset atrial or ventricular arrhythmia requiring DC cardioversion within 48 hours of study drug administration
Increased oxygenation requirements defined as: an increase in FiO2 of ≥ 0.2 AND increase in PEEP ≥ 5 cm H2O within 6 hours of study drug administration
Increase in COHb ≥ 10%
Increase in lactate by ≥ 2 mmol/L within 6 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)
Bilateral opacities on frontal chest radiograph (not fully explained by effusions, lobar/lung collapse, or nodules) within 1 week of a known clinical insult or new or worsening respiratory symptoms
A need for positive pressure ventilation by an endotracheal or tracheal tube
Respiratory failure not fully explained by cardiac failure or fluid overload; need objective assessment (e.g., echocardiography) to exclude hydrostatic edema if no risk factor present.
ARDS onset is defined as the time the last of criteria 1-4 are met. ARDS must persist through the enrollment time window of 168 hours.

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

Age less than 18 years
Greater than 168 hours since ARDS onset
Pregnant or breastfeeding
Prisoner
Patient, surrogate, or physician not committed to full support (exception: a patient will not be excluded if he/she would receive all supportive care except for attempts at resuscitation from cardiac arrest)
No consent/inability to obtain consent or appropriate legal representative not available
Physician refusal to allow enrollment in the trial
Moribund patient not expected to survive 24 hours
No arterial or central line/no intent to place an arterial or central line
No intent/unwillingness to follow lung protective ventilation strategy
Severe hypoxemia defined as SpO2 < 95 or PaO2 < 90 on FiO2 ≥ 0.9
Hemoglobin < 7.0 g/dL
Subjects who are Jehovah's Witnesses or are otherwise unable or unwilling to receive blood transfusions during hospitalization
Acute myocardial infarction (MI) or acute coronary syndrome (ACS) within the last 90 days
Coronary artery bypass graft (CABG) surgery within 30 days
Angina pectoris or use of nitrates with activities of daily living
Cardiopulmonary disease classified as NYHA class IV
Stroke (ischemic or hemorrhagic) within the prior 1 month, cardiac arrest requiring CPR within the prior 72 hours, or inability to assess mental status following cardiac arrest
Burns > 40% total body surface area (TBSA)
Severe airway inhalational injury
Use of high frequency oscillatory ventilation
Use of extracorporeal membrane oxygenation (ECMO)
Concomitant use of inhaled pulmonary vasodilator therapy (eg. nitric oxide [NO] or prostaglandins)
Diffuse alveolar hemorrhage from vasculitis
Concurrent participation in other investigational drug study

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.

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<![CDATA[ Newborn Heart Rate as a Catalyst for Improved Survival ]]>
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
birth weight
congenital anomalies
multiple gestation
any maternal complication

Exclusion Criteria:

Newborns transferred to the maternity unit following delivery at a referral hospital or in the community
Miscarriages, or previable newborns, defined as gestational age <28 weeks (or if gestational age is unavailable, birth weight <1,000g) at the time of delivery

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

]]>

<![CDATA[ A Single Dose Study of Oral Vadadustat in Subjects With Normal and Impaired Hepatic Function ]]>
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
Have a body weight ≥45 kg and body mass index (BMI) ≥18.5 kg/m2 to 40.0 kg/m2

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)
Any history of active malignancy within 2 years prior to or during screening, except for treated basal cell carcinoma of skin, curatively resected squamous cell carcinoma of skin, or cervical carcinoma in situ; any history of tuberculosis and/or prophylaxis for tuberculosis
Positive test for human immunodeficiency virus (HIV) antibody at Screening.
Hepatic or other organ or cell transplant
Subjects with alcoholic cirrhosis must be sober for a minimum of 6 months

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

]]>

<![CDATA[ Atezolizumab Plus One-year BCG Bladder Instillation in BCG-naive High-risk Non-muscle Invasive Bladder Cancer Patients ]]>
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
Arm B (experimental arm): BCG+ atezolizumab

The are two factors of stratifications (center and CIS).

Facilities

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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)
maintenance phase: full-dose BCG administered once per week for 3 weeks, at week 13 (i.e. 3 months after the first BCG instillation of induction, D1), at week 26 (6 months from D1) and week 52 (12 months from 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)
maintenance phase: full-dose BCG administered once per week for 3 weeks, at week 13 (i.e. 3 months after the first BCG instillation of induction, D1), at week 26 (6 months from D1) and week 52 (12 months from D1).
atezolizumab is administered by IV infusion every 3 weeks (21 [± 2] days) for 1 year (18 cycles as a maximum).

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
Email s-nenan@unicancer.fr Email 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)
Adult man and women ( age ≥18 years)

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
High grade (WHO 2004) and/or
Grade 3 (WHO1973) and/or
Carcinoma in situ (CIS)
Tumor tissue available from the surgery for central confirmation of the diagnosis and analysis the expression of PD-L1

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,
incomplete initial TURB,
no muscle in the specimen (can be omitted if TaLG/G1 tumors or primary CIS only was found)
Absence of metastasis in pelvis, abdomen, or chest, as confirmed by a negative baseline computed tomography (CT) or magnetic resonance imaging (MRI) scan no more than 90 days prior to the first study treatment
Eastern Cooperative Oncology Group (ECOG) performance status of ≤2
Life expectancy ≥12 weeks
Systolic blood pressure (BP) <160 mmHg and diastolic BP <95 mmHg, as documented within 7 days prior to the first study treatment (hypertension allowed provided it is controlled)

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
white blood cell (WBC) counts >2500/μL
Lymphocyte count ≥300/μL
Platelet count ≥100,000/μL
Hemoglobin ≥9.0 g/dL
aspartate aminotransferase (ASAT), alanine aminotransferase (ALAT), and alkaline phosphatase ≤2.5 × the upper limit of normal (ULN)
Serum bilirubin ≤1.0 × ULN Patients with known Gilbert disease who have serum bilirubin level ≤3 × ULN may be enrolled.
Partial thromboplastin time (PTT)/Prothrombin Time (PT) ≤1.5 × ULN or international normalized ratio (INR) <1.7 × ULN
Calculated creatinine clearance ≥20 mL/min (Cockcroft-Gault formula)
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of <1% per year during the treatment period and for at least 5 months after the last dose of atezolizumab
Patients affiliated to the social security system
Patient is willing and able to comply with the protocol for the duration of the trial including undergoing treatment and scheduled visits, and examinations including follow-up.

Exclusion Criteria:

Patient having received previous BCG therapy for bladder cancer
Any approved anti-cancer therapy, including systemic chemotherapy, or hormonal therapy within 3 weeks prior to initiation of study treatment. Hormone-replacement therapy or oral contraceptives are allowed
Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days or five half-lives of the drug, whichever is longer, prior to day 1 of study treatment

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.
Patients with low risk prostate cancer (defined as Stage T1/T2a, Gleason score ≤7 and PSA ≤10 ng/mL) who are treatment-naive and undergoing active surveillance are eligible.
Patients with malignancies of a negligible risk of metastasis or death (e.g., risk of metastasis or death <5% at 5 years) are eligible provided they meet all of the following criteria: malignancy treated with expected curative intent (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, or ductal carcinoma in situ treated surgically with curative intent) and no evidence of recurrence or metastasis by follow-up imaging and any disease-specific tumor markers.
Pregnancy or breastfeeding
History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation

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 controlled Type I diabetes mellitus on a stable dose of insulin regimen may be eligible for this study.
History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan may be eligible.
History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
Serum albumin <2.5 g/dL
Known HIV infection

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.
Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
Known active tuberculosis
Severe infections within 4 weeks prior to Cycle 1, Day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia

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
Patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or to prevent chronic obstructive pulmonary disease exacerbation) are 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
Prior allogeneic stem cell or solid organ transplant

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
Prior treatment with CD137 agonists or immune checkpoint-blockade therapies, including anti-CD40, anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies
Treatment with systemic immunostimulatory agents (including but not limited to interferons, interleukin 2 (IL-2)) within 6 weeks or five half-lives of the drug, whichever is shorter, prior to Cycle 1, Day 1

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.
The use of inhaled or low-dose (e.g., ≤10 mg/day prednisone) corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, mineralocorticoids (e.g., fludrocortisone for adrenal insufficiency) and low-dose corticosteroids for patients with orthostatic hypotension or adrenocortical insufficiency is allowed.
Person deprived of their liberty or under protective custody or guardianship

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

]]>

<![CDATA[ Oral Anticoagulation in Hemodialysis ]]>
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
signed informed consent for this extension trial

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.

]]>

<![CDATA[ Efficacy of Intrabronchial Voriconazole Instillation for Inoperable Pulmonary Aspergilloma ]]>
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.
To compare the percentage of patients having recurrence of hemoptysis during 3 months follow up.
To compare the severity of hemoptysis during recurrence in both groups.
To compare the change in size of aspergilloma after 3 – 6 months following last intrabronchial voriconazole instillation.
To compare the percentage of patients who need BAE during anytime till 3 – 6months.
To compare the percentage of patients with symptomatic improvement in Dyspnea On Exertion, Cough and recurrent respiratory infections.

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
Email 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
Email 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.
Who have no contra-indication of flexible fibre-optic bronchoscopy
Age > 18 yrs AND
Given the written informed consent to participate in the study.

Exclusion Criteria:

Patient who are not fit for FOB (e.g. hemodynamic instability)
Patient who have life threatening hemoptysis requiring immediate bronchial artery embolization
Patients who have underwent BAE in last 3 months
Pregnant woman

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

]]>

<![CDATA[ Combining Flash Glucose Monitoring and Online Peer Support to Improve Outcomes in Hispanics With Type 2 Diabetes ]]>
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
Self-report as Hispanic
Able to communicate in Spanish
Clinical diagnosis of T2D and HbA1c ≥8% per clinic records
Willing to wear a flash glucose monitor for 12 weeks
Access to the internet and willing to engage in an online peer support community
Willing to avoid Vitamin C 500 mg and Aspirin 325 mg or greater daily
Not using insulin

Exclusion Criteria:

Non-Spanish speaking
Using insulin
Already using a continuous glucose monitor or flash glucose monitor in previous 6 months
Participation in other diabetes clinical trials
Alcohol or drug abuse/dependency
Severe illness (physical or mental health), cognitive impairment, high dose steroids, hospitalized more than 2 times in past 12 months or other impairment that would, in the opinion of the investigators, interfere with ability to complete the study
Uncorrected hearing or vision impairment
Life expectancy <6 months

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.

]]>

<![CDATA[ The Use of Dexmedetomidine for EEG Sedation in Children With Behavioural Disorders ]]>
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
written informed consent

Exclusion Criteria:

ASA > 2
hypersensitivity of active substance
therapy with beta blockers or digoxin, arrhythmia

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
Email 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

]]>

<![CDATA[ ONSD and Neurotoxicity in Liver Transplant ]]>
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
History of Arachnoid cyst of the optic nerve.
History of eye trauma
History of optic nerve trauma.
Familial amylodotic polyneuropathy
Wilson disease.
Patient planned to use immunosuppression regimen other than tacrolimus.

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

]]>

<![CDATA[ Using Bupivacaine Locally in the Mastectomy Drains to Control Postoperative Pain ]]>
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
Bilateral breast cancer.
Patients with a history of a long duration of NSAID intake or other painkillers, drug abuse
Patients with chest wall pain like Tietze syndrome, history of angina pectoris or recent HZV infection.
Patients with known psychological or mental problems.
Patients who were not exposed to axillary dissection

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

]]>

<![CDATA[ Safety,Tolerability,and Efficacy of VCN-01 With Durvalumab in R/M Head and Neck Squamous Cell Carcinoma ]]>
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.
Adult subjects; age ≥ 18 years at time of study entry
ECOG Performance status 0 or 1
Life expectancy above 3 months
Body weight >30kg

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
Absolute neutrophil count ≥1500 mcL (or 1.0) x (≥ 1500 per mm3)
Platelets ≥100 000 mcL
Haemoglobin ≥9 g/dL
Total bilirubin ≤1.5 x ULN; total bilirubin ≤3×ULN in patients with documented Gilbert's Syndrome (unconjugated hyperbilirubinaemia) or in the presence of liver metastases
ALT and AST ≤2.5×ULN if no demonstrable liver metastases or ≤5×ULN in the presence of liver metastases
Creatinine ≤ 1.5 x UNL or measured creatinine clearance (CL) >40 mL/min or Calculated creatinine CL>40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance (see section 4.1.).
Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients (see section 4.1.).
Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
Have histologically and/or cytologically confirmed head and neck squamous cell carcinoma from the specific sites: oral cavity, oropharynx, larynx or hypopharynx that is recurrent/Mestastasic (R/M) and not amenable to curative therapy by surgery or radiation.
For patients in R/M disease: has undergone ≥1 previous regimens of cytoreductive chemo-therapies including prior exposure to anti-PD-(L)1. Patients have progressed or be refractory to anti-PD1 or anti-PDL1 therapy. Note: anti-PD1 or Anti-PDL1 therapy with other agents is acceptable. For patients with locally advanced disease those who has progressed in the last 6 months to previous line that include anti-PD1 or anti PD-L1 in the radical treatment.
Subjects must have at least 1 lesion that is measurable using RECIST guidelines. RECIST lesions must not have been previously treated with surgery, radiation therapy, or radiofrequency ablation unless there is documented progression after therapy.
Subjects must consent to provide paired pretreatment and on-treatment tumor biopsies (1 pre; 2 post).
Levels of neutralizing antibodies against adenovirus ≤1/350 dilution
All patients are required to have a fibroscan assessment performed during the screening period. Patients with fibrosis value ≥9.5 kPa will not be eligible.

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.
Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.

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.
Must not have required the use of additional immunosuppression other than corticosteroids for the management of an AE, not have experienced recurrence of an AE if re-challenged, and not currently require maintenance doses of > 10 mg prednisone or equivalent per day.

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.
Previously treated non-invasive in-situ carcinoma.
Cervical carcinoma stage 1B or less.
Non-invasive basal cell and squamous cell skin carcinoma.
Radically treated prostate cancer (prostatectomy or radiotherapy) with normal prostate-specific antigen, and not requiring ongoing antiandrogen hormonal therapy.
Other malignancy treated with curative intent and with no known active disease ≥3 years before the first dose of study drug and of low potential risk for recurrence.
Patients with other malignancies treated with curative intent and with no known active disease < 3 years and at low risk of recurrence, may be eligible upon discussion with the Medical Monitor.
Mean QT interval corrected for heart rate (QTc) ≥470 ms calculated from 3 electrocardiograms (ECGs) using Fridericia's Correction (within 15 minutes at 5 minutes apart).
Current or prior use of immunosuppressive medication within 28 days before the first dose of VCN-01/durvalumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid. Exceptions defined in section 4.2.
Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values considered not clinically significant or correctable by the investigator. The eligibility of patients who are still experiencing irreversible toxicity that is not reasonably expected to be exacerbated by the study drugs in this study (eg, hearing loss) must be reviewed and approved by the Study Physician. Patients with Grade ≥2 neuropathy or hearing loss will be evaluated on a case-by-case basis after consultation with the Study physician/Medical Monitor.
Has experienced immune-related AEs (irAEs) while receiving prior immunotherapy (including anti-CTLA4 treatment) and assessed as CTCAE grade ≥3
Has an active or prior documented autoimmune or inflammatory disorder (including but not limited to inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). (See section 4.2 for details and exceptions.)

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.
Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent or other minor procedures are acceptable.
History of allogenic organ transplantation.
Uncontrolled intercurrent illness, including but not limited to, uncontrolled ongoing or active infection (including viral emergent infections), symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent. Exception: patients who are finalizing their antibiotic treatment (for example 3 days left of a total of 7 or 10) for a respiratory tract infection are allowed to be included.
History of leptomeningeal carcinomatosis
Has untreated central nervous system (CNS) metastases identified either on the baseline brain imaging obtained during the screening period or identified prior to signing the ICF. Patients whose brain metastases have been treated may participate provided they show radiographic stability (defined as 2 brain images, both of which are obtained after treatment to the brain metastases. These imaging scans should both be obtained at least four weeks apart and show no evidence of intracranial progression). In addition, any neurologic symptoms that developed either as a result of the brain metastases or their treatment must have resolved or be stable either, without the use of steroids, or with stable doses of anticonvulsants and/or steroids. Steroid dose must be ≤10mg/day of prednisone or its equivalent (and anticonvulsants) for at least 14 days prior to the start of treatment.
Has a history of primary immunodeficiency
Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), hepatitis B (positive HBV surface antigen (HBsAg) result), hepatitis C (positive HCV RNA), or human immunodeficiency virus (positive HIV 1/2 antibodies). Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [HBcAb] and absence of HBsAg) are eligible. HBV DNA must be obtained in these patients prior to treatment. HBV carriers of those patients requiring antiviral therapy treatment of hepatitis B virus or Hepatitis C are not eligible to participate. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA. Patients with past or resolved tuberculosis are eligible.
Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. Note: Patients, if enrolled, should not receive live vaccine whilst receiving IP and up to 30 days after the last dose of IP.
Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control (according to the HMA CTFG guidelance) from screening to 90 days after the last dose of durvalumab.
Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
Viral syndrome diagnosed during the two weeks before inclusion
Patients receiving full-dose anticoagulant/antiplatelet therapy.
Patients with Li Fraumeni syndrome or with previous known retinoblastoma protein pathway germinal deficiency.
Judgment by the investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions and requirements.

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

]]>

<![CDATA[ Study for Evaluation of Murlentamab (GM102) Anti-tumoral Activity in Colorectal Cancers ]]>
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
Cohort II (GM102 in combination with trifluridine/tipiracil) in patients candidate to receive single agent trifluridine/tipiracil, after at least two lines of treatment for the advanced or metastatic disease. Patients will receive GM102 at the dose of 7 mg/kg administered by intravenous infusion at Day 1, Day 8, Day 15 and Day 22 and trifluridine/tipiracil at 35 mg/m² per dose twice daily orally administered on Days 1 to 5 and Days 8 to 12 of each 28-day cycle.
Cohort II expansion (GM102 in combination with trifluridine/tipiracil) same as cohort II except a loading dose of 10 mg/kg q1w during 28-day cycle 1

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.
Having failed the previous line of treatment for locally advanced or metastatic disease and having received at least two systemic chemotherapy regimens for metastatic colorectal cancer; adjuvant regimen can be considered as one chemotherapy regimen for metastatic disease if the participant had disease recurrence within 6 months of completion.
At least one of the tumor sites amenable to core needle biopsy (may not be the site of disease for measuring antitumor response). Patient must agree to this pre-treatment biopsy and on the principle of a second biopsy under treatment; however, if eventually the second biopsy cannot be performed, patients will continue on the study and will be considered evaluable for efficacy.
Available archived CRC tumor tissue sample
At least one measurable lesion (superior or equal to 1.0 cm longest diameter or superior or equal to 1.5 cm in short axis for malignant lymph nodes) based on RECIST (Response Evaluation Criteria in Solid Tumors) 1.1 on the screening CT-scan.
Written Informed Consent forms signed.
Willing and able to comply with the trial requirements.
Covered by healthcare insurance in accordance with local requirements.
For cohort I (single agent GM102) only: refractory patients, having exhausted all therapeutic options.
For cohort II (GM102 in combination with trifluridine/tipiracil) only: patients eligible for trifluridine/tipiracil who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-Vascular Endothelial Growth Factor (anti-VEGF) agents, regorafenib and anti-Epithelial Growth Factor Receptor (anti-EGFR) agents. Patients must have received at least 2 prior lines of standard chemotherapy for metastatic CRC.

Exclusion Criteria:

Age < 18 years old.
Eastern Cooperative Oncology Group (ECOG) performance status superior or equal to 2.
Life expectancy < 12 weeks.
Major surgery or radiotherapy within 21 days prior to Cycle 1 Day 1 or anticipation of needing such procedure while receiving study treatment.
Known or symptomatic brain metastasis (other than totally resected or previously irradiated and non-progressive/relapsing) or lepto-meningeal carcinomatosis.
Concurrent treatment with any other anticancer therapy (or investigational agent) or received any anticancer therapy (or investigational agent) within 4 weeks prior to first treatment.
Known severe anaphylactic or other hypersensitivity reactions to Investigational Medicinal Product (IMP) and/or its excipients.
Unresolved toxicity superior or equal to Grade 2 according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 attributed to any prior therapies (excluding anemia, alopecia, skin pigmentation, and platinum induced neurotoxicity).
Serious concomitant illness, e.g. active infection requiring systemic antibiotic, antifungal or antiviral drug, or physical examination or laboratory abnormalities, that, in the opinion of the Investigator, would compromise protocol objectives.
Poor bone marrow reserve as defined by white blood cell < 3.0 x 10E9/L, neutrophils < 1.5 x 10E9/L or haemoglobin < 9.0 g/dL or platelet count < 100 x 10E9/L.
Poor organ function as defined by any one of the following: serum creatinine > 1.5 x upper limit of normal (ULN), total bilirubin > 1.5 x ULN or > 2.5 x ULN if due to Gilbert's syndrome, AST and ALT > 2.5 x ULN in the absence of liver metastasis or > 5 x ULN in case of documented liver metastasis.
Severe New York Heart Association (NYHA) III and IV heart failure.
Pregnancy or breastfeeding.
Patient with reproductive potential who does not agree to use an accepted highly effective method of contraception – per investigator's judgment – during the study period and for at least 6 months following completion of study treatment.
Patient deprived of liberty by a judicial or administrative decision, patient admitted to a social institution or who is under a measure of legal protection, patient hospitalized without consent or who is in an emergency situation.
Known allergy to rodents.
Patients positive to Covid-19

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

]]>

<![CDATA[ Safety and Efficacy of Repeated Administration of NurOwn (MSC-NTF Cells) in Participants With Progressive MS ]]>
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.
Clinical diagnosis of Progressive MS (Primary and Secondary) based on the 2017 revised MacDonald Criteria and confirmation by the Investigator that the disease has entered the progressive stage for at least 6 months prior to enrollment.
No evidence of clinical MS relapse or high dose pulse corticosteroid treatment within 6 months prior to screening
Disability status at screening with an Expanded Disability Status Scale (EDSS) 3.0-6.5, inclusive.
Able to walk 25 feet in 60 seconds or less.
Stable dose of non-excluded MS Disease Modifying Therapy for at least 6 months prior to Screening Visit (Visit 1).
Women of childbearing potential shall either be surgically sterile, or must agree not to become pregnant for the duration of the study. Women must be willing to undergo a serum pregnancy test at screening, and at the conclusion of the study. Participants of childbearing potential must agree to use a medically approved form of birth control (abstinence, intrauterine device (IUD), oral contraception, barrier and spermicide or hormonal implant) throughout the duration of the study and for at least 3 months following the last transplantation. For those women who are sexually active and using oral contraceptives, a second form of barrier contraception is required. Men must be willing to consistently use two forms of contraceptive if their partners are of childbearing age.
Capable of providing informed consent and willing and able to follow study procedures, including willingness to undergo multiple/repeated lumbar puncture.

Exclusion Criteria:

Prior stem cell therapy of any kind.
Active participation in any other MS interventional study or use of unapproved MS investigational therapy within 90 days prior to the Screening Visit (Visit 1).
Inability to lie flat for the duration of intrathecal cell transplantation and/or bone marrow biopsy, or inability to tolerate study procedures for any other reason.
History of clinically significant autoimmune disease (excluding thyroid disease) that may confound study results, in the opinion of the Investigator and the medical monitor, myelodysplastic or myeloproliferative disorder, leukemia or lymphoma, whole body irradiation, hip fracture, or severe scoliosis.
Any unstable clinically significant medical condition other than multiple sclerosis (e.g., within six months of Screening Visit (Visit 1), had myocardial infarction, angina pectoris, and/or congestive heart failure), treatment with anticoagulants that, in the opinion of the investigator, would compromise the safety of participants.
Any history of malignancy within the previous 5 years, except for non-melanoma localized skin cancers (with no evidence of metastasis, significant invasion, or reoccurrence within three years of Screening Visit (Visit 1)).
Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) value >3.0 times the upper normal limit.
Serum creatinine value >2.0 times the upper normal limit.
Positive test for Hepatitis B (HBV; surface antigen (HBsAg) and antibodies to core antigen (IgG and IgM anti-HBc)), Hepatitis C (HCV), or human immunodeficiency virus (HIV) 1 and 2.
Current use of immunosuppressant medication or use of such medication within 6 months of study enrollment (aside from Rituximab or other approved B-cell immunotherapy). Alemtuzumab (Lemtrada), Cladribine (NDA submitted), Natalizumab (Tysabri), S1P modulators (Gilenya) are excluded for safety reasons due to the known risk of systemic autoimmune disease, malignancy, opportunistic infections, and cardiovascular toxicity associated with these therapies, as well as theoretical effects on MSC-NTF cell homing and migration, that may be associated with Natalizumab and/or S1P modulators (Gilenya).
Any history of acquired or inherited immune deficiency syndrome.
Any history of either substance abuse within the past year, or unstable psychiatric disease according to the Investigator's judgment.
Pregnant women or women currently breastfeeding.
Subjects for whom MRI is contraindicated (i.e., have a pacemaker or other metallic implanted device, or are unable to remain in the machine for period of time needed to acquire a scan.

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
Email 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

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<![CDATA[ Genetic Variants in Nicotinamide Adenine Dinucleotide (NAD) Synthesis Pathway ]]>
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;
Families (mother, father, biological offspring) with a history of VACTERL-associated malformations
Gravid or non-gravid women with a history of miscarriage and/or offspring with non-VACTERL-associated malformations
Willingness 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

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

]]>

<![CDATA[ Albumin-Bound Paclitaxel Combined With Carboplatin as Neoadjuvant Chemotherapy in Luminal B/HER-2 Negative Breast Cancer ]]>
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
Email zhimingshao@yahoo.com Email 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
Email szm@163.com Email 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.
2.Has histologically or cytologically confirmed unilateral primary invasive breast cancer with a clinical stage of T2-4NanyM0.
3.Immunohistochemical detection of ER+, PR+, HER-2 negative (if HER2 expression is 2+ patients need to be confirmed by in situ hybridization to detect no HER-2 gene amplification) and Ki-67 expression >20% of patients;
4.At least one measurable objective lesion according to RECIST 1.1 criteria.
5.ECOG performance status of 0-1.
6.Bone marrow function: Neutrophils ≥ 1.5×109/L, platelets ≥ 100×109/L, and hemoglobin ≥ 90 g/L.
7.Liver and renal function: Serum creatinine ≤ 1.5 times the upper limit of normal. AST and ALT ≤ 2.5 times the upper limit of normal Total bilirubin ≤ 1.5 times the upper limit of normal, or ≤ 2.5 times the upper limit of normal in patients with Gilbert's syndrome.
8.Has good compliance with the planned treatment, understand the study process and sign written informed consent.

Exclusion Criteria:

1.Any prior cytotoxic chemotherapy, endocrine therapy, biological therapy, or radiation therapy.
2.Patients with grade II or higher heart disease scored by the New York Heart Association (NYHA).
3.Severe systemic infection, or with other serious diseases.
4.Patients with known hypersensitivity or intolerance to chemotherapeutic agents or their excipients.
5.Other malignancies have occurred in the past 5 years, except for cured cervical carcinoma in situ, non-melanoma skin carcinoma.
6.Pregnant or lactating, and who refuse to take appropriate contraception during the course of this trial.
7.Have participated in other study studies within 30 days prior to the first dose of study drug.
8.Patients who, in the opinion of the Investigator, are not suitable for participation in the study.

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

]]>

<![CDATA[ Albumin-Bound Paclitaxel Followed by Epirubicin in Combination With Cyclophosphamide in Triple Negative Breast Cancer ]]>
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.
Email 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
Email 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.
Has histologically or cytologically confirmed unilateral primary invasive breast cancer with a clinical stage of T2-4NanyM0.
The expression of ER, PR, HER-2 was negative by immunohistochemistry (IHC), if HER2 expression is 2+ patients need to be confirmed by in situ hybridization to detect no HER-2 gene amplification.
At least one measurable objective lesion according to RECIST 1.1 criteria.
ECOG performance status of 0-1.
LVEF≥55%.
Bone marrow function: Neutrophils ≥ 1.5×109/L, platelets ≥ 100×109/L, and hemoglobin ≥ 90 g/L.
Liver and renal function: Serum creatinine ≤ 1.5 times the upper limit of normal. AST and ALT ≤ 2.5 times the upper limit of normal Total bilirubin ≤ 1.5 times the upper limit of normal, or ≤ 2.5 times the upper limit of normal in patients with Gilbert's syndrome.
Has good compliance with the planned treatment, understand the study process and sign written informed consent.

Exclusion Criteria:

Any prior cytotoxic chemotherapy, endocrine therapy, biological therapy, or radiation therapy.
Patients with grade II or higher heart disease scored by the New York Heart Association (NYHA).
Severe systemic infection, or with other serious diseases.
Patients with known hypersensitivity or intolerance to chemotherapeutic agents or their excipients.
Other malignancies have occurred in the past 5 years, except for cured cervical carcinoma in situ, non-melanoma skin carcinoma.
Pregnant or lactating, and who refuse to take appropriate contraception during the course of this trial.
Have participated in other study studies within 30 days prior to the first dose of study drug.
Patients who, in the opinion of the Investigator, are not suitable for participation in the study.

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

]]>

<![CDATA[ (Re)Vitalizing Pulmonary Rehabilitation for Patients With Chronic Respiratory Diseases ]]>
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);
Create an online platform for clinical storage and analysis of the data collected (Task 2);
Perform a cost-benefit analysis of the implemented PR programmes (Task 3);
Create a Portuguese online PR toolkit (Task 4);
Promote knowledge transfer about PR (Task 5). The plan is to implement community-based PR programmes in 4 primary care centres of 2 ACES (Baixo Vouga – BV, and Baixo-Mondego – BM) of the centre region and assess the impact of such intervention in several domains. Surrogate and patient/family centered outcome measures will be used. A cost-benefit analysis will be performed on acute exacerbations and healthcare utilization and costs. Finally, dissemination and knowledge transfer of the project will be conducted through: an international conference, activities with the community, three PR courses; the development of the Portuguese online PR toolkit to support the widespread implementation of PR in Portugal and via publications.

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
clinically stable in the previous month
≥ 18 years old
able to provide their own informed consent

Exclusion Criteria:

cognitive impairments
inability to understand and co-operate
history of neoplasic /immunologic disease or acute cardiac condition or a significant cardiac, musculoskeletal, neuromuscular or psychiatric condition.

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.

]]>

<![CDATA[ A Nurse Cohort Study in Xiamen, China ]]>
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.
Email 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
Email 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;
aged 20 years or over;
Working in the public hospitals for at least 1 year;
Signed the informed consent and agreed to participate in the study;
Assuming not moved out of Xiamen for at least 5 years;

Exclusion Criteria:

who are unambulatory;
who are receiving treatment modalities, which , if omitted, may result in immediate life threatening risk such as chemotherapy or radiotherapy for cancer, or dialysis for renal failure.

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

]]>

<![CDATA[ Multidirectional Yoga for Cognition ]]>
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
Capable of walking 50 feet with or without a walking aid-

Exclusion Criteria:

Regularly participating in yoga or other balance training program
Currently participating in another exercise study
Unable to commit to study duration
Uncontrolled neuromuscular or cardiovascular disease that prevents participation in an exercise study
Advised not to exercise by their physician

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

]]>

<![CDATA[ Study of Vadadustat in Hemodialysis Participants With Anemia Switching From Epoetin Alfa ]]>
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
Receiving chronic, outpatient in-center hemodialysis (TIW) for end-stage renal disease for at least 12 weeks prior to Screening
Maintained on intravenous Epoetin Alfa therapy for 8 weeks prior to and including Screening through Screening Visit 2 (SV2)

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;
ESA hyporesponder parallel study: Mean weekly Epoetin Alfa dose ≥300 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;
ESA hyporesponder parallel study: 2 Hb values between 8.0 and 10.0 grams per deciliter (g/dL), inclusive
Serum ferritin ≥100 nanograms per milliliter (ng/mL) and transferrin saturation (TSAT) ≥20% during Screening
Folate and vitamin B12 measurements ≥ lower limit of normal during Screening
Hemodialysis adequacy as indicated by single-pool Kt/Vurea ≥1.2 using the most recent historical measurement within 8 weeks prior to or during Screening
Understands the procedures and requirements of the study and provides written informed consent and authorization for protected health information disclosure

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)
Active bleeding or recent blood loss within 8 weeks prior to randomization
Red blood cell (RBC) transfusion within 8 weeks prior to randomization
Anticipated to discontinue hemodialysis during the study
Judged by the Investigator that the participant is likely to need rescue therapy (ESA administration or RBC transfusion) immediately after enrollment in the study
History of chronic liver disease (e.g., chronic infectious hepatitis, chronic autoimmune liver disease, cirrhosis or fibrosis of the liver)
Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT), alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT), or total bilirubin >1.5 x upper limit of normal (ULN) during Screening. Participants with a history of Gilbert's syndrome are not excluded.
Current uncontrolled hypertension as determined by the Investigator that would contraindicate the use of Epoetin Alfa
Acute coronary syndrome (hospitalization for unstable angina or myocardial infarction), surgical or percutaneous intervention for coronary, cerebrovascular or peripheral artery disease (aortic or lower extremity), surgical or percutaneous valvular replacement or repair, sustained ventricular tachycardia, hospitalization for heart failure (HF) or New York Heart Association Class IV HF, or stroke within 12 weeks prior to or during Screening
History of new or recurrent malignancy within 2 years prior to and during Screening or currently receiving treatment or suppressive therapy for cancer. Participants with treated basal cell carcinoma of skin, curatively resected squamous cell carcinoma of skin, or cervical carcinoma in situ are not excluded.
History of deep vein thrombosis or pulmonary embolism within 12 weeks prior to or during Screening
History of hemosiderosis or hemochromatosis
History of prior organ transplantation (participants with a history of failed kidney transplant or corneal transplants are not excluded)
Scheduled organ transplant from a living donor and participants on the kidney transplant wait-list who are expected to receive a transplant within 6 months
History of a prior hematopoietic stem cell or bone marrow transplant (stem cell therapy for knee arthritis is not excluded)
Known hypersensitivity to Vadadustat, Epoetin Alfa, or any of their excipients
Any prior use of a hypoxia-inducible factor prolyl-hydroxylase (HIF-PH) inhibitor or any use of an investigational medication within 30 days or 5 half-lives of the investigational medication (whichever is longer), prior to randomization

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;
not considered post-menopausal (no menses for >1 year with follicle stimulating hormone >40 U/Liter at 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;
positive serum pregnancy test at SV2;
unwilling to use two acceptable forms of contraception* (at least one of which must be a barrier method) starting Baseline/Day 1, throughout the Treatment Period and for 30 days after the final study drug administration
Breastfeeding during Screening or throughout the Treatment Period and for 30 days after the final study drug administration
Donation of ova starting at Screening, throughout the Treatment Period, and for 30 days after the final study drug administration
Male participants who have not had a vasectomy and do not agree to the following: use of an acceptable form of contraception* during the study and for 30 days after the last dose of the study drug; to not donate semen during the study and for at least 30 days after the last dose of Vadadustat
Participants with bilateral native nephrectomy

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;
Placement of an intrauterine device or intrauterine system;
Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.

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
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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 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 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 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
Result Group Id 56112570 Result Group Id 56112572 Result Group Id 56112573 Result Group Id 56112574 Result Group Id 56112571 Result Group Id 56112572 Result Group Id 56112573 Result Group Id 56112574 Result Group Id 56112575 Result Group Id 56112575 Result Group Id 56112576 Result Group Id 56112577 Result Group Id 56112569 Result Group Id 56112570 Result Group Id 56112569 Result Group Id 56112570 Result Group Id 56112571 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 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 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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 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 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 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 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
Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 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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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 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 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 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 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 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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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 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 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
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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab 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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MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0
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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 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: 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
Email 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 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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 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 56112562 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 56112541 Result Group Id 56112542 Result Group Id 56112550 Result Group Id 56112544 Result Group Id 56112545 Result Group Id 56112541 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 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 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 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 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 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 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 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 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 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 56112567 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112543 Result Group Id 56112544 Result Group Id 56112545 Result Group Id 56112563 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 56112564 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 56112545 Result Group Id 56112546 Result Group Id 56112547 Result Group Id 56112548 Result Group Id 56112566 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 56112546 Result Group Id 56112547 Result Group Id 56112548 Result Group Id 56112568 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 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 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
Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG008 Ctgov Group Code OG006 Ctgov Group Code OG007 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 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 OG000 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 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 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 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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) 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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 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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
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Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type 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

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<![CDATA[ Vibration Impact on Parkinson’s Tremor ]]>
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).
<![CDATA[

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
Tremor caused by their Parkinson's disease
Ability to provide informed consent

Exclusion Criteria:

Known diagnosis of Parkinson Plus Syndrome
Dementia
Other known non-PD cause of tremor
Other known non-PD cause of limb dysfunction
Presence of implantable cardiac device, severe neuropathy or sensory loss that would prevent perception of vibration stimulus
Non-English speaker
Prisoners
Pregnant women

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
Email 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

]]>

<![CDATA[ Docetaxel Combined With Carboplatin Plus Anlotinib as First Line Treatment in NSCLC ]]>
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.
Email 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
Email 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.
Patients with histologic or cytologic confirmation of advanced or metastatic Non squamous NSCLC with stage IIIB or IV disease.(For recurrent patients, adjuvant chemotherapy, neoadjuvant chemotherapy or neoadjuvant chemotherapy plus adjuvant were assessed for eligibility, and the last treatment time must be more than 6 months before enrollment)
There were at least one target lesions in the past three months has not yet accepted radiotherapy, and could be recorded by magnetic resonance imaging (MRI) or computer tomography (CT) measuring accurately at least in one direction(The maximum diameter needs to be recorded), including conventional CT ≥20 mm or spiral CT ≥10 mm.
Life expectancy ≥6 months
a performance status of 0 or 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Status.
With normal marrow, liver ,renal and coagulation function:
The blood routine examination need to be standard (no blood transfusion and blood products within 14 days, no g-csf and other hematopoietic stimulating factor correction)
The main organs function are normally, the following criteria are met:(1)Blood routine examination criteria should be met (no blood transfusion and blood products within 14 days, no correction by G-CSF and other hematopoietic stimuli): HB≥90 g/L; ANC ≥ 1.5×10^9/L; PLT ≥80×10^9/L;(2)Biochemical examinations must meet the following criteria: TBIL<1.5×ULN; ALT and AST < 2.5×ULN, and for patients with liver metastases < 5×ULN; Serum Cr ≤ 1.25×ULN or endogenous creatinine clearance > 60 ml/min (Cockcroft-Gault formula);

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;
Postmenopausal women under the age of 50 May also be considered postmenopausal if their amenorrhea is 12 months or more after the cessation of all exogenous hormone therapy and their luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels are within the reference value range of laboratory postmenopausal;
Have undergone irreversible sterilization surgery, including hysterectomy, bilateral ovectomy or bilateral salpingectomy, except for bilateral tubal ligation.
For men, consent is required to use appropriate methods of contraception or to be surgically sterilized during the trial and 8 weeks after the last administration of the trial drug.

Exclusion Criteria:

Small cell lung cancer (including lung cancer mixed with small cell lung cancer and non-small cell lung cancer), Lung sarcomatoid carcinoma;
Had histologically confirmed lung squamous cell carcinoma, or adenosquamous carcinoma;
Patients with pathological fracture in bone metastasis induced by non-small-cell lung cancer;
Tumor histology or cytology confirmed EGFR mutagenesis [EGFR sensitive mutations include 18 exon point mutations (G719X), 19 exon deletions, 20 exon S768I mutations and 21 exon point mutations (L858R and L861Q)] and ALK gene rearrangement positivity, include EGFR/ALK status cannot be determined for various reasons;
Imaging (CT or MRI) shows that the distance between tumor lesion and the large blood vessel is ≤ 5 mm, or there is a central tumor that invades the local large blood vessel; or there is a significant pulmonary cavity or necrotizing tumor; Medical history and combined history:
Active brain metastases, cancerous meningitis, spinal cord compression, or imaging CT or MRI screening for brain or pia mater disease (a patient with brain metastases who have completed treatment and stable symptoms in 28 days before enrollment may be enrolled, but should be confirmed by brain MRI, CT or venography evaluation as no cerebral hemorrhage symptoms and metastases in midbrain, pons, cerebellum, medulla oblongata, or spinal cord, brain metastases and local radiotherapy after two weeks to allow group);
The patient is participating in other clinical studies or completing the previous clinical study in less than 4 weeks;
Had malignant tumors except NSCLC within 5 years before enrollment(except for patients with carcinoma in situ of the cervix , basal cell or squamous cell skin cancer who have undergone a curative treatment, local prostate cancer after radical resection, ductal carcinoma in situ or papillary thyroid cancer after radical resection);
Abnormal blood coagulation (INR > 1.5 or prothrombin time (PT) > ULN + 4 seconds or APTT > 1.5 ULN), with bleeding tendency or undergoing thrombolytic or anticoagulant therapy; Note: Under the condition of prothrombin time international normalized ratio (INR) ≤ 1.5, low-dose heparin (adult daily dose of 0.6 million to 12,000 U) or low-dose aspirin (daily dosage ≤ 100 mg) is allowed for preventive purposes;
Renal insufficiency: urine routine indicates urinary protein ≥ ++, or confirmed 24-hour urine protein ≥ 1.0g;
The effects of surgery or trauma have been eliminated for less than 14 days before enrollment in subjects who have undergone major surgery or have severe trauma;
Severe acute or chronic infections requiring systemic treatment; Suffering from severe cardiovascular disease: myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmias (including men with QTc interval ≥ 450 ms, women ≥ 470 ms); according to NYHA criteria, grades III to IV Insufficient function, or cardiac color Doppler ultrasound examination indicates left ventricular ejection fraction (LVEF) <50%;
There is currently a peripheral neuropathy of ≥CTCAE 2 degrees, except for trauma;
Respiratory syndrome (≥CTC AE grade 2 dyspnea), serous effusion (including pleural effusion, ascites, pericardial effusion) requiring surgical treatment; Long-term unhealed wounds or fractures;
Decompensated diabetes or other ailments treated with high doses of glucocorticoids;
Factors that have a significant impact on oral drug absorption, such as inability to swallow, chronic diarrhea, and intestinal obstruction;
Clinically significant hemoptysis (daily hemoptysis greater than 50ml) within 3 months prior to enrollment; or significant clinically significant bleeding symptoms or defined bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood ++ and above, or suffering from vasculitis;
Events of venous/venous thrombosis occurring within the first 12 months prior to enrollment, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism;

Physical examination and laboratory findings:

A known history of HIV testing positive or acquired immunodeficiency syndrome (AIDS);
Untreated active hepatitis (hepatitis b: HBsAg positive and HBV DNA more than 1 x 103 copy /ml; Hepatitis c: HCV RNA is positive and liver function is abnormal); Combined with hepatitis b and hepatitis c infection;
Serious diseases that endanger patients' safety or affect patients' completion of research,according to the researchers' judgment.

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

]]>

<![CDATA[ Transmitted Lung Pressures With Biphasic Chest Cuirass ]]>
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
Undergo circumcision, hypospadias repair, or orchidopexy in the operating room of the John R. Oishei Children's Hospital

Exclusion Criteria:

Previous history of chronic lung disease or cyanotic heart disease or
Patients with significant chest wall abnormalities or other abnormalities that preclude proper placement of the biphasic chest cuirass.

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.

]]>

<![CDATA[ Internal Limiting Membrane and Macular Hole ]]>
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
Email 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
Email ngcpferreira@gmail.com Email 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
Male or female aged 18 years or older
Visual symptoms due to IMH
Intraocular pressure inferior to 21 mmHG
Signed informed consent form

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.

]]>

<![CDATA[ Neurosteroids for PTSD in Veterans ]]>
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
Email Virginia.Rhodes@va.gov Email 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
Email jennifer.naylor2@va.gov Email 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
No anticipated need to alter psychiatric medications for duration of study involvement
Ability to participate fully in the informed consent process

Exclusion Criteria:

History of allergy to pregnenolone
Medical disorders that may preclude safe administration of pregnenolone or exacerbate PTSD symptoms

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
prostate
uterine or breast cancer
others (at the discretion of the PI and medical oversight team)
Medical conditions not well controlled will be excluded, at the discretion of the PI and Medical Team

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
mood stabilizers such as carbamazepine, divalproex, lamotrigine, topiramate
atypical antipsychotics, and other agents including prazosin
However, there may be no changes in psychotropic medications for PTSD 4 weeks prior to study randomization
Benzodiazepine use
Current diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, or cognitive disorder due to a general medical condition other than mild TBI (assessed at screening)

Initiation or change in psychotherapy within 3 months of randomization

i.e., psychotherapy must be stable for 3 months prior to study start
Participants on hormonal therapies such as finasteride or hormonal birth control
Female participants who are pregnant or breast-feeding

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

]]>

<![CDATA[ [Trial of device that is not approved or cleared by the U.S. FDA] ]]>
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]

]]>

<![CDATA[ Bioequivalence Study of Sotalol, Tablets, 160 mg (Pharmtechnology LLC, Belarus), and Sotalex ®, Tablets, 160 mg (Bristol-Myers Squibb GmbH & Co. KGaA, Germany), in Healthy Volunteers Under Fasting Conditions ]]>
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
Body mass index 18.5-30 kg/m²
Subjects who have no signs of disease during the screening, and whose screening is conducted within 21 days after the registration in the trial
Subjects whose laboratory blood and urine values are within the normal range orof deviations are considered by researchers to be clinically insignificant
Non-smokers or ex-smokers (defined as completely quitting smoking for at least three months prior to being included in the test)
No known history of alcohol abuse
No known history of abuse of drugs (benzodiazepines, opioids, cocaine, barbiturates, amphetamine, etc.)
Willingness to comply with the protocol requirements regarding the restriction of the consumption of products containing xanthine (coffee, tea, chocolate, cola, etc.) for at least 48 hours and products containing tobacco, alcohol-containing products and beverages, grapefruit and/or its juice, food containing poppy at least 72 hours prior taking the investigational medicinal products and over the course of the study, as well as requirements regarding the intake of food, fluids and physical activity imposed by the study
Healthy subject according to medical history, physical examination and assessment of basic vital signs
No significant abnormalities on 12-lead ECG
No significant abnormalities on the chest x-ray obtained within 12 months prior the start of the study
Consent of women of childbearing age and male participants to use medically confirmed barrier methods of contraception (from the date of screening to the completion of the study), or surgical sterilization in history, or women in postmenopause (at least 24 months) or hysterectomy in history . If women use hormonal contraceptives,they should stop them at least 60 days prior the planned beginning of the study
The subject's voluntary willingness to provide written informed consent
The ability, at disceretion of the researcher, to follow all the requirements of the protocol
The ability, at judgment of the researcher, to follow all the requirements of the protocol

Exclusion Criteria:

Known history of allergy
Known contraindications to the use of investigational products or hypersensitivity to the active substance or components of drugs
Use of drugs with enzymatic-modifying activity, within 28 days prior the beginning of the study
Use any over-the-counter or prescription drugs (including vitamins, minerals, herbal remedies, and dietary supplements) within 14 days prior the administration of investigational products and over the course of the study
Intense physical exercises within 24 hours prior to the administration of investigational products
Any medical or surgical interventions that can disrupt the function of the hematopoietic system, the gastrointestinal tract (with the exception of appendectomy), the liver, urinary system and other body systems
Any chronic diseases or conditions of the urinary, cardiovascular, neuroendocrine, immune, central nervous systems, hematopoietic system, gastrointestinal tract, liver, organs of vision and other systems of the body and diabetes in medical history, mental illness in an active phase or the history
The presence of any hereditary disease
Participation in any clinical trials within 90 days prior the beginning of the current clincial study
Oncological diseaes in medical history
Any blood donation within 90 days prior the beginning of the current clincial study
Acute infectious diseases within 28 days prior the beginning of the current clincial study as well as positive testing for HIV, hepatitis B and C, and syphilis
Positive test for alcohol
Positive urinary screen test for drugs of abuse
Swallowing problems in mediical history
Positive urinary pregnancy test
Breast-feeding
Known history of venous access difficulties
Vegetarian diet
Sitting systolic blood pressure < 110 mm Hg or > 140 mm Hg and/or sitting diastolic blood pressure < 70 mm Hg or > 90 mm Hg.Heart rate <50 or >100 beats per minute at screening check-in
Values of the standard laboratory and instrumental tests outside of normal limits and are judged as clinically significant by investigators or require additional examination and interpretation.

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

]]>

<![CDATA[ Demonstration of a Novel Approach Using Surface-Image Guidance to Improve Delivery of Breast Radiotherapy ]]>
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
Biologically female
Ability to provide informed written consent in either English or Spanish
Surgical pathology and staging scans must demonstrate Ductal carcinoma in situ (DCIS) or invasive breast cancer, Stages 0, 1, 2, and 3
Patient will undergo adjuvant radiation therapy as a part of multimodality breast cancer treatment with plans for tangent field radiation treatment with or without loco-regional lymph node targeting, based on the clinical judgement of the treating physician
Willingness to maintain temporary skin markings for a part of their of radiation therapy duration
Absence of any conditions that may affect ability to have either tattoos or skin markings, as discussed in Exclusion Criteria

Exclusion Criteria:

Age < 18 years
Biologically non-female
Inability or unwillingness of subject to give written informed consent
Patients found at presentation to have very locally-advanced cancer (e.g. inflammatory breast cancer) or metastatic breast cancer (Stage 4)
Patients that will be treated with a deep-inspiration breath hold technique (typically younger patients being treated for left-sided tumors)
Current pregnancy, as this is a contraindication to receiving radiation therapy
History of prior radiotherapy to the chest wall or torso
Known allergy / sensitivity to standard medical marking tattoo ink (by design non-toxic, low-allergy), skin marking paint, or medical tape (e.g. Tegaderm)
Active drug or alcohol use or dependence evidenced by patient record and/or self-report that, in the opinion of the investigator, would interfere with adherence to daily radiation therapy

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

]]>

<![CDATA[ Anti-Schistosomiasis Vaccine: Sm14 Phase 2b-Sn in School Children ]]>
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.
Residence in the area during the period of the study.
Free of obvious/severe health problems except schistosomiasis, as established by clinical examination.
Written informed consent to participate obtained from subject's parents or legal guardian.
Free of obvious/severe health problems except schistosomiasis, established by blood analysis, i.e. hematological exams, liver and renal function tests.
Treated with 40mg/kg Praziquantel (PZQ) before inclusion (W-2 to W-4 before the first injection) in case of infection with S. mansoni and S. haematobium
Children of Group 1: not infected, no schistosomiasis history and living in area/village free of Sm and Sh transmission.
Children Groups 2 & 3: infected with mansoni or/and haematobium schistosomiasis.

Exclusion Criteria:

School child who does not respond to one of the inclusion criteria
Child under 20kg of body weight
Vaccination within 90 days preceding the first dose of Sm14 vaccine candidate, or planned use during the study period.
Current or previous chronic administration (defined as more than 14 days) of immunosuppressive drugs or other immuno-modifying drugs.
Known hypersensitivity to any component in the Sm14 vaccine or history of allergic disease.
Knowledge of non-infectious chronic disease
Known acute disease.
Other conditions which in opinion of the PI may potentially represent a danger for the patient to be enrolled.

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):

]]>

<![CDATA[ Neural Correlates of Self Body-shape Recognition in Anorexia Nervosa Mental ]]>
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)
With medical insurance
With normal vision
Only for the AN Group : Diagnosis of Anorexia Nervosa (AN) restrictive for at least one year and with a Body Masse index (BMI) between 14 and 18
Only for the control Group : BMI between 18 and 25 and without any psychiatric disorder

Exclusion Criteria:

Pregnant or breast-feeding women
With antecedent or current neurologic disease
With antecedent or current ophthalmologic disease
Contraindication for IRMf

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

]]>

<![CDATA[ Botulinum Toxin Type A Injection After Topical Anesthesia Versus Petrolatum Ointment ]]>
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.
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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
Perception of pain immediately after injection at each side
Patient satisfaction for each side
Patient's perception of difference in efficacy

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
Presence of horizontal forehead rhytides
Good eyebrow excursion (greater than or equal to 5 mm)
Able to understand and sign an informed consent form that has been approved by the Committee for the Protection of Human Subjects

Exclusion Criteria:

Previous injection of botulinum toxin in the intended treatment area for the study within the last 4 months
Known allergy to botulinum toxin
Known history of sensitivity to local anesthetics of the amide type
Existing disorder of neuromuscular transmission
Usage of medication with effect on neuromuscular function
Women of childbearing potential (who are not postmenopausal for at least 1 year or surgically sterile), who are pregnant or nursing or intend to become pregnant during the time of the study
Significant brow asymmetry (> 5mm)
Unable to follow-up for the duration of the study (16 weeks)

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
Email 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

]]>

<![CDATA[ Somatosensory Profiles in Individuals With Persistent Musculoskeletal Pain and Inflammatory Bowel Disease ]]>
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)
Clinical diagnosis of IBD or healthy control

Exclusion Criteria: Participants with IBD (with and without MSK pain) will be excluded if they report any of the following:

pregnancy
current history of drug or alcohol abuse
any condition resulting in altered sensation such as: nerve injuries, neurological conditions (e.g. stroke, multiple sclerosis, and Parkinson's disease)
surgery within the last 3 months

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

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Positive emotional style predicts resistance to illness after experimental exposure to rhinovirus or influenza a virus. Psychosom Med. 2006 Nov-Dec;68(6):809-15. doi: 10.1097/01.psy.0000245867.92364.3c. Epub 2006 Nov 13. Citation Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063. Citation Edwards RR, Smith MT, Stonerock G, Haythornthwaite JA. Pain-related catastrophizing in healthy women is associated with greater temporal summation of and reduced habituation to thermal pain. Clin J Pain. 2006 Oct;22(8):730-7. doi: 10.1097/01.ajp.0000210914.72794.bc. Citation Buchholz I, Janssen MF, Kohlmann T, Feng YS. A Systematic Review of Studies Comparing the Measurement Properties of the Three-Level and Five-Level Versions of the EQ-5D. Pharmacoeconomics. 2018 Jun;36(6):645-661. doi: 10.1007/s40273-018-0642-5. Citation Schoepfer AM, Vavricka S, Zahnd-Straumann N, Straumann A, Beglinger C. Monitoring inflammatory bowel disease activity: clinical activity is judged to be more relevant than endoscopic severity or biomarkers. J Crohns Colitis. 2012 May;6(4):412-8. doi: 10.1016/j.crohns.2011.09.008. Epub 2011 Oct 14. Citation Siegel CA, Whitman CB, Spiegel BMR, Feagan B, Sands B, Loftus EV Jr, Panaccione R, D'Haens G, Bernstein CN, Gearry R, Ng SC, Mantzaris GJ, Sartor B, Silverberg MS, Riddell R, Koutroubakis IE, O'Morain C, Lakatos PL, McGovern DPB, Halfvarson J, Reinisch W, Rogler G, Kruis W, Tysk C, Schreiber S, Danese S, Sandborn W, Griffiths A, Moum B, Gasche C, Pallone F, Travis S, Panes J, Colombel JF, Hanauer S, Peyrin-Biroulet L. Development of an index to define overall disease severity in IBD. Gut. 2018 Feb;67(2):244-254. doi: 10.1136/gutjnl-2016-312648. Epub 2016 Oct 25. Citation Peyrin-Biroulet L, Panes J, Sandborn WJ, Vermeire S, Danese S, Feagan BG, Colombel JF, Hanauer SB, Rycroft B. Defining Disease Severity in Inflammatory Bowel Diseases: Current and Future Directions. Clin Gastroenterol Hepatol. 2016 Mar;14(3):348-354.e17. doi: 10.1016/j.cgh.2015.06.001. Epub 2015 Jun 11. Citation Jensen MP, Tome-Pires C, de la Vega R, Galan S, Sole E, Miro J. What Determines Whether a Pain is Rated as Mild, Moderate, or Severe? The Importance of Pain Beliefs and Pain Interference. Clin J Pain. 2017 May;33(5):414-421. doi: 10.1097/AJP.0000000000000429. Citation Gershon RC, Rothrock N, Hanrahan R, Bass M, Cella D. The use of PROMIS and assessment center to deliver patient-reported outcome measures in clinical research. J Appl Meas. 2010;11(3):304-14. Citation Williamson A, Hoggart B. Pain: a review of three commonly used pain rating scales. J Clin Nurs. 2005 Aug;14(7):798-804. doi: 10.1111/j.1365-2702.2005.01121.x. Citation Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Hauser W, Katz RL, Mease PJ, Russell AS, Russell IJ, Walitt B. 2016 Revisions to the 2010/2011 fibromyalgia diagnostic criteria. Semin Arthritis Rheum. 2016 Dec;46(3):319-329. doi: 10.1016/j.semarthrit.2016.08.012. Epub 2016 Aug 30. Citation Neblett R, Cohen H, Choi Y, Hartzell MM, Williams M, Mayer TG, Gatchel RJ. The Central Sensitization Inventory (CSI): establishing clinically significant values for identifying central sensitivity syndromes in an outpatient chronic pain sample. J Pain. 2013 May;14(5):438-45. doi: 10.1016/j.jpain.2012.11.012. Epub 2013 Mar 13. Citation Mayer TG, Neblett R, Cohen H, Howard KJ, Choi YH, Williams MJ, Perez Y, Gatchel RJ. The development and psychometric validation of the central sensitization inventory. Pain Pract. 2012 Apr;12(4):276-85. doi: 10.1111/j.1533-2500.2011.00493.x. Epub 2011 Sep 27. Citation Whitton TL, Johnson RW, Lovell AT. Use of the Rydel-Seiffer graduated tuning fork in the assessment of vibration threshold in postherpetic neuralgia patients and healthy controls. Eur J Pain. 2005 Apr;9(2):167-71. doi: 10.1016/j.ejpain.2004.05.001. Citation Rolke R, Baron R, Maier C, Tolle TR, Treede -DR, Beyer A, Binder A, Birbaumer N, Birklein F, Botefur IC, Braune S, Flor H, Huge V, Klug R, Landwehrmeyer GB, Magerl W, Maihofner C, Rolko C, Schaub C, Scherens A, Sprenger T, Valet M, Wasserka B. Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values. Pain. 2006 Aug;123(3):231-243. doi: 10.1016/j.pain.2006.01.041. Epub 2006 May 11. Erratum In: Pain. 2006 Nov;125(1-2):197. Citation Feng Y, Schlosser FJ, Sumpio BE. The Semmes Weinstein monofilament examination as a screening tool for diabetic peripheral neuropathy. J Vasc Surg. 2009 Sep;50(3):675-82, 682.e1. doi: 10.1016/j.jvs.2009.05.017. Epub 2009 Jul 30. Citation Olaleye D, Perkins BA, Bril V. Evaluation of three screening tests and a risk assessment model for diagnosing peripheral neuropathy in the diabetes clinic. Diabetes Res Clin Pract. 2001 Nov;54(2):115-28. doi: 10.1016/s0168-8227(01)00278-9. Citation Schreuders TA, Selles RW, van Ginneken BT, Janssen WG, Stam HJ. Sensory evaluation of the hands in patients with Charcot-Marie-Tooth disease using Semmes-Weinstein monofilaments. J Hand Ther. 2008 Jan-Mar;21(1):28-34; quiz 35. doi: 10.1197/j.jht.2007.07.020. Citation Alqarni AM, Manlapaz D, Baxter D, Tumilty S, Mani R. Test Procedures to Assess Somatosensory Abnormalities in Individuals with Peripheral Joint Pain: A Systematic Review of Psychometric Properties. Pain Pract. 2018 Sep;18(7):895-924. doi: 10.1111/papr.12680. Epub 2018 Mar 6. Citation Neziri AY, Scaramozzino P, Andersen OK, Dickenson AH, Arendt-Nielsen L, Curatolo M. Reference values of mechanical and thermal pain tests in a pain-free population. Eur J Pain. 2011 Apr;15(4):376-83. doi: 10.1016/j.ejpain.2010.08.011. Epub 2010 Oct 6. Citation Neziri AY, Limacher A, Juni P, Radanov BP, Andersen OK, Arendt-Nielsen L, Curatolo M. Ranking of tests for pain hypersensitivity according to their discriminative ability in chronic neck pain. Reg Anesth Pain Med. 2013 Jul-Aug;38(4):308-20. doi: 10.1097/AAP.0b013e318295a3ea. Citation Mlekusch S, Neziri AY, Limacher A, Juni P, Arendt-Nielsen L, Curatolo M. Conditioned Pain Modulation in Patients With Acute and Chronic Low Back Pain. Clin J Pain. 2016 Feb;32(2):116-21. doi: 10.1097/AJP.0000000000000238. Citation Yarnitsky D, Bouhassira D, Drewes AM, Fillingim RB, Granot M, Hansson P, Landau R, Marchand S, Matre D, Nilsen KB, Stubhaug A, Treede RD, Wilder-Smith OH. Recommendations on practice of conditioned pain modulation (CPM) testing. Eur J Pain. 2015 Jul;19(6):805-6. doi: 10.1002/ejp.605. Epub 2014 Oct 20. Citation LeResche L, Turner JA, Saunders K, Shortreed SM, Von Korff M. Psychophysical tests as predictors of back pain chronicity in primary care. J Pain. 2013 Dec;14(12):1663-70. doi: 10.1016/j.jpain.2013.08.008. Citation Vuilleumier PH, Biurrun Manresa JA, Ghamri Y, Mlekusch S, Siegenthaler A, Arendt-Nielsen L, Curatolo M. Reliability of Quantitative Sensory Tests in a Low Back Pain Population. Reg Anesth Pain Med. 2015 Nov-Dec;40(6):665-73. doi: 10.1097/AAP.0000000000000289. Citation Meeus M, Roussel NA, Truijen S, Nijs J. Reduced pressure pain thresholds in response to exercise in chronic fatigue syndrome but not in chronic low back pain: an experimental study. J Rehabil Med. 2010 Oct;42(9):884-90. doi: 10.2340/16501977-0595. Citation Gerhardt A, Eich W, Janke S, Leisner S, Treede RD, Tesarz J. Chronic Widespread Back Pain is Distinct From Chronic Local Back Pain: Evidence From Quantitative Sensory Testing, Pain Drawings, and Psychometrics. Clin J Pain. 2016 Jul;32(7):568-79. doi: 10.1097/AJP.0000000000000300. Citation Marcuzzi A, Wrigley PJ, Dean CM, Adams R, Hush JM. The long-term reliability of static and dynamic quantitative sensory testing in healthy individuals. Pain. 2017 Jul;158(7):1217-1223. doi: 10.1097/j.pain.0000000000000901.

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<![CDATA[ High-Definition Transcranial Direct Current Stimulation (HD-tDCS) for Sensory Deficits in Complex Traumatic Brain Injury ]]>
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,
have suffered a mild TBI (alteration in neurological functioning < 24 hours, loss of consciousness (LOC) less than 30 minutes, Glasgow coma scale (GCS) score (if available) of between 13 and 15 acutely, and less than 24 hours of post-traumatic amnesia (PTA));
were injured between 3 months and 15 years ago;
have post-traumatic sensory symptoms as evidenced by endorsing at least 2 out of 12 sensory symptoms on the Neurobehavioral Symptom Inventory (NSI), a measure of post-traumatic symptoms from the NIH Common Data Elements (CDE) to a severity of "3" or higher,
are fluent in English,
have been on stable doses of any psychotropic medications for the past 2 months.
The imaging-only group will have the same inclusion and exclusion criteria except they will not have had a head injury.

Exclusion Criteria:

any history of moderate or severe TBI;
a prior history of other neurological disease or any history of seizures beyond immediate post-traumatic seizure, to as to reduce risk of exacerbation of epilepsy or other neurological symptoms;
history of psychosis, so as to reduce risk of psychiatric decompensation;
history of current or recent (within two years) substance/alcohol dependence, to reduce confounding effects on cognition and plasticity;
any discontinuity in skull electrical conductivity (i.e., unhealed burr holes in scalp) or artificially constructed (metal or plastic) craniotomy cover, to reduce risk of unimpeded electrical current;
presence of any implanted electrical device (e.g. pacemaker), to reduce risk of device malfunction;
recent medical hospitalization (within three weeks), to reduce risk of medical decompensation during the study;
any condition that would prevent the subject from completing the protocol; 9) appointment of a legal representative, as assessed via direct inquiry of the subject and a designated trusted other, to avoid coercion of a vulnerable population;

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

]]>

<![CDATA[ Ipilimumab, Nivolumab, and Radiation Therapy in Treating Patients With HPV Positive Advanced Oropharyngeal Squamous Cell Carcinoma ]]>
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
Email 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)
Clinical American Joint Committee on Cancer (AJCC) 7th edition stage T1N2a-N2CM0, T2N1-N2CM0, T3N0-N2CM0, equivalent to AJCC 8th edition stage 1 and 2 (T1 N2, T2 N1-N2, T3 N0-N2) excluding T1N0-N1 and T2N0 (Brian O'Sullivan et al. 2016)
Tumor positive for p16 immunohistochemistry (IHC) (defined as greater than 70% strong nuclear or nuclear and cytoplasmic staining of tumor cells) and HPV DNA in situ hybridization or HPV messenger ribonucleic acid (mRNA) RNAScope. Repeat samples may be required if adequate diagnostic tissue is unavailable for testing
Zubrod Performance Status of 0-1
Patients must have radiographically evident measurable disease at the primary site or at nodal stations per response evaluation criteria in solid tumors (Response Evaluation Criteria in Solid Tumors [RECIST]) 1.1 documented by diagnostic quality CT or magnetic resonance imaging (MRI) of the neck with contrast within 28 days prior to registration; a FDG-PET/CT of the neck performed for the purposes of radiation planning is acceptable as a substitute if the CT is of diagnostic quality
Diagnostic quality cross sectional imaging of the thorax within 28 days prior to registration. A 18-FDG-PET/CT or conventional CT are acceptable
FDG-PET/CT of the neck is required within 28 days prior to registration for comparison to post treatment FDG-PET/CT. Note: Repeat imaging for variability within 96 hours of this time frame should be allowed to avoid unnecessary re-imaging and its financial and potential physical consequences for patients
History and physical exam within 1 month prior to registration
Fiberoptic exam with laryngopharyngoscopy (mirror and/or fiberoptic and/or direct procedure) by radiation oncologist, medical oncologist or ear, nose, throat (ENT)/head and neck surgeons within 28 days prior to registration
Absolute neutrophil count (ANC) >= 1,500 cells/mm^3 (within 2 weeks prior to registration)
Platelets >= 100,000 cells/mm^3 (within 2 weeks prior to registration)
Hemoglobin >= 8.0 g/dl (within 2 weeks prior to registration); Note: The use of transfusion or other intervention to achieve Hgb >= 8.0 g/dl is acceptable
Serum creatinine < 1.5 mg/dl or creatinine clearance (CC) >= 50 ml/min determined by 24-hour collection or estimated by Cockcroft-Gault formula (within 2 weeks prior to registration)
Bilirubin < 2 mg/dl (within 2 weeks prior to registration)
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 3 x the upper limit of normal (within 2 weeks prior to registration)
Sodium (Na), potassium (K), chloride (Cl), glucose, calcium (Ca), magnesium (Mg), albumin, amylase, lipase, thyroid stimulating hormone (TSH) within 2 weeks prior to registration
Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential
Seronegative for active hepatitis-B or hepatitis-C infection and seronegative for human immunodeficiency virus (HIV)
Mandatory submission of hematoxylin and eosin (H&E) and paraffin-embedded tumor block or unstained slides

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
Carcinoma of the neck of unknown primary site origin (even if p16 positive)
Definitive clinical or radiologic evidence of metastatic disease or adenopathy below the clavicles
Gross total excision of both primary and nodal disease with curative intent; this includes tonsillectomy, local excision of primary site, and nodal excision that removes all clinically and radiographically evident disease
Simultaneous primary cancers or separate bilateral primary tumor sites
Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 1095 days (3 years) (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible)
Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable; patients who have received PD-1/PD-L1 or CTLA4 therapy for a previous malignancy are not eligible
Prior RT to the region of the study cancer that would result in overlap of radiation therapy fields
Severe, active co-morbidity defined as any of the following: Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months; acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration; chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration; hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; a diagnosis of immunodeficiency or use of any form of systemic immunosuppressive therapy. The use of physiologic doses of corticosteroids may be approved after consultation with the sponsor
Active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Steroid premedications for contrast allergy allowed
Has evidence of active, non-infectious pneumonitis
Has received a live vaccine within 30 days of planned start of study therapy
Pregnancy or breast-feeding; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic
History of severe hypersensitivity or contraindication to CT or PET contrast material uncontrolled with pre-medications (steroids, antihistamines)

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

]]>

<![CDATA[ Collaborative Organizational Approach to Selecting and Tailoring Implementation Strategies ]]>
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.

]]>

<![CDATA[ Cognitive Bias Modification for OCD ]]>
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
Email 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
Email 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
For CBM-I condition only: report a score of at least 131 on the Obsessive Beliefs Questionnaire-44 upon admission to the OCD Institute
For AAT condition only: endorse score of at least 7 on the DOCS subscale #1 (contamination subscale) upon admission to the OCD Institute
Able to complete a computer task for 20 minutes
Consent to main OCD Institute study protocol

Exclusion Criteria:

Currently undergoing electroconvulsive therapy (ECT)
Current symptoms of acute mania or psychosis
A reported diagnosis at admission of a psychotic disorder
History of traumatic brain injury

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

]]>

<![CDATA[ Vitamin D Supplementation for Acute Bronchiolitis ]]>
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
Basal serum vitamin D3 (The 25-hydroxy vitamin D): was done before enrollment of patients in the randomized trial.

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).
|Two ml blood was delivered into plain tube and centrifuged to obtain a clear non hemolyzed serum which was used for performing 25 (OH) vitamin D assays. The specimens were stored at – 20 until the time of the analysis. The serum 25 (OH) D levels were measured using the Enzyme-Linked Immunosorbent Assay (ELISA) method.

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.
Marked tachypnea.
Intercostal retractions indicating respiratory distress.
Inability to maintain oral hydration.
Parent unable to care for child at home.

Exclusion Criteria:

Infants with history of prematurity (< 37 weeks), chronic cardiopulmonary disease, immunodeficiency, neuromuscular disease, and any other chronic medical condition.
Patients receiving any micronutrient supplementation or therapies containing vitamin D for 4 weeks prior to the study period.
Infants with previous episodes of wheezing or a physician's diagnosis of asthma.
Patients with acute bronchiolitis having very severe clinical score.

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.

]]>

<![CDATA[ Buckle Me Up!: A Digital Emergency Department Discharge Intervention for Child Car Safety ]]>
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
Adolescents with significant developmental delay
Adolescents who are critically injured
No parent/guardian present at time of enrollment

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

]]>

<![CDATA[ DRIHNC – Dehydration Reduction in Head & Neck Cancer ]]>
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.
ECOG Performance status 0-2.
Life expectancy of ≥ 3 months, in the opinion of and as documented by the investigator.
Subjects must have organ and marrow function based on lab values deemed acceptable to proceed with radiation therapy. No additional or specific lab value cutoffs are required for this protocol given the nature of the intervention. General guidelines are provided below.
Hemoglobin ≥ 7 g/dl
Absolute neutrophil count ≥ 500/mcL
Platelet count ≥ 50,000/mcL
Total bilirubin within normal institutional limits
Subjects must have the ability to understand and the willingness to sign a written informed consent document.
HIV-positive subjects on combination antiretroviral therapy are eligible.

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.
Patients with active, uncontrolled, symptomatic volume overload congestive heart failure.

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

]]>

<![CDATA[ The Feasibility of Drug Delivery to Infants During Breastfeeding ]]>
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
Infant not feeding properly
Allergy or hypersensitivity against any ingredient of the commercially available Methylcobalamin Vitamin B12 Tablets (Just Vitamins Ltd, UK) used in the study (infant or mother)
Medical conditions that could negatively influence swallowing, and thus 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.

]]>

<![CDATA[ Study on Impact of Maximal Strength Training in Patients With COPD ]]>
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
Email mara.paneroni@icsmaugeri.it Email 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.
ET – A cycling session will follow the MST and last 40 minutes at constant-load, starting from a load intensity corresponding to patient specific AT. The intensity will be gradually increased with a symptom-based progression.

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
Email mara.paneroni@icsmaugeri.it Email 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
stable clinical condition

Exclusion Criteria:

pulmonary diseases other than COPD
type II diabetes or other metabolic diseases
malign disease
a respiratory tract infection within the last 4 wks
long oxygen therapy use.

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.

]]>

<![CDATA[ Neurocognitive Factors in Substance Use Treatment Response: The Ways of Rewarding Abstinence Project ]]>
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
Email Sarah.Forster2@va.gov Email 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
Email Sarah.Forster2@va.gov Email 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
DSM-5 Criteria for Cocaine Use Disorder (Mild, Moderate, or Severe)
Cocaine Use Within Past 60 Days
Stated Goal of Cocaine Abstinence or Reduced Cocaine Use
Normal or Corrected-to-Normal Vision
Average or Corrected Hearing

Exclusion Criteria:

History of Severe Traumatic Brain Injury, Seizure Disorder, or other Neurological Illness
Severe or Unstable Medical or Psychiatric Condition
Pregnant or Lactating Women
Moderate-to-Severe Neurocognitive Impairment per Medical Record, SLUMS < 21, or Mini MoCA < 11
In Ongoing Residential Treatment or Imminently Expected to Enter Residential Treatment During the Study Interval at Time of Screening

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

]]>

<![CDATA[ Low Dose Multi-OIT for Food Allergy (LoMo) ]]>
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
Serum immunoglobulin E (IgE) >0.35 kilounits/L (kU/L) (determined by UniCAP within the past 12 months) and/or a SPT to nut >3 mm compared to control
Positive oral food challenge (OFC) to less than 300mg of a nut in the nut mix at baseline (cumulative 444mg).

Exclusion Criteria:

History of frequent or repeated, severe or life-threatening episodes of anaphylactic shock
use of omalizumab or other non-traditional forms of allergen immunomodulatory therapy (not including corticosteroids) or biologic therapy in the 12 months prior to study entry
history of eosinophilic gastrointestinal disease, uncontrolled asthma as defined by Global Initiative for Asthma (GINA)
use of beta-blockers(oral)
use of angiotensin-converting enzyme inhibitors (ACE)
fails to tolerate 4mg of peanut after the first desensitization day
Other significant medical conditions that in the opinion of the investigator prevent participation in the study,
Previous intubation due to allergies or asthma,
Symptomatic atopic dermatitis or chronic urticaria which may interfere with ability to evaluate oral immunotherapy and /or requiring daily medication including antihistamines,
Patients with problems related to compliance or following study instructions, Inability to come to hospital every for dose escalation
Pregnancy
Non-fluency in English because participants may need to communicate with us after hours and be able to describe symptoms and concerns and follow instructions to treat anaphylaxis

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

]]>

<![CDATA[ Jail-Based Use of Smoking Cessation Treatment Study ]]>
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
Expected release from the Hennepin Adult Detention Center to the community within 90 days
Age 18-64
English fluency
Lives within 20 minutes of Hennepin County Medical Center and has no plans to move away from area for 4 months
Willing to attempt quitting or reducing smoking at discharge
Has a telephone
Cleared for nicotine lozenge safety by jail health care provider and willing to use at discharge

Exclusion Criteria:

Active tuberculosis
Current mental health crisis (i.e., currently experiencing significant mania, psychosis, or suicidality)
Unable to ambulate independently
Acute medical condition that would impair participant's ability to follow-up for assessments
Expected discharge to a control institutional setting (e.g., locked state mental health facility or prison)
Active pregnancy
Heart attack within the last two weeks

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.

]]>

<![CDATA[ Facilitating Sustainment Through Implementation Feedback: The SIC Coaching Model ]]>
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
Email courtp@oslc.org Email 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
Email lisas@oslc.org Email 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

]]>

<![CDATA[ Approaches for Improving Long-term Weight Loss ]]>
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.
<![CDATA[

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
Female

Exclusion Criteria:

Presence of any condition that would limit one's ability to exercise or lose weight safely
Recent weight loss
Current or recent enrollment in a weight loss or mindfulness-based treatment program
Women who are pregnant or planning on becoming pregnant
History of a serious psychiatric disorder
Recent cancer diagnosis (<1 year)
Does not own a smartphone

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
Email 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

]]>

<![CDATA[ Optimisation of Care in Vulnerable HIV Infected Individuals ]]>
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
A specific follow up will be set up with obligatory visits at week 4, week 12, week 24, week 36 and week 48 to assess the evolution of the previously identified issues. If needed, additional visits will be set up.
Regular (Day 15 and monthly) phone calls will be set up during the first six months of the OPTICARE program.
Each patient will be accompanied by a tutoring nurse who will be in direct contact with the patient.

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 personalized medical follow up with regular phone calls, home visits (if the patient agrees), assistance in taking HIV medication (set up pillbox, therapeutic education)
a close psychological and social support (connection with HIV organizations, participation to monthly support group)
a specific assistance related to dependence issues (connection with addiction organization, sex therapist consultation)

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
Email yasmine.dudoit@aphp.fr Email 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
A nurse
A social worker
A psychological therapist
A cultural mediator/member of patients community if needed for migrants

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
Email yasmine.dudoit@aphp.fr Email 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
In the 6 months period for patients < 250/mm3 CD4 cells or
In the 3 months period following a new HIV + diagnosis or an AIDS defining illnesses

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 presenting with an AIDS defining (<3 months) event in a context of lost to care prior to the event

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)
Migrants with a first arrival in France in the last 6 months
Women in postpartum period (3 months after delivery)
Psychiatric disease
Intravenous drug users, alcohol consumers (women > 40g/day or > 2 standard drinks /day; men > 60g/day ou > 3 standard drinks/day)

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.
Patients with HIV plasma viral load < 50 cp/ml

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

]]>

<![CDATA[ A Six Minute Walking Test Based Index as an Outcome Predictor in COPD Subjects. (Chronic Obstructive Pulmonary Disease) ]]>
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)
Under inhaler therapy for ≥30 days according to guidelines (23)
Smokers or o ex-smokers, smoke history ≥10 pack/years (p/y)
Informed Consent Signature.

Exclusion Criteria:

Associated Comorbidities with short term severe prognosis
Actual Cardiac Arrythmias
Pace-maker
Other associated respiratory diseases
Chronic Heart Failure New York Heart Association classes III, IV.
Use of drugs influencing the heart rate
Changes in drug therapy in the previous 30 days
Use of systemic steroids or antibiotics in the previous 30 days
Unscheduled visits or admission to the Emergency Room for symptoms worsening in the previous 30 days
Pneumonia during the previous 60 days
Myocardial Infarction in the previous 4 months
Subjective and objective inability to perform the 6MWT
Inability to carry the oxygen cylinder.

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.

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<![CDATA[ Fluid Management in the Post Anesthesia Care Unit ]]>
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
Medical history including regular medications
Hemodynamic data including heart rate, automatic non-invasive blood pressure measurements, temperature as well pulse oximetry as routine procedures will be recorded and stored by Metavision system
Anesthetic data including anesthetic method, anesthetic drugs, total fluid intake, anesthetic complications.
Laboratory values
Length of stay in PACU
Length of stay in hospital
Post-operative pulmonary complications
Acute kidney injury

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
Email 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
Email nadavs1@gmail.com Email 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.
Above 18 years old
Not requiring dialysis treatment
Not requiring advanced monitoring (arterial waveform analysis or cardiac output monitoring)
Eligible for signing an informed consent prior to surgery

Exclusion Criteria:

– Pregnancy
Inability to obtain an informed consent
Massive transfusion in OR (more than 5 blood products)
Colloids infusion needed
The requirement for greater than 0.1mcg/kg/min of noradrenaline at arrival to PACU

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.

]]>

<![CDATA[ Combating Dengue With Innovative, Paradigm-shift-Strategies: Early Dengue Surveillance in Adult Aedes Mosquitoes ]]>
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
Control arm: Permai Apartment, Lestari Apartment, Indah Apartment, and Vista 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
Email jonathanliew@um.edu.my Email 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
Reside in the study sites
Work at the study sites for at least 40 hours per week
Able to give consent
Willing to participate in blood taking

Exclusion Criteria:

Age below 18 years
Unable to give consent
Not willing to undergo venepuncture or finger-prick

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.

]]>

<![CDATA[ Decitabine Plus mBU/CY Preconditioning for Relapse/Refractory Acute Leukemia ]]>
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
Email yanchenhua@vip.sina.com Email 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
Email yanchenhua@vip.sina.com Email 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
patients with acute leukemia in the third(or more)complete remission (CR3) status

Exclusion Criteria:

pregnancy women
uncontrolled severe infection

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

]]>

<![CDATA[ Adherence to and Beliefs on Recommendations for Behavioral Treatment for Migraine ]]>
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+
English speaking

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
Email 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

]]>

<![CDATA[ Real World Effectiveness of Combining an Employer-based Weight Management Program With Medication for Chronic Weight Management in Employees With Obesity ]]>
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.
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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
Male or female, age more than or equal to 18 years at the time of signing informed consent
Body mass index (BMI) more than or equal 30 kg/m^2
Enrolled in Cleveland Clinic Employee Health Plan, and expecting to be covered by the Cleveland Clinic Employee Health Plan for the duration of the study

Exclusion Criteria:

Contraindications to all of the medications approved by the FDA for chronic weight management according to the label
Previous participation in this study. Participation is defined as signed informed consent
Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice)
Participation in another clinical trial within 30 days before screening
Treatment with any medication with the intention of weight loss within 90 days before screening
Previous or current participation in Cleveland Clinic's Integrated Medical Weight Management Program
History of (or plans during the study period for) bariatric surgery, or use of minimally-invasive weight loss devices (i.e. Intragastric balloons, lap bands) not removed within 1 year prior to screening
History of type 1 or type 2 diabetes mellitus
Hemoglobin A1c (HbA1c) more than or equal to 6.5% at screening or within 90 days prior to randomization
Any condition, unwillingness or inability, not covered by any of the other exclusion criteria, which, in the study clinician's opinion, might jeopardize the subject's safety or compliance with the protocol

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