A Study to Test Combination Treatments in People With Adv... | NCT02996110 | Trialant
NCT02996110
Sponsor
Bristol-Myers Squibb
Status
Completed
Last Update Posted
Dec 19, 2022Actual
Enrollment
182Actual
Phase
Phase 2
Conditions
Advanced Cancer
Interventions
Nivolumab
Ipilimumab
Relatlimab
BMS-986205
BMS-813160
Countries
United States
Australia
Austria
Canada
Israel
Italy
Protocol Section
Identification Module
NCT ID
NCT02996110
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CA018-005
Secondary IDs
ID
Type
Description
Link
2016-003082-26
EudraCT Number
Brief Title
A Study to Test Combination Treatments in People With Advanced Renal Cell Carcinoma
Official Title
A Phase 2, Real-time Assessment of Combination Therapies in Immuno-Oncology Study in Participants With Advanced Renal Cell Carcinoma (FRACTION-RCC)
Acronym
FRACTION-RCC
Organization
Bristol-Myers SquibbINDUSTRY
Status Module
Record Verification Date
Nov 2022
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Feb 2, 2017Actual
Primary Completion Date
Nov 23, 2021Actual
Completion Date
Nov 23, 2021Actual
First Submitted Date
Dec 15, 2016
First Submission Date that Met QC Criteria
Dec 16, 2016
First Posted Date
Dec 19, 2016Estimated
Results Waived
Not provided
Results First Submitted Date
Nov 18, 2022
Results First Submitted that Met QC Criteria
Nov 18, 2022
Results First Posted Date
Dec 19, 2022Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Nov 18, 2022
Last Update Posted Date
Dec 19, 2022Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Bristol-Myers SquibbINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to test the effectiveness and safety of various nivolumab combinations compared to nivolumab and ipilimumab in participants with advanced kidney cancer
Detailed Description
Not provided
Conditions Module
Conditions
Advanced Cancer
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
182Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Nivolumab + Ipilimumab
Active Comparator
Nivolumab + Ipilimumab
Biological: Nivolumab
Biological: Ipilimumab
Nivolumab + Relatlimab
Experimental
Nivolumab + Relatlimab
Biological: Nivolumab
Biological: Relatlimab
Nivolumab + BMS-986205
Experimental
Nivolumab + BMS-986205
Biological: Nivolumab
Drug: BMS-986205
Nivolumab + BMS-813160
Experimental
Nivolumab + BMS-813160 (CCR2/5 dual antagonist)
Biological: Nivolumab
Drug: BMS-813160
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Nivolumab
Biological
Specified Dose on Specified Days
Nivolumab + BMS-813160
Nivolumab + BMS-986205
Nivolumab + Ipilimumab
Nivolumab + Relatlimab
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Objective Response Rate (ORR) Per Investigator
ORR is percent of participants whose best overall response (BOR) is complete response (CR) or partial response (PR).
BOR is the best response from the start of the study treatment until objectively documented progression per RECIST v1.1 or subsequent anticancer therapy, whichever occurs first.
For participants who received re-treatment or were re-randomized, the re-treatment and re-randomized therapies were considered subsequent anticancer therapy.
CR is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) have reduction in short axis to <10 mm.
PR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
The Response Evaluation Criteria in Solid Tumors (RECIST) is a standard way to measure the response of a tumor to treatment.
CR+PR, confidence interval based on Clopper and Pearson method.
From first dose of study treatment until progression or subsequent anticancer therapy, whichever occurs first (assessed up to approximately 247 weeks)
Median Duration of Response (DOR) Per Investigator
Duration of Response is defined as the time between the date of first response and the date of first documented disease progression as determined by RECIST 1.1 or death due to any cause (death occurring after re-treatment or randomization to new combination treatment was not considered), whichever occurred first.
Complete Response (CR) is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.
Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Median computed using Kaplan -Meier method
From first dose to the date of first documented disease progression or death due to any cause (assessed from an average of 22 weeks up to approximately 247 weeks)
Progression Free Survival Rate (PFSR) at 24 Weeks.
The PFSR at 24 weeks is defined as the proportion of treated participants remaining progression free and surviving at 24 weeks since the first dosing date.
Progressive Disease (PD) is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Point estimates are derived from Kaplan-Meier analyses, the 95% CIs are derived from Greenwood formula
Secondary Outcomes
Measure
Description
Time Frame
Number of Participants With Adverse Events (AEs)
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
From first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks)
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Advanced Renal Cell Carcinoma
Must have at least 1 lesion with measurable disease
Life expectancy of at least 3 months
Karnofsky Performance Status (KPS) must be =>70%
Exclusion Criteria:
Patients/subjects with suspected or known central nervous system metastases unless adequately treated
Patients/subjects with autoimmune disease
Patients/subjects who need daily oxygen therapy
Other protocol defined inclusion/exclusion criteria apply
Of the 178 participants that were treated, 60 were initially randomized to Track 1 and 118 were initially randomized to Track 2. The 152 participants that started treatment in Track 2 include the total number of participants that received treatment in each arm which incorporates the 35 participants from Track 1 or 2 that were re-randomized to receive a different treatment combination in Track 2.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Arm 1: Nivolumab Plus Ipilimumab (BMS-734016)
Nivolumab was administered at 3 mg/kg via IV infusion followed by ipilimumab 1 mg/kg administered IV over approximately 30 minutes every 3 weeks for 4 doses. Six weeks after the last dose of combination study treatment nivolumab 480 mg was administered IV over approximately 30 minutes every 4 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Periods
Title
Milestones
Reasons Not Completed
Pre-Treatment
Type
Comment
Milestone Data
STARTED
Initial Randomization
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot_SAP
Yes
Yes
No
Study Protocol and Statistical Analysis Plan
Jan 11, 2022
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
No data available
No data is available for this block.
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Opdivo
BMS-936558
Ipilimumab
Biological
Specified Dose on Specified Days
Nivolumab + Ipilimumab
BMS-734016
Yervoy
Relatlimab
Biological
Specified Dose on Specified Days
Nivolumab + Relatlimab
BMS-986016
BMS-986205
Drug
Specified Dose on Specified Days
Nivolumab + BMS-986205
BMS-813160
Drug
Specified Dose on Specified Days
Nivolumab + BMS-813160
24 weeks after first treatment dose.
Number of Participants With Serious Adverse Events (SAEs)
Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), requires inpatient hospitalization or causes prolongation of existing hospitalization
From first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks)
Number of Participants With Adverse Events (AEs) Leading to Discontinuation
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
From first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks)
Number of Participants Who Died
Death is defined as the cessation of all vital functions of the body including the heartbeat, brain activity (including the brain stem), and breathing.
From first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks)
Number of Participants With Abnormal Thyroid Test Results - Track 1
The number of participants with laboratory abnormalities in specific thyroid tests based on SI conventional units. TSH = Thyroid Stimulating Hormone LLN = Lower Limit of Normal ULN = Upper Limit of Normal.
From first dose to 30 days after last dose of study therapy (approximately 108 weeks)
Number of Participants With Abnormal Thyroid Test Results - Track 2
The number of participants with laboratory abnormalities in specific thyroid tests based on SI conventional units. TSH = Thyroid Stimulating Hormone LLN = Lower Limit of Normal ULN = Upper Limit of Normal
From first dose to 30 days after last dose of study therapy (approximately 108 weeks)
Number of Participants With Abnormal Hepatic Test Results - Track 1
The number of participants with laboratory abnormalities in specific liver tests based on SI conventional units. ALT = Alanine Aminotransferase AST = Aspartate Aminotransferase ULN = Upper Limit of Normal
From first dose to 30 days after last dose of study therapy (approximately 108 weeks)
Number of Participants With Abnormal Hepatic Test Results - Track 2
The number of participants with laboratory abnormalities in specific liver tests based on SI conventional units. ALT = Alanine Aminotransferase AST = Aspartate Aminotransferase ULN = Upper Limit of Normal
From first dose to 30 days after last dose of study therapy (approximately 108 weeks)
Tampa
Florida
33612-9497
United States
Local Institution - 0031
Augusta
Georgia
30912
United States
Local Institution - 0006
Chicago
Illinois
60612
United States
Local Institution - 0007
Baltimore
Maryland
21287
United States
Dana Farber Cancer Institute
Boston
Massachusetts
02215
United States
Massachusetts General Hospital
Boston
Massachusetts
02215
United States
Local Institution - 0011
Detroit
Michigan
48201
United States
Local Institution - 0008
St Louis
Missouri
63110
United States
Roswell Park Cancer Institute
Buffalo
New York
14263
United States
Local Institution - 0005
New York
New York
10065
United States
Local Institution - 0043
Charlotte
North Carolina
28204
United States
Local Institution - 0014
Columbus
Ohio
43210
United States
Oregon Health & Science University
Portland
Oregon
97239
United States
Local Institution - 0002
Allentown
Pennsylvania
18103
United States
Hollings Cancer Center
Charleston
South Carolina
29425
United States
Local Institution - 0025
Nashville
Tennessee
37203
United States
Ut Southwestern Medical Center
Dallas
Texas
75390-8570
United States
Local Institution - 0024
Charlottesville
Virginia
22908
United States
University of Washington - Seattle Cancer Care Alliance
Nivolumab was administered at a flat dose of 240 mg via IV infusion every 2 weeks followed by 80 mg BMS-986016 administered IV approximately 60 minutes every 2 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
FG002
Arm 3: Nivolumab Plus BMS-986205
Nivolumab was administered as a flat dose of 480 mg via IV infusion every 4 weeks, and BMS-986205 taken orally at a dose of 100 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
FG003
Arm 4: Nivolumab Plus BMS-813160 150 mg
Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 150 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
FG004
Arm 5: Nivolumab Plus BMS-813160 300mg
Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 300 mg twice daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
FG00065 subjects
FG00156 subjects
FG00226 subjects
FG00317 subjects
FG00418 subjects
COMPLETED
Continuing Into Treatment Period
FG00065 subjects
FG00155 subjects
FG00225 subjects
FG00317 subjects
FG00416 subjects
NOT COMPLETED
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG0042 subjects
Type
Comment
Reasons
Other Reasons
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
Participant Withdrew Consent
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Track 1
Type
Comment
Milestone Data
STARTED
FG00030 subjects
FG00130 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
Re-Randomized to Track 2
FG0005 subjects
FG0016 subjects
FG0020 subjects
FG0030 subjects
FG004
COMPLETED
FG0007 subjects
FG0018 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG00023 subjects
FG00122 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Disease Progression
FG00015 subjects
FG00117 subjects
FG0020 subjects
FG003
Track 2
Type
Comment
Milestone Data
STARTED
FG00046 subjects
FG00132 subjects
FG00231 subjects
FG00321 subjects
FG00422 subjects
No Pre-Randomization
FG00035 subjects
FG00125 subjects
FG00225 subjects
FG00317 subjects
FG004
Re-Randomized From Track 1 Nivolumab + Relatlimab
FG0002 subjects
FG0010 subjects
FG0022 subjects
FG0031 subjects
Re-Randomized From Track 1 Nivolumab + Ipilimumab
FG0000 subjects
FG0013 subjects
FG0021 subjects
FG0031 subjects
Re-Randomized From Track 2 Nivolumab + Relatlimab
FG0007 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
Re-Randomized From Track 2 Nivolumab + BMS986205
FG0002 subjects
FG0012 subjects
FG0020 subjects
FG0031 subjects
Previously Un-Treated But Re-Randomized
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
Re-Randomized From Track 2 Nivolumab + Ipilimumab
FG0000 subjects
FG0012 subjects
FG0021 subjects
FG0030 subjects
COMPLETED
FG0004 subjects
FG0013 subjects
FG0021 subjects
FG0031 subjects
FG004
NOT COMPLETED
FG00042 subjects
FG00129 subjects
FG00230 subjects
FG00320 subjects
FG004
Type
Comment
Reasons
Disease Progression
FG00033 subjects
FG00126 subjects
FG00219 subjects
FG003
Arms 1 and 2 take into account both Track 1 and Track 2 participants as well as those rerandomized to the respective arms in Track 2.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Arm 1: Nivolumab Plus Ipilimumab (BMS-734016)
Nivolumab was administered at 3 mg/kg via IV infusion followed by ipilimumab 1 mg/kg administered IV over approximately 30 minutes every 3 weeks for 4 doses. Six weeks after the last dose of combination study treatment nivolumab 480 mg was administered IV over approximately 30 minutes every 4 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
BG001
Arm 2: Nivolumab Plus Relatlimab (BMS-986016)
Nivolumab was administered at a flat dose of 240 mg via IV infusion every 2 weeks followed by 80 mg BMS-986016 administered IV approximately 60 minutes every 2 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
BG002
Arm 3: Nivolumab Plus BMS-986205
Nivolumab was administered as a flat dose of 480 mg via IV infusion every 4 weeks, and BMS-986205 taken orally at a dose of 100 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
BG003
Arm 4: Nivolumab Plus BMS-813160 150 mg
Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 150 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
BG004
Arm 5: Nivolumab Plus BMS-813160 300mg
Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 300 mg twice daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00065
BG00156
BG00226
BG00317
BG00418
BG005182
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
The analysis population consists of all participants treated (including those re-randomized) in each Arm.
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Sex: Female, Male
The analysis population consists of all participants treated (including those re-randomized) in each Arm.
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00014
BG00116
BG002
Ethnicity (NIH/OMB)
The analysis population consists of all participants treated (including those re-randomized) in each Arm.
Count of Participants
Participants
Title
Denominators
Categories
Track 2
Title
Measurements
Hispanic or Latino
BG0003
BG0012
Race/Ethnicity, Customized
The analysis population consists of all participants treated (including those re-randomized) in each Arm.
Number
Participants
Title
Denominators
Categories
White
Title
Measurements
BG00062
BG00152
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Objective Response Rate (ORR) Per Investigator
ORR is percent of participants whose best overall response (BOR) is complete response (CR) or partial response (PR).
BOR is the best response from the start of the study treatment until objectively documented progression per RECIST v1.1 or subsequent anticancer therapy, whichever occurs first.
For participants who received re-treatment or were re-randomized, the re-treatment and re-randomized therapies were considered subsequent anticancer therapy.
CR is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) have reduction in short axis to <10 mm.
PR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
The Response Evaluation Criteria in Solid Tumors (RECIST) is a standard way to measure the response of a tumor to treatment.
CR+PR, confidence interval based on Clopper and Pearson method.
All treated participants. Some participants were re-randomized to receive multiple treatment options during the course of the study.
Posted
Number
95% Confidence Interval
Percent of participants
From first dose of study treatment until progression or subsequent anticancer therapy, whichever occurs first (assessed up to approximately 247 weeks)
ID
Title
Description
OG000
Arm 1: Nivolumab Plus Ipilimumab (BMS-734016)
Nivolumab was administered at 3 mg/kg via IV infusion followed by ipilimumab 1 mg/kg administered IV over approximately 30 minutes every 3 weeks for 4 doses. Six weeks after the last dose of combination study treatment nivolumab 480 mg was administered IV over approximately 30 minutes every 4 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
OG001
Arm 2: Nivolumab Plus Relatlimab (BMS-986016)
Nivolumab was administered at a flat dose of 240 mg via IV infusion every 2 weeks followed by 80 mg BMS-986016 administered IV approximately 60 minutes every 2 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
OG002
Arm 3: Nivolumab Plus BMS-986205
Nivolumab was administered as a flat dose of 480 mg via IV infusion every 4 weeks, and BMS-986205 taken orally at a dose of 100 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
OG003
Arm 4: Nivolumab Plus BMS-813160 150 mg
Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 150 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Units
Counts
Participants
OG00076
OG00162
OG00231
OG003
Title
Denominators
Categories
Track 1
ParticipantsOG00030
ParticipantsOG00130
ParticipantsOG0020
ParticipantsOG003
Primary
Median Duration of Response (DOR) Per Investigator
Duration of Response is defined as the time between the date of first response and the date of first documented disease progression as determined by RECIST 1.1 or death due to any cause (death occurring after re-treatment or randomization to new combination treatment was not considered), whichever occurred first.
Complete Response (CR) is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.
Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Median computed using Kaplan -Meier method
All treated participants with a best overall response of CR or PR. Some participants were re-randomized to receive multiple treatment options during the course of the study.
Posted
Median
Full Range
Weeks
From first dose to the date of first documented disease progression or death due to any cause (assessed from an average of 22 weeks up to approximately 247 weeks)
ID
Title
Description
OG000
Arm 1: Nivolumab Plus Ipilimumab (BMS-734016)
Nivolumab was administered at 3 mg/kg via IV infusion followed by ipilimumab 1 mg/kg administered IV over approximately 30 minutes every 3 weeks for 4 doses. Six weeks after the last dose of combination study treatment nivolumab 480 mg was administered IV over approximately 30 minutes every 4 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Primary
Progression Free Survival Rate (PFSR) at 24 Weeks.
The PFSR at 24 weeks is defined as the proportion of treated participants remaining progression free and surviving at 24 weeks since the first dosing date.
Progressive Disease (PD) is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Point estimates are derived from Kaplan-Meier analyses, the 95% CIs are derived from Greenwood formula
All treated participants. Some participants were re-randomized to receive multiple treatment options during the course of the study.
Posted
Number
95% Confidence Interval
Proportion of participants
24 weeks after first treatment dose.
ID
Title
Description
OG000
Arm 1: Nivolumab Plus Ipilimumab (BMS-734016)
Nivolumab was administered at 3 mg/kg via IV infusion followed by ipilimumab 1 mg/kg administered IV over approximately 30 minutes every 3 weeks for 4 doses. Six weeks after the last dose of combination study treatment nivolumab 480 mg was administered IV over approximately 30 minutes every 4 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
OG001
Secondary
Number of Participants With Adverse Events (AEs)
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
All treated participants. Some participants were re-randomized to receive multiple treatment options during the course of the study.
Posted
Number
Participants
From first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks)
ID
Title
Description
OG000
Arm 1: Nivolumab Plus Ipilimumab (BMS-734016)
Nivolumab was administered at 3 mg/kg via IV infusion followed by ipilimumab 1 mg/kg administered IV over approximately 30 minutes every 3 weeks for 4 doses. Six weeks after the last dose of combination study treatment nivolumab 480 mg was administered IV over approximately 30 minutes every 4 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
OG001
Arm 2: Nivolumab Plus Relatlimab (BMS-986016)
Nivolumab was administered at a flat dose of 240 mg via IV infusion every 2 weeks followed by 80 mg BMS-986016 administered IV approximately 60 minutes every 2 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Secondary
Number of Participants With Serious Adverse Events (SAEs)
Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), requires inpatient hospitalization or causes prolongation of existing hospitalization
All treated participants. Some participants were re-randomized to receive multiple treatment options during the course of the study.
Posted
Number
Participants
From first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks)
ID
Title
Description
OG000
Arm 1: Nivolumab Plus Ipilimumab (BMS-734016)
Nivolumab was administered at 3 mg/kg via IV infusion followed by ipilimumab 1 mg/kg administered IV over approximately 30 minutes every 3 weeks for 4 doses. Six weeks after the last dose of combination study treatment nivolumab 480 mg was administered IV over approximately 30 minutes every 4 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
OG001
Arm 2: Nivolumab Plus Relatlimab (BMS-986016)
Nivolumab was administered at a flat dose of 240 mg via IV infusion every 2 weeks followed by 80 mg BMS-986016 administered IV approximately 60 minutes every 2 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Secondary
Number of Participants With Adverse Events (AEs) Leading to Discontinuation
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
All treated participants. Some participants were re-randomized to receive multiple treatment options during the course of the study.
Posted
Number
Participants
From first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks)
ID
Title
Description
OG000
Arm 1: Nivolumab Plus Ipilimumab (BMS-734016)
Nivolumab was administered at 3 mg/kg via IV infusion followed by ipilimumab 1 mg/kg administered IV over approximately 30 minutes every 3 weeks for 4 doses. Six weeks after the last dose of combination study treatment nivolumab 480 mg was administered IV over approximately 30 minutes every 4 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
OG001
Arm 2: Nivolumab Plus Relatlimab (BMS-986016)
Nivolumab was administered at a flat dose of 240 mg via IV infusion every 2 weeks followed by 80 mg BMS-986016 administered IV approximately 60 minutes every 2 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Secondary
Number of Participants Who Died
Death is defined as the cessation of all vital functions of the body including the heartbeat, brain activity (including the brain stem), and breathing.
All treated participants. Some participants were re-randomized to receive multiple treatment options during the course of the study.
Posted
Number
Participants
From first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks)
ID
Title
Description
OG000
Arm 1: Nivolumab Plus Ipilimumab (BMS-734016)
Nivolumab was administered at 3 mg/kg via IV infusion followed by ipilimumab 1 mg/kg administered IV over approximately 30 minutes every 3 weeks for 4 doses. Six weeks after the last dose of combination study treatment nivolumab 480 mg was administered IV over approximately 30 minutes every 4 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
OG001
Arm 2: Nivolumab Plus Relatlimab (BMS-986016)
Nivolumab was administered at a flat dose of 240 mg via IV infusion every 2 weeks followed by 80 mg BMS-986016 administered IV approximately 60 minutes every 2 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Secondary
Number of Participants With Abnormal Thyroid Test Results - Track 1
The number of participants with laboratory abnormalities in specific thyroid tests based on SI conventional units. TSH = Thyroid Stimulating Hormone LLN = Lower Limit of Normal ULN = Upper Limit of Normal.
All treated participants with at least one on-treatment TSH measurement
Posted
Count of Participants
Participants
From first dose to 30 days after last dose of study therapy (approximately 108 weeks)
ID
Title
Description
OG000
Arm 1: Nivolumab Plus Ipilimumab (BMS-734016)
Nivolumab was administered at 3 mg/kg via IV infusion followed by ipilimumab 1 mg/kg administered IV over approximately 30 minutes every 3 weeks for 4 doses. Six weeks after the last dose of combination study treatment nivolumab 480 mg was administered IV over approximately 30 minutes every 4 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
OG001
Arm 2: Nivolumab Plus Relatlimab (BMS-986016)
Nivolumab was administered at a flat dose of 240 mg via IV infusion every 2 weeks followed by 80 mg BMS-986016 administered IV approximately 60 minutes every 2 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Secondary
Number of Participants With Abnormal Thyroid Test Results - Track 2
The number of participants with laboratory abnormalities in specific thyroid tests based on SI conventional units. TSH = Thyroid Stimulating Hormone LLN = Lower Limit of Normal ULN = Upper Limit of Normal
All treated participants with at Least One On-Treatment TSH measurement. Some participants were re-randomized to receive multiple treatment options during the course of the study.
Posted
Count of Participants
Participants
From first dose to 30 days after last dose of study therapy (approximately 108 weeks)
ID
Title
Description
OG000
Arm 1: Nivolumab Plus Ipilimumab (BMS-734016)
Nivolumab was administered at 3 mg/kg via IV infusion followed by ipilimumab 1 mg/kg administered IV over approximately 30 minutes every 3 weeks for 4 doses. Six weeks after the last dose of combination study treatment nivolumab 480 mg was administered IV over approximately 30 minutes every 4 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
OG001
Arm 2: Nivolumab Plus Relatlimab (BMS-986016)
Nivolumab was administered at a flat dose of 240 mg via IV infusion every 2 weeks followed by 80 mg BMS-986016 administered IV approximately 60 minutes every 2 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Secondary
Number of Participants With Abnormal Hepatic Test Results - Track 1
The number of participants with laboratory abnormalities in specific liver tests based on SI conventional units. ALT = Alanine Aminotransferase AST = Aspartate Aminotransferase ULN = Upper Limit of Normal
All treated participants with at least one on-treatment AST, ALT and/or bilirubin test measurement
Posted
Count of Participants
Participants
From first dose to 30 days after last dose of study therapy (approximately 108 weeks)
ID
Title
Description
OG000
Arm 1: Nivolumab Plus Ipilimumab (BMS-734016)
Nivolumab was administered at 3 mg/kg via IV infusion followed by ipilimumab 1 mg/kg administered IV over approximately 30 minutes every 3 weeks for 4 doses. Six weeks after the last dose of combination study treatment nivolumab 480 mg was administered IV over approximately 30 minutes every 4 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
OG001
Arm 2: Nivolumab Plus Relatlimab (BMS-986016)
Nivolumab was administered at a flat dose of 240 mg via IV infusion every 2 weeks followed by 80 mg BMS-986016 administered IV approximately 60 minutes every 2 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Secondary
Number of Participants With Abnormal Hepatic Test Results - Track 2
The number of participants with laboratory abnormalities in specific liver tests based on SI conventional units. ALT = Alanine Aminotransferase AST = Aspartate Aminotransferase ULN = Upper Limit of Normal
All treated participants with at least one on-treatment AST, ALT and/or bilirubin test measurement. Some participants were re-randomized to receive multiple treatment options during the course of the study.
Posted
Count of Participants
Participants
From first dose to 30 days after last dose of study therapy (approximately 108 weeks)
ID
Title
Description
OG000
Arm 1: Nivolumab Plus Ipilimumab (BMS-734016)
Nivolumab was administered at 3 mg/kg via IV infusion followed by ipilimumab 1 mg/kg administered IV over approximately 30 minutes every 3 weeks for 4 doses. Six weeks after the last dose of combination study treatment nivolumab 480 mg was administered IV over approximately 30 minutes every 4 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
OG001
Arm 2: Nivolumab Plus Relatlimab (BMS-986016)
Nivolumab was administered at a flat dose of 240 mg via IV infusion every 2 weeks followed by 80 mg BMS-986016 administered IV approximately 60 minutes every 2 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Time Frame
Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks).
Description
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Track 1: Nivolumab Plus Ipilimumab (BMS-734016)
Nivolumab was administered at 3 mg/kg via IV infusion followed by ipilimumab 1 mg/kg administered IV over approximately 30 minutes every 3 weeks for 4 doses. Six weeks after the last dose of combination study treatment nivolumab 480 mg was administered IV over approximately 30 minutes every 4 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
12
30
17
30
28
30
EG001
Track 1: Nivolumab Plus Relatlimab (BMS-986016)
Nivolumab was administered at a flat dose of 240 mg via IV infusion every 2 weeks followed by 80 mg BMS-986016 administered IV approximately 60 minutes every 2 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
15
31
15
30
29
30
EG002
Track 2: Nivolumab Plus Ipilimumab (BMS-734016)
Nivolumab was administered at 3 mg/kg via IV infusion followed by ipilimumab 1 mg/kg administered IV over approximately 30 minutes every 3 weeks for 4 doses. Six weeks after the last dose of combination study treatment nivolumab 480 mg was administered IV over approximately 30 minutes every 4 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
27
46
28
46
42
46
EG003
Track 2: Nivolumab Plus Relatlimab (BMS-986016)
Nivolumab was administered at a flat dose of 240 mg via IV infusion every 2 weeks followed by 80 mg BMS-986016 administered IV approximately 60 minutes every 2 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
17
32
16
32
31
32
EG004
Track 2: Nivolumab Plus BMS-986205
Nivolumab was administered as a flat dose of 480 mg via IV infusion every 4 weeks, and BMS-986205 taken orally at a dose of 100 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
13
32
16
31
29
31
EG005
Track 2: Nivolumab Plus BMS-813160 150 mg
Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 150 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
10
21
9
21
18
21
EG006
Track 2: Nivolumab Plus BMS-813160 300 mg
Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 300 mg twice daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
13
24
15
22
17
22
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected30 at risk
EG0021 affected46 at risk
EG0030 affected32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
Angina pectoris
Cardiac disorders
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected30 at risk
EG0021 affected46 at risk
EG003
Atrial fibrillation
Cardiac disorders
25.0
Systematic Assessment
EG0001 affected30 at risk
EG0011 affected30 at risk
EG0020 affected46 at risk
EG003
Cardiac arrest
Cardiac disorders
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected30 at risk
EG0022 affected46 at risk
EG003
Cardiac failure congestive
Cardiac disorders
25.0
Systematic Assessment
EG0001 affected30 at risk
EG0010 affected30 at risk
EG0021 affected46 at risk
EG003
Myocarditis
Cardiac disorders
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected30 at risk
EG0020 affected46 at risk
EG003
Pericarditis
Cardiac disorders
25.0
Systematic Assessment
EG0001 affected30 at risk
EG0010 affected30 at risk
EG0020 affected46 at risk
EG003
Ventricular tachycardia
Cardiac disorders
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected30 at risk
EG0021 affected46 at risk
EG003
Adrenal insufficiency
Endocrine disorders
25.0
Systematic Assessment
EG0001 affected30 at risk
EG0010 affected30 at risk
EG0020 affected46 at risk
EG003
Immune-mediated adrenal insufficiency
Endocrine disorders
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected30 at risk
EG0021 affected46 at risk
EG003
Inappropriate antidiuretic hormone secretion
Endocrine disorders
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected30 at risk
EG0020 affected46 at risk
EG003
Abdominal pain
Gastrointestinal disorders
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected30 at risk
EG0020 affected46 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected30 at risk
EG0021 affected46 at risk
EG003
Colitis
Gastrointestinal disorders
25.0
Systematic Assessment
EG0001 affected30 at risk
EG0010 affected30 at risk
EG0020 affected46 at risk
EG003
Diarrhoea
Gastrointestinal disorders
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected30 at risk
EG0020 affected46 at risk
EG003
Enteritis
Gastrointestinal disorders
25.0
Systematic Assessment
EG0001 affected30 at risk
EG0010 affected30 at risk
EG0020 affected46 at risk
EG003
Enterocolitis
Gastrointestinal disorders
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected30 at risk
EG0021 affected46 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected30 at risk
EG0020 affected46 at risk
EG003
Large intestinal obstruction
Gastrointestinal disorders
25.0
Systematic Assessment
EG0001 affected30 at risk
EG0010 affected30 at risk
EG0020 affected46 at risk
EG003
Lip swelling
Gastrointestinal disorders
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0011 affected30 at risk
EG0020 affected46 at risk
EG003
Lower gastrointestinal haemorrhage
Gastrointestinal disorders
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected30 at risk
EG0020 affected46 at risk
EG003
Mouth haemorrhage
Gastrointestinal disorders
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0011 affected30 at risk
EG0020 affected46 at risk
EG003
Nausea
Gastrointestinal disorders
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0011 affected30 at risk
EG0020 affected46 at risk
EG003
Oesophagitis
Gastrointestinal disorders
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected30 at risk
EG0021 affected46 at risk
EG003
Small intestinal haemorrhage
Gastrointestinal disorders
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected30 at risk
EG0021 affected46 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
25.0
Systematic Assessment
EG0001 affected30 at risk
EG0010 affected30 at risk
EG0020 affected46 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected30 at risk
EG0020 affected46 at risk
EG003
Vomiting
Gastrointestinal disorders
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0012 affected30 at risk
EG0020 affected46 at risk
EG003
Asthenia
General disorders
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected30 at risk
EG0020 affected46 at risk
EG003
Fatigue
General disorders
25.0
Systematic Assessment
EG0001 affected30 at risk
EG0010 affected30 at risk
EG0021 affected46 at risk
EG003
General physical health deterioration
General disorders
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected30 at risk
EG0021 affected46 at risk
EG003
Non-cardiac chest pain
General disorders
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected30 at risk
EG0021 affected46 at risk
EG003
Pain
General disorders
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0011 affected30 at risk
EG0020 affected46 at risk
EG003
Pyrexia
General disorders
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected30 at risk
EG0021 affected46 at risk
EG003
Biliary obstruction
Hepatobiliary disorders
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected30 at risk
EG0021 affected46 at risk
EG003
Cholecystitis
Hepatobiliary disorders
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected30 at risk
EG0021 affected46 at risk
EG003
Hepatotoxicity
Hepatobiliary disorders
25.0
Systematic Assessment
EG0001 affected30 at risk
EG0010 affected30 at risk
EG0020 affected46 at risk
EG003
Bronchitis
Infections and infestations
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected30 at risk
EG0020 affected46 at risk
EG003
Cellulitis
Infections and infestations
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected30 at risk
EG0021 affected46 at risk
EG003
Device related infection
Infections and infestations
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected30 at risk
EG0021 affected46 at risk
EG003
Epididymitis
Infections and infestations
25.0
Systematic Assessment
EG0001 affected30 at risk
EG0010 affected30 at risk
EG0020 affected46 at risk
EG003
Pneumonia
Infections and infestations
25.0
Systematic Assessment
EG0004 affected30 at risk
EG0010 affected30 at risk
EG0020 affected46 at risk
EG003
Pneumonia influenzal
Infections and infestations
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected30 at risk
EG0020 affected46 at risk
EG003
Pulmonary sepsis
Infections and infestations
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0011 affected30 at risk
EG0020 affected46 at risk
EG003
Sepsis
Infections and infestations
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected30 at risk
EG0021 affected46 at risk
EG003
Sialoadenitis
Infections and infestations
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected30 at risk
EG0021 affected46 at risk
EG003
Sinusitis
Infections and infestations
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected30 at risk
EG0021 affected46 at risk
EG003
Urinary tract infection
Infections and infestations
25.0
Systematic Assessment
EG0001 affected30 at risk
EG0010 affected30 at risk
EG0020 affected46 at risk
EG003
Urosepsis
Infections and infestations
25.0
Systematic Assessment
EG0001 affected30 at risk
EG0011 affected30 at risk
EG0020 affected46 at risk
EG003
Wound infection
Infections and infestations
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected30 at risk
EG0020 affected46 at risk
EG003
Acetabulum fracture
Injury, poisoning and procedural complications
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected30 at risk
EG0020 affected46 at risk
EG003
Fall
Injury, poisoning and procedural complications
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected30 at risk
EG0020 affected46 at risk
EG003
Fracture
Injury, poisoning and procedural complications
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected30 at risk
EG0020 affected46 at risk
EG003
Post procedural haematuria
Injury, poisoning and procedural complications
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected30 at risk
EG0020 affected46 at risk
EG003
Wound dehiscence
Injury, poisoning and procedural complications
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected30 at risk
EG0020 affected46 at risk
EG003
Amylase increased
Investigations
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected30 at risk
EG0021 affected46 at risk
EG003
Blood alkaline phosphatase increased
Investigations
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected30 at risk
EG0020 affected46 at risk
EG003
Blood creatinine increased
Investigations
25.0
Systematic Assessment
EG0001 affected30 at risk
EG0010 affected30 at risk
EG0020 affected46 at risk
EG003
Blood potassium increased
Investigations
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0011 affected30 at risk
EG0020 affected46 at risk
EG003
Lipase increased
Investigations
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected30 at risk
EG0021 affected46 at risk
EG003
Transaminases increased
Investigations
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0011 affected30 at risk
EG0020 affected46 at risk
EG003
Dehydration
Metabolism and nutrition disorders
25.0
Systematic Assessment
EG0002 affected30 at risk
EG0010 affected30 at risk
EG0020 affected46 at risk
EG003
Diabetic ketoacidosis
Metabolism and nutrition disorders
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected30 at risk
EG0021 affected46 at risk
EG003
Failure to thrive
Metabolism and nutrition disorders
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected30 at risk
EG0020 affected46 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
25.0
Systematic Assessment
EG0002 affected30 at risk
EG0013 affected30 at risk
EG0022 affected46 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected30 at risk
EG0020 affected46 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
25.0
Systematic Assessment
EG0001 affected30 at risk
EG0010 affected30 at risk
EG0020 affected46 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected30 at risk
EG0020 affected46 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected30 at risk
EG0021 affected46 at risk
EG003
Autoimmune myositis
Musculoskeletal and connective tissue disorders
25.0
Systematic Assessment
EG0001 affected30 at risk
EG0010 affected30 at risk
EG0020 affected46 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0011 affected30 at risk
EG0021 affected46 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected30 at risk
EG0020 affected46 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected30 at risk
EG0021 affected46 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
25.0
Systematic Assessment
EG0001 affected30 at risk
EG0010 affected30 at risk
EG0020 affected46 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected30 at risk
EG0020 affected46 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected30 at risk
EG0020 affected46 at risk
EG003
Polymyalgia rheumatica
Musculoskeletal and connective tissue disorders
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected30 at risk
EG0020 affected46 at risk
EG003
Bladder cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
25.0
Systematic Assessment
EG0001 affected30 at risk
EG0010 affected30 at risk
EG0020 affected46 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0011 affected30 at risk
EG0020 affected46 at risk
EG003
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
25.0
Systematic Assessment
EG0002 affected30 at risk
EG0015 affected30 at risk
EG0026 affected46 at risk
EG003
Metastases to bone
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected30 at risk
EG0020 affected46 at risk
EG003
Metastases to central nervous system
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0011 affected30 at risk
EG0020 affected46 at risk
EG003
Metastases to lung
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0011 affected30 at risk
EG0020 affected46 at risk
EG003
Metastatic renal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected30 at risk
EG0021 affected46 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected30 at risk
EG0020 affected46 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected30 at risk
EG0020 affected46 at risk
EG003
Aphasia
Nervous system disorders
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected30 at risk
EG0021 affected46 at risk
EG003
Brain oedema
Nervous system disorders
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0011 affected30 at risk
EG0020 affected46 at risk
EG003
Dizziness
Nervous system disorders
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0011 affected30 at risk
EG0020 affected46 at risk
EG003
Encephalopathy
Nervous system disorders
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0011 affected30 at risk
EG0020 affected46 at risk
EG003
Facial paralysis
Nervous system disorders
25.0
Systematic Assessment
EG0001 affected30 at risk
EG0010 affected30 at risk
EG0020 affected46 at risk
EG003
Immune-mediated neuropathy
Nervous system disorders
25.0
Systematic Assessment
EG0001 affected30 at risk
EG0010 affected30 at risk
EG0020 affected46 at risk
EG003
Neuralgia
Nervous system disorders
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected30 at risk
EG0020 affected46 at risk
EG003
Pyramidal tract syndrome
Nervous system disorders
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected30 at risk
EG0020 affected46 at risk
EG003
Seizure
Nervous system disorders
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0011 affected30 at risk
EG0021 affected46 at risk
EG003
Spinal cord compression
Nervous system disorders
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0012 affected30 at risk
EG0021 affected46 at risk
EG003
Acute kidney injury
Renal and urinary disorders
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected30 at risk
EG0020 affected46 at risk
EG003
Bladder perforation
Renal and urinary disorders
25.0
Systematic Assessment
EG0001 affected30 at risk
EG0010 affected30 at risk
EG0020 affected46 at risk
EG003
Immune-mediated nephritis
Renal and urinary disorders
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0011 affected30 at risk
EG0020 affected46 at risk
EG003
Oliguria
Renal and urinary disorders
25.0
Systematic Assessment
EG0001 affected30 at risk
EG0010 affected30 at risk
EG0020 affected46 at risk
EG003
Renal haematoma
Renal and urinary disorders
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected30 at risk
EG0020 affected46 at risk
EG003
Acute respiratory distress syndrome
Respiratory, thoracic and mediastinal disorders
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected30 at risk
EG0020 affected46 at risk
EG003
Atelectasis
Respiratory, thoracic and mediastinal disorders
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected30 at risk
EG0020 affected46 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected30 at risk
EG0020 affected46 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected30 at risk
EG0021 affected46 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
25.0
Systematic Assessment
EG0001 affected30 at risk
EG0010 affected30 at risk
EG0020 affected46 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected30 at risk
EG0020 affected46 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
25.0
Systematic Assessment
EG0001 affected30 at risk
EG0010 affected30 at risk
EG0020 affected46 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
25.0
Systematic Assessment
EG0001 affected30 at risk
EG0010 affected30 at risk
EG0020 affected46 at risk
EG003
Respiratory arrest
Respiratory, thoracic and mediastinal disorders
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected30 at risk
EG0020 affected46 at risk
EG003
Intertrigo
Skin and subcutaneous tissue disorders
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0011 affected30 at risk
EG0020 affected46 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
25.0
Systematic Assessment
EG0001 affected30 at risk
EG0010 affected30 at risk
EG0020 affected46 at risk
EG003
Deep vein thrombosis
Vascular disorders
25.0
Systematic Assessment
EG0001 affected30 at risk
EG0010 affected30 at risk
EG0020 affected46 at risk
EG003
Embolism
Vascular disorders
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected30 at risk
EG0020 affected46 at risk
EG003
Haematoma
Vascular disorders
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected30 at risk
EG0020 affected46 at risk
EG003
Hypotension
Vascular disorders
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0011 affected30 at risk
EG0020 affected46 at risk
EG003
Lymphoedema
Vascular disorders
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected30 at risk
EG0021 affected46 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
25.0
Systematic Assessment
EG0008 affected30 at risk
EG0015 affected30 at risk
EG0028 affected46 at risk
EG0034 affected32 at risk
EG0044 affected31 at risk
EG0052 affected21 at risk
EG0062 affected22 at risk
Sinus tachycardia
Cardiac disorders
25.0
Systematic Assessment
EG0001 affected30 at risk
EG0011 affected30 at risk
EG0020 affected46 at risk
EG003
Vertigo
Ear and labyrinth disorders
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0012 affected30 at risk
EG0021 affected46 at risk
EG003
Hyperthyroidism
Endocrine disorders
25.0
Systematic Assessment
EG0004 affected30 at risk
EG0013 affected30 at risk
EG0020 affected46 at risk
EG003
Hypothyroidism
Endocrine disorders
25.0
Systematic Assessment
EG0004 affected30 at risk
EG0016 affected30 at risk
EG0022 affected46 at risk
EG003
Dry eye
Eye disorders
25.0
Systematic Assessment
EG0001 affected30 at risk
EG0010 affected30 at risk
EG0020 affected46 at risk
EG003
Vision blurred
Eye disorders
25.0
Systematic Assessment
EG0002 affected30 at risk
EG0012 affected30 at risk
EG0020 affected46 at risk
EG003
Abdominal pain
Gastrointestinal disorders
25.0
Systematic Assessment
EG0003 affected30 at risk
EG0011 affected30 at risk
EG0025 affected46 at risk
EG003
Colitis
Gastrointestinal disorders
25.0
Systematic Assessment
EG0002 affected30 at risk
EG0010 affected30 at risk
EG0020 affected46 at risk
EG003
Constipation
Gastrointestinal disorders
25.0
Systematic Assessment
EG0003 affected30 at risk
EG0018 affected30 at risk
EG0025 affected46 at risk
EG003
Diarrhoea
Gastrointestinal disorders
25.0
Systematic Assessment
EG0006 affected30 at risk
EG0019 affected30 at risk
EG00214 affected46 at risk
EG003
Dry mouth
Gastrointestinal disorders
25.0
Systematic Assessment
EG0001 affected30 at risk
EG0014 affected30 at risk
EG0024 affected46 at risk
EG003
Epigastric discomfort
Gastrointestinal disorders
25.0
Systematic Assessment
EG0001 affected30 at risk
EG0010 affected30 at risk
EG0020 affected46 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected30 at risk
EG0023 affected46 at risk
EG003
Nausea
Gastrointestinal disorders
25.0
Systematic Assessment
EG00010 affected30 at risk
EG0017 affected30 at risk
EG00214 affected46 at risk
EG003
Oral pain
Gastrointestinal disorders
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected30 at risk
EG0022 affected46 at risk
EG003
Stomatitis
Gastrointestinal disorders
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected30 at risk
EG0026 affected46 at risk
EG003
Vomiting
Gastrointestinal disorders
25.0
Systematic Assessment
EG0005 affected30 at risk
EG0016 affected30 at risk
EG0027 affected46 at risk
EG003
Asthenia
General disorders
25.0
Systematic Assessment
EG0002 affected30 at risk
EG0010 affected30 at risk
EG0023 affected46 at risk
EG003
Chest discomfort
General disorders
25.0
Systematic Assessment
EG0001 affected30 at risk
EG0010 affected30 at risk
EG0020 affected46 at risk
EG003
Chills
General disorders
25.0
Systematic Assessment
EG0003 affected30 at risk
EG0012 affected30 at risk
EG0024 affected46 at risk
EG003
Fatigue
General disorders
25.0
Systematic Assessment
EG0009 affected30 at risk
EG00113 affected30 at risk
EG00215 affected46 at risk
EG003
Gait disturbance
General disorders
25.0
Systematic Assessment
EG0001 affected30 at risk
EG0010 affected30 at risk
EG0022 affected46 at risk
EG003
Mucosal inflammation
General disorders
25.0
Systematic Assessment
EG0001 affected30 at risk
EG0010 affected30 at risk
EG0020 affected46 at risk
EG003
Non-cardiac chest pain
General disorders
25.0
Systematic Assessment
EG0003 affected30 at risk
EG0011 affected30 at risk
EG0021 affected46 at risk
EG003
Oedema peripheral
General disorders
25.0
Systematic Assessment
EG0004 affected30 at risk
EG0013 affected30 at risk
EG0026 affected46 at risk
EG003
Pyrexia
General disorders
25.0
Systematic Assessment
EG0005 affected30 at risk
EG0012 affected30 at risk
EG0025 affected46 at risk
EG003
Bronchitis
Infections and infestations
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0011 affected30 at risk
EG0020 affected46 at risk
EG003
Conjunctivitis
Infections and infestations
25.0
Systematic Assessment
EG0001 affected30 at risk
EG0011 affected30 at risk
EG0023 affected46 at risk
EG003
Gastroenteritis
Infections and infestations
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0011 affected30 at risk
EG0020 affected46 at risk
EG003
Influenza
Infections and infestations
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0011 affected30 at risk
EG0021 affected46 at risk
EG003
Pneumonia
Infections and infestations
25.0
Systematic Assessment
EG0001 affected30 at risk
EG0011 affected30 at risk
EG0020 affected46 at risk
EG003
Upper respiratory tract infection
Infections and infestations
25.0
Systematic Assessment
EG0003 affected30 at risk
EG0012 affected30 at risk
EG0025 affected46 at risk
EG003
Urinary tract infection
Infections and infestations
25.0
Systematic Assessment
EG0001 affected30 at risk
EG0010 affected30 at risk
EG0024 affected46 at risk
EG003
Fall
Injury, poisoning and procedural complications
25.0
Systematic Assessment
EG0001 affected30 at risk
EG0014 affected30 at risk
EG0025 affected46 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0013 affected30 at risk
EG0022 affected46 at risk
EG003
Alanine aminotransferase increased
Investigations
25.0
Systematic Assessment
EG0001 affected30 at risk
EG0012 affected30 at risk
EG0025 affected46 at risk
EG003
Amylase increased
Investigations
25.0
Systematic Assessment
EG0002 affected30 at risk
EG0010 affected30 at risk
EG0023 affected46 at risk
EG003
Aspartate aminotransferase increased
Investigations
25.0
Systematic Assessment
EG0001 affected30 at risk
EG0011 affected30 at risk
EG0025 affected46 at risk
EG003
Blood alkaline phosphatase increased
Investigations
25.0
Systematic Assessment
EG0001 affected30 at risk
EG0013 affected30 at risk
EG0020 affected46 at risk
EG003
Blood bilirubin increased
Investigations
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected30 at risk
EG0022 affected46 at risk
EG003
Blood creatinine increased
Investigations
25.0
Systematic Assessment
EG0005 affected30 at risk
EG0013 affected30 at risk
EG0022 affected46 at risk
EG003
Lipase increased
Investigations
25.0
Systematic Assessment
EG0004 affected30 at risk
EG0011 affected30 at risk
EG0023 affected46 at risk
EG003
Weight decreased
Investigations
25.0
Systematic Assessment
EG0003 affected30 at risk
EG0011 affected30 at risk
EG0025 affected46 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
25.0
Systematic Assessment
EG0005 affected30 at risk
EG0015 affected30 at risk
EG00212 affected46 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
25.0
Systematic Assessment
EG0004 affected30 at risk
EG0012 affected30 at risk
EG0023 affected46 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
25.0
Systematic Assessment
EG0003 affected30 at risk
EG0011 affected30 at risk
EG0022 affected46 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
25.0
Systematic Assessment
EG0001 affected30 at risk
EG0011 affected30 at risk
EG0023 affected46 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
25.0
Systematic Assessment
EG0002 affected30 at risk
EG0011 affected30 at risk
EG0021 affected46 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
25.0
Systematic Assessment
EG0004 affected30 at risk
EG0010 affected30 at risk
EG0020 affected46 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
25.0
Systematic Assessment
EG0002 affected30 at risk
EG0011 affected30 at risk
EG0020 affected46 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
25.0
Systematic Assessment
EG0001 affected30 at risk
EG0012 affected30 at risk
EG0021 affected46 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
25.0
Systematic Assessment
EG0002 affected30 at risk
EG0012 affected30 at risk
EG0021 affected46 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
25.0
Systematic Assessment
EG0006 affected30 at risk
EG0011 affected30 at risk
EG0025 affected46 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
25.0
Systematic Assessment
EG0003 affected30 at risk
EG0015 affected30 at risk
EG0026 affected46 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
25.0
Systematic Assessment
EG0002 affected30 at risk
EG0010 affected30 at risk
EG0021 affected46 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected30 at risk
EG0021 affected46 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
25.0
Systematic Assessment
EG0002 affected30 at risk
EG0011 affected30 at risk
EG0020 affected46 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
25.0
Systematic Assessment
EG0003 affected30 at risk
EG0012 affected30 at risk
EG0026 affected46 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
25.0
Systematic Assessment
EG0002 affected30 at risk
EG0012 affected30 at risk
EG0021 affected46 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
25.0
Systematic Assessment
EG0002 affected30 at risk
EG0011 affected30 at risk
EG0022 affected46 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
25.0
Systematic Assessment
EG0003 affected30 at risk
EG0013 affected30 at risk
EG0020 affected46 at risk
EG003
Amnesia
Nervous system disorders
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected30 at risk
EG0022 affected46 at risk
EG003
Dizziness
Nervous system disorders
25.0
Systematic Assessment
EG0005 affected30 at risk
EG0013 affected30 at risk
EG0026 affected46 at risk
EG003
Dizziness postural
Nervous system disorders
25.0
Systematic Assessment
EG0002 affected30 at risk
EG0010 affected30 at risk
EG0020 affected46 at risk
EG003
Dysgeusia
Nervous system disorders
25.0
Systematic Assessment
EG0001 affected30 at risk
EG0013 affected30 at risk
EG0021 affected46 at risk
EG003
Headache
Nervous system disorders
25.0
Systematic Assessment
EG0004 affected30 at risk
EG00110 affected30 at risk
EG0025 affected46 at risk
EG003
Lethargy
Nervous system disorders
25.0
Systematic Assessment
EG0001 affected30 at risk
EG0011 affected30 at risk
EG0021 affected46 at risk
EG003
Paraesthesia
Nervous system disorders
25.0
Systematic Assessment
EG0001 affected30 at risk
EG0013 affected30 at risk
EG0021 affected46 at risk
EG003
Spinal cord compression
Nervous system disorders
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0012 affected30 at risk
EG0020 affected46 at risk
EG003
Taste disorder
Nervous system disorders
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected30 at risk
EG0020 affected46 at risk
EG003
Tremor
Nervous system disorders
25.0
Systematic Assessment
EG0002 affected30 at risk
EG0011 affected30 at risk
EG0020 affected46 at risk
EG003
Anxiety
Psychiatric disorders
25.0
Systematic Assessment
EG0001 affected30 at risk
EG0013 affected30 at risk
EG0021 affected46 at risk
EG003
Depression
Psychiatric disorders
25.0
Systematic Assessment
EG0001 affected30 at risk
EG0012 affected30 at risk
EG0020 affected46 at risk
EG003
Insomnia
Psychiatric disorders
25.0
Systematic Assessment
EG0005 affected30 at risk
EG0012 affected30 at risk
EG0024 affected46 at risk
EG003
Acute kidney injury
Renal and urinary disorders
25.0
Systematic Assessment
EG0003 affected30 at risk
EG0010 affected30 at risk
EG0020 affected46 at risk
EG003
Dysuria
Renal and urinary disorders
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected30 at risk
EG0023 affected46 at risk
EG003
Pollakiuria
Renal and urinary disorders
25.0
Systematic Assessment
EG0002 affected30 at risk
EG0010 affected30 at risk
EG0022 affected46 at risk
EG003
Urinary retention
Renal and urinary disorders
25.0
Systematic Assessment
EG0002 affected30 at risk
EG0010 affected30 at risk
EG0020 affected46 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
25.0
Systematic Assessment
EG00011 affected30 at risk
EG0016 affected30 at risk
EG00210 affected46 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
25.0
Systematic Assessment
EG0002 affected30 at risk
EG0010 affected30 at risk
EG0023 affected46 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
25.0
Systematic Assessment
EG0007 affected30 at risk
EG0014 affected30 at risk
EG0026 affected46 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
25.0
Systematic Assessment
EG0002 affected30 at risk
EG0010 affected30 at risk
EG0020 affected46 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
25.0
Systematic Assessment
EG0001 affected30 at risk
EG0010 affected30 at risk
EG0022 affected46 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
25.0
Systematic Assessment
EG0003 affected30 at risk
EG0010 affected30 at risk
EG0021 affected46 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
25.0
Systematic Assessment
EG0001 affected30 at risk
EG0014 affected30 at risk
EG0021 affected46 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
25.0
Systematic Assessment
EG0002 affected30 at risk
EG0011 affected30 at risk
EG0020 affected46 at risk
EG003
Pleuritic pain
Respiratory, thoracic and mediastinal disorders
25.0
Systematic Assessment
EG0002 affected30 at risk
EG0010 affected30 at risk
EG0021 affected46 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected30 at risk
EG0020 affected46 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0012 affected30 at risk
EG0021 affected46 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0014 affected30 at risk
EG0020 affected46 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0011 affected30 at risk
EG0021 affected46 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
25.0
Systematic Assessment
EG0002 affected30 at risk
EG0011 affected30 at risk
EG0022 affected46 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
25.0
Systematic Assessment
EG0002 affected30 at risk
EG0011 affected30 at risk
EG0020 affected46 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
25.0
Systematic Assessment
EG0003 affected30 at risk
EG0011 affected30 at risk
EG0020 affected46 at risk
EG003
Palmar-plantar erythrodysaesthesia syndrome
Skin and subcutaneous tissue disorders
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0011 affected30 at risk
EG0022 affected46 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
25.0
Systematic Assessment
EG00010 affected30 at risk
EG0016 affected30 at risk
EG00210 affected46 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
25.0
Systematic Assessment
EG0008 affected30 at risk
EG0017 affected30 at risk
EG00212 affected46 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
25.0
Systematic Assessment
EG0005 affected30 at risk
EG0011 affected30 at risk
EG0022 affected46 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
25.0
Systematic Assessment
EG0002 affected30 at risk
EG0010 affected30 at risk
EG0020 affected46 at risk
EG003
Rosacea
Skin and subcutaneous tissue disorders
25.0
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected30 at risk
EG0020 affected46 at risk
EG003
Hot flush
Vascular disorders
25.0
Systematic Assessment
EG0001 affected30 at risk
EG0012 affected30 at risk
EG0021 affected46 at risk
EG003
Hypertension
Vascular disorders
25.0
Systematic Assessment
EG0001 affected30 at risk
EG0012 affected30 at risk
EG0024 affected46 at risk
EG003
Hypotension
Vascular disorders
25.0
Systematic Assessment
EG0001 affected30 at risk
EG0011 affected30 at risk
EG0022 affected46 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Participant Requested to Discontinue Study Treatment
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
Administrative Reason by Sponsor
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
Participant no Longer Met Study Criteria
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
16 subjects
FG004
1 subjects
FG004
0 subjects
FG004
1 subjects
FG004
2 subjects
FG004
0 subjects
FG004
2 subjects
1 subjects
21 subjects
16 subjects
FG00415 subjects
Adverse Event Unrelated to Study Drug
FG0004 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0041 subjects
Death
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0041 subjects
Study Drug Toxicity
FG0004 subjects
FG0011 subjects
FG0024 subjects
FG0031 subjects
FG0040 subjects
Participant Requested to Discontinue Study Treatment
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG0031 subjects
FG0042 subjects
Participant Withdrew Consent
FG0001 subjects
FG0012 subjects
FG0023 subjects
FG0031 subjects
FG0041 subjects
Other Reasons
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0041 subjects
0
BG0040
BG0050
Between 18 and 65 years
BG00040
BG00141
BG00216
BG00312
BG00411
BG005120
>=65 years
BG00025
BG00115
BG00210
BG0035
BG0047
BG00562
6
BG0034
BG0049
BG00549
Male
BG00051
BG00140
BG00220
BG00313
BG0049
BG005133
BG002
2
BG0031
BG0040
BG0058
Not Hispanic or Latino
BG00037
BG00134
BG00219
BG00312
BG00410
BG005112
Unknown or Not Reported
BG00025
BG00120
BG0025
BG0034
BG0048
BG00562
23
BG00314
BG00417
BG005168
Asian Indian
Title
Measurements
BG0001
BG0010
BG0020
BG0030
BG0040
BG0051
Chinese
Title
Measurements
BG0000
BG0011
BG0020
BG0030
BG0040
BG0051
Asian Other
Title
Measurements
BG0001
BG0011
BG0020
BG0030
BG0040
BG0052
Other
Title
Measurements
BG0001
BG0012
BG0022
BG0032
BG0040
BG0057
Black or African American
Title
Measurements
BG0000
BG0010
BG0021
BG0031
BG0041
BG0053
OG004
Arm 5: Nivolumab Plus BMS-813160 300mg
Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 300 mg twice daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
21
OG00422
0
ParticipantsOG0040
Title
Measurements
OG00020(7.7 to 38.6)
OG00130(14.7 to 49.4)
Track 2
ParticipantsOG00046
ParticipantsOG00132
ParticipantsOG00231
ParticipantsOG00321
ParticipantsOG00422
Title
Measurements
OG00017.4(7.8 to 31.4)
OG0013.1(0.1 to 16.2)
OG0023.2(0.1 to 16.7)
OG003
OG001
Arm 2: Nivolumab Plus Relatlimab (BMS-986016)
Nivolumab was administered at a flat dose of 240 mg via IV infusion every 2 weeks followed by 80 mg BMS-986016 administered IV approximately 60 minutes every 2 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
OG002
Arm 3: Nivolumab Plus BMS-986205
Nivolumab was administered as a flat dose of 480 mg via IV infusion every 4 weeks, and BMS-986205 taken orally at a dose of 100 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
OG003
Arm 4: Nivolumab Plus BMS-813160 150 mg
Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 150 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
OG004
Arm 5: Nivolumab Plus BMS-813160 300mg
Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 300 mg twice daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Units
Counts
Participants
OG00014
OG00110
OG0021
OG0032
OG0040
Title
Denominators
Categories
Track 1
ParticipantsOG0006
ParticipantsOG0019
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
Title
Measurements
OG000NA(33.4 to 139.9)Insufficient number of participants with events. Five of the 6 participants received subsequent therapy prior to progression or death, thus their DOR was censored at the last tumor assessment.
OG00132.57(0.1 to 52.6)
Track 2
ParticipantsOG0008
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG0032
Arm 2: Nivolumab Plus Relatlimab (BMS-986016)
Nivolumab was administered at a flat dose of 240 mg via IV infusion every 2 weeks followed by 80 mg BMS-986016 administered IV approximately 60 minutes every 2 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
OG002
Arm 3: Nivolumab Plus BMS-986205
Nivolumab was administered as a flat dose of 480 mg via IV infusion every 4 weeks, and BMS-986205 taken orally at a dose of 100 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
OG003
Arm 4: Nivolumab Plus BMS-813160 150 mg
Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 150 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
OG004
Arm 5: Nivolumab Plus BMS-813160 300mg
Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 300 mg twice daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Units
Counts
Participants
OG00076
OG00162
OG00231
OG00321
OG00422
Title
Denominators
Categories
Track 1
ParticipantsOG00030
ParticipantsOG00130
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
Title
Measurements
OG0000.491(0.294 to 0.661)
OG0010.429(0.246 to 0.600)
Track 2
ParticipantsOG00046
ParticipantsOG00132
ParticipantsOG00231
ParticipantsOG00321
OG002
Arm 3: Nivolumab Plus BMS-986205
Nivolumab was administered as a flat dose of 480 mg via IV infusion every 4 weeks, and BMS-986205 taken orally at a dose of 100 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
OG003
Arm 4: Nivolumab Plus BMS-813160 150 mg
Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 150 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
OG004
Arm 5: Nivolumab Plus BMS-813160 300mg
Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 300 mg twice daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Units
Counts
Participants
OG00076
OG00162
OG00231
OG00321
OG00422
Title
Denominators
Categories
Track 1
ParticipantsOG00030
ParticipantsOG00130
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
Title
Measurements
OG00029
OG00130
Track 2
ParticipantsOG00046
ParticipantsOG00132
ParticipantsOG00231
ParticipantsOG00321
OG002
Arm 3: Nivolumab Plus BMS-986205
Nivolumab was administered as a flat dose of 480 mg via IV infusion every 4 weeks, and BMS-986205 taken orally at a dose of 100 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
OG003
Arm 4: Nivolumab Plus BMS-813160 150 mg
Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 150 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
OG004
Arm 5: Nivolumab Plus BMS-813160 300mg
Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 300 mg twice daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Units
Counts
Participants
OG00076
OG00162
OG00231
OG00321
OG00422
Title
Denominators
Categories
Track 1
ParticipantsOG00030
ParticipantsOG00130
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
Title
Measurements
OG00017
OG00115
Track 2
ParticipantsOG00046
ParticipantsOG00132
ParticipantsOG00231
ParticipantsOG00321
OG002
Arm 3: Nivolumab Plus BMS-986205
Nivolumab was administered as a flat dose of 480 mg via IV infusion every 4 weeks, and BMS-986205 taken orally at a dose of 100 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
OG003
Arm 4: Nivolumab Plus BMS-813160 150 mg
Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 150 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
OG004
Arm 5: Nivolumab Plus BMS-813160 300mg
Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 300 mg twice daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Units
Counts
Participants
OG00076
OG00162
OG00231
OG00321
OG00422
Title
Denominators
Categories
Track 1
ParticipantsOG00030
ParticipantsOG00130
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
Title
Measurements
OG0007
OG0017
Track 2
ParticipantsOG00046
ParticipantsOG00132
ParticipantsOG00231
ParticipantsOG00321
OG002
Arm 3: Nivolumab Plus BMS-986205
Nivolumab was administered as a flat dose of 480 mg via IV infusion every 4 weeks, and BMS-986205 taken orally at a dose of 100 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
OG003
Arm 4: Nivolumab Plus BMS-813160 150 mg
Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 150 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
OG004
Arm 5: Nivolumab Plus BMS-813160 300mg
Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 300 mg twice daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Units
Counts
Participants
OG00076
OG00162
OG00231
OG00321
OG00422
Title
Denominators
Categories
Track 1
ParticipantsOG00030
ParticipantsOG00130
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
Title
Measurements
OG00012
OG00115
Track 2
ParticipantsOG00046
ParticipantsOG00132
ParticipantsOG00231
ParticipantsOG00321
OG002
Arm 3: Nivolumab Plus BMS-986205
Nivolumab was administered as a flat dose of 480 mg via IV infusion every 4 weeks, and BMS-986205 taken orally at a dose of 100 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
OG003
Arm 4: Nivolumab Plus BMS-813160 150 mg
Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 150 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
OG004
Arm 5: Nivolumab Plus BMS-813160 300mg
Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 300 mg twice daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Units
Counts
Participants
OG00028
OG00127
OG0020
OG0030
OG0040
Title
Denominators
Categories
TSH > ULN
Title
Measurements
OG0008
OG0018
OG0020
OG0030
OG0040
TSH > ULN WITH TSH <= ULN AT BASELINE
Title
Measurements
OG0005
OG0018
OG0020
OG003
TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE <LLN
Title
Measurements
OG0003
OG0013
OG0020
OG003
TSH >ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN
Title
Measurements
OG0003
OG0012
OG0020
OG003
TSH > ULN WITH FT3/FT4 TEST MISSING
Title
Measurements
OG0002
OG0013
OG0020
OG003
TSH < LLN
Title
Measurements
OG00010
OG0015
OG0020
OG003
TSH <LLN WITH TSH >= LLN AT BASELINE
Title
Measurements
OG0009
OG0015
OG0020
OG003
TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN
Title
Measurements
OG0003
OG0010
OG0020
OG003
TSH <LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN
Title
Measurements
OG0002
OG0011
OG0020
OG003
TSH < LLN WITH FT3/FT4 TEST MISSING
Title
Measurements
OG0005
OG0014
OG0020
OG003
OG002
Arm 3: Nivolumab Plus BMS-986205
Nivolumab was administered as a flat dose of 480 mg via IV infusion every 4 weeks, and BMS-986205 taken orally at a dose of 100 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
OG003
Arm 4: Nivolumab Plus BMS-813160 150 mg
Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 150 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
OG004
Arm 5: Nivolumab Plus BMS-813160 300mg
Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 300 mg twice daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Units
Counts
Participants
OG00042
OG00130
OG00225
OG00317
OG00413
Title
Denominators
Categories
TSH > ULN
Title
Measurements
OG00014
OG00114
OG0026
OG0033
OG0044
TSH > ULN WITH TSH <= ULN AT BASELINE
Title
Measurements
OG0008
OG0016
OG0023
OG003
TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE <LLN
Title
Measurements
OG0005
OG0013
OG0021
OG003
TSH >ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN
Title
Measurements
OG0005
OG0014
OG0023
OG003
TSH > ULN WITH FT3/FT4 TEST MISSING
Title
Measurements
OG0004
OG0017
OG0022
OG003
TSH < LLN
Title
Measurements
OG0004
OG0015
OG0022
OG003
TSH <LLN WITH TSH >= LLN AT BASELINE
Title
Measurements
OG0002
OG0014
OG0021
OG003
TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN
Title
Measurements
OG0001
OG0010
OG0021
OG003
TSH <LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN
Title
Measurements
OG0000
OG0013
OG0020
OG003
TSH < LLN WITH FT3/FT4 TEST MISSING
Title
Measurements
OG0003
OG0012
OG0021
OG003
OG002
Arm 3: Nivolumab Plus BMS-986205
Nivolumab was administered as a flat dose of 480 mg via IV infusion every 4 weeks, and BMS-986205 taken orally at a dose of 100 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
OG003
Arm 4: Nivolumab Plus BMS-813160 150 mg
Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 150 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
OG004
Arm 5: Nivolumab Plus BMS-813160 300mg
Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 300 mg twice daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Units
Counts
Participants
OG00028
OG00130
OG0020
OG0030
OG0040
Title
Denominators
Categories
ALT OR AST > 3XULN
Title
Measurements
OG0002
OG0014
OG0020
OG0030
OG0040
ALT OR AST> 5XULN
Title
Measurements
OG0001
OG0012
OG0020
OG003
ALT OR AST> 10XULN
Title
Measurements
OG0000
OG0010
OG00200
OG003
ALT OR AST > 20XULN
Title
Measurements
OG0000
OG0010
OG0020
OG003
TOTAL BILIRUBIN > 2XULN
Title
Measurements
OG0000
OG0010
OG0020
OG003
ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 1 DAY
Title
Measurements
OG0000
OG0010
OG0020
OG003
ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 30 DAYS
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG002
Arm 3: Nivolumab Plus BMS-986205
Nivolumab was administered as a flat dose of 480 mg via IV infusion every 4 weeks, and BMS-986205 taken orally at a dose of 100 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
OG003
Arm 4: Nivolumab Plus BMS-813160 150 mg
Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 150 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
OG004
Arm 5: Nivolumab Plus BMS-813160 300mg
Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 300 mg twice daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.
Units
Counts
Participants
OG00044
OG00132
OG00229
OG00317
OG00418
Title
Denominators
Categories
ALT OR AST > 3XULN
Title
Measurements
OG0003
OG0011
OG0021
OG0030
OG0040
ALT OR AST> 5XULN
Title
Measurements
OG0002
OG0010
OG0021
OG003
ALT OR AST> 10XULN
Title
Measurements
OG0000
OG0010
OG0020
OG003
ALT OR AST > 20XULN
Title
Measurements
OG0000
OG0010
OG0020
OG003
TOTAL BILIRUBIN > 2XULN
Title
Measurements
OG0002
OG0010
OG0020
OG003
ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 1 DAY
Title
Measurements
OG0000
OG0010
OG0020
OG003
ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 30 DAYS
Title
Measurements
OG0000
OG0010
OG0020
OG003
0 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0041 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0051 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0051 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
1 affected
32 at risk
EG0041 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0051 affected21 at risk
EG0060 affected22 at risk
1 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0041 affected31 at risk
EG0050 affected21 at risk
EG0061 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
1 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0061 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0041 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0051 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0041 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0061 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0061 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0051 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0061 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
1 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0041 affected31 at risk
EG0051 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
3 affected
32 at risk
EG0042 affected31 at risk
EG0050 affected21 at risk
EG0062 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0051 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0061 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
1 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0041 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0061 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0061 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0061 affected22 at risk
1 affected
32 at risk
EG0042 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
1 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0041 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0041 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
1 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
1 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0041 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0041 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
2 affected
32 at risk
EG0040 affected31 at risk
EG0051 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0041 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
1 affected
32 at risk
EG0041 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
1 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0051 affected21 at risk
EG0061 affected22 at risk
5 affected
32 at risk
EG0043 affected31 at risk
EG0051 affected21 at risk
EG0064 affected22 at risk
0 affected
32 at risk
EG0041 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0041 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0041 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
1 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0061 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0061 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
1 affected
32 at risk
EG0041 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0052 affected21 at risk
EG0061 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0061 affected22 at risk
0 affected
32 at risk
EG0041 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0041 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0051 affected21 at risk
EG0060 affected22 at risk
1 affected
32 at risk
EG0042 affected31 at risk
EG0052 affected21 at risk
EG0060 affected22 at risk
1 affected
32 at risk
EG0042 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0041 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0041 affected31 at risk
EG0050 affected21 at risk
EG0061 affected22 at risk
1 affected
32 at risk
EG0042 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0051 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0051 affected21 at risk
EG0060 affected22 at risk
1 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
1 affected
32 at risk
EG0042 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
1 affected
32 at risk
EG0040 affected31 at risk
EG0051 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0041 affected31 at risk
EG0050 affected21 at risk
EG0061 affected22 at risk
0 affected
32 at risk
EG0043 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
3 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
4 affected
32 at risk
EG0042 affected31 at risk
EG0051 affected21 at risk
EG0061 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
12 affected
32 at risk
EG0046 affected31 at risk
EG0052 affected21 at risk
EG0062 affected22 at risk
7 affected
32 at risk
EG0045 affected31 at risk
EG0056 affected21 at risk
EG0061 affected22 at risk
1 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0061 affected22 at risk
2 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
1 affected
32 at risk
EG0042 affected31 at risk
EG0051 affected21 at risk
EG0060 affected22 at risk
8 affected
32 at risk
EG0048 affected31 at risk
EG0056 affected21 at risk
EG0064 affected22 at risk
2 affected
32 at risk
EG0040 affected31 at risk
EG0052 affected21 at risk
EG0061 affected22 at risk
3 affected
32 at risk
EG0041 affected31 at risk
EG0054 affected21 at risk
EG0060 affected22 at risk
2 affected
32 at risk
EG0046 affected31 at risk
EG0052 affected21 at risk
EG0060 affected22 at risk
2 affected
32 at risk
EG0043 affected31 at risk
EG0052 affected21 at risk
EG0061 affected22 at risk
1 affected
32 at risk
EG0040 affected31 at risk
EG0052 affected21 at risk
EG0060 affected22 at risk
3 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
11 affected
32 at risk
EG0048 affected31 at risk
EG0057 affected21 at risk
EG0066 affected22 at risk
2 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
1 affected
32 at risk
EG0040 affected31 at risk
EG0052 affected21 at risk
EG0060 affected22 at risk
3 affected
32 at risk
EG0040 affected31 at risk
EG0051 affected21 at risk
EG0060 affected22 at risk
4 affected
32 at risk
EG0045 affected31 at risk
EG0051 affected21 at risk
EG0060 affected22 at risk
5 affected
32 at risk
EG0042 affected31 at risk
EG0051 affected21 at risk
EG0062 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0052 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0041 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
3 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
2 affected
32 at risk
EG0041 affected31 at risk
EG0051 affected21 at risk
EG0061 affected22 at risk
3 affected
32 at risk
EG0040 affected31 at risk
EG0051 affected21 at risk
EG0061 affected22 at risk
4 affected
32 at risk
EG0043 affected31 at risk
EG0052 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0041 affected31 at risk
EG0050 affected21 at risk
EG0062 affected22 at risk
2 affected
32 at risk
EG0041 affected31 at risk
EG0051 affected21 at risk
EG0061 affected22 at risk
1 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
1 affected
32 at risk
EG0042 affected31 at risk
EG0052 affected21 at risk
EG0062 affected22 at risk
1 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
2 affected
32 at risk
EG0043 affected31 at risk
EG0053 affected21 at risk
EG0062 affected22 at risk
0 affected
32 at risk
EG0041 affected31 at risk
EG0051 affected21 at risk
EG0061 affected22 at risk
0 affected
32 at risk
EG0042 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0043 affected31 at risk
EG0052 affected21 at risk
EG0062 affected22 at risk
1 affected
32 at risk
EG0041 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
2 affected
32 at risk
EG0041 affected31 at risk
EG0051 affected21 at risk
EG0062 affected22 at risk
8 affected
32 at risk
EG0044 affected31 at risk
EG0055 affected21 at risk
EG0063 affected22 at risk
3 affected
32 at risk
EG0041 affected31 at risk
EG0052 affected21 at risk
EG0061 affected22 at risk
1 affected
32 at risk
EG0043 affected31 at risk
EG0050 affected21 at risk
EG0061 affected22 at risk
2 affected
32 at risk
EG0041 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
2 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
1 affected
32 at risk
EG0041 affected31 at risk
EG0050 affected21 at risk
EG0061 affected22 at risk
1 affected
32 at risk
EG0041 affected31 at risk
EG0051 affected21 at risk
EG0060 affected22 at risk
2 affected
32 at risk
EG0042 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
1 affected
32 at risk
EG0041 affected31 at risk
EG0052 affected21 at risk
EG0060 affected22 at risk
7 affected
32 at risk
EG0047 affected31 at risk
EG0052 affected21 at risk
EG0064 affected22 at risk
7 affected
32 at risk
EG0046 affected31 at risk
EG0053 affected21 at risk
EG0064 affected22 at risk
4 affected
32 at risk
EG0042 affected31 at risk
EG0051 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0042 affected31 at risk
EG0052 affected21 at risk
EG0061 affected22 at risk
1 affected
32 at risk
EG0040 affected31 at risk
EG0052 affected21 at risk
EG0060 affected22 at risk
2 affected
32 at risk
EG0043 affected31 at risk
EG0052 affected21 at risk
EG0061 affected22 at risk
5 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0061 affected22 at risk
1 affected
32 at risk
EG0041 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
5 affected
32 at risk
EG0044 affected31 at risk
EG0051 affected21 at risk
EG0062 affected22 at risk
2 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
4 affected
32 at risk
EG0042 affected31 at risk
EG0053 affected21 at risk
EG0061 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0042 affected31 at risk
EG0051 affected21 at risk
EG0060 affected22 at risk
1 affected
32 at risk
EG0042 affected31 at risk
EG0053 affected21 at risk
EG0063 affected22 at risk
0 affected
32 at risk
EG0042 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
4 affected
32 at risk
EG0041 affected31 at risk
EG0052 affected21 at risk
EG0061 affected22 at risk
0 affected
32 at risk
EG0041 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0043 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
1 affected
32 at risk
EG0040 affected31 at risk
EG0051 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0041 affected31 at risk
EG0050 affected21 at risk
EG0061 affected22 at risk
0 affected
32 at risk
EG0042 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
1 affected
32 at risk
EG0041 affected31 at risk
EG0052 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0041 affected31 at risk
EG0051 affected21 at risk
EG0061 affected22 at risk
0 affected
32 at risk
EG0041 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
1 affected
32 at risk
EG0040 affected31 at risk
EG0051 affected21 at risk
EG0060 affected22 at risk
1 affected
32 at risk
EG0041 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
8 affected
32 at risk
EG0046 affected31 at risk
EG0056 affected21 at risk
EG0062 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0051 affected21 at risk
EG0060 affected22 at risk
3 affected
32 at risk
EG0047 affected31 at risk
EG0052 affected21 at risk
EG0064 affected22 at risk
1 affected
32 at risk
EG0040 affected31 at risk
EG0051 affected21 at risk
EG0061 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0052 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
1 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0061 affected22 at risk
0 affected
32 at risk
EG0043 affected31 at risk
EG0051 affected21 at risk
EG0060 affected22 at risk
1 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0042 affected31 at risk
EG0050 affected21 at risk
EG0061 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0061 affected22 at risk
1 affected
32 at risk
EG0041 affected31 at risk
EG0053 affected21 at risk
EG0060 affected22 at risk
2 affected
32 at risk
EG0041 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
2 affected
32 at risk
EG0042 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
1 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
3 affected
32 at risk
EG0041 affected31 at risk
EG0051 affected21 at risk
EG0061 affected22 at risk
1 affected
32 at risk
EG0040 affected31 at risk
EG0052 affected21 at risk
EG0061 affected22 at risk
8 affected
32 at risk
EG0042 affected31 at risk
EG0053 affected21 at risk
EG0061 affected22 at risk
7 affected
32 at risk
EG0043 affected31 at risk
EG0054 affected21 at risk
EG0062 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0051 affected21 at risk
EG0061 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0040 affected31 at risk
EG0052 affected21 at risk
EG0060 affected22 at risk
0 affected
32 at risk
EG0042 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
1 affected
32 at risk
EG0041 affected31 at risk
EG0052 affected21 at risk
EG0060 affected22 at risk
2 affected
32 at risk
EG0041 affected31 at risk
EG0050 affected21 at risk
EG0060 affected22 at risk
9.5
(1.2 to 30.4)
OG0040.0(0.0 to 15.4)
Participants
OG004
0
Title
Measurements
OG00068.00(0.1 to 117.6)
OG00199.4(99.4 to 99.4)
OG002NA(NA to NA)Insufficient number of participants with events
OG003NA(NA to NA)Insufficient number of participants with events
Participants
OG004
22
Title
Measurements
OG0000.432(0.277 to 0.577)
OG0010.194(0.079 to 0.346)
OG0020.278(0.118 to 0.464)
OG0030.468(0.237 to 0.670)
OG004NA(NA to NA)Insufficient number of participants with events.