A Study of BMS-986207 Given Alone and in Combination With... | NCT02913313 | Trialant
NCT02913313
Sponsor
Bristol-Myers Squibb
Status
Completed
Last Update Posted
Apr 20, 2025Actual
Enrollment
101Actual
Phase
Phase 1Phase 2
Conditions
Broad Solid Tumor
Interventions
BMS-986207
Nivolumab
Ipilimumab
Countries
United States
Argentina
Australia
Canada
Chile
Japan
Romania
Singapore
Protocol Section
Identification Module
NCT ID
NCT02913313
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CA020-002
Secondary IDs
ID
Type
Description
Link
2016-002263-34
EudraCT Number
Brief Title
A Study of BMS-986207 Given Alone and in Combination With Nivolumab or With Nivolumab and Ipilimumab in Advanced Solid Tumors
Official Title
Phase 1/2a First-In-Human Study of BMS-986207 Monoclonal Antibody Alone and in Combination With Nivolumab or With Nivolumab and Ipilimumab in Advanced Solid Tumors
Acronym
Not provided
Organization
Bristol-Myers SquibbINDUSTRY
Status Module
Record Verification Date
Apr 2025
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
Nov 30, 2016Actual
Primary Completion Date
Jan 25, 2024Actual
Completion Date
Jan 25, 2024Actual
First Submitted Date
Sep 21, 2016
First Submission Date that Met QC Criteria
Sep 21, 2016
First Posted Date
Sep 23, 2016Estimated
Results Waived
Not provided
Results First Submitted Date
Jan 23, 2025
Results First Submitted that Met QC Criteria
Apr 2, 2025
Results First Posted Date
Apr 20, 2025Actual
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
Apr 2, 2025
Last Update Posted Date
Apr 20, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Bristol-Myers SquibbINDUSTRY
Collaborators
Name
Class
Ono Pharmaceutical Co., Ltd.
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
No
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 evaluate the safety and effectiveness of experimental medication BMS-986207 by itself, in combination with Nivolumab, and in combination with both nivolumab and ipilimumab in participants with solid cancers that are advanced or have spread.
Detailed Description
Not provided
Conditions Module
Conditions
Broad Solid Tumor
Keywords
First line NSCLC
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 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
101Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part 1A: Dose Escalation Monotherapy
Experimental
Drug: BMS-986207
Part 1B: Dose Escalation Combination Therapy
Experimental
Drug: BMS-986207
Biological: Nivolumab
Part 2A: Expansion Monotherapy
Experimental
Drug: BMS-986207
Part 2B: Expansion Combination Therapy
Experimental
Drug: BMS-986207
Biological: Nivolumab
Part 1C: Triplet Cohort
Experimental
Drug: BMS-986207
Biological: Nivolumab
Biological: Ipilimumab
Part 2C: Triplet Expansion
Experimental
Drug: BMS-986207
Biological: Nivolumab
Biological: Ipilimumab
Interventions
Name
Type
Description
Arm Group Labels
Other Names
BMS-986207
Drug
Specified dose on specified days
Part 1A: Dose Escalation Monotherapy
Part 1B: Dose Escalation Combination Therapy
Part 1C: Triplet Cohort
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Adverse Events
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization.
From first dose (Day 1) untill 100 days after last dose (Up to approximately 27 months)
Number of Participants Who Died
Participants who died with any cause are considered in the analysis.
From first dose (Day 1) untill 100 days after last dose (Up to approximately 27 months)
Part 1A, 1B and 1C and 2A: Number of Participants With Dose Limiting Toxicities
Criteria for Dose-Limiting Toxicities (DLTs): Hepatic DLTs (excluding HCC): Grade (Gr) 4 elevations in AST, ALT, ALP, or total bilirubin. Gr 3 elevations in AST, ALT, or ALP >5 days, with symptoms, or bilirubin >2xULN without cholestasis. Gr 2 AST or ALT with symptomatic liver inflammation. AST or ALT >3xULN and bilirubin >2xULN without cholestasis. Hepatic DLTs for HCC: AST or ALT >10xULN for >2 weeks. AST or ALT >15xULN. Total bilirubin >8xULN (elevated at entry) or >5xULN (normal at entry). ALT ≥10xULN and bilirubin ≥2xULN or baseline, without other causes. Hematologic DLTs: Gr 4 neutropenia ≥7 days. Gr 4 thrombocytopenia. Gr 3 thrombocytopenia with bleeding or platelet transfusion. Febrile neutropenia. Gr 3 hemolysis requiring intervention. Gr 4 anemia not due to underlying disease. Dermatologic DLTs: Gr 4 rash. Gr 3 rash not improving to ≤Gr 1 after 1-2 week delay. Other DLTs: Gr 2-4 eye issues, Gr 3-4 toxicities, excluding specific Gr 3 events like nausea, fever.
From first dose (Day 1) and up to 6 weeks
Part 1A, 1B and 1C and 2A: Number of Participants With Grade 3/Grade 4 Laboratory Abnormalities
Secondary Outcomes
Measure
Description
Time Frame
Objective Response Rate (ORR)
ORR is defined as the percentage of participants with a confirmed Best overall response of Complete Response (CR) or Partial Response (PR) by RECIST v1.1.
Complete Response (CR): 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): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Must have pre-existing or prior programmed death-ligand 1 (PD-L1) immunohistochemistry (IHC) results within 3 months of enrollment from testing of tumor tissue; PD-L1 expression must be tumor cell positive ≥ 1% for a participant to be eligible for enrollment
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria; radiographic tumor assessment performed within 28 days before randomization
Exclusion Criteria:
Primary central nervous system (CNS) disease, or tumors with CNS metastases as the only site of disease. Controlled brain metastases will be allowed to enroll
Other active malignancy requiring concurrent intervention
Uncontrolled or significant cardiovascular disease
Active, known, or suspected autoimmune disease
NSCLC without prior treatment in the advanced or metastatic setting (Part 2C)
Other protocol-defined inclusion/exclusion criteria apply
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with total 48 mg of BMS-986207 as 60 minutes intravenous infusion in one cycle (each cycle of 8 weeks).
FG001
Part 1A BMS-986207 20 mg
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
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 6, 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
Non-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
Part 2A: Expansion Monotherapy
Part 2B: Expansion Combination Therapy
Part 2C: Triplet Expansion
Nivolumab
Biological
Specified dose on specified days
Part 1B: Dose Escalation Combination Therapy
Part 1C: Triplet Cohort
Part 2B: Expansion Combination Therapy
Part 2C: Triplet Expansion
BMS-936558
Opdivo
Ipilimumab
Biological
Specified dose on specified days
Part 1C: Triplet Cohort
Part 2C: Triplet Expansion
BMS-734016
Yervoy
Blood samples were collected to assess the abnormalities in laboratory parameters. The laboratory parameters were graded by Common Terminology Criteria for Adverse Events (CTCAE). Grade 3=Severe; Grade 4=Life-threatening.
From first dose (Day 1) till 100 days after last dose (Up to approximately 27 months)
Part 2C: Objective Response Rate (ORR)
ORR is defined as the percentage of participants with a confirmed Best overall response of Complete Response (CR) or Partial Response (PR) by RECIST v1.1.
Complete Response (CR): 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): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
From first dose (Day 1) and up to 24 weeks
Part 2C: Duration of Response (DOR)
DOR is defined for participants who have a confirmed CR or PR as the date from first documented CR or PR per RECIST v1.1 to the date of the documentation of disease progression or death due to any cause, whichever is earlier.
Complete Response (CR): 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): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
From first dose (Day 1) and up to 24 weeks
Part 2C: Progression Free Survival Rate at Week 24
Progression Free Survival Rates at 24 weeks is defined as the percentage of participants who achieve PFS at 24 weeks. PFS for a participant is defined as the time from randomization date to the date of first objectively documented disease progression by investigator per response evaluation criteria in solid tumors (RECIST) v1.1 or death due to any cause, whichever occurs first. Based on Kaplan-Meier Estimates.
Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the 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.
Week 24
From first dose (Day 1) and up to 24 weeks
Duration of Response
DOR is defined for participants who have a confirmed CR or PR as the date from first documented CR or PR per RECIST v1.1 to the date of the documentation of disease progression or death due to any cause, whichever is earlier.
Complete Response (CR): 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): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
From first dose (Day 1) and up to 24 weeks
Progression Free Survival Rate at Week 24
Progression Free Survival Rates at 24 weeks is defined as the percentage of participants who achieve PFS at 24 weeks. PFS for a participant is defined as the time from randomization date to the date of first objectively documented disease progression by investigator per response evaluation criteria in solid tumors (RECIST) v1.1 or death due to any cause, whichever occurs first. Based on Kaplan-Meier Estimates.
Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the 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.
Week 24
Maximum Observed Concentration (Cmax) of BMS-986207
Cmax is defined as maximum plasma concentration of the drug.
Day 1 of Cycle 1, Cycle 2 and Cycle 3 (Each cycle is of 8 weeks)
BMS-986207 Time to Maximum Concentration (Tmax)
Time to observed maximum concentration (Tmax) is defined as the amount of time in hours for a drug to reach the maximum concentration after administration.
Day 1 of Cycle 1, Cycle 2 and Cycle 3 (Each cycle is of 8 weeks)
BMS-986207 Area Under the Serum Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC (0-T))
BMS-986207 area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC (0-T)).
Day 1 of Cycle 1, Cycle 2 and Cycle 3 (Each cycle is of 8 weeks)
BMS-986207 Area Under the Serum Concentration-time Curve in One Dosing Interval AUC (TAU)
Blood samples were collected for assessing AUC (TAU).
Day 1 of Cycle 1, Cycle 2 and Cycle 3 (Each cycle is of 8 weeks)
BMS-986207 Observed Serum Concentration at the End of a Dosing Interval (Ctau)
Blood samples were collected for assessing Ctau.
Day 1 of Cycle 1, Cycle 2 and Cycle 3 (Each cycle is of 8 weeks)
BMS-986207 Total Body Clearance (CLT)
Blood samples were collected for assessing CLT.
Day 1 of Cycle 1, Cycle 2 and Cycle 3 (Each cycle is of 8 weeks)
BMS-986207 Average Concentration Over a Dosing Interval (Css-avg)
Blood samples were collected for assessing Css-avg.
Day 1 of Cycle 1, Cycle 2 and Cycle 3 (Each cycle is of 8 weeks)
BMS-986207 Ratio of an Exposure Measure at Steady State to That After the First Dose (AI_TAU)
Blood samples were collected for assessing AI_TAU.
Day 1 of Cycle 1, Cycle 2 and Cycle 3 (Each cycle is of 8 weeks)
BMS-986207 Effective Elimination Half-life That Explains the Degree of Accumulation Observed for a Specific Exposure Measure (T-HALFeff)
Blood samples were collected for assessing T-HALFeff. Exposure measure includes AUC[TAU].
Day 1 of Cycle 1, Cycle 2 and Cycle 3 (Each cycle is of 8 weeks)
Number of Participants With Positive Anti-BMS-986207-Antibodies Results
Participants who were treated with BMS-986207 and at least one post-baseline evaluable ADA assessment were considered in the analysis
From first dose (Day 1) till 100 days after last dose (Up to approximately 27 months)
New York
New York
10032
United States
Local Institution - 0012
Philadelphia
Pennsylvania
19104
United States
Local Institution - 0002
Philadelphia
Pennsylvania
19111
United States
Local Institution - 0009
Pittsburgh
Pennsylvania
15213
United States
Local Institution - 0010
Salt Lake City
Utah
84112
United States
Local Institution - 0023
CABA
Buenos Aires F.D.
C1430EGF
Argentina
Local Institution - 0019
Córdoba
Córdoba Province
X5002HWE
Argentina
Local Institution - 0022
Buenos Aires
Distrito Federal
C1093AAS
Argentina
Local Institution - 0006
Nedlands
Western Australia
6009
Australia
Local Institution - 0008
Ottawa
Ontario
K1H 8L6
Canada
Local Institution - 0007
Toronto
Ontario
M5G 2M9
Canada
Local Institution - 0021
Santiago
Santiago Metropolitan
8420383
Chile
Local Institution - 0004
Kashiwa-shi
Chiba
2778577
Japan
Local Institution - 0005
Chuo-ku
Tokyo
1040045
Japan
Local Institution - 0017
Bucharest
022328
Romania
Local Institution - 0016
Cluj-Napoca
400015
Romania
Local Institution - 0018
Craiova
200542
Romania
Local Institution - 0015
Florești
407280
Romania
Local Institution - 0020
Singapore
119074
Singapore
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 20 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
FG002
Part 1A BMS-986207 80 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
FG003
Part 1A BMS-986207 240 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
FG004
Part 1A BMS-986207 800 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
FG005
Part 1A BMS-986207 1600 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w) or 2 doses of BMS-986207 administered every 4 weeks (q4w).
FG006
Part 2A BMS-986207 800 mg (CRC)
Participants with colorectal cancer (CRC) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
FG007
Part 1B BMS-986207 80 mg + Nivolumab 240 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
FG008
Part 1B BMS-986207 240 mg + Nivolumab 240 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
FG009
Part 1B BMS-986207 1600 mg + Nivolumab 480 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
FG010
Part 1B: BMS-986207 480 mg + Nivolumab 480 mg
Participants with CRC or ovarian cancer or hepatocellular carcinoma were administered with 480 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with Nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and Ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the Nivolumab infusion.
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
Participants with first-line non-small cell lung cancer were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
FG0001 subjects
FG0012 subjects
FG0023 subjects
FG0034 subjects
FG0048 subjects
FG0054 subjects
FG00620 subjects
FG0074 subjects
FG0084 subjects
FG0094 subjects
FG01018 subjects
FG0116 subjects
FG01218 subjects
FG0135 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0121 subjects
FG0130 subjects
NOT COMPLETED
FG0001 subjects
FG0012 subjects
FG0023 subjects
FG0034 subjects
FG0048 subjects
FG0054 subjects
FG00620 subjects
FG0074 subjects
FG0084 subjects
FG0094 subjects
FG01018 subjects
FG0116 subjects
FG01217 subjects
FG0135 subjects
Type
Comment
Reasons
DISEASE PROGRESSION
FG0001 subjects
FG0012 subjects
FG0022 subjects
FG0034 subjects
FG0046 subjects
FG0054 subjects
FG00619 subjects
FG0073 subjects
FG0084 subjects
FG0094 subjects
FG01011 subjects
FG0115 subjects
FG01214 subjects
FG0133 subjects
Not Reported
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Other reasons
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
ADVERSE EVENT UNRELATED TO STUDY DRUG
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
STUDY DRUG TOXICITY
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part 1A BMS-986207 Safety Run In
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with total 48 mg of BMS-986207 as 60 minutes intravenous infusion in one cycle (each cycle of 8 weeks).
BG001
Part 1A BMS-986207 20 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 20 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
BG002
Part 1A BMS-986207 80 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
BG003
Part 1A BMS-986207 240 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
BG004
Part 1A BMS-986207 800 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
BG005
Part 1A BMS-986207 1600 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w) or 2 doses of BMS-986207 administered every 4 weeks (q4w).
BG006
Part 2A BMS-986207 800 mg (CRC)
Participants with colorectal cancer (CRC) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
BG007
Part 1B BMS-986207 80 mg + Nivolumab 240 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
BG008
Part 1B BMS-986207 240 mg + Nivolumab 240 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
BG009
Part 1B BMS-986207 1600 mg + Nivolumab 480 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
BG010
Part 1B: BMS-986207 480 mg + Nivolumab 480 mg
Participants with CRC or ovarian cancer or hepatocellular carcinoma were administered with 480 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with Nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and Ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the Nivolumab infusion.
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
Participants with first-line non-small cell lung cancer were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
BG014
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0001
BG0012
BG0023
BG0034
BG0048
BG0054
BG00620
BG0074
BG0084
BG0094
BG01018
BG0116
BG01218
BG0135
BG014101
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00055.0
BG00170.0± 2.83
BG00261.0± 6.24
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0001
BG0012
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
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
Number of Participants With Adverse Events
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization.
All Treated Participants.
Posted
Count of Participants
Participants
From first dose (Day 1) untill 100 days after last dose (Up to approximately 27 months)
ID
Title
Description
OG000
Part 1A BMS-986207 Safety Run In
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with total 48 mg of BMS-986207 as 60 minutes intravenous infusion in one cycle (each cycle of 8 weeks).
OG001
Part 1A BMS-986207 20 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 20 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
OG002
Part 1A BMS-986207 80 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
OG003
Part 1A BMS-986207 240 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
OG004
Part 1A BMS-986207 800 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
OG005
Part 1A BMS-986207 1600 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w) or 2 doses of BMS-986207 administered every 4 weeks (q4w).
OG006
Part 2A BMS-986207 800 mg (CRC)
Participants with colorectal cancer (CRC) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
OG007
Part 1B BMS-986207 80 mg + Nivolumab 240 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
OG008
Part 1B BMS-986207 240 mg + Nivolumab 240 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
OG009
Part 1B BMS-986207 1600 mg + Nivolumab 480 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
OG010
Part 1B: BMS-986207 480 mg + Nivolumab 480 mg
Participants with CRC or ovarian cancer or hepatocellular carcinoma were administered with 480 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with Nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and Ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the Nivolumab infusion.
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
Participants with first-line non-small cell lung cancer were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
Units
Counts
Participants
OG0001
OG0012
OG0023
OG003
Title
Denominators
Categories
Participants with any Adverse Events
Title
Measurements
OG0001
OG0012
OG0023
OG003
Primary
Number of Participants Who Died
Participants who died with any cause are considered in the analysis.
All Treated Participants.
Posted
Count of Participants
Participants
From first dose (Day 1) untill 100 days after last dose (Up to approximately 27 months)
ID
Title
Description
OG000
Part 1A BMS-986207 Safety Run In
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with total 48 mg of BMS-986207 as 60 minutes intravenous infusion in one cycle (each cycle of 8 weeks).
OG001
Part 1A BMS-986207 20 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 20 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
OG002
Part 1A BMS-986207 80 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Primary
Part 1A, 1B and 1C and 2A: Number of Participants With Dose Limiting Toxicities
Criteria for Dose-Limiting Toxicities (DLTs): Hepatic DLTs (excluding HCC): Grade (Gr) 4 elevations in AST, ALT, ALP, or total bilirubin. Gr 3 elevations in AST, ALT, or ALP >5 days, with symptoms, or bilirubin >2xULN without cholestasis. Gr 2 AST or ALT with symptomatic liver inflammation. AST or ALT >3xULN and bilirubin >2xULN without cholestasis. Hepatic DLTs for HCC: AST or ALT >10xULN for >2 weeks. AST or ALT >15xULN. Total bilirubin >8xULN (elevated at entry) or >5xULN (normal at entry). ALT ≥10xULN and bilirubin ≥2xULN or baseline, without other causes. Hematologic DLTs: Gr 4 neutropenia ≥7 days. Gr 4 thrombocytopenia. Gr 3 thrombocytopenia with bleeding or platelet transfusion. Febrile neutropenia. Gr 3 hemolysis requiring intervention. Gr 4 anemia not due to underlying disease. Dermatologic DLTs: Gr 4 rash. Gr 3 rash not improving to ≤Gr 1 after 1-2 week delay. Other DLTs: Gr 2-4 eye issues, Gr 3-4 toxicities, excluding specific Gr 3 events like nausea, fever.
All Treated Participants. Pre-specified to be only collected for Part 1A, 1B, 1C and 2A arms.
Posted
Count of Participants
Participants
From first dose (Day 1) and up to 6 weeks
ID
Title
Description
OG000
Part 1A BMS-986207 Safety Run In
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with total 48 mg of BMS-986207 as 60 minutes intravenous infusion in one cycle (each cycle of 8 weeks).
OG001
Part 1A BMS-986207 20 mg
Primary
Part 1A, 1B and 1C and 2A: Number of Participants With Grade 3/Grade 4 Laboratory Abnormalities
Blood samples were collected to assess the abnormalities in laboratory parameters. The laboratory parameters were graded by Common Terminology Criteria for Adverse Events (CTCAE). Grade 3=Severe; Grade 4=Life-threatening.
All treated participants with available laboratory abnormality results. Pre-specified to be only collected for Part 1A, 1B, 1C and 2A arms.
Posted
Count of Participants
Participants
From first dose (Day 1) till 100 days after last dose (Up to approximately 27 months)
ID
Title
Description
OG000
Part 1A BMS-986207 Safety Run In
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with total 48 mg of BMS-986207 as 60 minutes intravenous infusion in one cycle (each cycle of 8 weeks).
OG001
Part 1A BMS-986207 20 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 20 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
OG002
Part 1A BMS-986207 80 mg
Primary
Part 2C: Objective Response Rate (ORR)
ORR is defined as the percentage of participants with a confirmed Best overall response of Complete Response (CR) or Partial Response (PR) by RECIST v1.1.
Complete Response (CR): 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): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Participants with first-line non-small cell lung cancer were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
Units
Counts
Participants
Primary
Part 2C: Duration of Response (DOR)
DOR is defined for participants who have a confirmed CR or PR as the date from first documented CR or PR per RECIST v1.1 to the date of the documentation of disease progression or death due to any cause, whichever is earlier.
Complete Response (CR): 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): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
All Treated Participants. Participants with CR or PR were included in the analysis.
Participants with first-line non-small cell lung cancer were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
Units
Counts
Participants
Primary
Part 2C: Progression Free Survival Rate at Week 24
Progression Free Survival Rates at 24 weeks is defined as the percentage of participants who achieve PFS at 24 weeks. PFS for a participant is defined as the time from randomization date to the date of first objectively documented disease progression by investigator per response evaluation criteria in solid tumors (RECIST) v1.1 or death due to any cause, whichever occurs first. Based on Kaplan-Meier Estimates.
Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the 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.
Participants with first-line non-small cell lung cancer were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
Secondary
Objective Response Rate (ORR)
ORR is defined as the percentage of participants with a confirmed Best overall response of Complete Response (CR) or Partial Response (PR) by RECIST v1.1.
Complete Response (CR): 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): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters
All Treated Participants.
Posted
Number
95% Confidence Interval
percentage of participants
From first dose (Day 1) and up to 24 weeks
ID
Title
Description
OG000
Part 1A BMS-986207 Safety Run In
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with total 48 mg of BMS-986207 as 60 minutes intravenous infusion in one cycle (each cycle of 8 weeks).
OG001
Part 1A BMS-986207 20 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 20 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
OG002
Part 1A BMS-986207 80 mg
Secondary
Duration of Response
DOR is defined for participants who have a confirmed CR or PR as the date from first documented CR or PR per RECIST v1.1 to the date of the documentation of disease progression or death due to any cause, whichever is earlier.
Complete Response (CR): 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): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
All Treated Participants. Participants with CR or PR were included in the analysis.
Posted
Median
Full Range
percentage of participants
From first dose (Day 1) and up to 24 weeks
ID
Title
Description
OG000
Part 1A BMS-986207 Safety Run In
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with total 48 mg of BMS-986207 as 60 minutes intravenous infusion in one cycle (each cycle of 8 weeks).
OG001
Part 1A BMS-986207 20 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 20 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
OG002
Secondary
Progression Free Survival Rate at Week 24
Progression Free Survival Rates at 24 weeks is defined as the percentage of participants who achieve PFS at 24 weeks. PFS for a participant is defined as the time from randomization date to the date of first objectively documented disease progression by investigator per response evaluation criteria in solid tumors (RECIST) v1.1 or death due to any cause, whichever occurs first. Based on Kaplan-Meier Estimates.
Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the 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.
All Treated Participants.
Posted
Number
95% Confidence Interval
percentage of participants
Week 24
ID
Title
Description
OG000
Part 1A BMS-986207 Safety Run In
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with total 48 mg of BMS-986207 as 60 minutes intravenous infusion in one cycle (each cycle of 8 weeks).
OG001
Part 1A BMS-986207 20 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 20 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Secondary
Maximum Observed Concentration (Cmax) of BMS-986207
Cmax is defined as maximum plasma concentration of the drug.
All treated participants who have evaluable concentration-time data were included in the analysis. Only participants with evaluable concentration-time data at particular timepoint are considered in the analysis. Participant in Part 1A BMS-986207 Safety Run In did not meet criteria of evaluable concentration-time data hence not included in the analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Day 1 of Cycle 1, Cycle 2 and Cycle 3 (Each cycle is of 8 weeks)
ID
Title
Description
OG000
Part 1A BMS-986207 20 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 20 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
OG001
Part 1A BMS-986207 80 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
OG002
Part 1A BMS-986207 240 mg
Secondary
BMS-986207 Time to Maximum Concentration (Tmax)
Time to observed maximum concentration (Tmax) is defined as the amount of time in hours for a drug to reach the maximum concentration after administration.
All treated participants who have evaluable concentration-time data were included in the analysis. Only participants with evaluable concentration-time data at particular timepoint are considered in the analysis. Participant in Part 1A BMS-986207 Safety Run In did not meet criteria of evaluable concentration-time data hence not included in the analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
hours
Day 1 of Cycle 1, Cycle 2 and Cycle 3 (Each cycle is of 8 weeks)
ID
Title
Description
OG000
Part 1A BMS-986207 20 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 20 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
OG001
Part 1A BMS-986207 80 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Secondary
BMS-986207 Area Under the Serum Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC (0-T))
BMS-986207 area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC (0-T)).
All treated participants who have evaluable concentration-time data were included in the analysis. Only participants with evaluable concentration-time data at particular timepoint are considered in the analysis. Participant in Part 1A BMS-986207 Safety Run In did not meet criteria of evaluable concentration-time data hence not included in the analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
h*ng/mL
Day 1 of Cycle 1, Cycle 2 and Cycle 3 (Each cycle is of 8 weeks)
ID
Title
Description
OG000
Part 1A BMS-986207 20 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 20 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
OG001
Part 1A BMS-986207 80 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Secondary
BMS-986207 Area Under the Serum Concentration-time Curve in One Dosing Interval AUC (TAU)
Blood samples were collected for assessing AUC (TAU).
All treated participants who have evaluable concentration-time data were included in the analysis. Only participants with evaluable concentration-time data at particular timepoint are considered in the analysis. Participant in Part 1A BMS-986207 Safety Run In did not meet criteria of evaluable concentration-time data hence not included in the analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
h*ng/mL
Day 1 of Cycle 1, Cycle 2 and Cycle 3 (Each cycle is of 8 weeks)
ID
Title
Description
OG000
Part 1A BMS-986207 20 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 20 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
OG001
Part 1A BMS-986207 80 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
OG002
Secondary
BMS-986207 Observed Serum Concentration at the End of a Dosing Interval (Ctau)
Blood samples were collected for assessing Ctau.
All treated participants who have evaluable concentration-time data were included in the analysis. Only participants with evaluable concentration-time data at particular timepoint are considered in the analysis. Participant in Part 1A BMS-986207 Safety Run In did not meet criteria of evaluable concentration-time data hence not included in the analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Day 1 of Cycle 1, Cycle 2 and Cycle 3 (Each cycle is of 8 weeks)
ID
Title
Description
OG000
Part 1A BMS-986207 20 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 20 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
OG001
Part 1A BMS-986207 80 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
OG002
Secondary
BMS-986207 Total Body Clearance (CLT)
Blood samples were collected for assessing CLT.
All treated participants who have evaluable concentration-time data were included in the analysis. Only participants with evaluable concentration-time data at particular timepoint are considered in the analysis. Participant in Part 1A BMS-986207 Safety Run In did not meet criteria of evaluable concentration-time data hence not included in the analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
L/h
Day 1 of Cycle 1, Cycle 2 and Cycle 3 (Each cycle is of 8 weeks)
ID
Title
Description
OG000
Part 1A BMS-986207 20 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 20 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
OG001
Part 1A BMS-986207 80 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
OG002
Part 1A BMS-986207 240 mg
Secondary
BMS-986207 Average Concentration Over a Dosing Interval (Css-avg)
Blood samples were collected for assessing Css-avg.
All treated participants who have evaluable concentration-time data were included in the analysis. Only participants with evaluable concentration-time data at particular timepoint are considered in the analysis. Participant in Part 1A BMS-986207 Safety Run In did not meet criteria of evaluable concentration-time data hence not included in the analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Day 1 of Cycle 1, Cycle 2 and Cycle 3 (Each cycle is of 8 weeks)
ID
Title
Description
OG000
Part 1A BMS-986207 20 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 20 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
OG001
Part 1A BMS-986207 80 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
OG002
Secondary
BMS-986207 Ratio of an Exposure Measure at Steady State to That After the First Dose (AI_TAU)
Blood samples were collected for assessing AI_TAU.
All treated participants who have evaluable concentration-time data were included in the analysis. Only participants with evaluable concentration-time data at particular timepoint are considered in the analysis. Participant in Part 1A BMS-986207 Safety Run In did not meet criteria of evaluable concentration-time data hence not included in the analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
Ratio
Day 1 of Cycle 1, Cycle 2 and Cycle 3 (Each cycle is of 8 weeks)
ID
Title
Description
OG000
Part 1A BMS-986207 20 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 20 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
OG001
Part 1A BMS-986207 80 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
OG002
Secondary
BMS-986207 Effective Elimination Half-life That Explains the Degree of Accumulation Observed for a Specific Exposure Measure (T-HALFeff)
Blood samples were collected for assessing T-HALFeff. Exposure measure includes AUC[TAU].
All treated participants who have evaluable concentration-time data were included in the analysis. Only participants with evaluable concentration-time data at particular timepoint are considered in the analysis. Participant in Part 1A BMS-986207 Safety Run In did not meet criteria of evaluable concentration-time data hence not included in the analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
hours
Day 1 of Cycle 1, Cycle 2 and Cycle 3 (Each cycle is of 8 weeks)
ID
Title
Description
OG000
Part 1A BMS-986207 20 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 20 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
OG001
Part 1A BMS-986207 80 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Secondary
Number of Participants With Positive Anti-BMS-986207-Antibodies Results
Participants who were treated with BMS-986207 and at least one post-baseline evaluable ADA assessment were considered in the analysis
All Treated Participants with Baseline and at Least One Post-baseline Evaluable ADA Assessment were included in the analysis.
Posted
Count of Participants
Participants
From first dose (Day 1) till 100 days after last dose (Up to approximately 27 months)
ID
Title
Description
OG000
Part 1A BMS-986207 Safety Run In
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with total 48 mg of BMS-986207 as 60 minutes intravenous infusion in one cycle (each cycle of 8 weeks).
OG001
Part 1A BMS-986207 20 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 20 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
OG002
Part 1A BMS-986207 80 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Time Frame
All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
Description
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
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
Part 1A BMS-986207 Safety Run In
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with total 48 mg of BMS-986207 as 60 minutes intravenous infusion in one cycle (each cycle of 8 weeks).
1
1
1
1
1
1
EG001
Part 1A BMS-986207 20 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 20 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
0
2
0
2
2
2
EG002
Part 1A BMS-986207 80 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
3
3
3
3
3
3
EG003
Part 1A BMS-986207 240 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
2
4
3
4
4
4
EG004
Part 1A BMS-986207 800 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
5
8
5
8
8
8
EG005
Part 1A BMS-986207 1600 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w) or 2 doses of BMS-986207 administered every 4 weeks (q4w).
2
4
1
4
4
4
EG006
Part 2A BMS-986207 800 mg (CRC)
Participants with colorectal cancer (CRC) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
15
20
11
20
20
20
EG007
Part 1B BMS-986207 80 mg + Nivolumab 240 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
2
4
3
4
3
4
EG008
Part 1B BMS-986207 240 mg + Nivolumab 240 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
4
4
2
4
4
4
EG009
Part 1B BMS-986207 1600 mg + Nivolumab 480 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
4
4
1
4
4
4
EG010
Part 1B: BMS-986207 480 mg + Nivolumab 480 mg
Participants with CRC or ovarian cancer or hepatocellular carcinoma were administered with 480 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with Nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and Ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the Nivolumab infusion.
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
Participants with first-line non-small cell lung cancer were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
3
5
5
5
5
5
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Atrial fibrillation
Cardiac disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected8 at risk
EG0050 affected4 at risk
EG0060 affected20 at risk
EG0070 affected4 at risk
EG0080 affected4 at risk
EG0090 affected4 at risk
EG0101 affected18 at risk
EG0110 affected6 at risk
EG0120 affected18 at risk
EG0130 affected5 at risk
Atrioventricular block complete
Cardiac disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Cardiac tamponade
Cardiac disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Myocarditis
Cardiac disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Adrenal insufficiency
Endocrine disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Inappropriate antidiuretic hormone secretion
Endocrine disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Exophthalmos
Eye disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Abdominal pain
Gastrointestinal disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Enterocolitis
Gastrointestinal disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Pyrexia
General disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Bile duct stenosis
Hepatobiliary disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Jaundice cholestatic
Hepatobiliary disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Allergic oedema
Immune system disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Hypersensitivity
Immune system disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Bacteraemia
Infections and infestations
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Cellulitis
Infections and infestations
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Encephalitis
Infections and infestations
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Pneumococcal sepsis
Infections and infestations
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Pneumonia
Infections and infestations
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Pneumonia aspiration
Infections and infestations
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0021 affected3 at risk
EG003
Septic shock
Infections and infestations
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Stoma site cellulitis
Infections and infestations
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Urinary tract infection
Infections and infestations
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Vascular device infection
Infections and infestations
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Wound infection
Infections and infestations
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Fall
Injury, poisoning and procedural complications
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Aspartate aminotransferase increased
Investigations
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Blood alkaline phosphatase increased
Investigations
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Blood bilirubin increased
Investigations
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Brain cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Colorectal adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Colorectal cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Hepatocellular carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
26.1
Systematic Assessment
EG0001 affected1 at risk
EG0010 affected2 at risk
EG0022 affected3 at risk
EG003
Metastases to central nervous system
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Epilepsy
Nervous system disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Spinal cord compression
Nervous system disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Syncope
Nervous system disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Vocal cord paralysis
Nervous system disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Pulmonary haemorrhage
Respiratory, thoracic and mediastinal disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Dermatitis bullous
Skin and subcutaneous tissue disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Embolism
Vascular disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0011 affected2 at risk
EG0021 affected3 at risk
EG0031 affected4 at risk
EG0042 affected8 at risk
EG0052 affected4 at risk
EG0063 affected20 at risk
EG0071 affected4 at risk
EG0082 affected4 at risk
EG0092 affected4 at risk
EG0103 affected18 at risk
EG0113 affected6 at risk
EG0123 affected18 at risk
EG0134 affected5 at risk
Iron deficiency anaemia
Blood and lymphatic system disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Pernicious anaemia
Blood and lymphatic system disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Splenomegaly
Blood and lymphatic system disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Atrial fibrillation
Cardiac disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Bradycardia
Cardiac disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Myocarditis
Cardiac disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Sinus tachycardia
Cardiac disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Tachycardia
Cardiac disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Ear pruritus
Ear and labyrinth disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Adrenal insufficiency
Endocrine disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Hyperthyroidism
Endocrine disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Hypothyroidism
Endocrine disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Conjunctival haemorrhage
Eye disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Ocular hyperaemia
Eye disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Periorbital oedema
Eye disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Periorbital swelling
Eye disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Vision blurred
Eye disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Visual impairment
Eye disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Abdominal distension
Gastrointestinal disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Abdominal pain
Gastrointestinal disorders
26.1
Systematic Assessment
EG0001 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Aptyalism
Gastrointestinal disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Ascites
Gastrointestinal disorders
26.1
Systematic Assessment
EG0001 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Constipation
Gastrointestinal disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Diarrhoea
Gastrointestinal disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0011 affected2 at risk
EG0020 affected3 at risk
EG003
Dry mouth
Gastrointestinal disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Dyspepsia
Gastrointestinal disorders
26.1
Systematic Assessment
EG0001 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Dysphagia
Gastrointestinal disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Flatulence
Gastrointestinal disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Frequent bowel movements
Gastrointestinal disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Gastrointestinal pain
Gastrointestinal disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Nausea
Gastrointestinal disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0021 affected3 at risk
EG003
Oesophageal rupture
Gastrointestinal disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Oesophagitis
Gastrointestinal disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Oesophagomediastinal fistula
Gastrointestinal disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0021 affected3 at risk
EG003
Oral pain
Gastrointestinal disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Proctalgia
Gastrointestinal disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Salivary duct inflammation
Gastrointestinal disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Stomatitis
Gastrointestinal disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Vomiting
Gastrointestinal disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Asthenia
General disorders
26.1
Systematic Assessment
EG0001 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Chills
General disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Fatigue
General disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0011 affected2 at risk
EG0020 affected3 at risk
EG003
Gait disturbance
General disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Influenza like illness
General disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Localised oedema
General disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Malaise
General disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0021 affected3 at risk
EG003
Multiple organ dysfunction syndrome
General disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Nodule
General disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Non-cardiac chest pain
General disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0021 affected3 at risk
EG003
Oedema peripheral
General disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0021 affected3 at risk
EG003
Pain
General disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Peripheral swelling
General disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Pyrexia
General disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0011 affected2 at risk
EG0020 affected3 at risk
EG003
Swelling face
General disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Vessel puncture site erythema
General disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Xerosis
General disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Hepatic function abnormal
Hepatobiliary disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Portal vein thrombosis
Hepatobiliary disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Bronchitis
Infections and infestations
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0021 affected3 at risk
EG003
COVID-19
Infections and infestations
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
COVID-19 pneumonia
Infections and infestations
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Cellulitis
Infections and infestations
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Cryptosporidiosis infection
Infections and infestations
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Encephalitis
Infections and infestations
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Eye infection
Infections and infestations
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Herpes zoster
Infections and infestations
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Localised infection
Infections and infestations
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Lower respiratory tract infection
Infections and infestations
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Nasopharyngitis
Infections and infestations
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Oral candidiasis
Infections and infestations
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0021 affected3 at risk
EG003
Paronychia
Infections and infestations
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Pharyngitis
Infections and infestations
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Pneumonia
Infections and infestations
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Pneumonia bacterial
Infections and infestations
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Skin infection
Infections and infestations
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Stoma site abscess
Infections and infestations
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Stoma site cellulitis
Infections and infestations
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Stoma site infection
Infections and infestations
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Upper respiratory tract infection
Infections and infestations
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Urinary tract infection
Infections and infestations
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Wound infection
Infections and infestations
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Eye contusion
Injury, poisoning and procedural complications
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Fall
Injury, poisoning and procedural complications
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Hand fracture
Injury, poisoning and procedural complications
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0011 affected2 at risk
EG0020 affected3 at risk
EG003
Radiation skin injury
Injury, poisoning and procedural complications
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Tooth fracture
Injury, poisoning and procedural complications
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Adjusted calcium increased
Investigations
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Alanine aminotransferase increased
Investigations
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Ammonia increased
Investigations
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Amylase increased
Investigations
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Aspartate aminotransferase decreased
Investigations
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Aspartate aminotransferase increased
Investigations
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Blood albumin decreased
Investigations
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Blood alkaline phosphatase increased
Investigations
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0021 affected3 at risk
EG003
Blood bilirubin increased
Investigations
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Blood calcium increased
Investigations
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Blood cholesterol increased
Investigations
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Blood creatinine increased
Investigations
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Blood glucose increased
Investigations
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Blood magnesium decreased
Investigations
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Blood potassium decreased
Investigations
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0021 affected3 at risk
EG003
Blood sodium decreased
Investigations
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Blood testosterone decreased
Investigations
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Blood thyroid stimulating hormone decreased
Investigations
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Blood thyroid stimulating hormone increased
Investigations
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0021 affected3 at risk
EG003
Blood urea increased
Investigations
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Blood uric acid increased
Investigations
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Drug level increased
Investigations
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0021 affected3 at risk
EG003
International normalised ratio increased
Investigations
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Lipase decreased
Investigations
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Lipase increased
Investigations
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0011 affected2 at risk
EG0020 affected3 at risk
EG003
Lymphocyte count decreased
Investigations
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Lymphocyte count increased
Investigations
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Neutrophil count decreased
Investigations
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Neutrophil count increased
Investigations
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Platelet count decreased
Investigations
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Protein total decreased
Investigations
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Troponin increased
Investigations
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Weight decreased
Investigations
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Weight increased
Investigations
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
White blood cell count decreased
Investigations
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Acidosis
Metabolism and nutrition disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Dehydration
Metabolism and nutrition disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Glucose tolerance impaired
Metabolism and nutrition disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0021 affected3 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0011 affected2 at risk
EG0020 affected3 at risk
EG003
Hyperphosphataemia
Metabolism and nutrition disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0021 affected3 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0021 affected3 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
26.1
Systematic Assessment
EG0001 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0021 affected3 at risk
EG003
Malnutrition
Metabolism and nutrition disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0011 affected2 at risk
EG0020 affected3 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0021 affected3 at risk
EG003
Exostosis
Musculoskeletal and connective tissue disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0011 affected2 at risk
EG0020 affected3 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Greater trochanteric pain syndrome
Musculoskeletal and connective tissue disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Joint range of motion decreased
Musculoskeletal and connective tissue disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0011 affected2 at risk
EG0020 affected3 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Spinal pain
Musculoskeletal and connective tissue disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0021 affected3 at risk
EG003
Colorectal cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Laryngeal papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Peritumoural oedema
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Aphasia
Nervous system disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Ataxia
Nervous system disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Brain oedema
Nervous system disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Disturbance in attention
Nervous system disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Dizziness
Nervous system disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Drooling
Nervous system disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Headache
Nervous system disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Hemiparesis
Nervous system disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Lethargy
Nervous system disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Neuropathy peripheral
Nervous system disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Paraesthesia
Nervous system disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Parkinsonism
Nervous system disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Sensory disturbance
Nervous system disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Somnolence
Nervous system disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Taste disorder
Nervous system disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Tremor
Nervous system disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Ulnar nerve palsy
Nervous system disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Vocal cord paralysis
Nervous system disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Affective disorder
Psychiatric disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Anxiety
Psychiatric disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Confusional state
Psychiatric disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Delirium
Psychiatric disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Depression
Psychiatric disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Hallucination
Psychiatric disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Insomnia
Psychiatric disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Acute kidney injury
Renal and urinary disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Dysuria
Renal and urinary disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Pollakiuria
Renal and urinary disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Proteinuria
Renal and urinary disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Urinary incontinence
Renal and urinary disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Urogenital fistula
Renal and urinary disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0011 affected2 at risk
EG0021 affected3 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0021 affected3 at risk
EG003
Laryngeal inflammation
Respiratory, thoracic and mediastinal disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0021 affected3 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0021 affected3 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Sneezing
Respiratory, thoracic and mediastinal disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Stridor
Respiratory, thoracic and mediastinal disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Throat irritation
Respiratory, thoracic and mediastinal disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Tracheal fistula
Respiratory, thoracic and mediastinal disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0021 affected3 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0021 affected3 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Dermatitis allergic
Skin and subcutaneous tissue disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Dermatitis bullous
Skin and subcutaneous tissue disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Hyperkeratosis
Skin and subcutaneous tissue disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Pain of skin
Skin and subcutaneous tissue disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Purpura
Skin and subcutaneous tissue disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0011 affected2 at risk
EG0020 affected3 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0021 affected3 at risk
EG003
Embolism
Vascular disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Hypertension
Vascular disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Hypotension
Vascular disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Vasculitis
Vascular disorders
26.1
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected2 at risk
EG0020 affected3 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
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
OG004
Part 1A BMS-986207 800 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
OG005
Part 1A BMS-986207 1600 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w) or 2 doses of BMS-986207 administered every 4 weeks (q4w).
OG006
Part 2A BMS-986207 800 mg (CRC)
Participants with colorectal cancer (CRC) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
OG007
Part 1B BMS-986207 80 mg + Nivolumab 240 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
OG008
Part 1B BMS-986207 240 mg + Nivolumab 240 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
OG009
Part 1B BMS-986207 1600 mg + Nivolumab 480 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
OG010
Part 1B: BMS-986207 480 mg + Nivolumab 480 mg
Participants with CRC or ovarian cancer or hepatocellular carcinoma were administered with 480 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with Nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and Ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the Nivolumab infusion.
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
Participants with first-line non-small cell lung cancer were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
Units
Counts
Participants
OG0001
OG0012
OG0023
OG0034
OG0048
OG0054
OG00620
OG0074
OG0084
OG0094
OG01018
OG0116
OG01218
OG0135
Title
Denominators
Categories
Title
Measurements
OG0001
OG0010
OG0023
OG0031
OG0041
OG0051
OG0068
OG0072
OG0082
OG0091
OG0101
OG0111
OG0123
OG0131
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 20 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
OG002
Part 1A BMS-986207 80 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
OG003
Part 1A BMS-986207 240 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
OG004
Part 1A BMS-986207 800 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
OG005
Part 1A BMS-986207 1600 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w) or 2 doses of BMS-986207 administered every 4 weeks (q4w).
OG006
Part 2A BMS-986207 800 mg (CRC)
Participants with colorectal cancer (CRC) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
OG007
Part 1B BMS-986207 80 mg + Nivolumab 240 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
OG008
Part 1B BMS-986207 240 mg + Nivolumab 240 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
OG009
Part 1B BMS-986207 1600 mg + Nivolumab 480 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
OG010
Part 1B: BMS-986207 480 mg + Nivolumab 480 mg
Participants with CRC or ovarian cancer or hepatocellular carcinoma were administered with 480 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with Nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and Ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the Nivolumab infusion.
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
Units
Counts
Participants
OG0001
OG0012
OG0023
OG0034
OG0048
OG0054
OG00620
OG0074
OG0084
OG0094
OG01018
OG0116
OG01218
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0112
OG0121
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
OG003
Part 1A BMS-986207 240 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
OG004
Part 1A BMS-986207 800 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
OG005
Part 1A BMS-986207 1600 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w) or 2 doses of BMS-986207 administered every 4 weeks (q4w).
OG006
Part 2A BMS-986207 800 mg (CRC)
Participants with colorectal cancer (CRC) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
OG007
Part 1B BMS-986207 80 mg + Nivolumab 240 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
OG008
Part 1B BMS-986207 240 mg + Nivolumab 240 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
OG009
Part 1B BMS-986207 1600 mg + Nivolumab 480 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
OG010
Part 1B: BMS-986207 480 mg + Nivolumab 480 mg
Participants with CRC or ovarian cancer or hepatocellular carcinoma were administered with 480 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with Nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and Ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the Nivolumab infusion.
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
Units
Counts
Participants
OG0001
OG0012
OG0023
OG0034
OG0048
OG0054
OG00620
OG0074
OG0084
OG0094
OG01018
OG0116
OG01218
Title
Denominators
Categories
HEMOGLOBIN (Grade 3)
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0034
ParticipantsOG0048
ParticipantsOG0054
ParticipantsOG00620
ParticipantsOG0074
ParticipantsOG0084
ParticipantsOG0094
ParticipantsOG01018
ParticipantsOG0116
ParticipantsOG01218
Title
Measurements
OG0000
OG0010
OG0020
OG003
PLATELET COUNT (Grade 3)
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0034
PLATELET COUNT (Grade 4)
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0034
LEUKOCYTES (Grade 3)
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0034
LEUKOCYTES (Grade 4)
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0034
NEUTROPHILS (ABSOLUTE) (Grade 3)
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0034
NEUTROPHILS (ABSOLUTE) (Grade 4)
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0034
LYMPHOCYTES (ABSOLUTE) (Grade 3)
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0034
LYMPHOCYTES (ABSOLUTE) (Grade 4)
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0034
ABSOLUTE NEUTROPHIL COUNT (Grade 3)
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0034
ABSOLUTE NEUTROPHIL COUNT (Grade 4)
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0034
APTT (Grade 3)
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
APTT (Grade 4)
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
ALKALINE PHOSPHATASE (Grade 3)
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0034
ALKALINE PHOSPHATASE (Grade 4)
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0034
ASPARTATE AMINOTRANSFERASE (Grade 3)
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0034
ASPARTATE AMINOTRANSFERASE (Grade 4)
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0034
ALANINE AMINOTRANSFERASE (Grade 3)
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0034
ALANINE AMINOTRANSFERASE (Grade 4)
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0034
G-GLUTAMYL TRANSFERASE (Grade 3)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0023
ParticipantsOG0032
G-GLUTAMYL TRANSFERASE (Grade 4)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0023
ParticipantsOG0032
BILIRUBIN, TOTAL (Grade 3)
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0034
BILIRUBIN, TOTAL (Grade 4)
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0034
CREATININE (Grade 3)
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0034
CREATININE (Grade 4)
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0034
CALCIUM (Grade 3)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
CALCIUM (Grade 4)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
PHOSPHORUS (Grade 3)
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0034
PHOSPHORUS (Grade 4)
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0034
ALBUMIN (Grade 3)
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0034
ALBUMIN (Grade 4)
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0034
AMYLASE (Grade 3)
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0034
AMYLASE (Grade 4)
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0034
LIPASE (Grade 3)
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0034
LIPASE (Grade 4)
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0034
URIC ACID (Grade 3)
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0034
URIC ACID (Grade 4)
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0034
HYPERNATREMIA (Grade 3)
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0034
HYPERNATREMIA (Grade 4)
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0034
HYPONATREMIA (Grade 3)
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0034
HYPONATREMIA (Grade 4)
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0034
HYPERKALEMIA (Grade 3)
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0034
HYPERKALEMIA (Grade 4)
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0034
HYPOKALEMIA (Grade 3)
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0034
HYPOKALEMIA (Grade 4)
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0034
HYPERCALCEMIA (Grade 3)
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0034
HYPERCALCEMIA (Grade 4)
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0034
HYPOCALCEMIA (Grade 3)
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0034
HYPOCALCEMIA (Grade 4)
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0034
HYPERMAGNESEMIA (Grade 3)
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0034
HYPERMAGNESEMIA (Grade 4)
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0034
HYPOMAGNESEMIA (Grade 3)
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0034
HYPOMAGNESEMIA (Grade 4)
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0034
OG0005
Title
Denominators
Categories
Title
Measurements
OG00020.0(0.5 to 71.6)
OG0001
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Not estimated due to inadequate number of events.
Units
Counts
Participants
OG0005
Title
Denominators
Categories
Title
Measurements
OG00080.0(20.4 to 96.9)
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
OG003
Part 1A BMS-986207 240 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
OG004
Part 1A BMS-986207 800 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
OG005
Part 1A BMS-986207 1600 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w) or 2 doses of BMS-986207 administered every 4 weeks (q4w).
OG006
Part 2A BMS-986207 800 mg (CRC)
Participants with colorectal cancer (CRC) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
OG007
Part 1B BMS-986207 80 mg + Nivolumab 240 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
OG008
Part 1B BMS-986207 240 mg + Nivolumab 240 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
OG009
Part 1B BMS-986207 1600 mg + Nivolumab 480 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
OG010
Part 1B: BMS-986207 480 mg + Nivolumab 480 mg
Participants with CRC or ovarian cancer or hepatocellular carcinoma were administered with 480 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with Nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and Ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the Nivolumab infusion.
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
Units
Counts
Participants
OG0001
OG0012
OG0023
OG0034
OG0048
OG0054
OG00620
OG0074
OG0084
OG0094
OG01018
OG0116
OG01218
Title
Denominators
Categories
Title
Measurements
OG0000.0(0.0 to 97.5)
OG0010.0(0.0 to 84.2)
OG0020.0(0.0 to 70.8)
OG0030.0(0.0 to 60.2)
OG0040.0(0.0 to 36.9)
OG0050.0(0.0 to 60.2)
OG0060.0(0.0 to 16.8)
OG0070.0(0.0 to 60.2)
OG0080.0(0.0 to 60.2)
OG0090.0(0.0 to 60.2)
OG01022.2(6.4 to 47.6)
OG01133.3(4.3 to 77.7)
OG0125.6(0.1 to 27.3)
Part 1A BMS-986207 80 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
OG003
Part 1A BMS-986207 240 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
OG004
Part 1A BMS-986207 800 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
OG005
Part 1A BMS-986207 1600 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w) or 2 doses of BMS-986207 administered every 4 weeks (q4w).
OG006
Part 2A BMS-986207 800 mg (CRC)
Participants with colorectal cancer (CRC) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
OG007
Part 1B BMS-986207 80 mg + Nivolumab 240 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
OG008
Part 1B BMS-986207 240 mg + Nivolumab 240 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
OG009
Part 1B BMS-986207 1600 mg + Nivolumab 480 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
OG010
Part 1B: BMS-986207 480 mg + Nivolumab 480 mg
Participants with CRC or ovarian cancer or hepatocellular carcinoma were administered with 480 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with Nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and Ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the Nivolumab infusion.
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0104
OG0112
OG0121
Title
Denominators
Categories
Title
Measurements
OG010NA(NA to NA)Not evaluable due to inadequate number of events
OG011NA(NA to NA)Not evaluable due to inadequate number of events
OG012NA(NA to NA)Not evaluable due to inadequate number of events
OG002
Part 1A BMS-986207 80 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
OG003
Part 1A BMS-986207 240 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
OG004
Part 1A BMS-986207 800 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
OG005
Part 1A BMS-986207 1600 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w) or 2 doses of BMS-986207 administered every 4 weeks (q4w).
OG006
Part 2A BMS-986207 800 mg (CRC)
Participants with colorectal cancer (CRC) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
OG007
Part 1B BMS-986207 80 mg + Nivolumab 240 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
OG008
Part 1B BMS-986207 240 mg + Nivolumab 240 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
OG009
Part 1B BMS-986207 1600 mg + Nivolumab 480 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
OG010
Part 1B: BMS-986207 480 mg + Nivolumab 480 mg
Participants with CRC or ovarian cancer or hepatocellular carcinoma were administered with 480 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with Nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and Ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the Nivolumab infusion.
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
Units
Counts
Participants
OG0001
OG0012
OG0023
OG0034
OG0048
OG0054
OG00620
OG0074
OG0084
OG0094
OG01018
OG0116
OG01218
Title
Denominators
Categories
Title
Measurements
OG000100.0(100.0 to 100.0)
OG001100.0(100.0 to 100.0)
OG00266.7(5.4 to 94.5)
OG003100.0(100.0 to 100.0)
OG00475.0(31.5 to 93.1)
OG005100.0(100.0 to 100.0)
OG00670.0(45.1 to 85.3)
OG007100.0(100.0 to 100.0)
OG008100.0(100.0 to 100.0)
OG00975.0(12.8 to 96.1)
OG01093.3(61.3 to 99.0)
OG01166.7(19.5 to 90.4)
OG01261.1(35.3 to 79.2)
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
OG003
Part 1A BMS-986207 800 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
OG004
Part 1A BMS-986207 1600 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w) or 2 doses of BMS-986207 administered every 4 weeks (q4w).
OG005
Part 2A BMS-986207 800 mg (CRC)
Participants with colorectal cancer (CRC) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
OG006
Part 1B BMS-986207 80 mg + Nivolumab 240 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
OG007
Part 1B BMS-986207 240 mg + Nivolumab 240 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
OG008
Part 1B BMS-986207 1600 mg + Nivolumab 480 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
OG009
Part 1B: BMS-986207 480 mg + Nivolumab 480 mg
Participants with CRC or ovarian cancer or hepatocellular carcinoma were administered with 480 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with Nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and Ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the Nivolumab infusion.
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
Participants with first-line non-small cell lung cancer were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
Units
Counts
Participants
OG0002
OG0013
OG0024
OG0038
OG0044
OG00520
OG0064
OG0074
OG0084
OG00918
OG0106
OG01118
OG0125
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0038
ParticipantsOG0044
ParticipantsOG00520
ParticipantsOG0064
ParticipantsOG0074
ParticipantsOG0084
ParticipantsOG00918
ParticipantsOG0106
ParticipantsOG01118
ParticipantsOG0125
Title
Measurements
OG0004952± 34
OG00127291± 11
OG00278548± 29
OG003
Cycle 2 Day 1
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0023
ParticipantsOG0034
Cycle 3 Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG002
Part 1A BMS-986207 240 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
OG003
Part 1A BMS-986207 800 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
OG004
Part 1A BMS-986207 1600 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w) or 2 doses of BMS-986207 administered every 4 weeks (q4w).
OG005
Part 2A BMS-986207 800 mg (CRC)
Participants with colorectal cancer (CRC) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
OG006
Part 1B BMS-986207 80 mg + Nivolumab 240 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
OG007
Part 1B BMS-986207 240 mg + Nivolumab 240 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
OG008
Part 1B BMS-986207 1600 mg + Nivolumab 480 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
OG009
Part 1B: BMS-986207 480 mg + Nivolumab 480 mg
Participants with CRC or ovarian cancer or hepatocellular carcinoma were administered with 480 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with Nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and Ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the Nivolumab infusion.
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
Participants with first-line non-small cell lung cancer were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
Units
Counts
Participants
OG0002
OG0013
OG0024
OG0038
OG0044
OG00520
OG0064
OG0074
OG0084
OG00918
OG0106
OG01118
OG0125
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0038
ParticipantsOG0044
ParticipantsOG00520
ParticipantsOG0064
ParticipantsOG0074
ParticipantsOG0084
ParticipantsOG00918
ParticipantsOG0106
ParticipantsOG01118
ParticipantsOG0125
Title
Measurements
OG0002.20± 169
OG0011.07± 9
OG0021.00± 5
OG003
Cycle 2 Day 1
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0023
ParticipantsOG0034
Cycle 3 Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG002
Part 1A BMS-986207 240 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
OG003
Part 1A BMS-986207 800 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
OG004
Part 1A BMS-986207 1600 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w) or 2 doses of BMS-986207 administered every 4 weeks (q4w).
OG005
Part 2A BMS-986207 800 mg (CRC)
Participants with colorectal cancer (CRC) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
OG006
Part 1B BMS-986207 80 mg + Nivolumab 240 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
OG007
Part 1B BMS-986207 240 mg + Nivolumab 240 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
OG008
Part 1B BMS-986207 1600 mg + Nivolumab 480 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
OG009
Part 1B: BMS-986207 480 mg + Nivolumab 480 mg
Participants with CRC or ovarian cancer or hepatocellular carcinoma were administered with 480 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with Nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and Ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the Nivolumab infusion.
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
Participants with first-line non-small cell lung cancer were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
Units
Counts
Participants
OG0002
OG0013
OG0024
OG0038
OG0044
OG00520
OG0064
OG0074
OG0084
OG00918
OG0106
OG01118
OG0125
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0038
ParticipantsOG0044
ParticipantsOG00520
ParticipantsOG0064
ParticipantsOG0074
ParticipantsOG0084
ParticipantsOG00918
ParticipantsOG0106
ParticipantsOG01118
ParticipantsOG0125
Title
Measurements
OG000903246± 16
OG0014040645± 20
OG00211778859± 27
OG003
Cycle 2 Day 1
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0023
ParticipantsOG0034
Cycle 3 Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Part 1A BMS-986207 240 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
OG003
Part 1A BMS-986207 800 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
OG004
Part 1A BMS-986207 1600 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w) or 2 doses of BMS-986207 administered every 4 weeks (q4w).
OG005
Part 2A BMS-986207 800 mg (CRC)
Participants with colorectal cancer (CRC) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
OG006
Part 1B BMS-986207 80 mg + Nivolumab 240 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
OG007
Part 1B BMS-986207 240 mg + Nivolumab 240 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
OG008
Part 1B BMS-986207 1600 mg + Nivolumab 480 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
OG009
Part 1B: BMS-986207 480 mg + Nivolumab 480 mg
Participants with CRC or ovarian cancer or hepatocellular carcinoma were administered with 480 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with Nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and Ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the Nivolumab infusion.
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
Participants with first-line non-small cell lung cancer were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
Units
Counts
Participants
OG0002
OG0013
OG0024
OG0038
OG0044
OG00520
OG0064
OG0074
OG0084
OG00918
OG0106
OG01118
OG0125
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0038
ParticipantsOG0044
ParticipantsOG00520
ParticipantsOG0064
ParticipantsOG0074
ParticipantsOG0084
ParticipantsOG00918
ParticipantsOG0104
ParticipantsOG01118
ParticipantsOG0125
Title
Measurements
OG000903246± 16
OG0014040645± 20
OG00211778859± 27
OG003
Cycle 2 Day 1
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0023
ParticipantsOG0034
Cycle 3 Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Part 1A BMS-986207 240 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
OG003
Part 1A BMS-986207 800 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
OG004
Part 1A BMS-986207 1600 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w) or 2 doses of BMS-986207 administered every 4 weeks (q4w).
OG005
Part 2A BMS-986207 800 mg (CRC)
Participants with colorectal cancer (CRC) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
OG006
Part 1B BMS-986207 80 mg + Nivolumab 240 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
OG007
Part 1B BMS-986207 240 mg + Nivolumab 240 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
OG008
Part 1B BMS-986207 1600 mg + Nivolumab 480 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
OG009
Part 1B: BMS-986207 480 mg + Nivolumab 480 mg
Participants with CRC or ovarian cancer or hepatocellular carcinoma were administered with 480 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with Nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and Ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the Nivolumab infusion.
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
Participants with first-line non-small cell lung cancer were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
Units
Counts
Participants
OG0002
OG0013
OG0024
OG0038
OG0044
OG00520
OG0064
OG0074
OG0084
OG00918
OG0106
OG01118
OG0125
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0038
ParticipantsOG0044
ParticipantsOG00520
ParticipantsOG0064
ParticipantsOG0074
ParticipantsOG0084
ParticipantsOG00918
ParticipantsOG0104
ParticipantsOG01118
ParticipantsOG0125
Title
Measurements
OG0001657± 24
OG0016526± 41
OG00220264± 34
OG003
Cycle 2 Day 1
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0023
ParticipantsOG0034
Cycle 3 Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
OG003
Part 1A BMS-986207 800 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
OG004
Part 1A BMS-986207 1600 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w) or 2 doses of BMS-986207 administered every 4 weeks (q4w).
OG005
Part 2A BMS-986207 800 mg (CRC)
Participants with colorectal cancer (CRC) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
OG006
Part 1B BMS-986207 80 mg + Nivolumab 240 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
OG007
Part 1B BMS-986207 240 mg + Nivolumab 240 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
OG008
Part 1B BMS-986207 1600 mg + Nivolumab 480 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
OG009
Part 1B: BMS-986207 480 mg + Nivolumab 480 mg
Participants with CRC or ovarian cancer or hepatocellular carcinoma were administered with 480 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with Nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and Ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the Nivolumab infusion.
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
Participants with first-line non-small cell lung cancer were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
Units
Counts
Participants
OG0001
OG0011
OG0023
OG0034
OG0042
OG0055
OG0063
OG0071
OG0081
OG0099
OG0102
OG0114
OG0122
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
Cycle 2 Day 1
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0023
ParticipantsOG0034
Cycle 3 Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Part 1A BMS-986207 240 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
OG003
Part 1A BMS-986207 800 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
OG004
Part 1A BMS-986207 1600 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w) or 2 doses of BMS-986207 administered every 4 weeks (q4w).
OG005
Part 2A BMS-986207 800 mg (CRC)
Participants with colorectal cancer (CRC) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
OG006
Part 1B BMS-986207 80 mg + Nivolumab 240 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
OG007
Part 1B BMS-986207 240 mg + Nivolumab 240 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
OG008
Part 1B BMS-986207 1600 mg + Nivolumab 480 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
OG009
Part 1B: BMS-986207 480 mg + Nivolumab 480 mg
Participants with CRC or ovarian cancer or hepatocellular carcinoma were administered with 480 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with Nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and Ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the Nivolumab infusion.
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
Participants with first-line non-small cell lung cancer were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
Units
Counts
Participants
OG0001
OG0011
OG0023
OG0034
OG0042
OG0055
OG0063
OG0071
OG0081
OG0099
OG0102
OG0114
OG0122
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
Cycle 2 Day 1
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0023
ParticipantsOG0034
Cycle 3 Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Part 1A BMS-986207 240 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
OG003
Part 1A BMS-986207 800 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
OG004
Part 1A BMS-986207 1600 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w) or 2 doses of BMS-986207 administered every 4 weeks (q4w).
OG005
Part 2A BMS-986207 800 mg (CRC)
Participants with colorectal cancer (CRC) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
OG006
Part 1B BMS-986207 80 mg + Nivolumab 240 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
OG007
Part 1B BMS-986207 240 mg + Nivolumab 240 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
OG008
Part 1B BMS-986207 1600 mg + Nivolumab 480 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
OG009
Part 1B: BMS-986207 480 mg + Nivolumab 480 mg
Participants with CRC or ovarian cancer or hepatocellular carcinoma were administered with 480 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with Nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and Ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the Nivolumab infusion.
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
Participants with first-line non-small cell lung cancer were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
Units
Counts
Participants
OG0001
OG0011
OG0023
OG0034
OG0042
OG0055
OG0063
OG0071
OG0081
OG0099
OG0102
OG0114
OG0122
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
Cycle 2 Day 1
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0023
ParticipantsOG0034
Cycle 3 Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG002
Part 1A BMS-986207 240 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
OG003
Part 1A BMS-986207 800 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
OG004
Part 1A BMS-986207 1600 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w) or 2 doses of BMS-986207 administered every 4 weeks (q4w).
OG005
Part 2A BMS-986207 800 mg (CRC)
Participants with colorectal cancer (CRC) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
OG006
Part 1B BMS-986207 80 mg + Nivolumab 240 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
OG007
Part 1B BMS-986207 240 mg + Nivolumab 240 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
OG008
Part 1B BMS-986207 1600 mg + Nivolumab 480 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
OG009
Part 1B: BMS-986207 480 mg + Nivolumab 480 mg
Participants with CRC or ovarian cancer or hepatocellular carcinoma were administered with 480 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with Nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and Ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the Nivolumab infusion.
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
Participants with first-line non-small cell lung cancer were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
Units
Counts
Participants
OG0001
OG0011
OG0023
OG0034
OG0042
OG0055
OG0062
OG0071
OG0081
OG0099
OG0101
OG0114
OG0121
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
Cycle 2 Day 1
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0023
ParticipantsOG0034
Cycle 3 Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG003
Part 1A BMS-986207 240 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
OG004
Part 1A BMS-986207 800 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
OG005
Part 1A BMS-986207 1600 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w) or 2 doses of BMS-986207 administered every 4 weeks (q4w).
OG006
Part 2A BMS-986207 800 mg (CRC)
Participants with colorectal cancer (CRC) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
OG007
Part 1B BMS-986207 80 mg + Nivolumab 240 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
OG008
Part 1B BMS-986207 240 mg + Nivolumab 240 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
OG009
Part 1B BMS-986207 1600 mg + Nivolumab 480 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
OG010
Part 1B: BMS-986207 480 mg + Nivolumab 480 mg
Participants with CRC or ovarian cancer or hepatocellular carcinoma were administered with 480 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with Nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and Ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the Nivolumab infusion.
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
Participants with first-line non-small cell lung cancer were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
Units
Counts
Participants
OG0001
OG0012
OG0023
OG0034
OG0048
OG0054
OG00620
OG0074
OG0084
OG0094
OG01014
OG0112
OG0125
OG0133
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0061
OG0070
OG0081
OG0090
OG0100
OG0110
OG0120
OG0130
0 affected
4 at risk
EG0040 affected8 at risk
EG0050 affected4 at risk
EG0060 affected20 at risk
EG0070 affected4 at risk
EG0080 affected4 at risk
EG0090 affected4 at risk
EG0101 affected18 at risk
EG0110 affected6 at risk
EG0120 affected18 at risk
EG0130 affected5 at risk
0 affected
4 at risk
EG0040 affected8 at risk
EG0050 affected4 at risk
EG0060 affected20 at risk
EG0070 affected4 at risk
EG0080 affected4 at risk
EG0090 affected4 at risk
EG0100 affected18 at risk
EG0110 affected6 at risk
EG0120 affected18 at risk
EG0131 affected5 at risk
0 affected
4 at risk
EG0040 affected8 at risk
EG0050 affected4 at risk
EG0060 affected20 at risk
EG0070 affected4 at risk
EG0080 affected4 at risk
EG0090 affected4 at risk
EG0100 affected18 at risk
EG0110 affected6 at risk
EG0121 affected18 at risk
EG0130 affected5 at risk
0 affected
4 at risk
EG0040 affected8 at risk
EG0050 affected4 at risk
EG0060 affected20 at risk
EG0070 affected4 at risk
EG0080 affected4 at risk
EG0090 affected4 at risk
EG0102 affected18 at risk
EG0110 affected6 at risk
EG0120 affected18 at risk
EG0130 affected5 at risk
0 affected
4 at risk
EG0040 affected8 at risk
EG0050 affected4 at risk
EG0060 affected20 at risk
EG0070 affected4 at risk
EG0080 affected4 at risk
EG0090 affected4 at risk
EG0100 affected18 at risk
EG0111 affected6 at risk
EG0120 affected18 at risk
EG0130 affected5 at risk
0 affected
4 at risk
EG0040 affected8 at risk
EG0050 affected4 at risk
EG0060 affected20 at risk
EG0070 affected4 at risk
EG0080 affected4 at risk
EG0090 affected4 at risk
EG0101 affected18 at risk
EG0110 affected6 at risk
EG0120 affected18 at risk
EG0130 affected5 at risk
1 affected
4 at risk
EG0040 affected8 at risk
EG0050 affected4 at risk
EG0060 affected20 at risk
EG0070 affected4 at risk
EG0080 affected4 at risk
EG0090 affected4 at risk
EG0100 affected18 at risk
EG0111 affected6 at risk
EG0120 affected18 at risk
EG0130 affected5 at risk
0 affected
4 at risk
EG0040 affected8 at risk
EG0050 affected4 at risk
EG0060 affected20 at risk
EG0070 affected4 at risk
EG0080 affected4 at risk
EG0090 affected4 at risk
EG0100 affected18 at risk
EG0111 affected6 at risk
EG0120 affected18 at risk
EG0130 affected5 at risk
0 affected
4 at risk
EG0040 affected8 at risk
EG0050 affected4 at risk
EG0060 affected20 at risk
EG0070 affected4 at risk
EG0080 affected4 at risk
EG0090 affected4 at risk
EG0100 affected18 at risk
EG0111 affected6 at risk
EG0120 affected18 at risk
EG0130 affected5 at risk
0 affected
4 at risk
EG0041 affected8 at risk
EG0050 affected4 at risk
EG0060 affected20 at risk
EG0070 affected4 at risk
EG0080 affected4 at risk
EG0090 affected4 at risk
EG0100 affected18 at risk
EG0110 affected6 at risk
EG0120 affected18 at risk
EG0130 affected5 at risk
0 affected
4 at risk
EG0040 affected8 at risk
EG0050 affected4 at risk
EG0061 affected20 at risk
EG0070 affected4 at risk
EG0080 affected4 at risk
EG0090 affected4 at risk
EG0100 affected18 at risk
EG0110 affected6 at risk
EG0120 affected18 at risk
EG0130 affected5 at risk
0 affected
4 at risk
EG0041 affected8 at risk
EG0050 affected4 at risk
EG0060 affected20 at risk
EG0070 affected4 at risk
EG0080 affected4 at risk
EG0090 affected4 at risk
EG0100 affected18 at risk
EG0110 affected6 at risk
EG0120 affected18 at risk
EG0130 affected5 at risk
1 affected
4 at risk
EG0040 affected8 at risk
EG0050 affected4 at risk
EG0060 affected20 at risk
EG0070 affected4 at risk
EG0080 affected4 at risk
EG0090 affected4 at risk
EG0100 affected18 at risk
EG0110 affected6 at risk
EG0120 affected18 at risk
EG0130 affected5 at risk
0 affected
4 at risk
EG0040 affected8 at risk
EG0050 affected4 at risk
EG0060 affected20 at risk
EG0071 affected4 at risk
EG0080 affected4 at risk
EG0090 affected4 at risk
EG0100 affected18 at risk
EG0110 affected6 at risk
EG0120 affected18 at risk
EG0130 affected5 at risk
0 affected
4 at risk
EG0040 affected8 at risk
EG0050 affected4 at risk
EG0062 affected20 at risk
EG0070 affected4 at risk
EG0080 affected4 at risk
EG0090 affected4 at risk
EG0100 affected18 at risk
EG0110 affected6 at risk
EG0121 affected18 at risk
EG0130 affected5 at risk
0 affected
4 at risk
EG0040 affected8 at risk
EG0050 affected4 at risk
EG0060 affected20 at risk
EG0070 affected4 at risk
EG0080 affected4 at risk
EG0090 affected4 at risk
EG0100 affected18 at risk
EG0110 affected6 at risk
EG0121 affected18 at risk
EG0130 affected5 at risk
0 affected
4 at risk
EG0040 affected8 at risk
EG0050 affected4 at risk
EG0061 affected20 at risk
EG0070 affected4 at risk
EG0080 affected4 at risk
EG0091 affected4 at risk
EG0100 affected18 at risk
EG0110 affected6 at risk
EG0120 affected18 at risk
EG0130 affected5 at risk
0 affected
4 at risk
EG0040 affected8 at risk
EG0050 affected4 at risk
EG0061 affected20 at risk
EG0070 affected4 at risk
EG0080 affected4 at risk
EG0090 affected4 at risk
EG0100 affected18 at risk
EG0110 affected6 at risk
EG0120 affected18 at risk
EG0130 affected5 at risk
0 affected
4 at risk
EG0040 affected8 at risk
EG0050 affected4 at risk
EG0060 affected20 at risk
EG0070 affected4 at risk
EG0080 affected4 at risk
EG0090 affected4 at risk
EG0101 affected18 at risk
EG0110 affected6 at risk
EG0120 affected18 at risk
EG0130 affected5 at risk
0 affected
4 at risk
EG0040 affected8 at risk
EG0050 affected4 at risk
EG0060 affected20 at risk
EG0070 affected4 at risk
EG0080 affected4 at risk
EG0090 affected4 at risk
EG0101 affected18 at risk
EG0110 affected6 at risk
EG0120 affected18 at risk
EG0130 affected5 at risk
0 affected
4 at risk
EG0040 affected8 at risk
EG0050 affected4 at risk
EG0061 affected20 at risk
EG0070 affected4 at risk
EG0080 affected4 at risk
EG0090 affected4 at risk
EG0100 affected18 at risk
EG0110 affected6 at risk
EG0121 affected18 at risk
EG0130 affected5 at risk
0 affected
4 at risk
EG0040 affected8 at risk
EG0050 affected4 at risk
EG0060 affected20 at risk
EG0070 affected4 at risk
EG0081 affected4 at risk
EG0090 affected4 at risk
EG0100 affected18 at risk
EG0110 affected6 at risk
EG0120 affected18 at risk
EG0130 affected5 at risk
0 affected
4 at risk
EG0040 affected8 at risk
EG0050 affected4 at risk
EG0060 affected20 at risk
EG0070 affected4 at risk
EG0080 affected4 at risk
EG0090 affected4 at risk
EG0100 affected18 at risk
EG0111 affected6 at risk
EG0120 affected18 at risk
EG0130 affected5 at risk
0 affected
4 at risk
EG0041 affected8 at risk
EG0050 affected4 at risk
EG0060 affected20 at risk
EG0070 affected4 at risk
EG0080 affected4 at risk
EG0090 affected4 at risk
EG0100 affected18 at risk
EG0110 affected6 at risk
EG0120 affected18 at risk
EG0130 affected5 at risk
0 affected
4 at risk
EG0041 affected8 at risk
EG0050 affected4 at risk
EG0060 affected20 at risk
EG0070 affected4 at risk
EG0081 affected4 at risk
EG0090 affected4 at risk
EG0101 affected18 at risk
EG0110 affected6 at risk
EG0120 affected18 at risk
EG0131 affected5 at risk
0 affected
4 at risk
EG0040 affected8 at risk
EG0050 affected4 at risk
EG0060 affected20 at risk
EG0070 affected4 at risk
EG0080 affected4 at risk
EG0090 affected4 at risk
EG0100 affected18 at risk
EG0110 affected6 at risk
EG0120 affected18 at risk
EG0130 affected5 at risk
0 affected
4 at risk
EG0040 affected8 at risk
EG0050 affected4 at risk
EG0060 affected20 at risk
EG0070 affected4 at risk
EG0080 affected4 at risk
EG0090 affected4 at risk
EG0100 affected18 at risk
EG0110 affected6 at risk
EG0120 affected18 at risk
EG0131 affected5 at risk
0 affected
4 at risk
EG0041 affected8 at risk
EG0050 affected4 at risk
EG0060 affected20 at risk
EG0070 affected4 at risk
EG0080 affected4 at risk
EG0090 affected4 at risk
EG0100 affected18 at risk
EG0110 affected6 at risk
EG0120 affected18 at risk
EG0130 affected5 at risk
0 affected
4 at risk
EG0041 affected8 at risk
EG0050 affected4 at risk
EG0060 affected20 at risk
EG0070 affected4 at risk
EG0080 affected4 at risk
EG0090 affected4 at risk
EG0100 affected18 at risk
EG0110 affected6 at risk
EG0120 affected18 at risk
EG0130 affected5 at risk
0 affected
4 at risk
EG0040 affected8 at risk
EG0050 affected4 at risk
EG0060 affected20 at risk
EG0070 affected4 at risk
EG0081 affected4 at risk
EG0090 affected4 at risk
EG0100 affected18 at risk
EG0110 affected6 at risk
EG0120 affected18 at risk
EG0130 affected5 at risk
0 affected
4 at risk
EG0040 affected8 at risk
EG0050 affected4 at risk
EG0060 affected20 at risk
EG0070 affected4 at risk
EG0080 affected4 at risk
EG0090 affected4 at risk
EG0100 affected18 at risk
EG0111 affected6 at risk
EG0120 affected18 at risk
EG0130 affected5 at risk
0 affected
4 at risk
EG0040 affected8 at risk
EG0050 affected4 at risk
EG0060 affected20 at risk
EG0070 affected4 at risk
EG0080 affected4 at risk
EG0090 affected4 at risk
EG0100 affected18 at risk
EG0110 affected6 at risk
EG0121 affected18 at risk
EG0130 affected5 at risk
0 affected
4 at risk
EG0040 affected8 at risk
EG0050 affected4 at risk
EG0060 affected20 at risk
EG0070 affected4 at risk
EG0080 affected4 at risk
EG0090 affected4 at risk
EG0100 affected18 at risk
EG0110 affected6 at risk
EG0121 affected18 at risk
EG0130 affected5 at risk
0 affected
4 at risk
EG0040 affected8 at risk
EG0050 affected4 at risk
EG0061 affected20 at risk
EG0070 affected4 at risk
EG0080 affected4 at risk
EG0090 affected4 at risk
EG0100 affected18 at risk
EG0110 affected6 at risk
EG0120 affected18 at risk
EG0130 affected5 at risk
0 affected
4 at risk
EG0040 affected8 at risk
EG0050 affected4 at risk
EG0061 affected20 at risk
EG0070 affected4 at risk
EG0080 affected4 at risk
EG0090 affected4 at risk
EG0100 affected18 at risk
EG0110 affected6 at risk
EG0120 affected18 at risk
EG0130 affected5 at risk
1 affected
4 at risk
EG0040 affected8 at risk
EG0050 affected4 at risk
EG0060 affected20 at risk
EG0070 affected4 at risk
EG0080 affected4 at risk
EG0090 affected4 at risk
EG0100 affected18 at risk
EG0110 affected6 at risk
EG0121 affected18 at risk
EG0130 affected5 at risk
0 affected
4 at risk
EG0040 affected8 at risk
EG0050 affected4 at risk
EG0060 affected20 at risk
EG0070 affected4 at risk
EG0080 affected4 at risk
EG0091 affected4 at risk
EG0100 affected18 at risk
EG0110 affected6 at risk
EG0121 affected18 at risk
EG0131 affected5 at risk
0 affected
4 at risk
EG0040 affected8 at risk
EG0050 affected4 at risk
EG0060 affected20 at risk
EG0070 affected4 at risk
EG0080 affected4 at risk
EG0090 affected4 at risk
EG0100 affected18 at risk
EG0110 affected6 at risk
EG0121 affected18 at risk
EG0130 affected5 at risk
0 affected
4 at risk
EG0040 affected8 at risk
EG0050 affected4 at risk
EG0060 affected20 at risk
EG0071 affected4 at risk
EG0080 affected4 at risk
EG0090 affected4 at risk
EG0101 affected18 at risk
EG0110 affected6 at risk
EG0120 affected18 at risk
EG0130 affected5 at risk
0 affected
4 at risk
EG0040 affected8 at risk
EG0050 affected4 at risk
EG0060 affected20 at risk
EG0070 affected4 at risk
EG0080 affected4 at risk
EG0090 affected4 at risk
EG0100 affected18 at risk
EG0110 affected6 at risk
EG0121 affected18 at risk
EG0130 affected5 at risk
0 affected
4 at risk
EG0040 affected8 at risk
EG0050 affected4 at risk
EG0061 affected20 at risk
EG0070 affected4 at risk
EG0080 affected4 at risk
EG0090 affected4 at risk
EG0100 affected18 at risk
EG0110 affected6 at risk
EG0120 affected18 at risk
EG0130 affected5 at risk
0 affected
4 at risk
EG0040 affected8 at risk
EG0050 affected4 at risk
EG0061 affected20 at risk
EG0070 affected4 at risk
EG0080 affected4 at risk
EG0090 affected4 at risk
EG0100 affected18 at risk
EG0110 affected6 at risk
EG0120 affected18 at risk
EG0130 affected5 at risk
0 affected
4 at risk
EG0040 affected8 at risk
EG0050 affected4 at risk
EG0060 affected20 at risk
EG0071 affected4 at risk
EG0080 affected4 at risk
EG0090 affected4 at risk
EG0100 affected18 at risk
EG0110 affected6 at risk
EG0120 affected18 at risk
EG0130 affected5 at risk
1 affected
4 at risk
EG0043 affected8 at risk
EG0051 affected4 at risk
EG0065 affected20 at risk
EG0071 affected4 at risk
EG0082 affected4 at risk
EG0091 affected4 at risk
EG0100 affected18 at risk
EG0112 affected6 at risk
EG0121 affected18 at risk
EG0131 affected5 at risk
0 affected
4 at risk
EG0040 affected8 at risk
EG0050 affected4 at risk
EG0062 affected20 at risk
EG0070 affected4 at risk
EG0080 affected4 at risk
EG0090 affected4 at risk
EG0100 affected18 at risk
EG0110 affected6 at risk
EG0120 affected18 at risk
EG0130 affected5 at risk
0 affected
4 at risk
EG0040 affected8 at risk
EG0050 affected4 at risk
EG0061 affected20 at risk
EG0070 affected4 at risk
EG0080 affected4 at risk
EG0090 affected4 at risk
EG0100 affected18 at risk
EG0110 affected6 at risk
EG0120 affected18 at risk
EG0130 affected5 at risk
0 affected
4 at risk
EG0040 affected8 at risk
EG0050 affected4 at risk
EG0060 affected20 at risk
EG0070 affected4 at risk
EG0080 affected4 at risk
EG0090 affected4 at risk
EG0100 affected18 at risk
EG0110 affected6 at risk
EG0121 affected18 at risk
EG0130 affected5 at risk
0 affected
4 at risk
EG0040 affected8 at risk
EG0050 affected4 at risk
EG0060 affected20 at risk
EG0070 affected4 at risk
EG0080 affected4 at risk
EG0090 affected4 at risk
EG0100 affected18 at risk
EG0110 affected6 at risk
EG0121 affected18 at risk
EG0130 affected5 at risk
0 affected
4 at risk
EG0040 affected8 at risk
EG0050 affected4 at risk
EG0060 affected20 at risk
EG0070 affected4 at risk
EG0080 affected4 at risk
EG0090 affected4 at risk
EG0101 affected18 at risk
EG0110 affected6 at risk
EG0120 affected18 at risk
EG0130 affected5 at risk
0 affected
4 at risk
EG0041 affected8 at risk
EG0050 affected4 at risk
EG0060 affected20 at risk
EG0070 affected4 at risk
EG0080 affected4 at risk
EG0090 affected4 at risk
EG0100 affected18 at risk
EG0110 affected6 at risk
EG0120 affected18 at risk
EG0130 affected5 at risk
0 affected
4 at risk
EG0041 affected8 at risk
EG0050 affected4 at risk
EG0060 affected20 at risk
EG0070 affected4 at risk
EG0080 affected4 at risk
EG0090 affected4 at risk
EG0101 affected18 at risk
EG0110 affected6 at risk
EG0120 affected18 at risk
EG0130 affected5 at risk
0 affected
4 at risk
EG0040 affected8 at risk
EG0050 affected4 at risk
EG0060 affected20 at risk
EG0070 affected4 at risk
EG0080 affected4 at risk
EG0090 affected4 at risk
EG0100 affected18 at risk
EG0110 affected6 at risk
EG0120 affected18 at risk
EG0132 affected5 at risk
0 affected
4 at risk
EG0040 affected8 at risk
EG0050 affected4 at risk
EG0060 affected20 at risk
EG0070 affected4 at risk
EG0080 affected4 at risk
EG0090 affected4 at risk
EG0100 affected18 at risk
EG0110 affected6 at risk
EG0121 affected18 at risk
EG0130 affected5 at risk
0 affected
4 at risk
EG0040 affected8 at risk
EG0050 affected4 at risk
EG0060 affected20 at risk
EG0070 affected4 at risk
EG0080 affected4 at risk
EG0090 affected4 at risk
EG0100 affected18 at risk
EG0111 affected6 at risk
EG0120 affected18 at risk
EG0130 affected5 at risk
0 affected
4 at risk
EG0040 affected8 at risk
EG0050 affected4 at risk
EG0061 affected20 at risk
EG0070 affected4 at risk
EG0080 affected4 at risk
EG0090 affected4 at risk
EG0101 affected18 at risk
EG0110 affected6 at risk
EG0120 affected18 at risk
EG0130 affected5 at risk
0 affected
4 at risk
EG0040 affected8 at risk
EG0050 affected4 at risk
EG0060 affected20 at risk
EG0071 affected4 at risk
EG0080 affected4 at risk
EG0090 affected4 at risk
EG0100 affected18 at risk
EG0110 affected6 at risk
EG0120 affected18 at risk
EG0130 affected5 at risk
0 affected
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EG0063 affected20 at risk
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EG0060 affected20 at risk
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EG0090 affected4 at risk
EG0101 affected18 at risk
EG0110 affected6 at risk
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0
OG0042
OG0050
OG0061
OG0071
OG0082
OG0091
OG0100
OG0110
OG0122
ParticipantsOG0048
ParticipantsOG0054
ParticipantsOG00620
ParticipantsOG0074
ParticipantsOG0084
ParticipantsOG0094
ParticipantsOG01018
ParticipantsOG0116
ParticipantsOG01218
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
ParticipantsOG0048
ParticipantsOG0054
ParticipantsOG00620
ParticipantsOG0074
ParticipantsOG0084
ParticipantsOG0094
ParticipantsOG01018
ParticipantsOG0116
ParticipantsOG01218
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
ParticipantsOG0048
ParticipantsOG0054
ParticipantsOG00620
ParticipantsOG0074
ParticipantsOG0084
ParticipantsOG0094
ParticipantsOG01018
ParticipantsOG0116
ParticipantsOG01218
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
ParticipantsOG0048
ParticipantsOG0054
ParticipantsOG00620
ParticipantsOG0074
ParticipantsOG0084
ParticipantsOG0094
ParticipantsOG01018
ParticipantsOG0116
ParticipantsOG01218
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
ParticipantsOG0048
ParticipantsOG0054
ParticipantsOG00620
ParticipantsOG0074
ParticipantsOG0084
ParticipantsOG0094
ParticipantsOG01018
ParticipantsOG0116
ParticipantsOG01218
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
ParticipantsOG0048
ParticipantsOG0054
ParticipantsOG00620
ParticipantsOG0074
ParticipantsOG0084
ParticipantsOG0094
ParticipantsOG01018
ParticipantsOG0116
ParticipantsOG01218
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
ParticipantsOG0048
ParticipantsOG0054
ParticipantsOG00620
ParticipantsOG0074
ParticipantsOG0084
ParticipantsOG0094
ParticipantsOG01018
ParticipantsOG0116
ParticipantsOG01217
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0041
OG0050
OG0064
OG0070
OG0082
OG0091
OG0102
OG0111
OG0122
ParticipantsOG0048
ParticipantsOG0054
ParticipantsOG00620
ParticipantsOG0074
ParticipantsOG0084
ParticipantsOG0094
ParticipantsOG01018
ParticipantsOG0116
ParticipantsOG01217
Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
ParticipantsOG0048
ParticipantsOG0054
ParticipantsOG00620
ParticipantsOG0074
ParticipantsOG0084
ParticipantsOG0094
ParticipantsOG01018
ParticipantsOG0116
ParticipantsOG01218
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
ParticipantsOG0048
ParticipantsOG0054
ParticipantsOG00620
ParticipantsOG0074
ParticipantsOG0084
ParticipantsOG0094
ParticipantsOG01018
ParticipantsOG0116
ParticipantsOG01218
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
Participants
OG004
2
ParticipantsOG0050
ParticipantsOG0061
ParticipantsOG0072
ParticipantsOG0081
ParticipantsOG0091
ParticipantsOG0100
ParticipantsOG0111
ParticipantsOG0127
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
Participants
OG004
2
ParticipantsOG0050
ParticipantsOG0061
ParticipantsOG0072
ParticipantsOG0081
ParticipantsOG0091
ParticipantsOG0100
ParticipantsOG0111
ParticipantsOG0127
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
ParticipantsOG0048
ParticipantsOG0054
ParticipantsOG00620
ParticipantsOG0074
ParticipantsOG0084
ParticipantsOG0094
ParticipantsOG01018
ParticipantsOG0116
ParticipantsOG01217
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041
OG0051
OG0064
OG0070
OG0081
OG0091
OG0100
OG0110
OG0121
ParticipantsOG0048
ParticipantsOG0054
ParticipantsOG00620
ParticipantsOG0074
ParticipantsOG0084
ParticipantsOG0094
ParticipantsOG01018
ParticipantsOG0116
ParticipantsOG01217
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
ParticipantsOG0048
ParticipantsOG0054
ParticipantsOG00620
ParticipantsOG0074
ParticipantsOG0084
ParticipantsOG0094
ParticipantsOG01018
ParticipantsOG0116
ParticipantsOG01217
Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG0040
OG0050
OG0061
OG0070
OG0080
OG0090
OG0100
OG0110
OG0121
ParticipantsOG0048
ParticipantsOG0054
ParticipantsOG00620
ParticipantsOG0074
ParticipantsOG0084
ParticipantsOG0094
ParticipantsOG01018
ParticipantsOG0116
ParticipantsOG01217
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
ParticipantsOG0048
ParticipantsOG0054
ParticipantsOG00620
ParticipantsOG0074
ParticipantsOG0084
ParticipantsOG0094
ParticipantsOG01018
ParticipantsOG0116
ParticipantsOG01217
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041
OG0050
OG0061
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
ParticipantsOG0048
ParticipantsOG0054
ParticipantsOG00620
ParticipantsOG0074
ParticipantsOG0084
ParticipantsOG0094
ParticipantsOG01018
ParticipantsOG0116
ParticipantsOG01217
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
ParticipantsOG0045
ParticipantsOG0053
ParticipantsOG00614
ParticipantsOG0072
ParticipantsOG0083
ParticipantsOG0093
ParticipantsOG0102
ParticipantsOG0113
ParticipantsOG01211
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0042
OG0050
OG0067
OG0070
OG0081
OG0092
OG0100
OG0111
OG0123
ParticipantsOG0045
ParticipantsOG0053
ParticipantsOG00614
ParticipantsOG0072
ParticipantsOG0083
ParticipantsOG0093
ParticipantsOG0102
ParticipantsOG0113
ParticipantsOG01211
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0061
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
ParticipantsOG0048
ParticipantsOG0054
ParticipantsOG00620
ParticipantsOG0074
ParticipantsOG0084
ParticipantsOG0094
ParticipantsOG01018
ParticipantsOG0116
ParticipantsOG01217
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041
OG0050
OG0062
OG0070
OG0080
OG0091
OG0100
OG0110
OG0121
ParticipantsOG0048
ParticipantsOG0054
ParticipantsOG00620
ParticipantsOG0074
ParticipantsOG0084
ParticipantsOG0094
ParticipantsOG01018
ParticipantsOG0116
ParticipantsOG01217
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
ParticipantsOG0048
ParticipantsOG0054
ParticipantsOG00620
ParticipantsOG0074
ParticipantsOG0084
ParticipantsOG0094
ParticipantsOG01018
ParticipantsOG0116
ParticipantsOG01217
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
ParticipantsOG0048
ParticipantsOG0054
ParticipantsOG00620
ParticipantsOG0074
ParticipantsOG0084
ParticipantsOG0094
ParticipantsOG01018
ParticipantsOG0116
ParticipantsOG01217
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0063
ParticipantsOG0071
ParticipantsOG0081
ParticipantsOG0090
ParticipantsOG0101
ParticipantsOG0111
ParticipantsOG0127
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0063
ParticipantsOG0071
ParticipantsOG0081
ParticipantsOG0090
ParticipantsOG0101
ParticipantsOG0111
ParticipantsOG0127
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
ParticipantsOG0048
ParticipantsOG0054
ParticipantsOG00620
ParticipantsOG0074
ParticipantsOG0084
ParticipantsOG0094
ParticipantsOG01018
ParticipantsOG0116
ParticipantsOG01217
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
ParticipantsOG0048
ParticipantsOG0054
ParticipantsOG00620
ParticipantsOG0074
ParticipantsOG0084
ParticipantsOG0094
ParticipantsOG01018
ParticipantsOG0116
ParticipantsOG01217
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
ParticipantsOG0048
ParticipantsOG0054
ParticipantsOG00620
ParticipantsOG0074
ParticipantsOG0084
ParticipantsOG0094
ParticipantsOG01018
ParticipantsOG0116
ParticipantsOG01217
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0081
OG0090
OG0100
OG0110
OG0120
ParticipantsOG0048
ParticipantsOG0054
ParticipantsOG00620
ParticipantsOG0074
ParticipantsOG0084
ParticipantsOG0094
ParticipantsOG01018
ParticipantsOG0116
ParticipantsOG01217
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
ParticipantsOG0048
ParticipantsOG0054
ParticipantsOG00620
ParticipantsOG0074
ParticipantsOG0084
ParticipantsOG0094
ParticipantsOG01018
ParticipantsOG0114
ParticipantsOG01216
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0111
OG0120
ParticipantsOG0048
ParticipantsOG0054
ParticipantsOG00620
ParticipantsOG0074
ParticipantsOG0084
ParticipantsOG0094
ParticipantsOG01018
ParticipantsOG0114
ParticipantsOG01216
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0101
OG0110
OG0120
ParticipantsOG0048
ParticipantsOG0054
ParticipantsOG00620
ParticipantsOG0074
ParticipantsOG0084
ParticipantsOG0094
ParticipantsOG01018
ParticipantsOG0114
ParticipantsOG01216
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0062
OG0070
OG0080
OG0090
OG0101
OG0110
OG0122
ParticipantsOG0048
ParticipantsOG0054
ParticipantsOG00620
ParticipantsOG0074
ParticipantsOG0084
ParticipantsOG0094
ParticipantsOG01018
ParticipantsOG0114
ParticipantsOG01216
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
ParticipantsOG0048
ParticipantsOG0054
ParticipantsOG00620
ParticipantsOG0074
ParticipantsOG0084
ParticipantsOG0094
ParticipantsOG01018
ParticipantsOG0116
ParticipantsOG01217
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
ParticipantsOG0048
ParticipantsOG0054
ParticipantsOG00620
ParticipantsOG0074
ParticipantsOG0084
ParticipantsOG0094
ParticipantsOG01018
ParticipantsOG0116
ParticipantsOG01217
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0051
OG0060
OG0070
OG0081
OG0090
OG0101
OG0110
OG0120
ParticipantsOG0048
ParticipantsOG0054
ParticipantsOG00620
ParticipantsOG0074
ParticipantsOG0084
ParticipantsOG0094
ParticipantsOG01018
ParticipantsOG0116
ParticipantsOG01217
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
ParticipantsOG0048
ParticipantsOG0054
ParticipantsOG00620
ParticipantsOG0074
ParticipantsOG0084
ParticipantsOG0094
ParticipantsOG01018
ParticipantsOG0116
ParticipantsOG01217
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
ParticipantsOG0048
ParticipantsOG0054
ParticipantsOG00620
ParticipantsOG0074
ParticipantsOG0084
ParticipantsOG0094
ParticipantsOG01018
ParticipantsOG0116
ParticipantsOG01217
Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG0040
OG0050
OG0060
OG0070
OG0081
OG0091
OG0100
OG0111
OG0124
ParticipantsOG0048
ParticipantsOG0054
ParticipantsOG00620
ParticipantsOG0074
ParticipantsOG0084
ParticipantsOG0094
ParticipantsOG01018
ParticipantsOG0116
ParticipantsOG01217
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
ParticipantsOG0048
ParticipantsOG0054
ParticipantsOG00620
ParticipantsOG0074
ParticipantsOG0084
ParticipantsOG0094
ParticipantsOG01018
ParticipantsOG0116
ParticipantsOG01217
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
ParticipantsOG0048
ParticipantsOG0054
ParticipantsOG00620
ParticipantsOG0074
ParticipantsOG0084
ParticipantsOG0094
ParticipantsOG01018
ParticipantsOG0116
ParticipantsOG01217
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
ParticipantsOG0048
ParticipantsOG0054
ParticipantsOG00620
ParticipantsOG0074
ParticipantsOG0084
ParticipantsOG0094
ParticipantsOG01018
ParticipantsOG0116
ParticipantsOG01217
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0061
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
ParticipantsOG0048
ParticipantsOG0054
ParticipantsOG00620
ParticipantsOG0074
ParticipantsOG0084
ParticipantsOG0094
ParticipantsOG01018
ParticipantsOG0116
ParticipantsOG01217
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
ParticipantsOG0048
ParticipantsOG0054
ParticipantsOG00620
ParticipantsOG0074
ParticipantsOG0084
ParticipantsOG0094
ParticipantsOG01018
ParticipantsOG0116
ParticipantsOG01217
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
ParticipantsOG0048
ParticipantsOG0054
ParticipantsOG00620
ParticipantsOG0074
ParticipantsOG0084
ParticipantsOG0094
ParticipantsOG01018
ParticipantsOG0116
ParticipantsOG01217
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
ParticipantsOG0048
ParticipantsOG0054
ParticipantsOG00620
ParticipantsOG0074
ParticipantsOG0084
ParticipantsOG0094
ParticipantsOG01018
ParticipantsOG0116
ParticipantsOG01217
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
ParticipantsOG0048
ParticipantsOG0054
ParticipantsOG00620
ParticipantsOG0074
ParticipantsOG0084
ParticipantsOG0094
ParticipantsOG01018
ParticipantsOG0116
ParticipantsOG01217
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
ParticipantsOG0048
ParticipantsOG0054
ParticipantsOG00620
ParticipantsOG0074
ParticipantsOG0084
ParticipantsOG0094
ParticipantsOG01018
ParticipantsOG0116
ParticipantsOG01217
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
ParticipantsOG0048
ParticipantsOG0054
ParticipantsOG00620
ParticipantsOG0074
ParticipantsOG0084
ParticipantsOG0094
ParticipantsOG01018
ParticipantsOG0116
ParticipantsOG01217
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
ParticipantsOG0048
ParticipantsOG0054
ParticipantsOG00620
ParticipantsOG0074
ParticipantsOG0084
ParticipantsOG0094
ParticipantsOG01018
ParticipantsOG0116
ParticipantsOG01217
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0121
ParticipantsOG0048
ParticipantsOG0054
ParticipantsOG00620
ParticipantsOG0074
ParticipantsOG0084
ParticipantsOG0094
ParticipantsOG01018
ParticipantsOG0116
ParticipantsOG01217
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
249112
± 16
OG004439192± 15
OG005259914± 27
OG00648703± 86
OG00767136± 31
OG008510696± 29
OG009124997± 27
OG010446640± 20
OG011215247± 31
OG012257979± 35
Participants
OG004
2
ParticipantsOG0055
ParticipantsOG0063
ParticipantsOG0071
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
Title
Measurements
OG0007540± NANot evaluable due to inadequate number of participants analyzed
OG00141200± NANot evaluable due to inadequate number of participants analyzed
OG002112632± 36
OG003349009± 28
OG004646106± 7
OG005351683± 29
OG00633291± 18
OG00773100± NANot evaluable due to inadequate number of participants analyzed
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0081
ParticipantsOG0099
ParticipantsOG0102
ParticipantsOG0114
ParticipantsOG0122
Title
Measurements
OG008486000± NANot evaluable due to inadequate number of participants analyzed
OG009165211± 20
OG010442029± 41
OG011272349± 65
OG012322580± 40
1.29
± 59
OG0041.59± 72
OG0051.11± 31
OG0069.63± 3383
OG0070.962± 5
OG0081.47± 75
OG0091.63± 110
OG0101.94± 50
OG0111.53± 62
OG0121.64± 23
Participants
OG004
2
ParticipantsOG0055
ParticipantsOG0063
ParticipantsOG0071
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
Title
Measurements
OG0005.00± NANot evaluable due to inadequate number of participants analyzed
OG0010.983± NANot evaluable due to inadequate number of participants analyzed
OG0020.989± 3
OG0034.92± 515
OG00410.0± 190
OG0054.08± 291
OG0062.51± 96
OG0071.00± NANot evaluable due to inadequate number of participants analyzed
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0081
ParticipantsOG0099
ParticipantsOG0102
ParticipantsOG0114
ParticipantsOG0122
Title
Measurements
OG0083.98± NANot evaluable due to inadequate number of participants analyzed
OG0091.88± 82
OG0101.00± 0
OG0111.03± 9
OG0121.42± 37
39736190
± 26
OG00466647788± 15
OG00533053505± 37
OG0064954133± 63
OG0077568790± 58
OG008103780934± 21
OG00926213882± 34
OG01055152586± 79
OG01134199336± 38
OG01238608827± 34
Participants
OG004
2
ParticipantsOG0055
ParticipantsOG0063
ParticipantsOG0071
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
Title
Measurements
OG0001433844± NANot evaluable due to inadequate number of participants analyzed
OG0018631703± NANot evaluable due to inadequate number of participants analyzed
OG00221669222± 46
OG00379172947± 31
OG004151321351± 17
OG00574976626± 45
OG0065329459± 43
OG00716061212± NANot evaluable due to inadequate number of participants analyzed
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0081
ParticipantsOG0099
ParticipantsOG0102
ParticipantsOG0114
ParticipantsOG0122
Title
Measurements
OG008113248878± NANot evaluable due to inadequate number of participants analyzed
OG00942867360± 24
OG010133901271± 49
OG01156012897± 46
OG01253257007± 82
42372351
± 16
OG00466647788± 15
OG00536019071± 29
OG0065436490± 49
OG0077962140± 46
OG008107854224± 27
OG00927192752± 27
OG01085887190± 28
OG01135370530± 35
OG01238608827± 34
Participants
OG004
2
ParticipantsOG0055
ParticipantsOG0063
ParticipantsOG0071
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
Title
Measurements
OG0001433844± NANot evaluable due to inadequate number of participants analyzed
OG0018631703± NANot evaluable due to inadequate number of participants analyzed
OG00221669222± 46
OG00375841795± 35
OG004151321351± 17
OG00572506970± 42
OG0066228807± 14
OG00716061212± NANot evaluable due to inadequate number of participants analyzed
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0081
ParticipantsOG0099
ParticipantsOG0102
ParticipantsOG0114
ParticipantsOG0122
Title
Measurements
OG008113248878± NANot evaluable due to inadequate number of participants analyzed
OG00944114081± 23
OG010124674549± 38
OG01156012897± 46
OG01253257007± 82
79783
± 18
OG004118571± 29
OG00551893± 53
OG0065875± 31
OG0079560± 158
OG00866597± 44
OG00917353± 56
OG01075172± 36
OG01126556± 54
OG01222879± 61
Participants
OG004
2
ParticipantsOG0055
ParticipantsOG0063
ParticipantsOG0071
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
Title
Measurements
OG0002790± NANot evaluable due to inadequate number of participants analyzed
OG00118500± NANot evaluable due to inadequate number of participants analyzed
OG00243315± 45
OG003157016± 48
OG004383682± 37
OG005136133± 54
OG00611449± 24
OG00734400± NANot evaluable due to inadequate number of participants analyzed
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0081
ParticipantsOG0099
ParticipantsOG0102
ParticipantsOG0114
ParticipantsOG0122
Title
Measurements
OG00883300± NANot evaluable due to inadequate number of participants analyzed
OG00934396± 43
OG010149964± 23
OG01161568± 53
OG01237051± 272
Participants
OG004
2
ParticipantsOG0055
ParticipantsOG0063
ParticipantsOG0071
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
Title
Measurements
OG0000.014± NANot evaluable due to inadequate number of participants analyzed
OG0010.009± NANot evaluable due to inadequate number of participants analyzed
OG0020.011± 46
OG0030.011± 35
OG0040.011± 17
OG0050.011± 42
OG0060.013± 14
OG0070.015± NANot evaluable due to inadequate number of participants analyzed
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0081
ParticipantsOG0099
ParticipantsOG0102
ParticipantsOG0114
ParticipantsOG0122
Title
Measurements
OG0080.014± NANot evaluable due to inadequate number of participants analyzed.
OG0090.011± 23
OG0100.007± 13
OG0110.011± 46
OG0120.011± 82
Participants
OG004
2
ParticipantsOG0055
ParticipantsOG0063
ParticipantsOG0071
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
Title
Measurements
OG0004281± NANot evaluable due to inadequate number of participants analyzed
OG00125746± NANot evaluable due to inadequate number of participants analyzed
OG00264581± 46
OG003225882± 35
OG004451954± 17
OG005209969± 46
OG00618650± 15
OG00748112± NANot evaluable due to inadequate number of participants analyzed
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0081
ParticipantsOG0099
ParticipantsOG0102
ParticipantsOG0114
ParticipantsOG0122
Title
Measurements
OG008168655± NANot evaluable due to inadequate number of participants analyzed
OG00967521± 23
OG010247899± 37
OG011113134± 46
OG012103591± 78
Participants
OG004
2
ParticipantsOG0055
ParticipantsOG0063
ParticipantsOG0071
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
Title
Measurements
OG0001.42± NANot evaluable due to inadequate number of participants analyzed
OG0012.00
OG0021.94± 17
OG0031.91± 29
OG0042.04± 2
OG0051.97± 11
OG0061.35± 57
OG0071.93± NANot evaluable due to inadequate number of participants analyzed
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0081
ParticipantsOG0099
ParticipantsOG0102
ParticipantsOG0114
ParticipantsOG0122
Title
Measurements
OG0081.40± NANot evaluable due to inadequate number of participants analyzed
OG0091.47± 11
OG0101.19± 34
OG0111.46± 8
OG0121.40± 102
Participants
OG004
2
ParticipantsOG0055
ParticipantsOG0062
ParticipantsOG0071
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
Title
Measurements
OG000189± NANot evaluable due to inadequate number of participants analyzed
OG001334± NANot evaluable due to inadequate number of participants analyzed
OG002319± 26
OG003306± 43
OG004344± 3
OG005338± 14
OG006293± 11
OG007317± NANot evaluable due to inadequate number of participants analyzed
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0081
ParticipantsOG0099
ParticipantsOG0101
ParticipantsOG0114
ParticipantsOG0121
Title
Measurements
OG008372± NANot evaluable due to inadequate number of participants analyzed
OG009390± 32
OG010317± NANot evaluable due to inadequate number of participants analyzed
OG011294± 16
OG012722± NANot evaluable due to inadequate number of participants analyzed