A Study to Evaluate the Safety, Tolerability, and Efficac... | NCT02061761 | Trialant
NCT02061761
Sponsor
Bristol-Myers Squibb
Status
Completed
Last Update Posted
Mar 24, 2023Actual
Enrollment
106Actual
Phase
Phase 1Phase 2
Conditions
Hematologic Neoplasms
Interventions
BMS-986016
BMS-936558
Countries
United States
Canada
Protocol Section
Identification Module
NCT ID
NCT02061761
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CA224-022
Secondary IDs
Not provided
Brief Title
A Study to Evaluate the Safety, Tolerability, and Efficacy of Relatlimab in Relapsed or Refractory B-Cell Malignancies
Official Title
A Phase 1/2a Dose Escalation and Cohort Expansion Study of the Safety, Tolerability, and Efficacy of Anti-LAG-3 Monoclonal Antibody (Relatlimab, BMS-986016) Administered Alone and in Combination With Anti-PD-1 Monoclonal Antibody (Nivolumab, BMS-936558) in Relapsed or Refractory B-Cell Malignancies
Acronym
Not provided
Organization
Bristol-Myers SquibbINDUSTRY
Status Module
Record Verification Date
Mar 2023
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
Mar 13, 2014Actual
Primary Completion Date
Feb 16, 2022Actual
Completion Date
Feb 16, 2022Actual
First Submitted Date
Feb 12, 2014
First Submission Date that Met QC Criteria
Feb 12, 2014
First Posted Date
Feb 13, 2014Estimated
Results Waived
Not provided
Results First Submitted Date
Feb 16, 2023
Results First Submitted that Met QC Criteria
Mar 20, 2023
Results First Posted Date
Mar 24, 2023Actual
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
Mar 20, 2023
Last Update Posted Date
Mar 24, 2023Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Bristol-Myers SquibbINDUSTRY
Collaborators
Not provided
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 primary objective of this study is to characterize the safety, tolerability, dose-limiting toxicities (DLTs), and maximum tolerated dose (MTD) of relatlimab administered alone or in combination with nivolumab to subjects with relapsed or refractory B-cell malignancies. Co-primary objective is to investigate the preliminary efficacy of relatlimab in combination with nivolumab in subjects with relapsed or refractory Hodgkin lymphoma (HL), and relapsed or refractory Diffused Large B Cell lymphoma (DLBCL)
Detailed Description
Not provided
Conditions Module
Conditions
Hematologic Neoplasms
Keywords
Hodgkin lymphoma
non-Hodgkin lymphoma
diffused large B-cell lymphoma
indolent lymphoma
chronic lymphocytic leukemia
relapsed
refractory
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
106Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part A - relatlimab (Dose escalation)
Experimental
Biological: BMS-986016
Part C - relatlimab + nivolumab (Dose escalation)
Experimental
Biological: BMS-986016
Biological: BMS-936558
Part B - relatlimab (Cohort expansion)
Experimental
Biological: BMS-986016
Part D - relatlimab + nivolumab (Cohort expansion)
Experimental
Biological: BMS-986016
Biological: BMS-936558
Interventions
Name
Type
Description
Arm Group Labels
Other Names
BMS-986016
Biological
Specified Dose on Specified Days
Part A - relatlimab (Dose escalation)
Part B - relatlimab (Cohort expansion)
Part C - relatlimab + nivolumab (Dose escalation)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation
Number of participants with any grade adverse events (AEs), any grade serious adverse events (SAEs) and any grade AEs leading to discontinuation of any drug. The severity of AEs will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
From first dose to 100 days post last dose (Up to 51 months)
Number of Participants Who Died
Number of participants who died due to any cause.
From first dose to 135 days post last dose (Up to 52 months)
Number of Participants With On-Treatment Laboratory Abnormalities in Specific Hepatics Tests
Number of participants with laboratory abnormalities in specific hepatic tests based on SI unit convention. The number of participants with the following laboratory abnormalities from on-treatment evaluations will be summarized:
ALT or AST > 3 x ULN, > 5 x ULN, > 10 x ULN and > 20 x ULN
Total bilirubin > 2 x ULN
ALP > 1.5 x ULN
Concurrent (within 1 day) ALT or AST > 3 x ULN and total bilirubin > 1.5 x ULN
Concurrent (within 30 days) ALT or AST > 3 x ULN and total bilirubin > 1.5 x ULN
Concurrent (within 1 day) ALT or AST > 3 x ULN and total bilirubin > 2 x ULN
Concurrent (within 30 days) ALT or AST > 3 x ULN and total bilirubin > 2 x ULN
From first dose to 30 days post last dose (Up to 49 months)
Objective Response Rate (ORR) - Part D
Investigator-assessed ORR per International Working Group (IWG 2007) response criteria for malignant lymphoma is defined as the number of participants with a best overall documented response (BOR) of either a complete response (CR) or partial response (PR).
Complete response: Disappearance of all evidence of disease. Partial response: Regression of measurable disease and no new sites. >= 50% decrease in sum of the produce of the diameters of up to 6 largest dominant masses (index lesions); no increase in size of other nodes (non-index lesions).
Progressive disease: Any new lesion or increase by >=50% of previously involved sites from nadir.
Secondary Outcomes
Measure
Description
Time Frame
BMS-986016 Maximum Observed Serum Concentration (Cmax)
BMS-986016 Maximum Observed Serum Concentration (Cmax). Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.
Period 0 = treatment period Period 1 = Re-challenge period
PK assessment include the following timepoints: pre-dose, 1, 4, 24, 48, 96, 144, 192 hours end-of-infusion on cycle 1 Day 1, Cycle 3 Day 1
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Must have histologic or cytologic confirmation of chronic lymphocytic leukemia, Hodgkin lymphoma, Non-Hodgkin lymphoma, or Multiple Myeloma and have relapsed following prior treatment or been refractory to prior treatment
Must have progressed or been refractory to, at least one prior standard therapy, including radiation, immunomodulatory agents (eg, lenalidomide), immunotherapy, cytotoxic chemotherapy, and select antibody (anti-CD20, alemtuzumab, or anti-CD30) therapy.
Must be more than 100 days post autologous transplant
Exclusion Criteria:
Known or suspected central nervous system (CNS) metastases or with the CNS as the only site of active disease (controlled CNS metastases are allowed)
Known or suspected autoimmune disease
History of allergy to anti-PD-1 or anti-PD-L1 antibody therapy or to other monoclonal antibodies or related compounds or to any of their components
Other protocol-defined inclusion/exclusion criteria apply
Gopal AK, Armand P, Neelapu SS, Bartlett NL, Spurgeon SE, Kuruvilla J, Savage KJ, Leonard JP, Gelb AB, Ahmed N, Dong S, Bathena SP, Suryawanshi R, Wu JQ, Wang S, Gladstone DE. Nivolumab plus relatlimab for patients with relapsed or progressed B-cell malignancies in RELATIVITY-022. Blood Adv. 2025 Jul 8;9(13):3383-3394. doi: 10.1182/bloodadvances.2024015086.
Dose escalation (part A): BMS-986016 20mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Started treatment
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
Nov 17, 2020
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
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Single Group 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 D - relatlimab + nivolumab (Cohort expansion)
From first dose date to the date of disease progression per investigator or the date of subsequent therapy, whichever occurs first (Up to approximately 95 months)
Duration of Response (DoR) - Part D
Investigator-assessed DoR per International Working Group (IWG 2007)) response criteria for malignant lymphoma is defined as the time between the date of first documented response (complete response or partial response) to the date of the first objectively documented progression, or death due to any cause, whichever occurs first.
Complete response: Disappearance of all evidence of disease. Partial response: Regression of measurable disease and no new sites. >= 50% decrease in sum of the produce of the diameters of up to 6 largest dominant masses (index lesions); no increase in size of other nodes (non-index lesions).
Progressive disease: Any new lesion or increase by >=50% of previously involved sites from nadir.
From first dose to the date of the first objectively documented progression, or death due to any cause, whichever occurs first (Up to approximately 95 months)
BMS-986016 Time of Maximum Observed Serum Concentration (Tmax)
BMS-986016 Time of Maximum Observed Serum Concentration (Tmax). Period 0 = treatment period Period 1 = Re-challenge period
PK assessment include the following timepoints: pre-dose, 1, 4, 24, 48, 96, 144, 192 hours end-of-infusion on cycle 1 Day 1, Cycle 3 Day 1
BMS-986016 Area Under the Concentration-time Curve in One Dosing Interval (AUC(TAU))
BMS-986016 Area under the concentration-time curve in one dosing interval (AUC(TAU)). Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.
Period 0 = treatment period Period 1 = Re-challenge period
PK assessment include the following timepoints: pre-dose, 1, 4, 24, 48, 96, 144, 192 hours end-of-infusion on cycle 1 Day 1, Cycle 3 Day 1
BMS-986016 Concentration at the End of a Dosing Interval (Ctau)
BMS-986016 Concentration at the end of a dosing interval (Ctau). Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.
Period 0 = treatment period Period 1 = Re-challenge period
PK assessment include the following timepoints: pre-dose, 1, 4, 24, 48, 96, 144, 192 hours end-of-infusion on cycle 1 Day 1, Cycle 3 Day 1
BMS-986016 Effective Elimination Half-life That Explains the Degree of AUC Accumulation Observed (T 1/2eff AUC)
BMS-986016 effective elimination half-life that explains the degree of AUC accumulation observed (t 1/2eff AUC). Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.
Period 0 = treatment period Period 1 = Re-challenge period
PK assessment include the following timepoints: pre-dose, 1, 4, 24, 48, 96, 144, 192 hours end-of-infusion on cycle 1 Day 1, Cycle 3 Day 1
BMS-986016 Total Body Clearance (CL/T)
BMS-986016 total body clearance (CL/T). Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.
Period 0 = treatment period Period 1 = Re-challenge period
PK assessment include the following timepoints: pre-dose, 1, 4, 24, 48, 96, 144, 192 hours end-of-infusion on cycle 1 Day 1, Cycle 3 Day 1
BMS-986016 Cmax Accumulation Index (AI_Cmax)
BMS-986016 cmax accumulation index (AI_Cmax). AI is calculated based on ratio of Cmax at steady state to Cmax after the first dose. Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.
Period 0 = treatment period Period 1 - Re-challenge period
PK assessment include the following timepoints: pre-dose, 1, 4, 24, 48, 96, 144, 192 hours end-of-infusion on cycle 1 Day 1, Cycle 3 Day 1
BMS-986016 Accumulation Index (AI_AUC)
BMS-986016 accumulation index (AI_AUC). AI is calculated based on ratio of AUC(TAU) at steady state to AUC(TAU) after the first dose. Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.
Period 0 = treatment period Period 1 - Re-challenge period
PK assessment include the following timepoints: pre-dose, 1, 4, 24, 48, 96, 144, 192 hours end-of-infusion on cycle 1 Day 1, Cycle 3 Day 1
BMS-986016 Ctau Accumulation Index (AI_Ctau)
BMS-986016 Ctau accumulation index (AI_Ctau). AI is calculated based on ratio of Ctau at steady state to Ctau after the first dose. Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.
Period 0 = treatment period Period 1 - Re-challenge period
PK assessment include the following timepoints: pre-dose, 1, 4, 24, 48, 96, 144, 192 hours end-of-infusion on cycle 1 Day 1, Cycle 3 Day 1
BMS-986016 Average Concentration Over a Dosing Interval ([AUC(TAU)/Tau] (Css,Avg)
BMS-986016 average concentration over a dosing interval ([AUC(TAU)/tau] (Css,avg). Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.
Period 0 = treatment period Period 1 - Re-challenge period
PK assessment include the following timepoints: pre-dose, 1, 4, 24, 48, 96, 144, 192 hours end-of-infusion on cycle 1 Day 1, Cycle 3 Day 1
BMS-986016 trough observed serum concentration (Ctrough). Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.
Period 0 = treatment period Period 1 - Re-challenge period
PK assessment include the following timepoints: pre-dose, 1, 4, 24, 48, 96, 144, 192 hours end-of-infusion on cycle 1 Day 15, 29, 43, Cycle 2 Day 1, 15, 29, Cycle 3 Day 1, 15, Cycle 5 Day 1, Cycle 7 Day 1, Cycle 9 Day 1, and Cycle 11 Day 1
Number of Participants With Anti-BMS-986016 Antibodies (ADA)
Number of participants with anti-BMS-986016 antibodies (ADA) with status as baseline ADA positive, ADA positive and ADA negative. Baseline ADA positive participant is defined as a participant with positive seroconversion detected in the last sample before initiation of treatment. ADA-positive participant is a participant with at least one ADA-positive sample relative to baseline after initiation of the treatment. ADA negative participant is defined as a participant with no ADA positive sample after the initiation of treatment.
From first dose to 135 days post last dose (Up to 52 months)
Number of Participants With Anti-Nivolumab Antibodies (ADA)
Number of participants with anti-Nivolumab antibodies (ADA) with status as baseline ADA positive, ADA positive and ADA negative. Baseline ADA positive participant is defined as a participant with positive seroconversion detected in the last sample before initiation of treatment. ADA-positive participant is a participant with at least one ADA-positive sample relative to baseline after initiation of the treatment. ADA negative participant is defined as a participant with no ADA positive sample after the initiation of treatment.
From first dose to 135 days post last dose (Up to 52 months)
Boston
Massachusetts
02215
United States
Barbara Ann Karmanos Cancer Institute
Detroit
Michigan
48201
United States
Local Institution - 0010
St Louis
Missouri
63110
United States
Weill Cornell Medical College
New York
New York
10021
United States
Local Institution - 0002
Portland
Oregon
97239
United States
Local Institution - 0006
Houston
Texas
77030
United States
Local Institution - 0001
Seattle
Washington
98109
United States
Local Institution - 0011
Vancouver
British Columbia
V5Z 4E6
Canada
Local Institution - 0012
Toronto
Ontario
M5G 2M9
Canada
Derived
El Halabi L, Adam J, Gravelle P, Marty V, Danu A, Lazarovici J, Ribrag V, Bosq J, Camara-Clayette V, Laurent C, Ghez D. Expression of the Immune Checkpoint Regulators LAG-3 and TIM-3 in Classical Hodgkin Lymphoma. Clin Lymphoma Myeloma Leuk. 2021 Apr;21(4):257-266.e3. doi: 10.1016/j.clml.2020.11.009. Epub 2020 Nov 12.
Dose escalation (part A): BMS-986016 80mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
FG002
BMS-986016 800mg
Dose escalation (part A): BMS-986016 800mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
FG003
BMS-986016 240mg
Dose escalation (part A): BMS-986016 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
FG004
BMS-986016 240mg Part B
Dose expansion (part B): BMS-986016 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
FG005
BMS-986016 80mg + Nivolumab
Dose escalation (part C): BMS-986016 IV 80mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
FG006
BMS-986016 240mg + Nivolumab
Dose escalation (part C): BMS-986016 IV 240mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
FG007
BMS-986016 160mg + Nivolumab
Dose escalation (part C): BMS-986016 IV 160mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
FG008
BMS-986016 160mg + Nivolumab Part D
Dose expansion (part D): BMS-986016 IV 160mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
FG0003 subjects
FG0019 subjects
FG0026 subjects
FG0039 subjects
FG00411 subjects
FG0057 subjects
FG0061 subjects
FG0074 subjects
FG00856 subjects
Chronic Lymphocytic Leukemia (CLL)
Tumor type eligible for expansion
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0042 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
Diffuse Large B-Cell Lymphoma (DLBCL)
Tumor type eligible for expansion
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0042 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG00815 subjects
Indolent Non-Hodgkin Lymphoma (iNHL)
Tumor type eligible for expansion
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0044 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
Hodgkin Lymphoma (HL)
Tumor type eligible for expansion
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0043 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
HL-anti-PD-1 Naive
Tumor type eligible for expansion
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG00821 subjects
HL-anti-PD-1 Progressed
Tumor type eligible for expansion
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG00820 subjects
COMPLETED
Completed treatment
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0052 subjects
FG0060 subjects
FG0070 subjects
FG0085 subjects
NOT COMPLETED
FG0003 subjects
FG0018 subjects
FG0026 subjects
FG0039 subjects
FG00411 subjects
FG0055 subjects
FG0061 subjects
FG0074 subjects
FG00851 subjects
Type
Comment
Reasons
Disease progression
FG0002 subjects
FG0018 subjects
FG0024 subjects
FG0035 subjects
FG0049 subjects
FG0053 subjects
FG0061 subjects
FG0072 subjects
FG00828 subjects
Study Drug toxicity
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Adverse event unrelated to study Drug
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Participant request to discontinue study treatment
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG0032 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Maximum clinical benefit
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Participant no longer meets study criteria
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Other reasons
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
BMS-986016 20mg
Dose escalation (part A): BMS-986016 20mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
BG001
BMS-986016 800mg
Dose escalation (part A): BMS-986016 800mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
BG002
BMS-986016 80mg
Dose escalation (part A): BMS-986016 80mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
BG003
BMS-986016 240mg
Dose escalation (part A) and dose expansion (part B): BMS-986016 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
BG004
BMS-986016 80mg + Nivolumab
Dose escalation (part C): BMS-986016 IV 80mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
BG005
BMS-986016 240mg + Nivolumab
Dose escalation (part C): BMS-986016 IV 240mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
BG006
BMS-986016 160mg + Nivolumab
Dose escalation (part C) and dose expansion (part D): BMS-986016 IV 160mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0003
BG0019
BG0026
BG00320
BG0047
BG0051
BG00660
BG007106
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0000
BG0015
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 (AEs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation
Number of participants with any grade adverse events (AEs), any grade serious adverse events (SAEs) and any grade AEs leading to discontinuation of any drug. The severity of AEs will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
All treated participants
Posted
Count of Participants
Participants
From first dose to 100 days post last dose (Up to 51 months)
ID
Title
Description
OG000
BMS-986016 20mg
Dose escalation (part A): BMS-986016 20mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG001
BMS-986016 80mg
Dose escalation (part A): BMS-986016 80mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG002
BMS-986016 800mg
Dose escalation (part A): BMS-986016 800mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG003
BMS-986016 240mg
Dose escalation (part A) and dose expansion (part B): BMS-986016 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG004
BMS-986016 80mg + Nivolumab
Dose escalation (part C): BMS-986016 IV 80mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG005
BMS-986016 240mg + Nivolumab
Dose escalation (part C): BMS-986016 IV 240mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG006
BMS-986016 160mg + Nivolumab
Dose escalation (part C) and dose expansion (part D): BMS-986016 IV 160mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
Units
Counts
Participants
OG0003
OG0019
OG0026
OG003
Title
Denominators
Categories
AEs
Title
Measurements
OG0003
OG0019
OG0025
OG003
Primary
Number of Participants Who Died
Number of participants who died due to any cause.
All treated participants
Posted
Count of Participants
Participants
From first dose to 135 days post last dose (Up to 52 months)
ID
Title
Description
OG000
BMS-986016 20mg
Dose escalation (part A): BMS-986016 20mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG001
BMS-986016 80mg
Dose escalation (part A): BMS-986016 80mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG002
BMS-986016 800mg
Dose escalation (part A): BMS-986016 800mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
Primary
Number of Participants With On-Treatment Laboratory Abnormalities in Specific Hepatics Tests
Number of participants with laboratory abnormalities in specific hepatic tests based on SI unit convention. The number of participants with the following laboratory abnormalities from on-treatment evaluations will be summarized:
ALT or AST > 3 x ULN, > 5 x ULN, > 10 x ULN and > 20 x ULN
Total bilirubin > 2 x ULN
ALP > 1.5 x ULN
Concurrent (within 1 day) ALT or AST > 3 x ULN and total bilirubin > 1.5 x ULN
Concurrent (within 30 days) ALT or AST > 3 x ULN and total bilirubin > 1.5 x ULN
Concurrent (within 1 day) ALT or AST > 3 x ULN and total bilirubin > 2 x ULN
Concurrent (within 30 days) ALT or AST > 3 x ULN and total bilirubin > 2 x ULN
All treated participants with at least one on-treatment measurement of the corresponding laboratory parameter
Posted
Count of Participants
Participants
From first dose to 30 days post last dose (Up to 49 months)
ID
Title
Description
OG000
BMS-986016 20mg
Dose escalation (part A): BMS-986016 20mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG001
BMS-986016 80mg
Primary
Objective Response Rate (ORR) - Part D
Investigator-assessed ORR per International Working Group (IWG 2007) response criteria for malignant lymphoma is defined as the number of participants with a best overall documented response (BOR) of either a complete response (CR) or partial response (PR).
Complete response: Disappearance of all evidence of disease. Partial response: Regression of measurable disease and no new sites. >= 50% decrease in sum of the produce of the diameters of up to 6 largest dominant masses (index lesions); no increase in size of other nodes (non-index lesions).
Progressive disease: Any new lesion or increase by >=50% of previously involved sites from nadir.
Pre-specified only to be collected in all treated participants by tumor type for Part D
Posted
Number
95% Confidence Interval
Percentage of participants
From first dose date to the date of disease progression per investigator or the date of subsequent therapy, whichever occurs first (Up to approximately 95 months)
ID
Title
Description
OG000
HL Naive BMS-986016 160mg + Nivolumab
Dose expansion (part D): BMS-986016 IV 160mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, or until meeting criteria for discontinuation, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG001
DLBCL BMS-986016 160mg + Nivolumab
Primary
Duration of Response (DoR) - Part D
Investigator-assessed DoR per International Working Group (IWG 2007)) response criteria for malignant lymphoma is defined as the time between the date of first documented response (complete response or partial response) to the date of the first objectively documented progression, or death due to any cause, whichever occurs first.
Complete response: Disappearance of all evidence of disease. Partial response: Regression of measurable disease and no new sites. >= 50% decrease in sum of the produce of the diameters of up to 6 largest dominant masses (index lesions); no increase in size of other nodes (non-index lesions).
Progressive disease: Any new lesion or increase by >=50% of previously involved sites from nadir.
Pre-specified only to be collected in all responders (CR or PR) by tumor type for Part D
Posted
Median
95% Confidence Interval
Months
From first dose to the date of the first objectively documented progression, or death due to any cause, whichever occurs first (Up to approximately 95 months)
ID
Title
Description
OG000
HL Naive BMS-986016 160mg + Nivolumab
Dose expansion (part D): BMS-986016 IV 160mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, or until meeting criteria for discontinuation, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG001
DLBCL BMS-986016 160mg + Nivolumab
Secondary
BMS-986016 Maximum Observed Serum Concentration (Cmax)
BMS-986016 Maximum Observed Serum Concentration (Cmax). Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.
Period 0 = treatment period Period 1 = Re-challenge period
All participants who received at least one dose of BMS-986016 and have evaluable serum concentration data
Posted
Geometric Mean
Geometric Coefficient of Variation
ug/mL
PK assessment include the following timepoints: pre-dose, 1, 4, 24, 48, 96, 144, 192 hours end-of-infusion on cycle 1 Day 1, Cycle 3 Day 1
ID
Title
Description
OG000
BMS-986016 20mg
Dose escalation (part A): BMS-986016 20mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG001
BMS-986016 80mg
Dose escalation (part A): BMS-986016 80mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
Secondary
BMS-986016 Time of Maximum Observed Serum Concentration (Tmax)
BMS-986016 Time of Maximum Observed Serum Concentration (Tmax). Period 0 = treatment period Period 1 = Re-challenge period
All participants who received at least one dose of BMS-986016 and have evaluable serum concentration data
Posted
Median
Full Range
Hours
PK assessment include the following timepoints: pre-dose, 1, 4, 24, 48, 96, 144, 192 hours end-of-infusion on cycle 1 Day 1, Cycle 3 Day 1
ID
Title
Description
OG000
BMS-986016 20mg
Dose escalation (part A): BMS-986016 20mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG001
BMS-986016 80mg
Dose escalation (part A): BMS-986016 80mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
Secondary
BMS-986016 Area Under the Concentration-time Curve in One Dosing Interval (AUC(TAU))
BMS-986016 Area under the concentration-time curve in one dosing interval (AUC(TAU)). Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.
Period 0 = treatment period Period 1 = Re-challenge period
All participants who received at least one dose of BMS-986016 and have evaluable serum concentration data
Posted
Geometric Mean
Geometric Coefficient of Variation
h*ug/mL
PK assessment include the following timepoints: pre-dose, 1, 4, 24, 48, 96, 144, 192 hours end-of-infusion on cycle 1 Day 1, Cycle 3 Day 1
ID
Title
Description
OG000
BMS-986016 20mg
Dose escalation (part A): BMS-986016 20mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG001
BMS-986016 80mg
Dose escalation (part A): BMS-986016 80mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
Secondary
BMS-986016 Concentration at the End of a Dosing Interval (Ctau)
BMS-986016 Concentration at the end of a dosing interval (Ctau). Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.
Period 0 = treatment period Period 1 = Re-challenge period
All participants who received at least one dose of BMS-986016 and have evaluable serum concentration data
Posted
Geometric Mean
Geometric Coefficient of Variation
h*ug/mL
PK assessment include the following timepoints: pre-dose, 1, 4, 24, 48, 96, 144, 192 hours end-of-infusion on cycle 1 Day 1, Cycle 3 Day 1
ID
Title
Description
OG000
BMS-986016 20mg
Dose escalation (part A): BMS-986016 20mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG001
BMS-986016 80mg
Dose escalation (part A): BMS-986016 80mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
Secondary
BMS-986016 Effective Elimination Half-life That Explains the Degree of AUC Accumulation Observed (T 1/2eff AUC)
BMS-986016 effective elimination half-life that explains the degree of AUC accumulation observed (t 1/2eff AUC). Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.
Period 0 = treatment period Period 1 = Re-challenge period
All participants who received at least one dose of BMS-986016 and have evaluable serum concentration data
Posted
Mean
Standard Deviation
Hours
PK assessment include the following timepoints: pre-dose, 1, 4, 24, 48, 96, 144, 192 hours end-of-infusion on cycle 1 Day 1, Cycle 3 Day 1
ID
Title
Description
OG000
BMS-986016 20mg
Dose escalation (part A): BMS-986016 20mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG001
BMS-986016 80mg
Dose escalation (part A): BMS-986016 80mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
Secondary
BMS-986016 Total Body Clearance (CL/T)
BMS-986016 total body clearance (CL/T). Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.
Period 0 = treatment period Period 1 = Re-challenge period
All participants who received at least one dose of BMS-986016 and have evaluable serum concentration data
Posted
Geometric Mean
Geometric Coefficient of Variation
mL/h
PK assessment include the following timepoints: pre-dose, 1, 4, 24, 48, 96, 144, 192 hours end-of-infusion on cycle 1 Day 1, Cycle 3 Day 1
ID
Title
Description
OG000
BMS-986016 20mg
Dose escalation (part A): BMS-986016 20mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG001
BMS-986016 80mg
Dose escalation (part A): BMS-986016 80mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
Secondary
BMS-986016 Cmax Accumulation Index (AI_Cmax)
BMS-986016 cmax accumulation index (AI_Cmax). AI is calculated based on ratio of Cmax at steady state to Cmax after the first dose. Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.
Period 0 = treatment period Period 1 - Re-challenge period
All participants who received at least one dose of BMS-986016 and have evaluable serum concentration data
Posted
Geometric Mean
Geometric Coefficient of Variation
ug/mL
PK assessment include the following timepoints: pre-dose, 1, 4, 24, 48, 96, 144, 192 hours end-of-infusion on cycle 1 Day 1, Cycle 3 Day 1
ID
Title
Description
OG000
BMS-986016 20mg
Dose escalation (part A): BMS-986016 20mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG001
BMS-986016 80mg
Dose escalation (part A): BMS-986016 80mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
Secondary
BMS-986016 Accumulation Index (AI_AUC)
BMS-986016 accumulation index (AI_AUC). AI is calculated based on ratio of AUC(TAU) at steady state to AUC(TAU) after the first dose. Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.
Period 0 = treatment period Period 1 - Re-challenge period
All participants who received at least one dose of BMS-986016 and have evaluable serum concentration data
Posted
Geometric Mean
Geometric Coefficient of Variation
Ratio
PK assessment include the following timepoints: pre-dose, 1, 4, 24, 48, 96, 144, 192 hours end-of-infusion on cycle 1 Day 1, Cycle 3 Day 1
ID
Title
Description
OG000
BMS-986016 20mg
Dose escalation (part A): BMS-986016 20mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG001
BMS-986016 80mg
Dose escalation (part A): BMS-986016 80mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
Secondary
BMS-986016 Ctau Accumulation Index (AI_Ctau)
BMS-986016 Ctau accumulation index (AI_Ctau). AI is calculated based on ratio of Ctau at steady state to Ctau after the first dose. Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.
Period 0 = treatment period Period 1 - Re-challenge period
All participants who received at least one dose of BMS-986016 and have evaluable serum concentration data
Posted
Geometric Mean
Geometric Coefficient of Variation
Ratio
PK assessment include the following timepoints: pre-dose, 1, 4, 24, 48, 96, 144, 192 hours end-of-infusion on cycle 1 Day 1, Cycle 3 Day 1
ID
Title
Description
OG000
BMS-986016 20mg
Dose escalation (part A): BMS-986016 20mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG001
BMS-986016 80mg
Dose escalation (part A): BMS-986016 80mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
Secondary
BMS-986016 Average Concentration Over a Dosing Interval ([AUC(TAU)/Tau] (Css,Avg)
BMS-986016 average concentration over a dosing interval ([AUC(TAU)/tau] (Css,avg). Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.
Period 0 = treatment period Period 1 - Re-challenge period
All participants who received at least one dose of BMS-986016 and have evaluable serum concentration data
Posted
Geometric Mean
Geometric Coefficient of Variation
ug/mL
PK assessment include the following timepoints: pre-dose, 1, 4, 24, 48, 96, 144, 192 hours end-of-infusion on cycle 1 Day 1, Cycle 3 Day 1
ID
Title
Description
OG000
BMS-986016 20mg
Dose escalation (part A): BMS-986016 20mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG001
BMS-986016 80mg
Dose escalation (part A): BMS-986016 80mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
BMS-986016 trough observed serum concentration (Ctrough). Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.
Period 0 = treatment period Period 1 - Re-challenge period
All participants who received at least one dose of BMS-986016 and have evaluable serum concentration data
Posted
Geometric Mean
Geometric Coefficient of Variation
ug/mL
PK assessment include the following timepoints: pre-dose, 1, 4, 24, 48, 96, 144, 192 hours end-of-infusion on cycle 1 Day 15, 29, 43, Cycle 2 Day 1, 15, 29, Cycle 3 Day 1, 15, Cycle 5 Day 1, Cycle 7 Day 1, Cycle 9 Day 1, and Cycle 11 Day 1
ID
Title
Description
OG000
BMS-986016 20mg
Dose escalation (part A): BMS-986016 20mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG001
BMS-986016 80mg
Dose escalation (part A): BMS-986016 80mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
Secondary
Number of Participants With Anti-BMS-986016 Antibodies (ADA)
Number of participants with anti-BMS-986016 antibodies (ADA) with status as baseline ADA positive, ADA positive and ADA negative. Baseline ADA positive participant is defined as a participant with positive seroconversion detected in the last sample before initiation of treatment. ADA-positive participant is a participant with at least one ADA-positive sample relative to baseline after initiation of the treatment. ADA negative participant is defined as a participant with no ADA positive sample after the initiation of treatment.
All BMS-986016 treated participants with baseline and at least one post-baseline assessment
Posted
Count of Participants
Participants
From first dose to 135 days post last dose (Up to 52 months)
ID
Title
Description
OG000
BMS-986016 20mg
Dose escalation (part A): BMS-986016 20mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG001
BMS-986016 80mg
Dose escalation (part A): BMS-986016 80mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
Secondary
Number of Participants With Anti-Nivolumab Antibodies (ADA)
Number of participants with anti-Nivolumab antibodies (ADA) with status as baseline ADA positive, ADA positive and ADA negative. Baseline ADA positive participant is defined as a participant with positive seroconversion detected in the last sample before initiation of treatment. ADA-positive participant is a participant with at least one ADA-positive sample relative to baseline after initiation of the treatment. ADA negative participant is defined as a participant with no ADA positive sample after the initiation of treatment.
All Nivolumab treated participants with baseline and at least one post-baseline assessment
Posted
Count of Participants
Participants
From first dose to 135 days post last dose (Up to 52 months)
ID
Title
Description
OG000
BMS-986016 20mg
Dose escalation (part A): BMS-986016 20mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG001
BMS-986016 80mg
Dose escalation (part A): BMS-986016 80mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
Time Frame
Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
Description
Not provided
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
All Mono Esc 20 Q2W
Dose escalation (part A): BMS-986016 800mg up to twelve 8-week treatment cycles, confirmed progressive disease, or until meeting criteria for discontinuation, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
2
3
1
3
3
3
EG001
All Mono Esc 80 Q2W
Dose escalation (part A): BMS-986016 800mg up to twelve 8-week treatment cycles, confirmed progressive disease, or until meeting criteria for discontinuation, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
3
9
5
9
9
9
EG002
All Mono Esc 240 Q2W
Dose escalation (part A): BMS-986016 800mg up to twelve 8-week treatment cycles, confirmed progressive disease, or until meeting criteria for discontinuation, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
0
9
1
9
8
9
EG003
All Mono Esc 800 Q2W
Dose escalation (part A): BMS-986016 800mg up to twelve 8-week treatment cycles, confirmed progressive disease, or until meeting criteria for discontinuation, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
1
6
2
6
5
6
EG004
CLL BMS-986016 240mg
Dose expansion (part B): BMS-986016 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, or until meeting criteria for discontinuation, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
1
2
1
2
2
2
EG005
DLBCL BMS-986016 240mg
Dose expansion (part B): BMS-986016 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, or until meeting criteria for discontinuation, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
2
2
2
2
2
2
EG006
iNHL BMS-986016 240mg
Dose expansion (part B): BMS-986016 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, or until meeting criteria for discontinuation, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
0
4
2
4
4
4
EG007
HL BMS-986016 240mg
Dose expansion (part B): BMS-986016 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, or until meeting criteria for discontinuation, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
0
3
1
3
3
3
EG008
All Combo Esc 80/240 Q2W
Dose escalation (part C): BMS-986016 IV 80mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, or until meeting criteria for discontinuation, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
5
7
4
7
7
7
EG009
All Combo Esc 160/240 Q2W
Dose escalation (part C): BMS-986016 IV 160mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, or until meeting criteria for discontinuation, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
2
4
2
4
4
4
EG010
All Combo Esc 240/240 Q2W
Dose escalation (part C): BMS-986016 IV 240mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, or until meeting criteria for discontinuation, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
0
1
0
1
1
1
EG011
HL Naive BMS-986016 160mg + Nivolumab
Dose expansion (part D): BMS-986016 IV 160mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, or until meeting criteria for discontinuation, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
1
21
6
21
20
21
EG012
DLBCL BMS-986016 160mg + Nivolumab
Dose expansion (part D): BMS-986016 IV 160mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, or until meeting criteria for discontinuation, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
13
15
11
15
11
15
EG013
HL Post I/O BMS-986016 160mg + Nivolumab
Dose expansion (part D): BMS-986016 IV 160mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, or until meeting criteria for discontinuation, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
3
20
9
20
20
20
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG0030 affected6 at risk
EG0040 affected2 at risk
EG0051 affected2 at risk
EG0060 affected4 at risk
EG0070 affected3 at risk
EG0080 affected7 at risk
EG0090 affected4 at risk
EG0100 affected1 at risk
EG0110 affected21 at risk
EG0120 affected15 at risk
EG0130 affected20 at risk
Neutropenia
Blood and lymphatic system disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Adrenal insufficiency
Endocrine disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Hypercalcaemia of malignancy
Endocrine disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected9 at risk
EG0020 affected9 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected9 at risk
EG0020 affected9 at risk
EG003
Oesophageal spasm
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Asthenia
General disorders
MedDRA 25.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Fatigue
General disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Pain
General disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Pyrexia
General disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Autoimmune hepatitis
Hepatobiliary disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Hypertransaminasaemia
Hepatobiliary disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Kidney infection
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Meningitis aseptic
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Pneumonia fungal
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Sepsis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected9 at risk
EG0020 affected9 at risk
EG003
Subcutaneous abscess
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected9 at risk
EG0020 affected9 at risk
EG003
Periprosthetic fracture
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Radiation oesophagitis
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Blood thyroid stimulating hormone increased
Investigations
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Diabetic ketoacidosis
Metabolism and nutrition disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Failure to thrive
Metabolism and nutrition disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected9 at risk
EG0020 affected9 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0013 affected9 at risk
EG0020 affected9 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Encephalitis autoimmune
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Headache
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Ophthalmic migraine
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Paraparesis
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected9 at risk
EG0020 affected9 at risk
EG003
Radiculopathy
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected9 at risk
EG0020 affected9 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Bronchial obstruction
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0021 affected9 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Hypotension
Vascular disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 25.1
Systematic Assessment
EG0001 affected3 at risk
EG0011 affected9 at risk
EG0020 affected9 at risk
EG0030 affected6 at risk
EG0041 affected2 at risk
EG0050 affected2 at risk
EG0060 affected4 at risk
EG0070 affected3 at risk
EG0082 affected7 at risk
EG0091 affected4 at risk
EG0100 affected1 at risk
EG0114 affected21 at risk
EG0122 affected15 at risk
EG0135 affected20 at risk
Leukocytosis
Blood and lymphatic system disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Lymph node pain
Blood and lymphatic system disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected9 at risk
EG0021 affected9 at risk
EG003
Lymphocytosis
Blood and lymphatic system disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0021 affected9 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Pancytopenia
Blood and lymphatic system disorders
MedDRA 25.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Splenic infarction
Blood and lymphatic system disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Sinus bradycardia
Cardiac disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected9 at risk
EG0020 affected9 at risk
EG003
Hypoacusis
Ear and labyrinth disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected9 at risk
EG0020 affected9 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Adrenal insufficiency
Endocrine disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 25.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Diplopia
Eye disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Eye oedema
Eye disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected9 at risk
EG0020 affected9 at risk
EG003
Eye pain
Eye disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Eyelid function disorder
Eye disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected9 at risk
EG0020 affected9 at risk
EG003
Vision blurred
Eye disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected9 at risk
EG0020 affected9 at risk
EG003
Vitreous floaters
Eye disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0021 affected9 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected9 at risk
EG0020 affected9 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected9 at risk
EG0020 affected9 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected9 at risk
EG0022 affected9 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected9 at risk
EG0021 affected9 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0021 affected9 at risk
EG003
Anal erythema
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Anal incontinence
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Angular cheilitis
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0001 affected3 at risk
EG0013 affected9 at risk
EG0021 affected9 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0001 affected3 at risk
EG0013 affected9 at risk
EG0020 affected9 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Food poisoning
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected9 at risk
EG0020 affected9 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Gingival pain
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Glossitis
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Immune-mediated enterocolitis
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Large intestine polyp
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected9 at risk
EG0024 affected9 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Tongue ulceration
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Application site reaction
General disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Catheter site related reaction
General disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0021 affected9 at risk
EG003
Chest discomfort
General disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected9 at risk
EG0020 affected9 at risk
EG003
Chills
General disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Fatigue
General disorders
MedDRA 25.1
Systematic Assessment
EG0001 affected3 at risk
EG0014 affected9 at risk
EG0026 affected9 at risk
EG003
Influenza like illness
General disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Malaise
General disorders
MedDRA 25.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected9 at risk
EG0020 affected9 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 25.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Oedema peripheral
General disorders
MedDRA 25.1
Systematic Assessment
EG0001 affected3 at risk
EG0013 affected9 at risk
EG0020 affected9 at risk
EG003
Pain
General disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected9 at risk
EG0020 affected9 at risk
EG003
Peripheral swelling
General disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Pyrexia
General disorders
MedDRA 25.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Vaccination site reaction
General disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Biliary obstruction
Hepatobiliary disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Hepatotoxicity
Hepatobiliary disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Jaundice
Hepatobiliary disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Food allergy
Immune system disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Body tinea
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected9 at risk
EG0020 affected9 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected9 at risk
EG0020 affected9 at risk
EG003
Candida infection
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Cystitis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Eye infection
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Fungal foot infection
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Fungal infection
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Influenza
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Otitis media
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Parainfluenzae virus infection
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Pharyngitis streptococcal
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Pneumonia bacterial
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Post procedural infection
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Respiratory syncytial virus infection
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0021 affected9 at risk
EG003
Subcutaneous abscess
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0001 affected3 at risk
EG0012 affected9 at risk
EG0022 affected9 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0002 affected3 at risk
EG0012 affected9 at risk
EG0020 affected9 at risk
EG003
Viral infection
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0021 affected9 at risk
EG003
Device placement issue
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Eye contusion
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0013 affected9 at risk
EG0021 affected9 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Tooth fracture
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Wrist fracture
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected9 at risk
EG0020 affected9 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Amylase increased
Investigations
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 25.1
Systematic Assessment
EG0001 affected3 at risk
EG0011 affected9 at risk
EG0020 affected9 at risk
EG003
Blood glucose increased
Investigations
MedDRA 25.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Blood thyroid stimulating hormone increased
Investigations
MedDRA 25.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
C-reactive protein increased
Investigations
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Heart rate increased
Investigations
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Lipase increased
Investigations
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0021 affected9 at risk
EG003
Occult blood positive
Investigations
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Platelet count decreased
Investigations
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Weight decreased
Investigations
MedDRA 25.1
Systematic Assessment
EG0003 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 25.1
Systematic Assessment
EG0002 affected3 at risk
EG0011 affected9 at risk
EG0021 affected9 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Folate deficiency
Metabolism and nutrition disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected9 at risk
EG0020 affected9 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Hypermagnesaemia
Metabolism and nutrition disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected9 at risk
EG0020 affected9 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected9 at risk
EG0020 affected9 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected9 at risk
EG0020 affected9 at risk
EG003
Hypovolaemia
Metabolism and nutrition disorders
MedDRA 25.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Vitamin D deficiency
Metabolism and nutrition disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0001 affected3 at risk
EG0011 affected9 at risk
EG0020 affected9 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected9 at risk
EG0020 affected9 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0002 affected3 at risk
EG0013 affected9 at risk
EG0021 affected9 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Hypertrophic osteoarthropathy
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Limb discomfort
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected9 at risk
EG0020 affected9 at risk
EG003
Mobility decreased
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected9 at risk
EG0020 affected9 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected9 at risk
EG0020 affected9 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected9 at risk
EG0020 affected9 at risk
EG003
Musculoskeletal disorder
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0021 affected9 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0021 affected9 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0001 affected3 at risk
EG0011 affected9 at risk
EG0020 affected9 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Ageusia
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Burning sensation
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0021 affected9 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0021 affected9 at risk
EG003
Dysarthria
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected9 at risk
EG0020 affected9 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Headache
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected9 at risk
EG0021 affected9 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected9 at risk
EG0020 affected9 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Migraine
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Neuralgia
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0021 affected9 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Subarachnoid haemorrhage
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Tremor
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected9 at risk
EG0020 affected9 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Depressed mood
Psychiatric disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0021 affected9 at risk
EG003
Depression
Psychiatric disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0021 affected9 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 25.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0021 affected9 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected9 at risk
EG0020 affected9 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 25.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Breast pain
Reproductive system and breast disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected9 at risk
EG0020 affected9 at risk
EG003
Erectile dysfunction
Reproductive system and breast disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Menstruation irregular
Reproductive system and breast disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Vulvovaginal pruritus
Reproductive system and breast disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected9 at risk
EG0021 affected9 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Systematic Assessment
EG0001 affected3 at risk
EG0011 affected9 at risk
EG0021 affected9 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected9 at risk
EG0020 affected9 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected9 at risk
EG0022 affected9 at risk
EG003
Orthopnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected9 at risk
EG0020 affected9 at risk
EG003
Paranasal sinus discomfort
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Paranasal sinus hypersecretion
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected9 at risk
EG0020 affected9 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected9 at risk
EG0020 affected9 at risk
EG003
Respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected9 at risk
EG0021 affected9 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected9 at risk
EG0020 affected9 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0021 affected9 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0021 affected9 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected9 at risk
EG0020 affected9 at risk
EG003
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected9 at risk
EG0020 affected9 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected9 at risk
EG0020 affected9 at risk
EG003
Lichen planus
Skin and subcutaneous tissue disorders
MedDRA 25.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected9 at risk
EG0020 affected9 at risk
EG003
Pain of skin
Skin and subcutaneous tissue disorders
MedDRA 25.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Papule
Skin and subcutaneous tissue disorders
MedDRA 25.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected9 at risk
EG0020 affected9 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Seborrhoea
Skin and subcutaneous tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Sensitive skin
Skin and subcutaneous tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Skin exfoliation
Skin and subcutaneous tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA 25.1
Systematic Assessment
EG0002 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected9 at risk
EG0020 affected9 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Vitiligo
Skin and subcutaneous tissue disorders
MedDRA 25.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected9 at risk
EG0020 affected9 at risk
EG003
Flushing
Vascular disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Hot flush
Vascular disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected9 at risk
EG0020 affected9 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected9 at risk
EG0020 affected9 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.
Dose escalation (part A) and dose expansion (part B): BMS-986016 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG004
BMS-986016 80mg + Nivolumab
Dose escalation (part C): BMS-986016 IV 80mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG005
BMS-986016 240mg + Nivolumab
Dose escalation (part C): BMS-986016 IV 240mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG006
BMS-986016 160mg + Nivolumab
Dose escalation (part C) and dose expansion (part D): BMS-986016 IV 160mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
Units
Counts
Participants
OG0003
OG0019
OG0026
OG00320
OG0047
OG0051
OG00660
Title
Denominators
Categories
Title
Measurements
OG0000
OG0012
OG0021
OG0032
OG0042
OG0050
OG00610
Dose escalation (part A): BMS-986016 80mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG002
BMS-986016 800mg
Dose escalation (part A): BMS-986016 800mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG003
BMS-986016 240mg
Dose escalation (part A) and dose expansion (part B): BMS-986016 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG004
BMS-986016 80mg + Nivolumab
Dose escalation (part C): BMS-986016 IV 80mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG005
BMS-986016 240mg + Nivolumab
Dose escalation (part C): BMS-986016 IV 240mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG006
BMS-986016 160mg + Nivolumab
Dose escalation (part C) and dose expansion (part D): BMS-986016 IV 160mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
Units
Counts
Participants
OG0003
OG0019
OG0025
OG00320
OG0047
OG0051
OG00657
Title
Denominators
Categories
ALT OR AST > 3XULN
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0065
ALT OR AST > 5XULN
Title
Measurements
OG0000
OG0010
OG0020
OG003
ALT OR AST > 10XULN
Title
Measurements
OG0000
OG0010
OG0020
OG003
ALT OR AST > 20XULN
Title
Measurements
OG0000
OG0010
OG0020
OG003
TOTAL BILIRUBIN > 2XULN
Title
Measurements
OG0000
OG0010
OG0020
OG003
ALP > 1.5XULN
Title
Measurements
OG0001
OG0011
OG0020
OG003
CONCURRENT ALT OR AST ELEVATION > 3XULN WITH TOTAL BILIRUBIN > 1.5XULN WITHIN ONE DAY
Title
Measurements
OG0000
OG0010
OG0020
OG003
CONCURRENT ALT OR AST ELEVATION > 3XULN WITH TOTAL BILIRUBIN > 1.5XULN WITHIN 30 DAYS
Title
Measurements
OG0000
OG0010
OG0020
OG003
CONCURRENT ALT OR AST ELEVATION > 3XULN WITH TOTAL BILIRUBIN > 2XULN WITHIN ONE DAY
Title
Measurements
OG0000
OG0010
OG0020
OG003
CONCURRENT ALT OR AST ELEVATION > 3XULN WITH TOTAL BILIRUBIN > 2XULN WITHIN 30 DAYS
Title
Measurements
OG0000
OG0010
OG0020
OG003
Dose expansion (part D): BMS-986016 IV 160mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, or until meeting criteria for discontinuation, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG002
HL Post I/O BMS-986016 160mg + Nivolumab
Dose expansion (part D): BMS-986016 IV 160mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, or until meeting criteria for discontinuation, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
Units
Counts
Participants
OG00021
OG00115
OG00220
Title
Denominators
Categories
Title
Measurements
OG00061.9(38.4 to 81.9)
OG0016.7(0.2 to 31.9)
OG00215.0(3.2 to 37.9)
Dose expansion (part D): BMS-986016 IV 160mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, or until meeting criteria for discontinuation, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG002
HL Post I/O BMS-986016 160mg + Nivolumab
Dose expansion (part D): BMS-986016 IV 160mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, or until meeting criteria for discontinuation, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
Units
Counts
Participants
OG00013
OG0011
OG0023
Title
Denominators
Categories
Title
Measurements
OG00014.16(2.56 to NA)Upper limit not available due to insufficient number of participants with events
OG001NA(NA to NA)insufficient number of participants with events
OG0026.37(1.84 to NA)Upper limit not available due to insufficient number of participants with events
OG002
BMS-986016 800mg
Dose escalation (part A): BMS-986016 800mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG003
BMS-986016 240mg
Dose escalation (part A) and dose expansion (part B): BMS-986016 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG004
BMS-986016 80mg + Nivolumab
Dose escalation (part C): BMS-986016 IV 80mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG005
BMS-986016 240mg + Nivolumab
Dose escalation (part C): BMS-986016 IV 240mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG006
BMS-986016 160mg + Nivolumab
Dose escalation (part C) and dose expansion (part D): BMS-986016 IV 160mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
Units
Counts
Participants
OG0003
OG0017
OG0026
OG00320
OG0047
OG0051
OG00637
Title
Denominators
Categories
Period 0, Cycle 1, Day 1 (P0C1D1)
ParticipantsOG0003
ParticipantsOG0017
ParticipantsOG0026
ParticipantsOG00320
ParticipantsOG0047
ParticipantsOG0051
ParticipantsOG00637
Title
Measurements
OG0003.697± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 40
OG00122.738± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 29
OG002224.802± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 32
OG003
P0C3D1
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0021
ParticipantsOG0037
P1C1D1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
P1C3D1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG002
BMS-986016 800mg
Dose escalation (part A): BMS-986016 800mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG003
BMS-986016 240mg
Dose escalation (part A) and dose expansion (part B): BMS-986016 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG004
BMS-986016 80mg + Nivolumab
Dose escalation (part C): BMS-986016 IV 80mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG005
BMS-986016 240mg + Nivolumab
Dose escalation (part C): BMS-986016 IV 240mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG006
BMS-986016 160mg + Nivolumab
Dose escalation (part C) and dose expansion (part D): BMS-986016 IV 160mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
Units
Counts
Participants
OG0003
OG0017
OG0026
OG00320
OG0047
OG0051
OG00637
Title
Denominators
Categories
Period 0, Cycle 1, Day 1 (P0C1D1)
ParticipantsOG0003
ParticipantsOG0017
ParticipantsOG0026
ParticipantsOG00320
ParticipantsOG0047
ParticipantsOG0051
ParticipantsOG00637
Title
Measurements
OG0000.97(0.97 to 0.97)
OG0011.300(1.00 to 4.00)
OG0024.167(1.00 to 24.00)
OG003
P0C3D1
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0021
ParticipantsOG0037
P1C1D1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
P1C3D1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG002
BMS-986016 800mg
Dose escalation (part A): BMS-986016 800mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG003
BMS-986016 240mg
Dose escalation (part A) and dose expansion (part B): BMS-986016 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG004
BMS-986016 80mg + Nivolumab
Dose escalation (part C): BMS-986016 IV 80mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG005
BMS-986016 240mg + Nivolumab
Dose escalation (part C): BMS-986016 IV 240mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG006
BMS-986016 160mg + Nivolumab
Dose escalation (part C) and dose expansion (part D): BMS-986016 IV 160mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
Units
Counts
Participants
OG0003
OG0017
OG0026
OG00320
OG0047
OG0051
OG00637
Title
Denominators
Categories
Period 0, Cycle 1, Day 1 (P0C1D1)
ParticipantsOG0003
ParticipantsOG0017
ParticipantsOG0025
ParticipantsOG00318
ParticipantsOG0047
ParticipantsOG0051
ParticipantsOG00626
Title
Measurements
OG000401.438± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 38
OG0012852.533± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 57
OG00244296.525± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 20
OG003
P0C3D1
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0021
ParticipantsOG0035
P1C1D1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
P1C3D1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG002
BMS-986016 800mg
Dose escalation (part A): BMS-986016 800mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG003
BMS-986016 240mg
Dose escalation (part A) and dose expansion (part B): BMS-986016 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG004
BMS-986016 80mg + Nivolumab
Dose escalation (part C): BMS-986016 IV 80mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG005
BMS-986016 240mg + Nivolumab
Dose escalation (part C): BMS-986016 IV 240mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG006
BMS-986016 160mg + Nivolumab
Dose escalation (part C) and dose expansion (part D): BMS-986016 IV 160mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
Units
Counts
Participants
OG0003
OG0017
OG0025
OG00318
OG0047
OG0051
OG00626
Title
Denominators
Categories
Period 0, Cycle 1, Day 1 (P0C1D1)
ParticipantsOG0003
ParticipantsOG0017
ParticipantsOG0025
ParticipantsOG00318
ParticipantsOG0047
ParticipantsOG0051
ParticipantsOG00626
Title
Measurements
OG0000.158± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 79
OG0011.037± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 86
OG00275.589± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 31
OG003
P0C3D1
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0021
ParticipantsOG0035
P1C1D1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
P1C3D1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG002
BMS-986016 800mg
Dose escalation (part A): BMS-986016 800mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG003
BMS-986016 240mg
Dose escalation (part A) and dose expansion (part B): BMS-986016 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG004
BMS-986016 80mg + Nivolumab
Dose escalation (part C): BMS-986016 IV 80mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG005
BMS-986016 240mg + Nivolumab
Dose escalation (part C): BMS-986016 IV 240mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG006
BMS-986016 160mg + Nivolumab
Dose escalation (part C) and dose expansion (part D): BMS-986016 IV 160mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
Units
Counts
Participants
OG0002
OG0011
OG0021
OG0035
OG0042
OG0051
OG00612
Title
Denominators
Categories
Period 0, Cycle 1, Day 1 (P0C1D1)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
P0C3D1
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG0035
P1C1D1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
P1C3D1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG002
BMS-986016 800mg
Dose escalation (part A): BMS-986016 800mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG003
BMS-986016 240mg
Dose escalation (part A) and dose expansion (part B): BMS-986016 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG004
BMS-986016 80mg + Nivolumab
Dose escalation (part C): BMS-986016 IV 80mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG005
BMS-986016 240mg + Nivolumab
Dose escalation (part C): BMS-986016 IV 240mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG006
BMS-986016 160mg + Nivolumab
Dose escalation (part C) and dose expansion (part D): BMS-986016 IV 160mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
Units
Counts
Participants
OG0002
OG0012
OG0021
OG0035
OG0043
OG0051
OG00612
Title
Denominators
Categories
Period 0, Cycle 1, Day 1 (P0C1D1)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
P0C3D1
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0021
ParticipantsOG0035
P1C1D1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
P1C3D1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG002
BMS-986016 800mg
Dose escalation (part A): BMS-986016 800mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG003
BMS-986016 240mg
Dose escalation (part A) and dose expansion (part B): BMS-986016 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG004
BMS-986016 80mg + Nivolumab
Dose escalation (part C): BMS-986016 IV 80mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG005
BMS-986016 240mg + Nivolumab
Dose escalation (part C): BMS-986016 IV 240mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG006
BMS-986016 160mg + Nivolumab
Dose escalation (part C) and dose expansion (part D): BMS-986016 IV 160mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
Units
Counts
Participants
OG0002
OG0012
OG0021
OG0037
OG0043
OG0051
OG00612
Title
Denominators
Categories
Period 0, Cycle 1, Day 1 (P0C1D1)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
P0C3D1
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0021
ParticipantsOG0037
P1C1D1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
P1C3D1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG002
BMS-986016 800mg
Dose escalation (part A): BMS-986016 800mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG003
BMS-986016 240mg
Dose escalation (part A) and dose expansion (part B): BMS-986016 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG004
BMS-986016 80mg + Nivolumab
Dose escalation (part C): BMS-986016 IV 80mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG005
BMS-986016 240mg + Nivolumab
Dose escalation (part C): BMS-986016 IV 240mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG006
BMS-986016 160mg + Nivolumab
Dose escalation (part C) and dose expansion (part D): BMS-986016 IV 160mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
Units
Counts
Participants
OG0002
OG0012
OG0021
OG0035
OG0043
OG0051
OG00612
Title
Denominators
Categories
Period 0, Cycle 1, Day 1 (P0C1D1)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
P0C3D1
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0021
ParticipantsOG0035
P1C1D1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
P1C3D1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG002
BMS-986016 800mg
Dose escalation (part A): BMS-986016 800mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG003
BMS-986016 240mg
Dose escalation (part A) and dose expansion (part B): BMS-986016 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG004
BMS-986016 80mg + Nivolumab
Dose escalation (part C): BMS-986016 IV 80mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG005
BMS-986016 240mg + Nivolumab
Dose escalation (part C): BMS-986016 IV 240mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG006
BMS-986016 160mg + Nivolumab
Dose escalation (part C) and dose expansion (part D): BMS-986016 IV 160mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
Units
Counts
Participants
OG0002
OG0012
OG0021
OG0035
OG0043
OG0051
OG00612
Title
Denominators
Categories
Period 0, Cycle 1, Day 1 (P0C1D1)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
P0C3D1
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0021
ParticipantsOG0035
P1C1D1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
P1C3D1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG002
BMS-986016 800mg
Dose escalation (part A): BMS-986016 800mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG003
BMS-986016 240mg
Dose escalation (part A) and dose expansion (part B): BMS-986016 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG004
BMS-986016 80mg + Nivolumab
Dose escalation (part C): BMS-986016 IV 80mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG005
BMS-986016 240mg + Nivolumab
Dose escalation (part C): BMS-986016 IV 240mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG006
BMS-986016 160mg + Nivolumab
Dose escalation (part C) and dose expansion (part D): BMS-986016 IV 160mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
Units
Counts
Participants
OG0002
OG0012
OG0021
OG0035
OG0043
OG0051
OG00612
Title
Denominators
Categories
Period 0, Cycle 1, Day 1 (P0C1D1)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
P0C3D1
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0021
ParticipantsOG0035
P1C1D1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
P1C3D1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG002
BMS-986016 800mg
Dose escalation (part A): BMS-986016 800mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG003
BMS-986016 240mg
Dose escalation (part A) and dose expansion (part B): BMS-986016 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG004
BMS-986016 80mg + Nivolumab
Dose escalation (part C): BMS-986016 IV 80mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG005
BMS-986016 240mg + Nivolumab
Dose escalation (part C): BMS-986016 IV 240mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG006
BMS-986016 160mg + Nivolumab
Dose escalation (part C) and dose expansion (part D): BMS-986016 IV 160mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
Units
Counts
Participants
OG0003
OG0017
OG0025
OG00319
OG0047
OG0051
OG00648
Title
Denominators
Categories
P0C1D15
ParticipantsOG0003
ParticipantsOG0017
ParticipantsOG0025
ParticipantsOG00318
ParticipantsOG0047
ParticipantsOG0051
ParticipantsOG00644
Title
Measurements
OG0000.064± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV =145
OG0011.457± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 85
OG00275.589± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 31
OG003
P0C1D29
ParticipantsOG0003
ParticipantsOG0016
ParticipantsOG0025
ParticipantsOG00319
P0C1D43
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
P0C2D1
ParticipantsOG0002
ParticipantsOG0014
ParticipantsOG0024
ParticipantsOG00314
P0C2D15
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
P0C2D29
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
P0C3D1
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0021
ParticipantsOG0037
P0C3D15
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0021
ParticipantsOG0036
P0C5D1
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0020
ParticipantsOG0033
P0C7D1
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0031
P0C9D1
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0031
P0C11D1
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0031
P1C1D15
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
P1C1D29
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
P1C1D43
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
P1C2D1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
P1C2D15
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
P1C2D29
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
P1C3D1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
P1C3D15
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
P1C5D1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
P1C7D1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
P1C9D1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
P1C11D1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG002
BMS-986016 800mg
Dose escalation (part A): BMS-986016 800mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG003
BMS-986016 240mg
Dose escalation (part A) and dose expansion (part B): BMS-986016 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG004
BMS-986016 80mg + Nivolumab
Dose escalation (part C): BMS-986016 IV 80mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG005
BMS-986016 240mg + Nivolumab
Dose escalation (part C): BMS-986016 IV 240mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG006
BMS-986016 160mg + Nivolumab
Dose escalation (part C) and dose expansion (part D): BMS-986016 IV 160mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
Units
Counts
Participants
OG0003
OG0017
OG0025
OG00319
OG0047
OG0051
OG00652
Title
Denominators
Categories
Baseline ADA Positive
Title
Measurements
OG0000
OG0011
OG0021
OG0036
OG0040
OG0050
OG0065
ADA Positive
Title
Measurements
OG0000
OG0010
OG0020
OG003
ADA Negative
Title
Measurements
OG0003
OG0017
OG0025
OG003
OG002
BMS-986016 800mg
Dose escalation (part A): BMS-986016 800mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG003
BMS-986016 240mg
Dose escalation (part A) and dose expansion (part B): BMS-986016 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG004
BMS-986016 80mg + Nivolumab
Dose escalation (part C): BMS-986016 IV 80mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG005
BMS-986016 240mg + Nivolumab
Dose escalation (part C): BMS-986016 IV 240mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
OG006
BMS-986016 160mg + Nivolumab
Dose escalation (part C) and dose expansion (part D): BMS-986016 IV 160mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0044
OG0051
OG00646
Title
Denominators
Categories
Baseline ADA Positive
Title
Measurements
OG0040
OG0050
OG0060
ADA Positive
Title
Measurements
OG0040
OG0050
OG0061
ADA Negative
Title
Measurements
OG0044
OG0051
OG00645
0 affected
6 at risk
EG0040 affected2 at risk
EG0050 affected2 at risk
EG0060 affected4 at risk
EG0070 affected3 at risk
EG0080 affected7 at risk
EG0091 affected4 at risk
EG0100 affected1 at risk
EG0110 affected21 at risk
EG0121 affected15 at risk
EG0130 affected20 at risk
0 affected
6 at risk
EG0040 affected2 at risk
EG0050 affected2 at risk
EG0060 affected4 at risk
EG0070 affected3 at risk
EG0080 affected7 at risk
EG0090 affected4 at risk
EG0100 affected1 at risk
EG0110 affected21 at risk
EG0121 affected15 at risk
EG0131 affected20 at risk
0 affected
6 at risk
EG0040 affected2 at risk
EG0050 affected2 at risk
EG0060 affected4 at risk
EG0070 affected3 at risk
EG0080 affected7 at risk
EG0090 affected4 at risk
EG0100 affected1 at risk
EG0112 affected21 at risk
EG0120 affected15 at risk
EG0130 affected20 at risk
0 affected
6 at risk
EG0040 affected2 at risk
EG0050 affected2 at risk
EG0060 affected4 at risk
EG0070 affected3 at risk
EG0080 affected7 at risk
EG0090 affected4 at risk
EG0100 affected1 at risk
EG0110 affected21 at risk
EG0120 affected15 at risk
EG0130 affected20 at risk
1 affected
6 at risk
EG0040 affected2 at risk
EG0050 affected2 at risk
EG0060 affected4 at risk
EG0070 affected3 at risk
EG0080 affected7 at risk
EG0090 affected4 at risk
EG0100 affected1 at risk
EG0110 affected21 at risk
EG0120 affected15 at risk
EG0131 affected20 at risk
0 affected
6 at risk
EG0040 affected2 at risk
EG0050 affected2 at risk
EG0060 affected4 at risk
EG0070 affected3 at risk
EG0080 affected7 at risk
EG0090 affected4 at risk
EG0100 affected1 at risk
EG0110 affected21 at risk
EG0120 affected15 at risk
EG0131 affected20 at risk
0 affected
6 at risk
EG0040 affected2 at risk
EG0050 affected2 at risk
EG0060 affected4 at risk
EG0070 affected3 at risk
EG0080 affected7 at risk
EG0090 affected4 at risk
EG0100 affected1 at risk
EG0110 affected21 at risk
EG0120 affected15 at risk
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EG0050 affected2 at risk
EG0060 affected4 at risk
EG0070 affected3 at risk
EG0082 affected7 at risk
EG0091 affected4 at risk
EG0100 affected1 at risk
EG0110 affected21 at risk
EG0120 affected15 at risk
EG0131 affected20 at risk
0 affected
6 at risk
EG0040 affected2 at risk
EG0050 affected2 at risk
EG0060 affected4 at risk
EG0070 affected3 at risk
EG0081 affected7 at risk
EG0090 affected4 at risk
EG0100 affected1 at risk
EG0110 affected21 at risk
EG0120 affected15 at risk
EG0130 affected20 at risk
0 affected
6 at risk
EG0040 affected2 at risk
EG0050 affected2 at risk
EG0060 affected4 at risk
EG0070 affected3 at risk
EG0081 affected7 at risk
EG0090 affected4 at risk
EG0100 affected1 at risk
EG0110 affected21 at risk
EG0120 affected15 at risk
EG0130 affected20 at risk
0 affected
6 at risk
EG0040 affected2 at risk
EG0050 affected2 at risk
EG0060 affected4 at risk
EG0070 affected3 at risk
EG0080 affected7 at risk
EG0091 affected4 at risk
EG0100 affected1 at risk
EG0110 affected21 at risk
EG0120 affected15 at risk
EG0130 affected20 at risk
0 affected
6 at risk
EG0040 affected2 at risk
EG0050 affected2 at risk
EG0060 affected4 at risk
EG0070 affected3 at risk
EG0080 affected7 at risk
EG0090 affected4 at risk
EG0100 affected1 at risk
EG0110 affected21 at risk
EG0120 affected15 at risk
EG0130 affected20 at risk
1 affected
6 at risk
EG0040 affected2 at risk
EG0050 affected2 at risk
EG0061 affected4 at risk
EG0071 affected3 at risk
EG0080 affected7 at risk
EG0091 affected4 at risk
EG0101 affected1 at risk
EG0111 affected21 at risk
EG0120 affected15 at risk
EG0131 affected20 at risk
0 affected
6 at risk
EG0040 affected2 at risk
EG0050 affected2 at risk
EG0060 affected4 at risk
EG0070 affected3 at risk
EG0080 affected7 at risk
EG0090 affected4 at risk
EG0100 affected1 at risk
EG0110 affected21 at risk
EG0120 affected15 at risk
EG0130 affected20 at risk
0 affected
6 at risk
EG0040 affected2 at risk
EG0050 affected2 at risk
EG0060 affected4 at risk
EG0070 affected3 at risk
EG0080 affected7 at risk
EG0090 affected4 at risk
EG0101 affected1 at risk
EG0110 affected21 at risk
EG0120 affected15 at risk
EG0130 affected20 at risk
0 affected
6 at risk
EG0040 affected2 at risk
EG0050 affected2 at risk
EG0060 affected4 at risk
EG0070 affected3 at risk
EG0081 affected7 at risk
EG0091 affected4 at risk
EG0100 affected1 at risk
EG0113 affected21 at risk
EG0121 affected15 at risk
EG0133 affected20 at risk
0 affected
6 at risk
EG0040 affected2 at risk
EG0050 affected2 at risk
EG0060 affected4 at risk
EG0070 affected3 at risk
EG0080 affected7 at risk
EG0090 affected4 at risk
EG0100 affected1 at risk
EG0110 affected21 at risk
EG0121 affected15 at risk
EG0130 affected20 at risk
0 affected
6 at risk
EG0040 affected2 at risk
EG0050 affected2 at risk
EG0062 affected4 at risk
EG0070 affected3 at risk
EG0083 affected7 at risk
EG0091 affected4 at risk
EG0101 affected1 at risk
EG0118 affected21 at risk
EG0120 affected15 at risk
EG0130 affected20 at risk
0 affected
6 at risk
EG0040 affected2 at risk
EG0050 affected2 at risk
EG0060 affected4 at risk
EG0070 affected3 at risk
EG0081 affected7 at risk
EG0090 affected4 at risk
EG0100 affected1 at risk
EG0110 affected21 at risk
EG0120 affected15 at risk
EG0130 affected20 at risk
0 affected
6 at risk
EG0040 affected2 at risk
EG0050 affected2 at risk
EG0060 affected4 at risk
EG0070 affected3 at risk
EG0082 affected7 at risk
EG0090 affected4 at risk
EG0100 affected1 at risk
EG0112 affected21 at risk
EG0122 affected15 at risk
EG0132 affected20 at risk
1 affected
6 at risk
EG0040 affected2 at risk
EG0050 affected2 at risk
EG0060 affected4 at risk
EG0070 affected3 at risk
EG0080 affected7 at risk
EG0090 affected4 at risk
EG0100 affected1 at risk
EG0110 affected21 at risk
EG0120 affected15 at risk
EG0130 affected20 at risk
0 affected
6 at risk
EG0040 affected2 at risk
EG0050 affected2 at risk
EG0060 affected4 at risk
EG0070 affected3 at risk
EG0081 affected7 at risk
EG0090 affected4 at risk
EG0100 affected1 at risk
EG0111 affected21 at risk
EG0120 affected15 at risk
EG0131 affected20 at risk
0 affected
6 at risk
EG0040 affected2 at risk
EG0050 affected2 at risk
EG0060 affected4 at risk
EG0070 affected3 at risk
EG0081 affected7 at risk
EG0090 affected4 at risk
EG0100 affected1 at risk
EG0110 affected21 at risk
EG0120 affected15 at risk
EG0130 affected20 at risk
0 affected
6 at risk
EG0040 affected2 at risk
EG0050 affected2 at risk
EG0060 affected4 at risk
EG0070 affected3 at risk
EG0080 affected7 at risk
EG0091 affected4 at risk
EG0100 affected1 at risk
EG0110 affected21 at risk
EG0120 affected15 at risk
EG0130 affected20 at risk
0 affected
6 at risk
EG0040 affected2 at risk
EG0050 affected2 at risk
EG0060 affected4 at risk
EG0070 affected3 at risk
EG0080 affected7 at risk
EG0090 affected4 at risk
EG0101 affected1 at risk
EG0110 affected21 at risk
EG0120 affected15 at risk
EG0130 affected20 at risk
0 affected
6 at risk
EG0040 affected2 at risk
EG0051 affected2 at risk
EG0060 affected4 at risk
EG0070 affected3 at risk
EG0080 affected7 at risk
EG0090 affected4 at risk
EG0100 affected1 at risk
EG0110 affected21 at risk
EG0120 affected15 at risk
EG0130 affected20 at risk
0 affected
6 at risk
EG0040 affected2 at risk
EG0050 affected2 at risk
EG0060 affected4 at risk
EG0070 affected3 at risk
EG0080 affected7 at risk
EG0090 affected4 at risk
EG0100 affected1 at risk
EG0110 affected21 at risk
EG0120 affected15 at risk
EG0130 affected20 at risk
0 affected
6 at risk
EG0040 affected2 at risk
EG0050 affected2 at risk
EG0060 affected4 at risk
EG0070 affected3 at risk
EG0080 affected7 at risk
EG0091 affected4 at risk
EG0100 affected1 at risk
EG0110 affected21 at risk
EG0120 affected15 at risk
EG0131 affected20 at risk
0 affected
6 at risk
EG0040 affected2 at risk
EG0050 affected2 at risk
EG0060 affected4 at risk
EG0070 affected3 at risk
EG0080 affected7 at risk
EG0090 affected4 at risk
EG0100 affected1 at risk
EG0110 affected21 at risk
EG0120 affected15 at risk
EG0130 affected20 at risk
0 affected
6 at risk
EG0040 affected2 at risk
EG0050 affected2 at risk
EG0060 affected4 at risk
EG0070 affected3 at risk
EG0080 affected7 at risk
EG0090 affected4 at risk
EG0100 affected1 at risk
EG0110 affected21 at risk
EG0122 affected15 at risk
EG0130 affected20 at risk
0 affected
6 at risk
EG0040 affected2 at risk
EG0050 affected2 at risk
EG0060 affected4 at risk
EG0070 affected3 at risk
EG0080 affected7 at risk
EG0090 affected4 at risk
EG0101 affected1 at risk
EG0110 affected21 at risk
EG0120 affected15 at risk
EG0130 affected20 at risk
0 affected
6 at risk
EG0040 affected2 at risk
EG0050 affected2 at risk
EG0060 affected4 at risk
EG0070 affected3 at risk
EG0080 affected7 at risk
EG0090 affected4 at risk
EG0100 affected1 at risk
EG0111 affected21 at risk
EG0120 affected15 at risk
EG0130 affected20 at risk
0 affected
6 at risk
EG0040 affected2 at risk
EG0050 affected2 at risk
EG0060 affected4 at risk
EG0070 affected3 at risk
EG0081 affected7 at risk
EG0090 affected4 at risk
EG0100 affected1 at risk
EG0110 affected21 at risk
EG0120 affected15 at risk
EG0130 affected20 at risk
0
OG0040
OG0050
OG0061
0
OG0040
OG0050
OG0061
0
OG0040
OG0050
OG0061
1
OG0040
OG0050
OG0061
1
OG0041
OG0050
OG0068
0
OG0040
OG0050
OG0062
0
OG0040
OG0050
OG0062
0
OG0040
OG0050
OG0061
0
OG0040
OG0050
OG0061
68.718
± NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 54
OG00419.990± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 25
OG00557.900± NAinsufficient numbers of participants with events
OG00640.402± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 26
Participants
OG004
3
ParticipantsOG0051
ParticipantsOG00613
Title
Measurements
OG0006.660± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 21
OG00131.917± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 81
OG002673.000± NAinsufficient numbers of participants with events
OG003116.419± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 49
OG00444.532± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 12
OG005149.000± NAinsufficient numbers of participants with events
OG00688.196± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 44
Participants
OG004
0
ParticipantsOG0051
ParticipantsOG0061
Title
Measurements
OG00559.600± NAinsufficient numbers of participants with events
OG00668.400± NAinsufficient numbers of participants with events
Participants
OG004
0
ParticipantsOG0051
ParticipantsOG0061
Title
Measurements
OG005165.000± NAinsufficient numbers of participants with events
OG006163.000± NAinsufficient numbers of participants with events
1.825
(0.97 to 95.75)
OG0043.950(1.00 to 5.00)
OG0050.97(0.97 to 0.97)
OG0061.600(0.97 to 24.07)
Participants
OG004
3
ParticipantsOG0051
ParticipantsOG00613
Title
Measurements
OG0000.984(0.97 to 1.00)
OG00110.975(1.37 to 20.58)
OG002168.22(168.22 to 168.22)
OG0031.233(0.97 to 23.87)
OG0041.017(1.00 to 4.00)
OG0051.000(1.00 to 1.00)
OG0063.467(0.92 to 46.45)
Participants
OG004
0
ParticipantsOG0051
ParticipantsOG0061
Title
Measurements
OG0054.000(4.00 to 4.00)
OG0061.750(1.75 to 1.75)
Participants
OG004
0
ParticipantsOG0051
ParticipantsOG0061
Title
Measurements
OG00524.000(24.00 to 24.00)
OG0060.900(0.90 to 0.90)
9086.827
± NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 41
OG0042908.011± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 38
OG0059480.758± NAinsufficient numbers of participants with events
OG0065327.954± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 40
Participants
OG004
3
ParticipantsOG0051
ParticipantsOG00612
Title
Measurements
OG000712.408± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 6
OG0014898.034± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 116
OG002176405.369± NAinsufficient numbers of participants with events
OG00318783.970± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 87
OG0046166.165± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 64
OG00534573.957± NAinsufficient numbers of participants with events
OG00620464.075± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 48
Participants
OG004
0
ParticipantsOG0051
ParticipantsOG0061
Title
Measurements
OG00511259.871± NAinsufficient numbers of participants with events
OG00611433.253± NAinsufficient numbers of participants with events
Participants
OG004
0
ParticipantsOG0051
ParticipantsOG0061
Title
Measurements
OG00538472.003± NAinsufficient numbers of participants with events
OG00633919.259± NAinsufficient numbers of participants with events
12.221
± NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 75
OG0043.848± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 53
OG00519.500± NAinsufficient numbers of participants with events
OG0068.417± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 57
Participants
OG004
3
ParticipantsOG0051
ParticipantsOG00612
Title
Measurements
OG0000.256± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 125
OG0012.266± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 140
OG002293.000± NAinsufficient numbers of participants with events
OG00330.970± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 110
OG0049.556± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 78
OG005103.000± NAinsufficient numbers of participants with events
OG00647.016± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 54
Participants
OG004
0
ParticipantsOG0051
ParticipantsOG0061
Title
Measurements
OG00525.900± NAinsufficient numbers of participants with events
OG00624.200± NAinsufficient numbers of participants with events
Participants
OG004
0
ParticipantsOG0051
ParticipantsOG0061
Title
Measurements
OG00586.600± NAinsufficient numbers of participants with events
OG00686.100± NAinsufficient numbers of participants with events
Participants
OG004
2
ParticipantsOG0051
ParticipantsOG00612
Title
Measurements
OG000240.671± 143.5338
OG001742.843± NAinsufficient numbers of participants with events
OG002547.986± NAinsufficient numbers of participants with events
OG003428.698± 346.4046
OG004548.741± 78.0213
OG005720.317± NAinsufficient numbers of participants with events
OG006674.755± 296.9473
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
Participants
OG004
0
ParticipantsOG0051
ParticipantsOG0061
Title
Measurements
OG005638.597± NAinsufficient numbers of participants with events
OG006524.637± NAinsufficient numbers of participants with events
Participants
OG004
3
ParticipantsOG0051
ParticipantsOG00612
Title
Measurements
OG00028.074± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 6
OG00116.333± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 116
OG0024.535± NAinsufficient numbers of participants with events
OG00312.777± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 75
OG00412.974± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 96
OG0056.942± NAinsufficient numbers of participants with events
OG0067.819± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 41
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
Participants
OG004
0
ParticipantsOG0051
ParticipantsOG0061
Title
Measurements
OG0056.238± NAinsufficient numbers of participants with events
OG0064.717± NAinsufficient numbers of participants with events
Participants
OG004
3
ParticipantsOG0051
ParticipantsOG00612
Title
Measurements
OG0001.981± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 40
OG0011.701± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 68
OG0022.009± NAinsufficient numbers of participants with events
OG0031.734± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 42
OG0042.369± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 12
OG0052.573± NAinsufficient numbers of participants with events
OG0062.139± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 28
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
Participants
OG004
0
ParticipantsOG0051
ParticipantsOG0061
Title
Measurements
OG0052.768± NAinsufficient numbers of participants with events
OG0062.383± NAinsufficient numbers of participants with events
Participants
OG004
3
ParticipantsOG0051
ParticipantsOG00612
Title
Measurements
OG0001.577± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 34
OG0011.850± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 86
OG0022.894± NAinsufficient numbers of participants with events
OG0032.186± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 58
OG0042.017± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 50
OG0053.647± NAinsufficient numbers of participants with events
OG0063.268± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 32
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
Participants
OG004
0
ParticipantsOG0051
ParticipantsOG0061
Title
Measurements
OG0053.417± NAinsufficient numbers of participants with events
OG0062.967± NAinsufficient numbers of participants with events
Participants
OG004
3
ParticipantsOG0051
ParticipantsOG00612
Title
Measurements
OG0000.743± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV =118
OG0012.494± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 74
OG0024.741± NAinsufficient numbers of participants with events
OG0032.310± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 68
OG0041.686± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 69
OG0055.282± NAinsufficient numbers of participants with events
OG0064.162± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 26
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
Participants
OG004
0
ParticipantsOG0051
ParticipantsOG0061
Title
Measurements
OG0053.344± NAinsufficient numbers of participants with events
OG0063.558± NAinsufficient numbers of participants with events
Participants
OG004
3
ParticipantsOG0051
ParticipantsOG00612
Title
Measurements
OG0002.117± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV =6
OG00114.738± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 116
OG002526.269± NAinsufficient numbers of participants with events
OG00357.790± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 85
OG00418.345± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 64
OG005103.805± NAinsufficient numbers of participants with events
OG00661.385± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 46
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
Participants
OG004
0
ParticipantsOG0051
ParticipantsOG0061
Title
Measurements
OG005120.595± NAinsufficient numbers of participants with events
OG006109.013± NAinsufficient numbers of participants with events
12.221
± NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 75
OG0043.848± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 53
OG00519.500± NAinsufficient numbers of participants with events
OG00610.609± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 46
Participants
OG004
4
ParticipantsOG0051
ParticipantsOG00648
Title
Measurements
OG0000.088± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV =141
OG0014.324± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV =78
OG002155.896± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 33
OG00320.982± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 78
OG00413.066± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 17
OG00532.400± NAinsufficient numbers of participants with events
OG00618.221± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 41
Participants
OG004
4
ParticipantsOG0051
ParticipantsOG00637
Title
Measurements
OG0049.435± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 55
OG00544.700± NAinsufficient numbers of participants with events
OG00625.234± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 43
Participants
OG004
3
ParticipantsOG0051
ParticipantsOG00634
Title
Measurements
OG0000.777± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV =141
OG0016.609± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV =75
OG002298.666± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 43
OG00337.013± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 114
OG0049.389± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 74
OG00559.000± NAinsufficient numbers of participants with events
OG00628.428± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 43
Participants
OG004
2
ParticipantsOG0051
ParticipantsOG00625
Title
Measurements
OG0046.209± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 123
OG00562.000± NAinsufficient numbers of participants with events
OG00630.218± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 45
Participants
OG004
1
ParticipantsOG0051
ParticipantsOG0066
Title
Measurements
OG002289.000± NAinsufficient numbers of participants with events
OG00426.700± NAinsufficient numbers of participants with events
OG00570.900± NAinsufficient numbers of participants with events
OG00636.675± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 50
Participants
OG004
2
ParticipantsOG0051
ParticipantsOG00621
Title
Measurements
OG0001.020± NAinsufficient numbers of participants with events
OG00119.018± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV =86
OG002313.000± NAinsufficient numbers of participants with events
OG00316.648± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 121
OG0046.867± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 125
OG00593.300± NAinsufficient numbers of participants with events
OG00645.535± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 46
Participants
OG004
3
ParticipantsOG0051
ParticipantsOG00623
Title
Measurements
OG0000.256± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV =125
OG0012.266± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV =140
OG002293.000± NAinsufficient numbers of participants with events
OG0039.450± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 127
OG0049.556± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 78
OG005103.000± NAinsufficient numbers of participants with events
OG00645.685± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 48
Participants
OG004
2
ParticipantsOG0051
ParticipantsOG00614
Title
Measurements
OG0000.729± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV =45
OG0011.917± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV =141
OG00318.198± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV =81
OG00423.381± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 41
OG005149.000± NAinsufficient numbers of participants with events
OG00657.068± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 56
Participants
OG004
2
ParticipantsOG0051
ParticipantsOG0066
Title
Measurements
OG00159.600± NAinsufficient numbers of participants with events
OG0035.760± NAinsufficient numbers of participants with events
OG00420.264± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 70
OG005143.000± NAinsufficient numbers of participants with events
OG00658.408± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 40
Participants
OG004
1
ParticipantsOG0051
ParticipantsOG0064
Title
Measurements
OG00162.000± NAinsufficient numbers of participants with events
OG0035.860± NAinsufficient numbers of participants with events
OG00422.800± NAinsufficient numbers of participants with events
OG005117.000± NAinsufficient numbers of participants with events
OG00656.054± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 62
Participants
OG004
1
ParticipantsOG0051
ParticipantsOG0063
Title
Measurements
OG00148.100± NAinsufficient numbers of participants with events
OG0034.710± NAinsufficient numbers of participants with events
OG00431.200± NAinsufficient numbers of participants with events
OG005165.000± NAinsufficient numbers of participants with events
OG00667.268± NAGeometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 64
Participants
OG004
0
ParticipantsOG0051
ParticipantsOG0061
Title
Measurements
OG00525.900± NAinsufficient numbers of participants with events
OG00624.200± NAinsufficient numbers of participants with events
Participants
OG004
0
ParticipantsOG0051
ParticipantsOG0061
Title
Measurements
OG00543.600± NAinsufficient numbers of participants with events
OG00641.000± NAinsufficient numbers of participants with events
Participants
OG004
0
ParticipantsOG0051
ParticipantsOG0061
Title
Measurements
OG00561.800± NAinsufficient numbers of participants with events
OG00656.000± NAinsufficient numbers of participants with events
Participants
OG004
0
ParticipantsOG0051
ParticipantsOG0061
Title
Measurements
OG00573.800± NAinsufficient numbers of participants with events
OG00658.700± NAinsufficient numbers of participants with events
Participants
OG004
0
ParticipantsOG0051
ParticipantsOG0061
Title
Measurements
OG00584.700± NAinsufficient numbers of participants with events
OG00669.400± NAinsufficient numbers of participants with events
Participants
OG004
0
ParticipantsOG0051
ParticipantsOG0061
Title
Measurements
OG00581.500± NAinsufficient numbers of participants with events
OG00671.900± NAinsufficient numbers of participants with events
Participants
OG004
0
ParticipantsOG0051
ParticipantsOG0061
Title
Measurements
OG00594.600± NAinsufficient numbers of participants with events
OG00685.500± NAinsufficient numbers of participants with events
Participants
OG004
0
ParticipantsOG0051
ParticipantsOG0061
Title
Measurements
OG00586.600± NAinsufficient numbers of participants with events
OG00686.100± NAinsufficient numbers of participants with events
Participants
OG004
0
ParticipantsOG0051
ParticipantsOG0061
Title
Measurements
OG005109.000± NAinsufficient numbers of participants with events
OG00670.100± NAinsufficient numbers of participants with events
Participants
OG004
0
ParticipantsOG0051
ParticipantsOG0061
Title
Measurements
OG005107.000± NAinsufficient numbers of participants with events
OG006105.000± NAinsufficient numbers of participants with events
Participants
OG004
0
ParticipantsOG0051
ParticipantsOG0061
Title
Measurements
OG005115.000± NAinsufficient numbers of participants with events
OG006110.000± NAinsufficient numbers of participants with events
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0061
Title
Measurements
OG006115.000± NAinsufficient numbers of participants with events