An Investigational Immunotherapy Study of BMS-986258 Alon... | NCT03446040 | Trialant
NCT03446040
Sponsor
Bristol-Myers Squibb
Status
Terminated
Last Update Posted
Sep 18, 2025Actual
Enrollment
92Actual
Phase
Phase 1Phase 2
Conditions
Advanced Cancer
Interventions
BMS-986258
Nivolumab
rHuPH20
Countries
United States
Australia
Canada
Japan
Protocol Section
Identification Module
NCT ID
NCT03446040
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CA031-002
Secondary IDs
ID
Type
Description
Link
2019-000442-35
EudraCT Number
Brief Title
An Investigational Immunotherapy Study of BMS-986258 Alone and in Combination With Nivolumab in Participants With Solid Cancers That Are Advanced or Have Spread
Official Title
A Phase 1/2 First-in-Human Study of BMS-986258 Alone and in Combination With Nivolumab in Advanced Malignant Tumors
Acronym
Not provided
Organization
Bristol-Myers SquibbINDUSTRY
Status Module
Record Verification Date
Aug 2025
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Business objectives have changed
Expanded Access Info
No
Start Date
Mar 8, 2018Actual
Primary Completion Date
Aug 29, 2024Actual
Completion Date
Aug 29, 2024Actual
First Submitted Date
Feb 21, 2018
First Submission Date that Met QC Criteria
Feb 21, 2018
First Posted Date
Feb 26, 2018Actual
Results Waived
Not provided
Results First Submitted Date
Aug 8, 2025
Results First Submitted that Met QC Criteria
Aug 29, 2025
Results First Posted Date
Sep 18, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Aug 29, 2025
Last Update Posted Date
Sep 18, 2025Actual
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 purpose of this study is to determine whether BMS-986258 both monotherapy and in combination with Nivolumab is safe and tolerable in the treatment of advanced malignant tumors.
Detailed Description
Not provided
Conditions Module
Conditions
Advanced Cancer
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
92Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part A Dose Escalation: BMS-986258
Experimental
Biological: BMS-986258
Part A1: BMS-986258 + Recombinant human hyaluronidase PH20 (rHuPH20)
Experimental
Biological: BMS-986258
Drug: rHuPH20
Part B Dose Escalation: BMS-986258 + nivolumab
Experimental
Biological: BMS-986258
Biological: Nivolumab
Part C Cohort Expansion: BMS-986258 + nivolumab
Experimental
Biological: BMS-986258
Biological: Nivolumab
Interventions
Name
Type
Description
Arm Group Labels
Other Names
BMS-986258
Biological
Specified dose on specified days
Part A Dose Escalation: BMS-986258
Part A1: BMS-986258 + Recombinant human hyaluronidase PH20 (rHuPH20)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Adverse Events (AEs)
An Adverse Event (AE) is any new untoward medical occurrence or worsening of a preexisting medical condition in a study participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.
A Serious Adverse Event (SAE) is any untoward medical occurrence that, at any dose:
Results in death
Is life-threatening (defined as an event in which the participant was at risk of death at the time of the event)
Requires inpatient hospitalization or causes prolongation of existing hospitalization
Results in persistent or significant disability/incapacity
Is a congenital anomaly/birth defect.
From first dose until 100 days after last dose of study therapy (up to approximately 78 weeks)
Number of Participants Who Died During the Study
The number of participants who died during the study.
From first dose until death due to any cause (up to approximately 78 months)
Number of Participants With Dose Limiting Toxicities (DLTs)
Dose-limiting toxicity (DLT) refers to a side effect or adverse reaction caused by a drug that is severe enough to prevent an increase in dose or level of that drug. It is typically identified during clinical trials to determine the highest dose of a drug that can be given safely without causing unacceptable side effects.
A participant was considered DLT evaluable if they received 1 dose of BMS-986258 in Part A or 1 dose of BMS-986258 and nivolumab 480mg in Part B and completed the DLT observation period.
Participants who withdraw from the study during the 4-week DLT evaluation period for reasons other than a DLT may be replaced with a new participant at the same dose level.
From first dose (Cycle 1 Day 1) until day 28 (Cycle 1 Day 28)
Secondary Outcomes
Measure
Description
Time Frame
Objective Response Rate (ORR)
Objective response rate (ORR) is defined as the percent of treated participants whose best overall response (BOR) is either complete response (CR) or partial response (PR) per RECIST v1.1.
Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Histologic confirmation of one of the 5 tumors [renal cell carcinoma (RCC), colorectal cancer (CRC), non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN), triple negative breast cancer (TNBC)] (metastatic, recurrent, and/or unresectable), with measurable disease per response evaluation criteria in solid tumors v1.1 (RECIST v1.1)
Eastern Cooperative Oncology Group Performance Status of 0 or 1
Participants must have received, and then progressed, relapsed, or been intolerant to, at least 1 standard treatment regimen in the advanced or metastatic setting according to solid tumor histologies
Women must agree to follow specific methods of contraception, if applicable
Exclusion Criteria:
Active, known or suspected autoimmune disease
Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study therapy
Other active malignancy requiring concurrent intervention
Other protocol-defined inclusion/exclusion criteria apply
Participants were treated in Part A, Part A1, and Part B. No participants were enrolled or treated in Part C. 4 participants in Part A1 transitioned to Part B.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part A: BMS-986258 8 mg
Participants received 8 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
FG001
Part A: BMS-986258 24 mg
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Started = Treated
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
Jun 16, 2021
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
No data available
No data is available for this block.
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Part B Dose Escalation: BMS-986258 + nivolumab
Part C Cohort Expansion: BMS-986258 + nivolumab
Nivolumab
Biological
Specified dose on specified days
Part B Dose Escalation: BMS-986258 + nivolumab
Part C Cohort Expansion: BMS-986258 + nivolumab
Opdivo
BMS-936558
rHuPH20
Drug
Specified dose on specified days
Part A1: BMS-986258 + Recombinant human hyaluronidase PH20 (rHuPH20)
Enhanze
From first dose until disease progression or death, whichever occurred first (up to approximately 78 months)
Median Duration of Response (mDOR)
Median duration of response (mDOR) for a participant with a best overall response (BOR) of complete response (CR) or partial response (PR) is defined as the time between the date of first response and the date of the first objectively documented disease progression (DP) per RECIST v1.1 or death, whichever occurred first.
Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Disease Progression (DP): At least a 20% increase in the sum of the diameters of target lesions, with an absolute increase of at least 5 mm, or the appearance of new lesions.
Based on Kaplan-Meier estimates.
From first dose until disease progression or death whichever occurred first (up to approximately 78 months)
Progression-Free Survival (PFS) Rate at 6, 9, and 12 Months
Progression free survival (PFS) for a participant is defined as the time from the first dosing date to the date of first objectively documented disease progression or death due to any cause, whichever occurred first.
Disease Progression (DP): At least a 20% increase in the sum of the diameters of target lesions, with an absolute increase of at least 5 mm, or the appearance of new lesions.
At 6, 9, and 12 months after first dose
Maximum Plasma Concentration (Cmax) of BMS-986258
Cmax (Maximum Concentration) is the highest level of a drug in the blood after it has been taken. It shows the peak level of the drug, which helps in understanding how much of the drug is absorbed and how strong its effects might be.
Part A and B: On Cycle 1 Day 1 and Cycle 3 Day 1 (1 cycle = 8 weeks); Part A1: On Cycle 1 Day 1 and Cycle 1 Day 29 (1 cycle = 8 weeks)
Area Under the Curve From Time 0 to T (AUC(0-T)) of BMS-986258
AUC (0-T) is the total exposure to the drug over a specific period; from the time you take it until a specified time.
It helps in understanding the overall amount of drug that has been in your body over that time period.
Part A and B: On Cycle 1 Day 1 and Cycle 3 Day 1 (1 cycle = 8 weeks); Part A1: On Cycle 1 Day 1 and Cycle 1 Day 29 (1 cycle = 8 weeks)
Area Under the Curve Over the Dosing Interval AUC(TAU) of BMS-986258
AUC(TAU) (Area Under the Curve over the Dosing Interval) is the total exposure to the drug over one complete dosing interval (the time between doses). It helps in understanding how much of the drug is in your body over the entire period between doses, which is important for determining the right dosing schedule.
Part A and B: 0 to 28 days post-dose on Cycle 1 Day 1 and Cycle 3 Day 1 (1 cycle = 8 weeks); Part A1: 0 to 28 days post-dose on Cycle 1 Day 1 and Cycle 1 Day 29 (1 cycle = 8 weeks)
Concentration at the End of the Dosing Interval (Ctau) of BMS-986258
Ctau (Concentration at the End of the Dosing Interval) is the level of the drug in the blood just before the next dose is due. It shows how much of the drug remains in your body before taking the next dose, which helps in ensuring that the drug levels stay effective without dropping too low.
Part A and B: On Cycle 1 Day 29 and Cycle 3 Day 29 (1 cycle = 8 weeks); Part A1: On Cycle 1 Day 29 and Cycle 2 Day 1 predose (1 cycle = 8 weeks)
Time to Reach Maximum Concentration (Tmax) of BMS-986258
Tmax (Time to Reach Maximum Concentration) is the time it takes for the drug to reach its highest level in the blood after taking it. It helps in understanding how quickly the drug starts to work and reaches its peak effect.
Part A and B: On Cycle 1 Day 1 and Cycle 3 Day 1 (1 cycle = 8 weeks); Part A1: On Cycle 1 Day 1 and Cycle 1 Day 29 (1 cycle = 8 weeks)
Number of Participants With Anti-Drug Antibodies to BMS-986258 or Nivolumab
Baseline ADA-positive participant is defined as a participant who has an ADA-detected sample at baseline. ADA-positive participant is a participant with at least 1 ADA-positive sample relative to baseline after initiation of the treatment
From first dose until 100 days after last dose of study therapy (up to approximately 78 weeks)
Participants received 24 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
FG002
Part A: BMS-986258 72 mg
Participants received 72 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
FG003
Part A: BMS-986258 200 mg
Participants received 200 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
FG004
Part A: BMS-986258 480 mg
Participants received 480 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
FG005
Part A: BMS-986258 800 mg
Participants received 800 mg BMS-986258 IV every 4 weeks (Q4W) for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
FG006
Part A: BMS-986258 1200 mg
Participants received 1200 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
FG007
Part A: BMS-986258 1600 mg
Participants received 1600 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
FG008
Part A: BMS-986258 2400 mg
Participants received 2400 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
FG009
Part B: BMS-986258 480 mg + NIVO 480 mg
Participants received 480 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
FG010
Part B: BMS-986258 800 mg + NIVO 480 mg
Participants received 800 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
FG011
Part B: BMS-986258 1200 mg + NIVO 480 mg
Participants received 1200 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
FG012
Part B: BMS-986258 1600 mg + NIVO 480 mg
Participants received 1600 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
FG013
Part A1: BMS-986258 1200 mg + ENHANZE
Participants received 1200 mg BMS-986258 with rHuPH20 (ENHANZE) SC for the first dose in Cycle 1. All subsequent doses of BMS-986258 were received as monotherapy IV, every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
FG0003 subjects
FG0013 subjects
FG0024 subjects
FG0034 subjects
FG0044 subjects
FG0059 subjects
FG0063 subjects
FG0075 subjects
FG0088 subjects
FG0094 subjects
FG01011 subjects
FG0114 subjects
FG01215 subjects
FG01315 subjects
Transitioned From Part A1
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0112 subjects
FG0122 subjects
FG0130 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0084 subjects
FG0090 subjects
FG0101 subjects
FG0110 subjects
FG0128 subjects
FG0136 subjects
NOT COMPLETED
FG0003 subjects
FG0013 subjects
FG0024 subjects
FG0034 subjects
FG0044 subjects
FG0059 subjects
FG0063 subjects
FG0075 subjects
FG0084 subjects
FG0094 subjects
FG01010 subjects
FG0114 subjects
FG0127 subjects
FG0139 subjects
Type
Comment
Reasons
Disease progression
FG0003 subjects
FG0013 subjects
FG0023 subjects
FG0034 subjects
FG0044 subjects
FG0056 subjects
FG0063 subjects
FG0074 subjects
FG0082 subjects
FG0094 subjects
FG0109 subjects
FG0113 subjects
FG0127 subjects
FG0137 subjects
Study drug toxicity
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Participant requested to discontinue study treatment
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
Participant withdrew consent
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Not reported
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part A: BMS-986258 8 mg
Participants received 8 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
BG001
Part A: BMS-986258 24 mg
Participants received 24 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
BG002
Part A: BMS-986258 72 mg
Participants received 72 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
BG003
Part A: BMS-986258 200 mg
Participants received 200 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
BG004
Part A: BMS-986258 480 mg
Participants received 480 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
BG005
Part A: BMS-986258 800 mg
Participants received 800 mg BMS-986258 IV every 4 weeks (Q4W) for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
BG006
Part A: BMS-986258 1200 mg
Participants received 1200 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
BG007
Part A: BMS-986258 1600 mg
Participants received 1600 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
BG008
Part A: BMS-986258 2400 mg
Participants received 2400 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
BG009
Part B: BMS-986258 480 mg + NIVO 480 mg
Participants received 480 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
BG010
Part B: BMS-986258 800 mg + NIVO 480 mg
Participants received 800 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
BG011
Part B: BMS-986258 1200 mg + NIVO 480 mg
Participants received 1200 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
BG012
Part B: BMS-986258 1600 mg + NIVO 480 mg
Participants received 1600 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
BG013
Part A1: BMS-986258 1200 mg + ENHANZE
Participants received 1200 mg BMS-986258 with rHuPH20 (ENHANZE) SC for the first dose in Cycle 1. All subsequent doses of BMS-986258 were received as monotherapy IV, every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
BG014
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0003
BG0013
BG0024
BG0034
BG0044
BG0059
BG0063
BG0075
BG0088
BG0094
BG01011
BG0114
BG01215
BG01315
BG01492
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00060.7± 16.17
BG00145.7± 6.03
BG00261.5± 3.11
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0001
BG0010
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0001
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0011
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)
An Adverse Event (AE) is any new untoward medical occurrence or worsening of a preexisting medical condition in a study participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.
A Serious Adverse Event (SAE) is any untoward medical occurrence that, at any dose:
Results in death
Is life-threatening (defined as an event in which the participant was at risk of death at the time of the event)
Requires inpatient hospitalization or causes prolongation of existing hospitalization
Results in persistent or significant disability/incapacity
Is a congenital anomaly/birth defect.
All treated participants. Participants who started in the Part A1 group but transitioned to Part B are accounted for in both treatment groups.
Posted
Count of Participants
Participants
From first dose until 100 days after last dose of study therapy (up to approximately 78 weeks)
ID
Title
Description
OG000
Part A: BMS-986258 8 mg
Participants received 8 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG001
Part A: BMS-986258 24 mg
Participants received 24 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG002
Part A: BMS-986258 72 mg
Participants received 72 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG003
Part A: BMS-986258 200 mg
Participants received 200 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG004
Part A: BMS-986258 480 mg
Participants received 480 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG005
Part A: BMS-986258 800 mg
Participants received 800 mg BMS-986258 IV every 4 weeks (Q4W) for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG006
Part A: BMS-986258 1200 mg
Participants received 1200 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG007
Part A: BMS-986258 1600 mg
Units
Counts
Participants
OG0003
OG0013
OG0024
OG003
Title
Denominators
Categories
Adverse Events (AEs)
Title
Measurements
OG0003
OG0013
OG0024
OG003
Primary
Number of Participants Who Died During the Study
The number of participants who died during the study.
All treated participants. Participants who crossed over from part A1 are accounted for under their original arm assignment.
Posted
Count of Participants
Participants
From first dose until death due to any cause (up to approximately 78 months)
ID
Title
Description
OG000
Part A: BMS-986258 8 mg
Participants received 8 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG001
Part A: BMS-986258 24 mg
Participants received 24 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG002
Part A: BMS-986258 72 mg
Participants received 72 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG003
Part A: BMS-986258 200 mg
Participants received 200 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
Primary
Number of Participants With Dose Limiting Toxicities (DLTs)
Dose-limiting toxicity (DLT) refers to a side effect or adverse reaction caused by a drug that is severe enough to prevent an increase in dose or level of that drug. It is typically identified during clinical trials to determine the highest dose of a drug that can be given safely without causing unacceptable side effects.
A participant was considered DLT evaluable if they received 1 dose of BMS-986258 in Part A or 1 dose of BMS-986258 and nivolumab 480mg in Part B and completed the DLT observation period.
Participants who withdraw from the study during the 4-week DLT evaluation period for reasons other than a DLT may be replaced with a new participant at the same dose level.
All treated participants who were evaluable for DLTs.
Posted
Count of Participants
Participants
From first dose (Cycle 1 Day 1) until day 28 (Cycle 1 Day 28)
ID
Title
Description
OG000
Part A: BMS-986258 8 mg
Participants received 8 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG001
Part A: BMS-986258 24 mg
Participants received 24 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG002
Part A: BMS-986258 72 mg
Secondary
Objective Response Rate (ORR)
Objective response rate (ORR) is defined as the percent of treated participants whose best overall response (BOR) is either complete response (CR) or partial response (PR) per RECIST v1.1.
Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
All treated participants. Prespecified to be reported collectively per Part. Participants who crossed over from part A1 to Part B are accounted for in both arms.
Posted
Number
95% Confidence Interval
Percent of Participants
From first dose until disease progression or death, whichever occurred first (up to approximately 78 months)
ID
Title
Description
OG000
Part A: All Doses
Participants received BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks))
OG001
Part B: All Doses
Participants received BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks))
OG002
Part A1: BMS-986258 1200 mg + ENHANZE
Participants received 1200 mg BMS-986258 with rHuPH20 (ENHANZE) SC for the first dose in Cycle 1. All subsequent doses of BMS-986258 were received as monotherapy IV, every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
Secondary
Median Duration of Response (mDOR)
Median duration of response (mDOR) for a participant with a best overall response (BOR) of complete response (CR) or partial response (PR) is defined as the time between the date of first response and the date of the first objectively documented disease progression (DP) per RECIST v1.1 or death, whichever occurred first.
Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Disease Progression (DP): At least a 20% increase in the sum of the diameters of target lesions, with an absolute increase of at least 5 mm, or the appearance of new lesions.
Based on Kaplan-Meier estimates.
All treated participants witha complete or partial response. Prespecified to be reported collectively per Part. Response evaluable participants who crossed over from part A1 to Part B are accounted for in both arms.
Posted
Median
95% Confidence Interval
Months
From first dose until disease progression or death whichever occurred first (up to approximately 78 months)
ID
Title
Description
OG000
Part A: All Doses
Participants received BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks))
OG001
Part B: All Doses
Participants received BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks))
Secondary
Progression-Free Survival (PFS) Rate at 6, 9, and 12 Months
Progression free survival (PFS) for a participant is defined as the time from the first dosing date to the date of first objectively documented disease progression or death due to any cause, whichever occurred first.
Disease Progression (DP): At least a 20% increase in the sum of the diameters of target lesions, with an absolute increase of at least 5 mm, or the appearance of new lesions.
All treated participants. Prespecified to be reported collectively per Part. Treated participants who crossed over from part A1 to Part B are accounted for in both arms.
Posted
Number
95% Confidence Interval
Percent of Participants
At 6, 9, and 12 months after first dose
ID
Title
Description
OG000
Part A: All Doses
Participants received BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks))
OG001
Part B: All Doses
Participants received BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks))
OG002
Part A1: BMS-986258 1200 mg + ENHANZE
Participants received 1200 mg BMS-986258 with rHuPH20 (ENHANZE) SC for the first dose in Cycle 1. All subsequent doses of BMS-986258 were received as monotherapy IV, every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
Secondary
Maximum Plasma Concentration (Cmax) of BMS-986258
Cmax (Maximum Concentration) is the highest level of a drug in the blood after it has been taken. It shows the peak level of the drug, which helps in understanding how much of the drug is absorbed and how strong its effects might be.
All treated participants with available PK results. PK evaluable participants who crossed over from Part A1 to Part B are accounted for in both arms.
Posted
Geometric Mean
Geometric Coefficient of Variation
ug/mL
Part A and B: On Cycle 1 Day 1 and Cycle 3 Day 1 (1 cycle = 8 weeks); Part A1: On Cycle 1 Day 1 and Cycle 1 Day 29 (1 cycle = 8 weeks)
ID
Title
Description
OG000
Part A: BMS-986258 8 mg
Participants received 8 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG001
Part A: BMS-986258 24 mg
Participants received 24 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG002
Part A: BMS-986258 72 mg
Participants received 72 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
Secondary
Area Under the Curve From Time 0 to T (AUC(0-T)) of BMS-986258
AUC (0-T) is the total exposure to the drug over a specific period; from the time you take it until a specified time.
It helps in understanding the overall amount of drug that has been in your body over that time period.
All treated participants with available PK results. PK evaluable participants who crossed over from Part A1 to Part B are accounted for in both arms.
Posted
Geometric Mean
Geometric Coefficient of Variation
h*ug/mL
Part A and B: On Cycle 1 Day 1 and Cycle 3 Day 1 (1 cycle = 8 weeks); Part A1: On Cycle 1 Day 1 and Cycle 1 Day 29 (1 cycle = 8 weeks)
ID
Title
Description
OG000
Part A: BMS-986258 8 mg
Participants received 8 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG001
Part A: BMS-986258 24 mg
Participants received 24 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG002
Part A: BMS-986258 72 mg
Participants received 72 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
Secondary
Area Under the Curve Over the Dosing Interval AUC(TAU) of BMS-986258
AUC(TAU) (Area Under the Curve over the Dosing Interval) is the total exposure to the drug over one complete dosing interval (the time between doses). It helps in understanding how much of the drug is in your body over the entire period between doses, which is important for determining the right dosing schedule.
All treated participants with available PK results. PK evaluable participants who crossed over from Part A1 to Part B are accounted for in both arms.
Posted
Geometric Mean
Geometric Coefficient of Variation
h*ug/mL
Part A and B: 0 to 28 days post-dose on Cycle 1 Day 1 and Cycle 3 Day 1 (1 cycle = 8 weeks); Part A1: 0 to 28 days post-dose on Cycle 1 Day 1 and Cycle 1 Day 29 (1 cycle = 8 weeks)
ID
Title
Description
OG000
Part A: BMS-986258 8 mg
Participants received 8 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG001
Part A: BMS-986258 24 mg
Participants received 24 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG002
Part A: BMS-986258 72 mg
Participants received 72 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
Secondary
Concentration at the End of the Dosing Interval (Ctau) of BMS-986258
Ctau (Concentration at the End of the Dosing Interval) is the level of the drug in the blood just before the next dose is due. It shows how much of the drug remains in your body before taking the next dose, which helps in ensuring that the drug levels stay effective without dropping too low.
All treated participants with available PK results. PK evaluable participants who crossed over from Part A1 to Part B are accounted for in both arms.
Posted
Geometric Mean
Geometric Coefficient of Variation
ug/mL
Part A and B: On Cycle 1 Day 29 and Cycle 3 Day 29 (1 cycle = 8 weeks); Part A1: On Cycle 1 Day 29 and Cycle 2 Day 1 predose (1 cycle = 8 weeks)
ID
Title
Description
OG000
Part A: BMS-986258 8 mg
Participants received 8 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG001
Part A: BMS-986258 24 mg
Participants received 24 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG002
Part A: BMS-986258 72 mg
Participants received 72 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
Secondary
Time to Reach Maximum Concentration (Tmax) of BMS-986258
Tmax (Time to Reach Maximum Concentration) is the time it takes for the drug to reach its highest level in the blood after taking it. It helps in understanding how quickly the drug starts to work and reaches its peak effect.
All treated participants with available PK results. PK evaluable participants who crossed over from Part A1 to Part B are accounted for in both arms.
Posted
Geometric Mean
Full Range
Hours
Part A and B: On Cycle 1 Day 1 and Cycle 3 Day 1 (1 cycle = 8 weeks); Part A1: On Cycle 1 Day 1 and Cycle 1 Day 29 (1 cycle = 8 weeks)
ID
Title
Description
OG000
Part A: BMS-986258 8 mg
Participants received 8 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG001
Part A: BMS-986258 24 mg
Participants received 24 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG002
Part A: BMS-986258 72 mg
Participants received 72 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
Secondary
Number of Participants With Anti-Drug Antibodies to BMS-986258 or Nivolumab
Baseline ADA-positive participant is defined as a participant who has an ADA-detected sample at baseline. ADA-positive participant is a participant with at least 1 ADA-positive sample relative to baseline after initiation of the treatment
All treated participants with baseline and at least one post-baseline pre-infusion ADA assessment. Prespecified to be reported collectively per Part. PK evaluable participants who crossed over from Part A1 to Part B are accounted for in both arms.
Posted
Count of Participants
Participants
From first dose until 100 days after last dose of study therapy (up to approximately 78 weeks)
ID
Title
Description
OG000
Part A: All Doses
Participants received BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks))
OG001
Part B: All Doses
Participants received BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks))
OG002
Part A1: BMS-986258 1200 mg + ENHANZE
Participants received 1200 mg BMS-986258 with rHuPH20 (ENHANZE) SC for the first dose in Cycle 1. All subsequent doses of BMS-986258 were received as monotherapy IV, every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
Time Frame
All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks).
Description
ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Part A: BMS-986258 8 mg
Participants received 8 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks).
3
3
1
3
2
3
EG001
Part A: BMS-986258 24 mg
Participants received 24 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks).
3
3
2
3
2
3
EG002
Part A: BMS-986258 72 mg
Participants received 72 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks).
3
4
3
4
4
4
EG003
Part A: BMS-986258 200 mg
Participants received 200 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks).
3
4
1
4
4
4
EG004
Part A: BMS-986258 480 mg
Participants received 480 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks).
3
4
0
4
4
4
EG005
Part A: BMS-986258 800 mg
Participants received 800 mg BMS-986258 IV every 4 weeks (Q4W) for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks).
7
9
4
9
8
9
EG006
Part A: BMS-986258 1200 mg
Participants received 1200 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks).
3
3
1
3
2
3
EG007
Part A: BMS-986258 1600 mg
Participants received 1600 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks).
4
5
3
5
5
5
EG008
Part A: BMS-986258 2400 mg
Participants received 2400 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks).
5
8
2
8
8
8
EG009
Part B: BMS-986258 480 mg + NIVO 480 mg
Participants received 480 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks).
3
4
2
4
4
4
EG010
Part B: BMS-986258 800 mg + NIVO 480 mg
Participants received 800 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks).
9
11
6
11
9
11
EG011
Part B: BMS-986258 1200 mg + NIVO 480 mg
Participants received 1200 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks).
0
4
1
4
4
4
EG012
Part B: BMS-986258 1600 mg + NIVO 480 mg
Participants received 1600 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks).
10
15
6
15
15
15
EG013
Part A1: BMS-986258 1200 mg + ENHANZE
Participants received 1200 mg BMS-986258 with rHuPH20 (ENHANZE) SC for the first dose in Cycle 1. All subsequent doses of BMS-986258 were received as monotherapy IV, every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks).
7
11
3
11
9
11
EG014
Part A1 Crossover to Part B: 1200 mg BMS + 480 mg Nivo
Participants received 1200 mg BMS-986258 with rHuPH20 (ENHANZE) SC for the first dose in Cycle 1. All subsequent doses of BMS-986258 were received as monotherapy IV, every 4 weeks (Q4W) twice per cycle. Upon crossover, participants received 1200 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for a total treatment duration of up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
1
2
0
2
2
2
EG015
Part A1 Crossover to Part B: 1600 mg BMS + 480 mg Nivo
Participants received 1200 mg BMS-986258 with rHuPH20 (ENHANZE) SC for the first dose in Cycle 1. All subsequent doses of BMS-986258 were received as monotherapy IV, every 4 weeks (Q4W) twice per cycle. Upon crossover, participants received 1600 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for a total treatment duration of up to 96 weeks (12 treatment cycles (each cycle = 8 weeks).
0
2
0
2
2
2
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Angina pectoris
Cardiac disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG0030 affected4 at risk
EG0040 affected4 at risk
EG0051 affected9 at risk
EG0060 affected3 at risk
EG0070 affected5 at risk
EG0080 affected8 at risk
EG0090 affected4 at risk
EG0100 affected11 at risk
EG0110 affected4 at risk
EG0120 affected15 at risk
EG0130 affected11 at risk
EG0140 affected2 at risk
EG0150 affected2 at risk
Abdominal pain
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Diarrhoea
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected4 at risk
EG003
Asthenia
General disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Death
General disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Face oedema
General disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Fatigue
General disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
General physical health deterioration
General disorders
27.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Multiple organ dysfunction syndrome
General disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Biliary obstruction
Hepatobiliary disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Pneumonia
Infections and infestations
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Sepsis
Infections and infestations
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Skin infection
Infections and infestations
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Vascular device infection
Infections and infestations
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Alanine aminotransferase increased
Investigations
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Aspartate aminotransferase increased
Investigations
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Blood bilirubin increased
Investigations
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Dehydration
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Infected neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0022 affected4 at risk
EG003
Metastases to central nervous system
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Asterixis
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Ataxia
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Cognitive disorder
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Myelopathy
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Myoclonus
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Confusional state
Psychiatric disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Haematuria
Renal and urinary disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
27.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG0031 affected4 at risk
EG0040 affected4 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected5 at risk
EG0082 affected8 at risk
EG0090 affected4 at risk
EG0100 affected11 at risk
EG0111 affected4 at risk
EG0121 affected15 at risk
EG0130 affected11 at risk
EG0140 affected2 at risk
EG0152 affected2 at risk
Neutropenia
Blood and lymphatic system disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Sinus tachycardia
Cardiac disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Hypoacusis
Ear and labyrinth disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Hypothyroidism
Endocrine disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Cataract
Eye disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Eyelid ptosis
Eye disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Vision blurred
Eye disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Abdominal distension
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Abdominal pain
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected3 at risk
EG0022 affected4 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Aphthous ulcer
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Ascites
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Cheilitis
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Constipation
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Diarrhoea
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected3 at risk
EG0021 affected4 at risk
EG003
Dry mouth
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Dyspepsia
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected4 at risk
EG003
Dysphagia
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Eructation
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected4 at risk
EG003
Haematochezia
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Lip dry
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Nausea
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0022 affected4 at risk
EG003
Rectal discharge
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Salivary duct inflammation
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Stomatitis
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Vomiting
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected4 at risk
EG003
Chills
General disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Facial pain
General disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Fatigue
General disorders
27.0
Systematic Assessment
EG0001 affected3 at risk
EG0011 affected3 at risk
EG0023 affected4 at risk
EG003
Injection site reaction
General disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Malaise
General disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Mucosal inflammation
General disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Non-cardiac chest pain
General disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Oedema peripheral
General disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Pain
General disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Peripheral swelling
General disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Pyrexia
General disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Hypersensitivity
Immune system disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected4 at risk
EG003
Bronchitis
Infections and infestations
27.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
COVID-19
Infections and infestations
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Candida infection
Infections and infestations
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Cystitis
Infections and infestations
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Folliculitis
Infections and infestations
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Fungal infection
Infections and infestations
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Oral herpes
Infections and infestations
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Pneumonia
Infections and infestations
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Tooth abscess
Infections and infestations
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Upper respiratory tract infection
Infections and infestations
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Urinary tract infection
Infections and infestations
27.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0022 affected4 at risk
EG003
Contusion
Injury, poisoning and procedural complications
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Drain site complication
Injury, poisoning and procedural complications
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Alanine aminotransferase increased
Investigations
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Amylase increased
Investigations
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Aspartate aminotransferase increased
Investigations
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Blood alkaline phosphatase increased
Investigations
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Blood bilirubin increased
Investigations
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Blood creatine phosphokinase increased
Investigations
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Blood creatinine increased
Investigations
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Blood iron decreased
Investigations
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Blood pressure increased
Investigations
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Blood thyroid stimulating hormone increased
Investigations
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Blood urea increased
Investigations
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
C-reactive protein increased
Investigations
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Lipase increased
Investigations
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Lymphocyte count decreased
Investigations
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Platelet count decreased
Investigations
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Troponin increased
Investigations
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Weight decreased
Investigations
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
White blood cell count decreased
Investigations
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0022 affected4 at risk
EG003
Dehydration
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0021 affected4 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Limb mass
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Tumour haemorrhage
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Dizziness
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Dysgeusia
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Headache
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Hypoaesthesia
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Lethargy
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Neuropathy peripheral
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Paraesthesia
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Seizure
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Tremor
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Anxiety
Psychiatric disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Confusional state
Psychiatric disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Depression
Psychiatric disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Insomnia
Psychiatric disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Acute kidney injury
Renal and urinary disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Calculus bladder
Renal and urinary disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Chromaturia
Renal and urinary disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Urinary hesitation
Renal and urinary disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected4 at risk
EG003
Testicular pain
Reproductive system and breast disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected4 at risk
EG003
Vaginal discharge
Reproductive system and breast disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected4 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected4 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Decubitus ulcer
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Macule
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Onychomadesis
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Palmar-plantar erythrodysaesthesia syndrome
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Purpura
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Hot flush
Vascular disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Hypertension
Vascular disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Systolic hypertension
Vascular disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Thrombosis
Vascular disorders
27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected4 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Participants received 1600 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG008
Part A: BMS-986258 2400 mg
Participants received 2400 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG009
Part B: BMS-986258 480 mg + NIVO 480 mg
Participants received 480 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG010
Part B: BMS-986258 800 mg + NIVO 480 mg
Participants received 800 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG011
Part B: BMS-986258 1200 mg + NIVO 480 mg
Participants received 1200 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG012
Part B: BMS-986258 1600 mg + NIVO 480 mg
Participants received 1600 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG013
Part A1: BMS-986258 1200 mg + ENHANZE
Participant received 1200 mg BMS-986258 with rHuPH20 (ENHANZE) SC for the first dose in Cycle 1. All subsequent doses of BMS-986258 were received as monotherapy IV, every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
4
OG0044
OG0059
OG0063
OG0075
OG0088
OG0094
OG01011
OG0116
OG01217
OG01315
4
OG0044
OG0058
OG0062
OG0075
OG0088
OG0094
OG01011
OG0116
OG01217
OG01313
Serious Adverse Events (SAEs)
Title
Measurements
OG0001
OG0012
OG0023
OG0031
OG0040
OG0054
OG0061
OG0073
OG0082
OG0092
OG0106
OG0111
OG0126
OG0133
Adverse Events (AEs) leading to discontinuation of study treatment
Title
Measurements
OG0000
OG0010
OG0021
OG0031
OG0040
OG0052
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0123
OG0130
OG004
Part A: BMS-986258 480 mg
Participants received 480 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG005
Part A: BMS-986258 800 mg
Participants received 800 mg BMS-986258 IV every 4 weeks (Q4W) for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG006
Part A: BMS-986258 1200 mg
Participants received 1200 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG007
Part A: BMS-986258 1600 mg
Participants received 1600 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG008
Part A: BMS-986258 2400 mg
Participants received 2400 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG009
Part B: BMS-986258 480 mg + NIVO 480 mg
Participants received 480 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG010
Part B: BMS-986258 800 mg + NIVO 480 mg
Participants received 800 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG011
Part B: BMS-986258 1200 mg + NIVO 480 mg
Participants received 1200 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG012
Part B: BMS-986258 1600 mg + NIVO 480 mg
Participants received 1600 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG013
Part A1: BMS-986258 1200 mg + ENHANZE
Participant received 1200 mg BMS-986258 with rHuPH20 (ENHANZE) SC for the first dose in Cycle 1. All subsequent doses of BMS-986258 were received as monotherapy IV, every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
Units
Counts
Participants
OG0003
OG0013
OG0024
OG0034
OG0044
OG0059
OG0063
OG0075
OG0088
OG0094
OG01011
OG0114
OG01215
OG01315
Title
Denominators
Categories
Title
Measurements
OG0003
OG0013
OG0023
OG0033
OG0043
OG0057
OG0063
OG0074
OG0085
OG0093
OG0109
OG0110
OG01210
OG0138
Participants received 72 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG003
Part A: BMS-986258 200 mg
Participants received 200 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG004
Part A: BMS-986258 480 mg
Participants received 480 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG005
Part A: BMS-986258 800 mg
Participants received 800 mg BMS-986258 IV every 4 weeks (Q4W) for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG006
Part A: BMS-986258 1200 mg
Participants received 1200 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG007
Part A: BMS-986258 1600 mg
Participants received 1600 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG008
Part A: BMS-986258 2400 mg
Participants received 2400 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG009
Part B: BMS-986258 480 mg + NIVO 480 mg
Participants received 480 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG010
Part B: BMS-986258 800 mg + NIVO 480 mg
Participants received 800 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG011
Part B: BMS-986258 1200 mg + NIVO 480 mg
Participants received 1200 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG012
Part B: BMS-986258 1600 mg + NIVO 480 mg
Participants received 1600 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG013
Part A1: BMS-986258 1200 mg + ENHANZE
Participants received 1200 mg BMS-986258 with rHuPH20 (ENHANZE) SC for the first dose in Cycle 1. All subsequent doses of BMS-986258 were received as monotherapy IV, every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
Units
Counts
Participants
OG0003
OG0013
OG0024
OG0034
OG0043
OG0054
OG0063
OG0073
OG0085
OG0093
OG0105
OG0112
OG0125
OG0131
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
OG0130
Units
Counts
Participants
OG00043
OG00137
OG00215
Title
Denominators
Categories
Title
Measurements
OG0000(0.00 to 8.22)
OG0015.4(0.66 to 18.19)
OG0020(0.00 to 21.80)
OG002
Part A1: BMS-986258 1200 mg + ENHANZE
Participants received 1200 mg BMS-986258 with rHuPH20 (ENHANZE) SC for the first dose in Cycle 1. All subsequent doses of BMS-986258 were received as monotherapy IV, every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
Units
Counts
Participants
OG0000
OG0012
OG0020
Title
Denominators
Categories
Title
Measurements
OG001NA(NA to NA)Insufficient number of events to calculate median, LL, and UL by K-M methodology.
Units
Counts
Participants
OG00043
OG00137
OG00215
Title
Denominators
Categories
6-month
Title
Measurements
OG00021.4(9.3 to 36.8)
OG00121.9(8.4 to 39.3)
OG0028.7(0.5 to 32.0)
9-month
Title
Measurements
OG00017.1(6.2 to 32.6)
OG0018.2(0.8 to 27.7)
OG0028.7(0.5 to 32.0)
12-month
Title
Measurements
OG00017.1(6.2 to 32.6)
OG0010.0(NA to NA)95% CI not calculated as PFS-Rate = 0%
OG0020.0(NA to NA)95% CI not calculated as PFS-Rate = 0%
OG003
Part A: BMS-986258 200 mg
Participants received 200 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG004
Part A: BMS-986258 480 mg
Participants received 480 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG005
Part A: BMS-986258 800 mg
Participants received 800 mg BMS-986258 IV every 4 weeks (Q4W) for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG006
Part A: BMS-986258 1200 mg
Participants received 1200 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG007
Part A: BMS-986258 1600 mg
Participants received 1600 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG008
Part A: BMS-986258 2400 mg
Participants received 2400 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG009
Part B: BMS-986258 480 mg + NIVO 480 mg
Participants received 480 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG010
Part B: BMS-986258 800 mg + NIVO 480 mg
Participants received 800 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG011
Part B: BMS-986258 1200 mg + NIVO 480 mg
Participants received 1200 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG012
Part B: BMS-986258 1600 mg + NIVO 480 mg
Participants received 1600 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG013
Part A1: BMS-986258 1200 mg + ENHANZE
Participant received 1200 mg BMS-986258 with rHuPH20 (ENHANZE) SC for the first dose in Cycle 1. All subsequent doses of BMS-986258 were received as monotherapy IV, every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
Units
Counts
Participants
OG0003
OG0013
OG0024
OG0034
OG0044
OG0059
OG0063
OG0075
OG0088
OG0094
OG01010
OG0113
OG01215
OG0139
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0034
ParticipantsOG0044
ParticipantsOG0059
ParticipantsOG0063
ParticipantsOG0075
ParticipantsOG0088
ParticipantsOG0094
ParticipantsOG01010
ParticipantsOG0113
ParticipantsOG01215
ParticipantsOG0139
Title
Measurements
OG0002.27± 53.8
OG0015.34± 36.2
OG00231.5± 10.9
OG003
Cycle 3 Day 1
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0031
Cycle 1 Day 29
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG003
Part A: BMS-986258 200 mg
Participants received 200 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG004
Part A: BMS-986258 480 mg
Participants received 480 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG005
Part A: BMS-986258 800 mg
Participants received 800 mg BMS-986258 IV every 4 weeks (Q4W) for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG006
Part A: BMS-986258 1200 mg
Participants received 1200 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG007
Part A: BMS-986258 1600 mg
Participants received 1600 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG008
Part A: BMS-986258 2400 mg
Participants received 2400 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG009
Part B: BMS-986258 480 mg + NIVO 480 mg
Participants received 480 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG010
Part B: BMS-986258 800 mg + NIVO 480 mg
Participants received 800 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG011
Part B: BMS-986258 1200 mg + NIVO 480 mg
Participants received 1200 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG012
Part B: BMS-986258 1600 mg + NIVO 480 mg
Participants received 1600 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG013
Part A1: BMS-986258 1200 mg + ENHANZE
Participant received 1200 mg BMS-986258 with rHuPH20 (ENHANZE) SC for the first dose in Cycle 1. All subsequent doses of BMS-986258 were received as monotherapy IV, every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
Units
Counts
Participants
OG0003
OG0013
OG0024
OG0034
OG0044
OG0059
OG0063
OG0075
OG0088
OG0094
OG01010
OG0113
OG01215
OG0139
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0034
ParticipantsOG0044
ParticipantsOG0059
ParticipantsOG0063
ParticipantsOG0075
ParticipantsOG0088
ParticipantsOG0094
ParticipantsOG01010
ParticipantsOG0113
ParticipantsOG01215
ParticipantsOG0139
Title
Measurements
OG00053.7± 50.8
OG001457± 56
OG0024690± 43.3
OG003
Cycle 3 Day 1
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0031
Cycle 1 Day 29
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG003
Part A: BMS-986258 200 mg
Participants received 200 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG004
Part A: BMS-986258 480 mg
Participants received 480 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG005
Part A: BMS-986258 800 mg
Participants received 800 mg BMS-986258 IV every 4 weeks (Q4W) for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG006
Part A: BMS-986258 1200 mg
Participants received 1200 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG007
Part A: BMS-986258 1600 mg
Participants received 1600 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG008
Part A: BMS-986258 2400 mg
Participants received 2400 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG009
Part B: BMS-986258 480 mg + NIVO 480 mg
Participants received 480 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG010
Part B: BMS-986258 800 mg + NIVO 480 mg
Participants received 800 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG011
Part B: BMS-986258 1200 mg + NIVO 480 mg
Participants received 1200 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG012
Part B: BMS-986258 1600 mg + NIVO 480 mg
Participants received 1600 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG013
Part A1: BMS-986258 1200 mg + ENHANZE
Participant received 1200 mg BMS-986258 with rHuPH20 (ENHANZE) SC for the first dose in Cycle 1. All subsequent doses of BMS-986258 were received as monotherapy IV, every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
Units
Counts
Participants
OG0000
OG0013
OG0024
OG0034
OG0044
OG0058
OG0063
OG0075
OG0088
OG0094
OG01010
OG0113
OG01215
OG0137
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0000
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0034
ParticipantsOG0044
ParticipantsOG0058
ParticipantsOG0063
ParticipantsOG0075
ParticipantsOG0088
ParticipantsOG0094
ParticipantsOG01010
ParticipantsOG0113
ParticipantsOG01215
ParticipantsOG0137
Title
Measurements
OG001587± 41.9
OG0024870± 43.7
OG0038400± 105
OG004
Cycle 3 Day 1
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0031
Cycle 1 Day 29
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG003
Part A: BMS-986258 200 mg
Participants received 200 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG004
Part A: BMS-986258 480 mg
Participants received 480 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG005
Part A: BMS-986258 800 mg
Participants received 800 mg BMS-986258 IV every 4 weeks (Q4W) for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG006
Part A: BMS-986258 1200 mg
Participants received 1200 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG007
Part A: BMS-986258 1600 mg
Participants received 1600 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG008
Part A: BMS-986258 2400 mg
Participants received 2400 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG009
Part B: BMS-986258 480 mg + NIVO 480 mg
Participants received 480 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG010
Part B: BMS-986258 800 mg + NIVO 480 mg
Participants received 800 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG011
Part B: BMS-986258 1200 mg + NIVO 480 mg
Participants received 1200 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG012
Part B: BMS-986258 1600 mg + NIVO 480 mg
Participants received 1600 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG013
Part A1: BMS-986258 1200 mg + ENHANZE
Participant received 1200 mg BMS-986258 with rHuPH20 (ENHANZE) SC for the first dose in Cycle 1. All subsequent doses of BMS-986258 were received as monotherapy IV, every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
Units
Counts
Participants
OG0000
OG0013
OG0024
OG0034
OG0044
OG0058
OG0063
OG0075
OG0088
OG0094
OG01010
OG0113
OG01215
OG0137
Title
Denominators
Categories
Cycle 1 Day 29 predose
ParticipantsOG0000
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0034
ParticipantsOG0044
ParticipantsOG0058
ParticipantsOG0063
ParticipantsOG0075
ParticipantsOG0088
ParticipantsOG0094
ParticipantsOG01010
ParticipantsOG0113
ParticipantsOG01215
ParticipantsOG0137
Title
Measurements
OG0010.0245± 52.3
OG0021.58± 116
OG0032.59± 369
OG004
Cycle 3 Day 29 predose
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0031
Cycle 2 Day 1 predose
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG003
Part A: BMS-986258 200 mg
Participants received 200 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG004
Part A: BMS-986258 480 mg
Participants received 480 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG005
Part A: BMS-986258 800 mg
Participants received 800 mg BMS-986258 IV every 4 weeks (Q4W) for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG006
Part A: BMS-986258 1200 mg
Participants received 1200 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG007
Part A: BMS-986258 1600 mg
Participants received 1600 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG008
Part A: BMS-986258 2400 mg
Participants received 2400 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG009
Part B: BMS-986258 480 mg + NIVO 480 mg
Participants received 480 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG010
Part B: BMS-986258 800 mg + NIVO 480 mg
Participants received 800 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG011
Part B: BMS-986258 1200 mg + NIVO 480 mg
Participants received 1200 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG012
Part B: BMS-986258 1600 mg + NIVO 480 mg
Participants received 1600 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
OG013
Part A1: BMS-986258 1200 mg + ENHANZE
Participant received 1200 mg BMS-986258 with rHuPH20 (ENHANZE) SC for the first dose in Cycle 1. All subsequent doses of BMS-986258 were received as monotherapy IV, every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
Units
Counts
Participants
OG0003
OG0013
OG0024
OG0034
OG0044
OG0059
OG0063
OG0075
OG0088
OG0094
OG01010
OG0113
OG01215
OG0139
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0034
ParticipantsOG0044
ParticipantsOG0059
ParticipantsOG0063
ParticipantsOG0075
ParticipantsOG0088
ParticipantsOG0094
ParticipantsOG01010
ParticipantsOG0113
ParticipantsOG01215
ParticipantsOG0139
Title
Measurements
OG0000.808(0.033 to 4)
OG0011.23(0.117 to 4)
OG0021.4(0.45 to 4)
OG003
Cycle 3 Day 1
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0031
Cycle 1 Day 29
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Units
Counts
Participants
OG00035
OG00128
OG00214
Title
Denominators
Categories
Baseline ADA positive: BMS-986258
ParticipantsOG00035
ParticipantsOG00127
ParticipantsOG00214
Title
Measurements
OG0000
OG0010
OG0020
ADA positive: BMS-986258
ParticipantsOG00035
ParticipantsOG00127
ParticipantsOG00214
Title
Measurements
OG000
Baseline ADA positive: nivolumab
ParticipantsOG0000
ParticipantsOG00128
ParticipantsOG0021
Title
Measurements
OG001
ADA positive: nivolumab
ParticipantsOG0000
ParticipantsOG00128
ParticipantsOG0021
Title
Measurements
OG001
0 affected
4 at risk
EG0040 affected4 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0071 affected5 at risk
EG0080 affected8 at risk
EG0090 affected4 at risk
EG0100 affected11 at risk
EG0110 affected4 at risk
EG0120 affected15 at risk
EG0130 affected11 at risk
EG0140 affected2 at risk
EG0150 affected2 at risk
0 affected
4 at risk
EG0040 affected4 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected5 at risk
EG0080 affected8 at risk
EG0090 affected4 at risk
EG0101 affected11 at risk
EG0110 affected4 at risk
EG0120 affected15 at risk
EG0130 affected11 at risk
EG0140 affected2 at risk
EG0150 affected2 at risk
0 affected
4 at risk
EG0040 affected4 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected5 at risk
EG0080 affected8 at risk
EG0090 affected4 at risk
EG0100 affected11 at risk
EG0110 affected4 at risk
EG0120 affected15 at risk
EG0130 affected11 at risk
EG0140 affected2 at risk
EG0150 affected2 at risk
0 affected
4 at risk
EG0040 affected4 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected5 at risk
EG0080 affected8 at risk
EG0090 affected4 at risk
EG0101 affected11 at risk
EG0110 affected4 at risk
EG0120 affected15 at risk
EG0130 affected11 at risk
EG0140 affected2 at risk
EG0150 affected2 at risk
0 affected
4 at risk
EG0040 affected4 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected5 at risk
EG0080 affected8 at risk
EG0090 affected4 at risk
EG0100 affected11 at risk
EG0110 affected4 at risk
EG0121 affected15 at risk
EG0130 affected11 at risk
EG0140 affected2 at risk
EG0150 affected2 at risk
0 affected
4 at risk
EG0040 affected4 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0071 affected5 at risk
EG0080 affected8 at risk
EG0090 affected4 at risk
EG0100 affected11 at risk
EG0110 affected4 at risk
EG0120 affected15 at risk
EG0130 affected11 at risk
EG0140 affected2 at risk
EG0150 affected2 at risk
0 affected
4 at risk
EG0040 affected4 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected5 at risk
EG0080 affected8 at risk
EG0090 affected4 at risk
EG0101 affected11 at risk
EG0110 affected4 at risk
EG0120 affected15 at risk
EG0130 affected11 at risk
EG0140 affected2 at risk
EG0150 affected2 at risk
0 affected
4 at risk
EG0040 affected4 at risk
EG0051 affected9 at risk
EG0061 affected3 at risk
EG0070 affected5 at risk
EG0080 affected8 at risk
EG0090 affected4 at risk
EG0100 affected11 at risk
EG0110 affected4 at risk
EG0120 affected15 at risk
EG0130 affected11 at risk
EG0140 affected2 at risk
EG0150 affected2 at risk
0 affected
4 at risk
EG0040 affected4 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected5 at risk
EG0080 affected8 at risk
EG0090 affected4 at risk
EG0100 affected11 at risk
EG0110 affected4 at risk
EG0120 affected15 at risk
EG0131 affected11 at risk
EG0140 affected2 at risk
EG0150 affected2 at risk
0 affected
4 at risk
EG0040 affected4 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected5 at risk
EG0080 affected8 at risk
EG0090 affected4 at risk
EG0100 affected11 at risk
EG0110 affected4 at risk
EG0121 affected15 at risk
EG0130 affected11 at risk
EG0140 affected2 at risk
EG0150 affected2 at risk
0 affected
4 at risk
EG0040 affected4 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected5 at risk
EG0081 affected8 at risk
EG0090 affected4 at risk
EG0101 affected11 at risk
EG0110 affected4 at risk
EG0120 affected15 at risk
EG0130 affected11 at risk
EG0140 affected2 at risk
EG0150 affected2 at risk
0 affected
4 at risk
EG0040 affected4 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected5 at risk
EG0080 affected8 at risk
EG0090 affected4 at risk
EG0100 affected11 at risk
EG0111 affected4 at risk
EG0121 affected15 at risk
EG0130 affected11 at risk
EG0140 affected2 at risk
EG0150 affected2 at risk
0 affected
4 at risk
EG0040 affected4 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0071 affected5 at risk
EG0080 affected8 at risk
EG0090 affected4 at risk
EG0100 affected11 at risk
EG0110 affected4 at risk
EG0120 affected15 at risk
EG0130 affected11 at risk
EG0140 affected2 at risk
EG0150 affected2 at risk
0 affected
4 at risk
EG0040 affected4 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected5 at risk
EG0080 affected8 at risk
EG0090 affected4 at risk
EG0100 affected11 at risk
EG0110 affected4 at risk
EG0121 affected15 at risk
EG0130 affected11 at risk
EG0140 affected2 at risk
EG0150 affected2 at risk
0 affected
4 at risk
EG0040 affected4 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected5 at risk
EG0080 affected8 at risk
EG0090 affected4 at risk
EG0100 affected11 at risk
EG0110 affected4 at risk
EG0121 affected15 at risk
EG0130 affected11 at risk
EG0140 affected2 at risk
EG0150 affected2 at risk
0 affected
4 at risk
EG0040 affected4 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected5 at risk
EG0080 affected8 at risk
EG0090 affected4 at risk
EG0100 affected11 at risk
EG0110 affected4 at risk
EG0121 affected15 at risk
EG0130 affected11 at risk
EG0140 affected2 at risk
EG0150 affected2 at risk
0 affected
4 at risk
EG0040 affected4 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected5 at risk
EG0080 affected8 at risk
EG0090 affected4 at risk
EG0100 affected11 at risk
EG0110 affected4 at risk
EG0121 affected15 at risk
EG0130 affected11 at risk
EG0140 affected2 at risk
EG0150 affected2 at risk
0 affected
4 at risk
EG0040 affected4 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected5 at risk
EG0080 affected8 at risk
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EG0110 affected4 at risk
EG0120 affected15 at risk
EG0132 affected11 at risk
EG0141 affected2 at risk
EG0150 affected2 at risk
0 affected
4 at risk
EG0040 affected4 at risk
EG0051 affected9 at risk
EG0060 affected3 at risk
EG0070 affected5 at risk
EG0080 affected8 at risk
EG0090 affected4 at risk
EG0100 affected11 at risk
EG0110 affected4 at risk
EG0120 affected15 at risk
EG0130 affected11 at risk
EG0140 affected2 at risk
EG0150 affected2 at risk
0 affected
4 at risk
EG0040 affected4 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected5 at risk
EG0080 affected8 at risk
EG0090 affected4 at risk
EG0100 affected11 at risk
EG0110 affected4 at risk
EG0121 affected15 at risk
EG0130 affected11 at risk
EG0140 affected2 at risk
EG0150 affected2 at risk
0 affected
4 at risk
EG0040 affected4 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected5 at risk
EG0080 affected8 at risk
EG0090 affected4 at risk
EG0101 affected11 at risk
EG0110 affected4 at risk
EG0120 affected15 at risk
EG0130 affected11 at risk
EG0140 affected2 at risk
EG0150 affected2 at risk
0 affected
4 at risk
EG0040 affected4 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected5 at risk
EG0080 affected8 at risk
EG0090 affected4 at risk
EG0100 affected11 at risk
EG0110 affected4 at risk
EG0120 affected15 at risk
EG0130 affected11 at risk
EG0141 affected2 at risk
EG0150 affected2 at risk
0 affected
4 at risk
EG0040 affected4 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected5 at risk
EG0081 affected8 at risk
EG0090 affected4 at risk
EG0101 affected11 at risk
EG0110 affected4 at risk
EG0122 affected15 at risk
EG0130 affected11 at risk
EG0140 affected2 at risk
EG0150 affected2 at risk
0 affected
4 at risk
EG0040 affected4 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected5 at risk
EG0080 affected8 at risk
EG0090 affected4 at risk
EG0101 affected11 at risk
EG0110 affected4 at risk
EG0120 affected15 at risk
EG0130 affected11 at risk
EG0140 affected2 at risk
EG0150 affected2 at risk
0 affected
4 at risk
EG0041 affected4 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0072 affected5 at risk
EG0082 affected8 at risk
EG0091 affected4 at risk
EG0100 affected11 at risk
EG0112 affected4 at risk
EG0124 affected15 at risk
EG0130 affected11 at risk
EG0141 affected2 at risk
EG0151 affected2 at risk
0 affected
4 at risk
EG0040 affected4 at risk
EG0050 affected9 at risk
EG0061 affected3 at risk
EG0070 affected5 at risk
EG0080 affected8 at risk
EG0090 affected4 at risk
EG0100 affected11 at risk
EG0110 affected4 at risk
EG0121 affected15 at risk
EG0130 affected11 at risk
EG0140 affected2 at risk
EG0150 affected2 at risk
0 affected
4 at risk
EG0040 affected4 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected5 at risk
EG0080 affected8 at risk
EG0090 affected4 at risk
EG0100 affected11 at risk
EG0110 affected4 at risk
EG0121 affected15 at risk
EG0130 affected11 at risk
EG0140 affected2 at risk
EG0150 affected2 at risk
0 affected
4 at risk
EG0040 affected4 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected5 at risk
EG0080 affected8 at risk
EG0090 affected4 at risk
EG0100 affected11 at risk
EG0110 affected4 at risk
EG0121 affected15 at risk
EG0130 affected11 at risk
EG0140 affected2 at risk
EG0150 affected2 at risk
0 affected
4 at risk
EG0040 affected4 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0071 affected5 at risk
EG0080 affected8 at risk
EG0090 affected4 at risk
EG0100 affected11 at risk
EG0110 affected4 at risk
EG0120 affected15 at risk
EG0130 affected11 at risk
EG0140 affected2 at risk
EG0150 affected2 at risk
0 affected
4 at risk
EG0040 affected4 at risk
EG0050 affected9 at risk
EG0060 affected3 at risk
EG0070 affected5 at risk
EG0081 affected8 at risk
EG0090 affected4 at risk
EG0100 affected11 at risk
EG0110 affected4 at risk
EG0120 affected15 at risk
EG0130 affected11 at risk
EG0140 affected2 at risk
EG0150 affected2 at risk
0 affected
4 at risk
EG0040 affected4 at risk
EG0051 affected9 at risk
EG0060 affected3 at risk
EG0070 affected5 at risk
EG0080 affected8 at risk
EG0090 affected4 at risk
EG0100 affected11 at risk
EG0110 affected4 at risk
EG0120 affected15 at risk
EG0130 affected11 at risk
EG0140 affected2 at risk
EG0150 affected2 at risk
0 affected
4 at risk
EG0040 affected4 at risk
EG0051 affected9 at risk
EG0060 affected3 at risk
EG0070 affected5 at risk
EG0080 affected8 at risk
EG0090 affected4 at risk
EG0100 affected11 at risk
EG0110 affected4 at risk
EG0120 affected15 at risk
EG0130 affected11 at risk
EG0140 affected2 at risk
EG0150 affected2 at risk
47.2
± 120
OG004121± 30.7
OG005239± 35.6
OG006423± 12.9
OG007412± 26.7
OG008890± 29.2
OG009154± 43.4
OG010244± 24.8
OG011449± 31.5
OG012579± 19.4
OG013121± 44.1
Participants
OG004
0
ParticipantsOG0052
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0081
ParticipantsOG0092
ParticipantsOG0101
ParticipantsOG0112
ParticipantsOG0127
ParticipantsOG0130
Title
Measurements
OG0019.26± NAInsufficient number of participants to calculate geometric CV
OG00350± NAInsufficient number of participants to calculate geometric CV
OG005356± NAInsufficient number of participants to calculate geometric CV
OG008605± NAInsufficient number of participants to calculate geometric CV
OG009111± NAInsufficient number of participants to calculate geometric CV
OG010161± NAInsufficient number of participants to calculate geometric CV
OG011422± NAInsufficient number of participants to calculate geometric CV
OG012684± 18.1
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0134
Title
Measurements
OG013479± 21.2
8180
± 101
OG00426100± 46.7
OG00546000± 83.9
OG00697000± 23.3
OG00775300± 44.5
OG008179000± 24.3
OG00929000± 51.4
OG01044300± 34.9
OG01184100± 83.2
OG012118000± 25.4
OG01348500± 51.1
Participants
OG004
0
ParticipantsOG0052
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0081
ParticipantsOG0092
ParticipantsOG0101
ParticipantsOG0112
ParticipantsOG0127
ParticipantsOG0130
Title
Measurements
OG0011400± NAInsufficient number of participants to calculate geometric CV
OG00313400± NAInsufficient number of participants to calculate geometric CV
OG005102000± NAInsufficient number of participants to calculate geometric CV
OG008135000± NAInsufficient number of participants to calculate geometric CV
OG00929800± NAInsufficient number of participants to calculate geometric CV
OG01038200± NAInsufficient number of participants to calculate geometric CV
OG01189000± NAInsufficient number of participants to calculate geometric CV
OG012171000± 27
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0134
Title
Measurements
OG013138000± 21
26900
± 47.4
OG00556400± 45
OG006100000± 18
OG00785800± 21.9
OG008187000± 29.5
OG00929000± 51.4
OG01047300± 29.4
OG01189600± 67.9
OG012120000± 22.5
OG01346200± 53.9
Participants
OG004
0
ParticipantsOG0052
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0081
ParticipantsOG0091
ParticipantsOG0101
ParticipantsOG0112
ParticipantsOG0127
ParticipantsOG0130
Title
Measurements
OG0011440± NAInsufficient number of participants to calculate geometric CV
OG00313400± NAInsufficient number of participants to calculate geometric CV
OG005102000± NAInsufficient number of participants to calculate geometric CV
OG008135000± NAInsufficient number of participants to calculate geometric CV
OG00918600± NAInsufficient number of participants to calculate geometric CV
OG01038200± NAInsufficient number of participants to calculate geometric CV
OG01189000± NAInsufficient number of participants to calculate geometric CV
OG012172000± 26.1
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0134
Title
Measurements
OG013134000± 17.3
15.5
± 68.6
OG00537.2± 62.9
OG00655.7± 55.2
OG00736.9± 68.5
OG008109± 44.6
OG00915.6± 82.3
OG01023.5± 70.3
OG01139.8± 229
OG01268.4± 47.1
OG01337.7± 80.2
ParticipantsOG0040
ParticipantsOG0052
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0081
ParticipantsOG0091
ParticipantsOG0101
ParticipantsOG0112
ParticipantsOG0127
ParticipantsOG0130
Title
Measurements
OG0010.0711± NAInsufficient number of participants to calculate geometric CV
OG0038.32± NAInsufficient number of participants to calculate geometric CV
OG00580.3± NAInsufficient number of participants to calculate geometric CV
OG00871.3± NAInsufficient number of participants to calculate geometric CV
OG0097.77± NAInsufficient number of participants to calculate geometric CV
OG01025± NAInsufficient number of participants to calculate geometric CV
OG01137.1± NAInsufficient number of participants to calculate geometric CV