Study of BMS-986315 Alone and in Combination With Nivolum... | NCT04349267 | Trialant
NCT04349267
Sponsor
Bristol-Myers Squibb
Status
Completed
Last Update Posted
Dec 17, 2025Actual
Enrollment
44Actual
Phase
Phase 1Phase 2
Conditions
Advanced Solid Tumor
Interventions
BMS-986315
nivolumab
cetuximab
Countries
United States
Canada
Mexico
Protocol Section
Identification Module
NCT ID
NCT04349267
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CA047-004
Secondary IDs
Not provided
Brief Title
Study of BMS-986315 Alone and in Combination With Nivolumab or Cetuximab in Participants With Advanced Solid Tumors
Official Title
A Phase 1/2 Study of BMS-986315 as Monotherapy and in Combination With Nivolumab or Cetuximab in Participants With Advanced Solid Tumors
Acronym
Not provided
Organization
Bristol-Myers SquibbINDUSTRY
Status Module
Record Verification Date
Dec 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jul 14, 2020Actual
Primary Completion Date
Aug 22, 2024Actual
Completion Date
Aug 22, 2024Actual
First Submitted Date
Apr 15, 2020
First Submission Date that Met QC Criteria
Apr 15, 2020
First Posted Date
Apr 16, 2020Actual
Results Waived
Not provided
Results First Submitted Date
Aug 18, 2025
Results First Submitted that Met QC Criteria
Dec 2, 2025
Results First Posted Date
Dec 17, 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
Dec 2, 2025
Last Update Posted Date
Dec 17, 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 evaluate BMS-986315 alone and in combination with nivolumab or cetuximab in participants with advanced solid tumors.
Detailed Description
Not provided
Conditions Module
Conditions
Advanced Solid Tumor
Keywords
NSCLC (Non-small cell lung cancer)
RCC (Renal cell carcinoma)
SCCHN (Squamous cell carcinoma of the head and neck)
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
44Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
BMS-986315
Experimental
Biological: BMS-986315
BMS-986315 + nivolumab
Experimental
Biological: BMS-986315
Biological: nivolumab
BMS-986315 + cetuximab
Experimental
Biological: BMS-986315
Biological: cetuximab
Interventions
Name
Type
Description
Arm Group Labels
Other Names
BMS-986315
Biological
Specified dose on specified days
BMS-986315
BMS-986315 + cetuximab
BMS-986315 + nivolumab
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Adverse Events and Deaths
An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after signing of informed consent, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory test result), symptom, or disease temporally associated with the study intervention. Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, and requires inpatient hospitalization or causes prolongation of existing hospitalization.
From first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months)
Number of Participants With Dose Limiting Toxicities (DLTs)
A Dose Limiting Toxicity (DLT) is a treatment-related adverse event that is severe enough to prevent an increase in dose or continuation of therapy. DLTs include specific hepatic, hematologic, dermatologic, and other toxicities, such as Grade 4 liver enzyme elevations, Grade 4 cytopenias, persistent Grade 3 rashes, or serious organ toxicities unresponsive to treatment. Certain Grade 3 events (e.g., transient nausea, electrolyte imbalances) are excluded if they resolve quickly or with standard care.
From first dose (Day 1) untill Day 28
Secondary Outcomes
Measure
Description
Time Frame
Objective Response Rate (ORR)
ORR is defined as the percentage of participants whose best overall response (BOR) is either CR or PR per response evaluation criteria in solid tumors (RECIST) v1.1 based on Clopper-Pearson method.
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm.
Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Participants must have histologic confirmation of advanced (metastatic, recurrent, and/or unresectable) squamous cell carcinoma of the head and neck (SCCHN), nonsmall cell lung cancer (NSCLC), or renal cell cancer (RCC) with measurable disease per RECIST 1.1
Participants expected to have received standard of care therapies including an available PD-(L)1 inhibitor
Eastern cooperative oncology group performance status of 0 or 1
Women of childbearing potential must agree to follow methods of contraception
Exclusion Criteria:
Participants with active, known or suspected autoimmune disease
Participants with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications
Uncontrolled or significant cardiovascular disease
History of or with active interstitial lung disease or pulmonary fibrosis
Prior participation in anti-natural killer cell receptor (anti-NKG2A) clinical study
History of allergy or hypersensitivity to study drug components
Other protocol-defined inclusion/exclusion criteria apply
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 80 mg once in 4 weeks (Q4W) intravenously.
FG001
Part 1A BMS-986315-200 mg
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot_SAP
Yes
Yes
No
Study Protocol and Statistical Analysis Plan
Nov 11, 2020
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Argentina
Chile
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
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
nivolumab
Biological
Specified dose on specified days
BMS-986315 + nivolumab
cetuximab
Biological
Specified dose on specified days
BMS-986315 + cetuximab
From the date of randomization to the date of first objectively documented progression or death, whichever occurs first (up to approximately 25 months)
Duration of Response (DoR)
DOR for a participant with a best overall response (BOR) of CR or PR is defined as the time between the date of first response and the date of the first objectively documented tumor progression by investigator per response evaluation criteria in solid tumors (RECIST) v1.1 or death, whichever occurs first. Median computed using Kaplan-Meier method.
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm.
Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
From the date of randomization to the date of first objectively documented progression or death, whichever occurs first (up to approximately 25 months)
Progression Free Survival (PFS) Rate
Progression Free Survival Rates at 6 months is defined as the percentage of participants who achieve PFS at 6 months. PFS for a participant is defined as the time from randomization date to the date of first objectively documented disease progression by investigator per response evaluation criteria in solid tumors (RECIST) v1.1 or death due to any cause, whichever occurs first. Based on Kaplan-Meier Estimates.
Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
At 6 months
Maximum Plasma Concentration (Cmax) of BMS-986315
Blood samples were collected to assess pharmacokinetic (PK) parameters.
Cycle 1 Day 1
Time to Maximum Plasma Concentration (Tmax) of BMS-986315
Blood samples were collected to assess pharmacokinetic (PK) parameters.
Cycle 1 Day 1
Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC[0-t]) of BMS-986315
Blood samples were collected to assess pharmacokinetic (PK) parameters.
Cycle 1 Day 1
Area Under the Concentration-time Curve in One Dosing Interval (AUC[Tau]) of BMS-986315
Blood samples were collected to assess pharmacokinetic (PK) parameters.
Cycle 1 Day 1
Concentration in a Dosing Interval (Ctau) of BMS-986315
Blood samples were collected to assess pharmacokinetic (PK) parameters.
Cycle 1 Day 1
Number of Participants With Anti-Drug Antibody (ADA)
An ADA positive participant was defined as participant with at least one ADA-positive sample relative to baseline (ADA negative at baseline or ADA titer to be at least 4-fold or greater (>=) than baseline positive titer) at any time after initiation of treatment.
Cycle 1 Day 1
Germantown
Tennessee
38138
United States
Local Institution - 0014
Edmonton
Alberta
T6X 1E8
Canada
Local Institution - 0011
Vancouver
British Columbia
V5Z 4E6
Canada
Local Institution - 0004
Toronto
Ontario
M5G 2M9
Canada
Local Institution - 0005
Montreal
Quebec
H2X 3E4
Canada
Local Institution - 0013
Ottawa
K1H 8L6
Canada
Local Institution
Mexico City
Mexico City
06100
Mexico
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously.
FG002
Part 1A BMS-986315-600 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously.
FG003
Part 1A BMS-986315-1200 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously.
FG004
Part 1B BMS-986315-200 mg + Nivolumab 480 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
FG005
Part 1B BMS-986315-600 mg + Nivolumab 480 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
FG006
Part 1B BMS-986315-1200 mg + Nivolumab 480 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
FG0002 subjects
FG0012 subjects
FG0023 subjects
FG0033 subjects
FG0045 subjects
FG00514 subjects
FG00615 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0041 subjects
FG0055 subjects
FG0063 subjects
NOT COMPLETED
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG0033 subjects
FG0044 subjects
FG0059 subjects
FG00612 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
Other reason
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Disease Progression
FG0002 subjects
FG0010 subjects
FG0022 subjects
FG0033 subjects
FG004
Participant withdrew consent
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part 1A BMS-986315-80 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 80 mg once in 4 weeks (Q4W) intravenously.
BG001
Part 1A BMS-986315-200 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously.
BG002
Part 1A BMS-986315-600 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously.
BG003
Part 1A BMS-986315-1200 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously.
BG004
Part 1B BMS-986315-200 mg + Nivolumab 480 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
BG005
Part 1B BMS-986315-600 mg + Nivolumab 480 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
BG006
Part 1B BMS-986315-1200 mg + Nivolumab 480 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0002
BG0012
BG0023
BG0033
BG0045
BG00514
BG00615
BG00744
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
BG00061.0± 18.38
BG00168.5± 2.12
BG00265.0± 9.00
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0002
BG0011
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Asian
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants With Adverse Events and Deaths
An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after signing of informed consent, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory test result), symptom, or disease temporally associated with the study intervention. Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, and requires inpatient hospitalization or causes prolongation of existing hospitalization.
All treated participants
Posted
Count of Participants
Participants
From first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months)
ID
Title
Description
OG000
Part 1A BMS-986315-80 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 80 mg once in 4 weeks (Q4W) intravenously.
OG001
Part 1A BMS-986315-200 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously.
OG002
Part 1A BMS-986315-600 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously.
OG003
Part 1A BMS-986315-1200 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously.
OG004
Part 1B BMS-986315-200 mg + Nivolumab 480 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
OG005
Part 1B BMS-986315-600 mg + Nivolumab 480 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
OG006
Part 1B BMS-986315-1200 mg + Nivolumab 480 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
Units
Counts
Participants
OG0002
OG0012
OG0023
OG003
Title
Denominators
Categories
Any adverse events
Title
Measurements
OG0002
OG0012
OG0023
OG003
Primary
Number of Participants With Dose Limiting Toxicities (DLTs)
A Dose Limiting Toxicity (DLT) is a treatment-related adverse event that is severe enough to prevent an increase in dose or continuation of therapy. DLTs include specific hepatic, hematologic, dermatologic, and other toxicities, such as Grade 4 liver enzyme elevations, Grade 4 cytopenias, persistent Grade 3 rashes, or serious organ toxicities unresponsive to treatment. Certain Grade 3 events (e.g., transient nausea, electrolyte imbalances) are excluded if they resolve quickly or with standard care.
All treated participants.
Posted
Count of Participants
Participants
From first dose (Day 1) untill Day 28
ID
Title
Description
OG000
Part 1A BMS-986315-80 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 80 mg once in 4 weeks (Q4W) intravenously.
OG001
Part 1A BMS-986315-200 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously.
OG002
Part 1A BMS-986315-600 mg
Secondary
Objective Response Rate (ORR)
ORR is defined as the percentage of participants whose best overall response (BOR) is either CR or PR per response evaluation criteria in solid tumors (RECIST) v1.1 based on Clopper-Pearson method.
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm.
Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
All treated participants.
Posted
Number
95% Confidence Interval
percentage of participants
From the date of randomization to the date of first objectively documented progression or death, whichever occurs first (up to approximately 25 months)
ID
Title
Description
OG000
Part 1A BMS-986315-80 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 80 mg once in 4 weeks (Q4W) intravenously.
OG001
Part 1A BMS-986315-200 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously.
Secondary
Duration of Response (DoR)
DOR for a participant with a best overall response (BOR) of CR or PR is defined as the time between the date of first response and the date of the first objectively documented tumor progression by investigator per response evaluation criteria in solid tumors (RECIST) v1.1 or death, whichever occurs first. Median computed using Kaplan-Meier method.
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm.
Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
All treated participants. Only confirmed responders (CR or PR) were included in the analysis.
Posted
Median
95% Confidence Interval
months
From the date of randomization to the date of first objectively documented progression or death, whichever occurs first (up to approximately 25 months)
ID
Title
Description
OG000
Part 1A BMS-986315-80 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 80 mg once in 4 weeks (Q4W) intravenously.
OG001
Secondary
Progression Free Survival (PFS) Rate
Progression Free Survival Rates at 6 months is defined as the percentage of participants who achieve PFS at 6 months. PFS for a participant is defined as the time from randomization date to the date of first objectively documented disease progression by investigator per response evaluation criteria in solid tumors (RECIST) v1.1 or death due to any cause, whichever occurs first. Based on Kaplan-Meier Estimates.
Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
All treated participants.
Posted
Number
percentage of participants
At 6 months
ID
Title
Description
OG000
Part 1A BMS-986315-80 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 80 mg once in 4 weeks (Q4W) intravenously.
OG001
Part 1A BMS-986315-200 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously.
Secondary
Maximum Plasma Concentration (Cmax) of BMS-986315
Blood samples were collected to assess pharmacokinetic (PK) parameters.
Evaluable PK Population
Posted
Geometric Mean
Geometric Coefficient of Variation
ug/mL
Cycle 1 Day 1
ID
Title
Description
OG000
Part 1A BMS-986315-80 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 80 mg once in 4 weeks (Q4W) intravenously.
OG001
Part 1A BMS-986315-200 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously.
OG002
Part 1A BMS-986315-600 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously.
OG003
Part 1A BMS-986315-1200 mg
Secondary
Time to Maximum Plasma Concentration (Tmax) of BMS-986315
Blood samples were collected to assess pharmacokinetic (PK) parameters.
Evaluable PK Population
Posted
Geometric Mean
Geometric Coefficient of Variation
hours
Cycle 1 Day 1
ID
Title
Description
OG000
Part 1A BMS-986315-80 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 80 mg once in 4 weeks (Q4W) intravenously.
OG001
Part 1A BMS-986315-200 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously.
OG002
Part 1A BMS-986315-600 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously.
OG003
Part 1A BMS-986315-1200 mg
Secondary
Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC[0-t]) of BMS-986315
Blood samples were collected to assess pharmacokinetic (PK) parameters.
Evaluable PK Population
Posted
Geometric Mean
Geometric Coefficient of Variation
h*ug/mL
Cycle 1 Day 1
ID
Title
Description
OG000
Part 1A BMS-986315-80 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 80 mg once in 4 weeks (Q4W) intravenously.
OG001
Part 1A BMS-986315-200 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously.
OG002
Part 1A BMS-986315-600 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously.
OG003
Secondary
Area Under the Concentration-time Curve in One Dosing Interval (AUC[Tau]) of BMS-986315
Blood samples were collected to assess pharmacokinetic (PK) parameters.
Evaluable PK Population
Posted
Geometric Mean
Geometric Coefficient of Variation
h*ug/mL
Cycle 1 Day 1
ID
Title
Description
OG000
Part 1A BMS-986315-80 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 80 mg once in 4 weeks (Q4W) intravenously.
OG001
Part 1A BMS-986315-200 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously.
OG002
Part 1A BMS-986315-600 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously.
OG003
Secondary
Concentration in a Dosing Interval (Ctau) of BMS-986315
Blood samples were collected to assess pharmacokinetic (PK) parameters.
Evaluable PK Population
Posted
Geometric Mean
Geometric Coefficient of Variation
ug/mL
Cycle 1 Day 1
ID
Title
Description
OG000
Part 1A BMS-986315-80 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 80 mg once in 4 weeks (Q4W) intravenously.
OG001
Part 1A BMS-986315-200 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously.
OG002
Part 1A BMS-986315-600 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously.
OG003
Part 1A BMS-986315-1200 mg
Secondary
Number of Participants With Anti-Drug Antibody (ADA)
An ADA positive participant was defined as participant with at least one ADA-positive sample relative to baseline (ADA negative at baseline or ADA titer to be at least 4-fold or greater (>=) than baseline positive titer) at any time after initiation of treatment.
All treated participants with baseline and at least one post-baseline evaluable ADA assessment. Participants in Part 1A did not have at least one post-baseline evaluable assessment, hence no participants are included in analysis of Part1A.
Posted
Count of Participants
Participants
Cycle 1 Day 1
ID
Title
Description
OG000
Part 1A BMS-986315-80 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 80 mg once in 4 weeks (Q4W) intravenously.
OG001
Part 1A BMS-986315-200 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously.
OG002
Part 1A BMS-986315-600 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously.
Time Frame
All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
Description
All-cause mortality, serious and other adverse events were collected for all the treated participants.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Part 1A BMS-986315-80 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 80 mg once in 4 weeks (Q4W) intravenously.
1
2
0
2
2
2
EG001
Part 1A BMS-986315-200 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously.
1
2
2
2
1
2
EG002
Part 1A BMS-986315-600 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously.
3
3
0
3
3
3
EG003
Part 1A BMS-986315-1200 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously.
2
3
0
3
3
3
EG004
Part 1B BMS-986315-200 mg + Nivolumab 480 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
4
5
3
5
4
5
EG005
Part 1B BMS-986315-600 mg + Nivolumab 480 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
7
14
8
14
14
14
EG006
Part 1B BMS-986315-1200 mg + Nivolumab 480 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
14
15
10
15
15
15
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected5 at risk
EG0050 affected14 at risk
EG0061 affected15 at risk
Pericardial effusion
Cardiac disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Sudden death
General disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Arthritis infective
Infections and infestations
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Cellulitis
Infections and infestations
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Ludwig angina
Infections and infestations
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Pneumonia
Infections and infestations
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Sepsis
Infections and infestations
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Joint dislocation
Injury, poisoning and procedural complications
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Post procedural complication
Injury, poisoning and procedural complications
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0011 affected2 at risk
EG0020 affected3 at risk
EG003
Metastases to spinal cord
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Pancreatic neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0011 affected2 at risk
EG0020 affected3 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0011 affected2 at risk
EG0020 affected3 at risk
EG003
Encephalopathy
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
VIth nerve disorder
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Acute kidney injury
Renal and urinary disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Pharyngeal stenosis
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Deep vein thrombosis
Vascular disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected5 at risk
EG0052 affected14 at risk
EG0063 affected15 at risk
Febrile neutropenia
Blood and lymphatic system disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Angina pectoris
Cardiac disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Atrial flutter
Cardiac disorders
27.0
Systematic Assessment
EG0001 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Sinus tachycardia
Cardiac disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Cerumen impaction
Ear and labyrinth disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Ear pain
Ear and labyrinth disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Hypoacusis
Ear and labyrinth disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Tinnitus
Ear and labyrinth disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Hypothyroidism
Endocrine disorders
27.0
Systematic Assessment
EG0001 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Detachment of retinal pigment epithelium
Eye disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Eye disorder
Eye disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Vision blurred
Eye disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Abdominal distension
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected3 at risk
EG003
Abdominal pain
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
27.0
Systematic Assessment
EG0001 affected2 at risk
EG0010 affected2 at risk
EG0021 affected3 at risk
EG003
Ascites
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Constipation
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Diarrhoea
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Dry mouth
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Dyspepsia
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Dysphagia
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Flatulence
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Mouth haemorrhage
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Nausea
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Oral dysaesthesia
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Oral pain
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected3 at risk
EG003
Saliva altered
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Salivary hypersecretion
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Small intestinal haemorrhage
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Tongue oedema
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Umbilical hernia
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Vomiting
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Catheter site pain
General disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Chest discomfort
General disorders
27.0
Systematic Assessment
EG0001 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Chills
General disorders
27.0
Systematic Assessment
EG0001 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Face oedema
General disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Fatigue
General disorders
27.0
Systematic Assessment
EG0001 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Localised oedema
General disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Mucosal inflammation
General disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Oedema
General disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Oedema peripheral
General disorders
27.0
Systematic Assessment
EG0001 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Pain
General disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Peripheral swelling
General disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Pyrexia
General disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Abscess neck
Infections and infestations
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Arthritis infective
Infections and infestations
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Atypical pneumonia
Infections and infestations
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Bronchitis
Infections and infestations
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Candida infection
Infections and infestations
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Cellulitis
Infections and infestations
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Conjunctivitis
Infections and infestations
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Gastroenteritis viral
Infections and infestations
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Herpes simplex reactivation
Infections and infestations
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Herpes zoster
Infections and infestations
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Lip infection
Infections and infestations
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Ludwig angina
Infections and infestations
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Oesophageal candidiasis
Infections and infestations
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Oral candidiasis
Infections and infestations
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Otitis media
Infections and infestations
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Pharyngitis streptococcal
Infections and infestations
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Pneumonia
Infections and infestations
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Pulmonary sepsis
Infections and infestations
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Pyelonephritis
Infections and infestations
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Rash pustular
Infections and infestations
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Sinusitis
Infections and infestations
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Skin infection
Infections and infestations
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Upper respiratory tract infection
Infections and infestations
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Urinary tract infection
Infections and infestations
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Wound infection
Infections and infestations
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Fall
Injury, poisoning and procedural complications
27.0
Systematic Assessment
EG0001 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
27.0
Systematic Assessment
EG0001 affected2 at risk
EG0010 affected2 at risk
EG0021 affected3 at risk
EG003
Amylase increased
Investigations
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Aspartate aminotransferase increased
Investigations
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Blood bilirubin increased
Investigations
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Blood creatinine increased
Investigations
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
C-reactive protein increased
Investigations
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Hepatic enzyme increased
Investigations
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Influenza A virus test positive
Investigations
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Lipase increased
Investigations
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0011 affected2 at risk
EG0020 affected3 at risk
EG003
Platelet count decreased
Investigations
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Troponin increased
Investigations
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Weight decreased
Investigations
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0001 affected2 at risk
EG0010 affected2 at risk
EG0021 affected3 at risk
EG003
Dehydration
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected3 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Hyperphosphataemia
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Hypervolaemia
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Increased appetite
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0001 affected2 at risk
EG0011 affected2 at risk
EG0020 affected3 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0001 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Intervertebral disc degeneration
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Joint stiffness
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0001 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Musculoskeletal discomfort
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0011 affected2 at risk
EG0021 affected3 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Osteoarthropathy
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0001 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Trismus
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected3 at risk
EG003
Tumour haemorrhage
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Aura
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Cognitive disorder
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected3 at risk
EG003
Dizziness
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Dysgeusia
Nervous system disorders
27.0
Systematic Assessment
EG0001 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Headache
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Hypersomnia
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Hypogeusia
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Neuralgia
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Neuropathy peripheral
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected3 at risk
EG003
Paraesthesia
Nervous system disorders
27.0
Systematic Assessment
EG0001 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Seizure
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Syncope
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Taste disorder
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Transient ischaemic attack
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Anxiety
Psychiatric disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Confusional state
Psychiatric disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Depression
Psychiatric disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Insomnia
Psychiatric disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Bladder dilatation
Renal and urinary disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Chromaturia
Renal and urinary disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Chronic kidney disease
Renal and urinary disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Proteinuria
Renal and urinary disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected3 at risk
EG003
Breast pain
Reproductive system and breast disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Vulvovaginal dryness
Reproductive system and breast disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Aphonia
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0001 affected2 at risk
EG0010 affected2 at risk
EG0021 affected3 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Dyspnoea at rest
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0001 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Laryngeal haemorrhage
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected3 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0001 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Sputum discoloured
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Hyperkeratosis
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0001 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Macule
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0001 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Palmar-plantar erythrodysaesthesia syndrome
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Pruritus allergic
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Scab
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected3 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Haematoma
Vascular disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0011 affected2 at risk
EG0020 affected3 at risk
EG003
Hot flush
Vascular disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Hypertension
Vascular disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0011 affected2 at risk
EG0020 affected3 at risk
EG003
Hypotension
Vascular disorders
27.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Female Urogenital Diseases and Pregnancy Complications
D000091642
Urogenital Diseases
D007674
Kidney Diseases
D014570
Urologic Diseases
D052801
Male Urogenital Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D000077594
Nivolumab
D000068818
Cetuximab
Ancestor Terms
ID
Term
D061067
Antibodies, Monoclonal, Humanized
D000911
Antibodies, Monoclonal
D000906
Antibodies
D007136
Immunoglobulins
D007162
Immunoproteins
D001798
Blood Proteins
D011506
Proteins
D000602
Amino Acids, Peptides, and Proteins
D012712
Serum Globulins
D005916
Globulins
Browse Leaves
Not provided
Browse Branches
Not provided
1 subjects
FG0051 subjects
FG0061 subjects
3 subjects
FG0057 subjects
FG00610 subjects
0 subjects
FG0050 subjects
FG0061 subjects
63.0
± 13.00
BG00470.8± 6.91
BG00567.4± 9.71
BG00661.1± 8.93
BG00764.9± 9.55
0
BG0030
BG0041
BG0056
BG0066
BG00716
Male
BG0000
BG0011
BG0023
BG0033
BG0044
BG0058
BG0069
BG00728
0
BG0030
BG0040
BG0050
BG0060
BG0070
Not Hispanic or Latino
BG0001
BG0011
BG0022
BG0033
BG0044
BG00511
BG00610
BG00732
Unknown or Not Reported
BG0001
BG0011
BG0021
BG0030
BG0041
BG0053
BG0065
BG00712
0
BG0030
BG0040
BG0051
BG0061
BG0072
Black or African American
BG0000
BG0011
BG0020
BG0031
BG0041
BG0050
BG0061
BG0074
White
BG0002
BG0011
BG0023
BG0031
BG0044
BG00512
BG00612
BG00735
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0031
BG0040
BG0051
BG0061
BG0073
3
OG0045
OG00514
OG00615
3
OG0045
OG00514
OG00615
Serious Adverse Events
Title
Measurements
OG0000
OG0012
OG0020
OG0030
OG0043
OG0058
OG00610
AEs leading to discontinuation
Title
Measurements
OG0000
OG0011
OG0020
OG0030
OG0040
OG0052
OG0062
Deaths
Title
Measurements
OG0001
OG0011
OG0020
OG0030
OG0041
OG0052
OG0064
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously.
OG003
Part 1A BMS-986315-1200 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously.
OG004
Part 1B BMS-986315-200 mg + Nivolumab 480 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
OG005
Part 1B BMS-986315-600 mg + Nivolumab 480 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
OG006
Part 1B BMS-986315-1200 mg + Nivolumab 480 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
Units
Counts
Participants
OG0002
OG0012
OG0023
OG0033
OG0045
OG00514
OG00615
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG002
Part 1A BMS-986315-600 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously.
OG003
Part 1A BMS-986315-1200 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously.
OG004
Part 1B BMS-986315-200 mg + Nivolumab 480 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
OG005
Part 1B BMS-986315-600 mg + Nivolumab 480 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
OG006
Part 1B BMS-986315-1200 mg + Nivolumab 480 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
Units
Counts
Participants
OG0002
OG0012
OG0023
OG0033
OG0045
OG00514
OG00615
Title
Denominators
Categories
Title
Measurements
OG0000.0(0.0 to 84.2)
OG0010.0(0.0 to 84.2)
OG0020.0(0.0 to 70.8)
OG0030.0(0.0 to 70.8)
OG0040.0(0.0 to 52.2)
OG0057.1(0.2 to 33.9)
OG0060.0(0.0 to 21.8)
Part 1A BMS-986315-200 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously.
OG002
Part 1A BMS-986315-600 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously.
OG003
Part 1A BMS-986315-1200 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously.
OG004
Part 1B BMS-986315-200 mg + Nivolumab 480 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
OG005
Part 1B BMS-986315-600 mg + Nivolumab 480 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
OG006
Part 1B BMS-986315-1200 mg + Nivolumab 480 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0051
OG0060
Title
Denominators
Categories
Title
Measurements
OG005NA(NA to NA)Median was not reached due to insufficient number of participants with events" and "95% CI not calculable for a single participant
OG002
Part 1A BMS-986315-600 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously.
OG003
Part 1A BMS-986315-1200 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously.
OG004
Part 1B BMS-986315-200 mg + Nivolumab 480 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
OG005
Part 1B BMS-986315-600 mg + Nivolumab 480 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
OG006
Part 1B BMS-986315-1200 mg + Nivolumab 480 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
Units
Counts
Participants
OG0002
OG0012
OG0023
OG0033
OG0045
OG00514
OG00615
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously.
OG004
Part 1B BMS-986315-200 mg + Nivolumab 480 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
OG005
Part 1B BMS-986315-600 mg + Nivolumab 480 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
OG006
Part 1B BMS-986315-1200 mg + Nivolumab 480 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
Units
Counts
Participants
OG0002
OG0012
OG0023
OG0033
OG0045
OG00511
OG00613
Title
Denominators
Categories
Title
Measurements
OG00028.8519± 40
OG00151.9309± 13
OG002168.2658± 3
OG003283.6735± 66
OG00463.1812± 15
OG005160.8894± 35
OG006309.0469± 24
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously.
OG004
Part 1B BMS-986315-200 mg + Nivolumab 480 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
OG005
Part 1B BMS-986315-600 mg + Nivolumab 480 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
OG006
Part 1B BMS-986315-1200 mg + Nivolumab 480 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
Units
Counts
Participants
OG0002
OG0012
OG0023
OG0033
OG0045
OG00511
OG00613
Title
Denominators
Categories
Title
Measurements
OG0002.1916± 168
OG0012.5151± 84
OG0021.0747± 10
OG0031.8572± 104
OG0041.4213± 63
OG0053.5165± 249
OG0061.9030± 78
Part 1A BMS-986315-1200 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously.
OG004
Part 1B BMS-986315-200 mg + Nivolumab 480 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
OG005
Part 1B BMS-986315-600 mg + Nivolumab 480 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
OG006
Part 1B BMS-986315-1200 mg + Nivolumab 480 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
Units
Counts
Participants
OG0002
OG0012
OG0023
OG0033
OG0045
OG00511
OG00613
Title
Denominators
Categories
Title
Measurements
OG0006885.1959± 33
OG00112122.1650± 18
OG00241381.3449± 12
OG00362500.0455± 56
OG00412885.5705± 20
OG00536893.5416± 32
OG00662110.3402± 33
Part 1A BMS-986315-1200 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously.
OG004
Part 1B BMS-986315-200 mg + Nivolumab 480 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
OG005
Part 1B BMS-986315-600 mg + Nivolumab 480 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
OG006
Part 1B BMS-986315-1200 mg + Nivolumab 480 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
Units
Counts
Participants
OG0002
OG0012
OG0023
OG0033
OG0045
OG00511
OG00613
Title
Denominators
Categories
Title
Measurements
OG0006345.4606± 21
OG00113113.1903± 6
OG00241381.3449± 12
OG00362500.0455± 56
OG00412885.5705± 20
OG00536893.5416± 32
OG00670405.3800± 29
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously.
OG004
Part 1B BMS-986315-200 mg + Nivolumab 480 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
OG005
Part 1B BMS-986315-600 mg + Nivolumab 480 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
OG006
Part 1B BMS-986315-1200 mg + Nivolumab 480 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
Units
Counts
Participants
OG0002
OG0012
OG0023
OG0033
OG0045
OG00511
OG00613
Title
Denominators
Categories
Title
Measurements
OG0004.4119± 20
OG00110.7013± 23
OG00233.1011± 4
OG00351.1321± 66
OG00410.5418± 26
OG00528.3387± 40
OG00649.2124± 48
OG003
Part 1A BMS-986315-1200 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously.
OG004
Part 1B BMS-986315-200 mg + Nivolumab 480 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
OG005
Part 1B BMS-986315-600 mg + Nivolumab 480 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
OG006
Part 1B BMS-986315-1200 mg + Nivolumab 480 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.