A Study of BMS-986253 in Combination With Nivolumab or Ni... | NCT03400332 | Trialant
NCT03400332
Sponsor
Bristol-Myers Squibb
Status
Completed
Last Update Posted
Feb 24, 2026Actual
Enrollment
281Actual
Phase
Phase 1Phase 2
Conditions
Cancer
Melanoma
Interventions
BMS-986253
Nivolumab
Ipilimumab
Placebo
Countries
United States
Australia
Belgium
Canada
France
Germany
Italy
Poland
Spain
Sweden
Switzerland
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT03400332
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CA027-002
Secondary IDs
ID
Type
Description
Link
2023-509061-20
Registry Identifier
EU Trial Number
Brief Title
A Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers
Official Title
A Phase 1/2 Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers
Acronym
Not provided
Organization
Bristol-Myers SquibbINDUSTRY
Status Module
Record Verification Date
Jan 2026
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Feb 12, 2018Actual
Primary Completion Date
Apr 26, 2024Actual
Completion Date
Dec 4, 2025Actual
First Submitted Date
Jan 12, 2018
First Submission Date that Met QC Criteria
Jan 12, 2018
First Posted Date
Jan 17, 2018Actual
Results Waived
Not provided
Results First Submitted Date
Apr 16, 2025
Results First Submitted that Met QC Criteria
Jun 17, 2025
Results First Posted Date
Jun 19, 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
Feb 4, 2026
Last Update Posted Date
Feb 24, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Bristol-Myers SquibbINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to investigate experimental medication BMS-986253 in combination with Nivolumab or Nivolumab plus Ipilimumab in participants with advanced cancers.
Detailed Description
Not provided
Conditions Module
Conditions
Cancer
Melanoma
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
281Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part 1A: BMS-986253 + nivolumab
Experimental
Drug: BMS-986253
Biological: Nivolumab
Part 1B: BMS-986253 + nivolumab
Experimental
Drug: BMS-986253
Biological: Nivolumab
Part 1C: BMS-986253 + nivolumab + ipilimumab
Experimental
Drug: BMS-986253
Biological: Nivolumab
Biological: Ipilimumab
Part 2A: BMS-986253 + nivolumab + ipilimumab
Experimental
Drug: BMS-986253
Biological: Nivolumab
Biological: Ipilimumab
Part 2B: Placebo + nivolumab + ipilimumab
Placebo Comparator
Biological: Nivolumab
Biological: Ipilimumab
Other: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
BMS-986253
Drug
Specified dose on specified days
Part 1A: BMS-986253 + nivolumab
Part 1B: BMS-986253 + nivolumab
Part 1C: BMS-986253 + nivolumab + ipilimumab
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants Experiencing Adverse Events (AEs) - Part 1
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Adverse events are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal.
This endpoint was prespecified in the protocol to include only participants in Part 1.
From first dose up to 100 days after last dose (up to 65 months)
Number of Participants Experiencing Serious Adverse Events (SAEs) - Part 1
A serious adverse event is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event.
This endpoint was prespecified in the protocol to include only participants in Part 1.
From first dose up to 100 days after last dose (up to 65 months)
Number of Participants Experiencing Dose Limiting Toxicities (DLTs) - Part 1
Dose-Limiting Toxicities (DLTs) are effects of a treatment that are serious enough to prevent an increase in dose of that treatment, as advised by the Dose Review Team. DLTs will be defined based on the incidence, intensity, and duration of AEs that are possibly related to study treatment. DLTs will include gastrointestinal, hepatic, hematologic, dermatologic, and other AEs.
This endpoint was prespecified in the protocol to include only participants in Part 1.
From first dose up to 100 days after last dose (up to 65 months)
Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation - Part 1
Secondary Outcomes
Measure
Description
Time Frame
Objective Response Rate (ORR) - Part 1
Objective Response Rate per investigator is the percentage of participants who have a confirmed complete or partial best overall response (BOR) among participants who have measurable disease at baseline. Complete Response (CR) is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to =< 10 mm. Partial Response (PR) is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Baseline was defined as evaluations or events that occur before the date and time of the first dose of study treatment or evaluations on the same date and time of the first dose of study treatment were also considered as baseline evaluations. This endpoint was prespecified in the protocol to include only participants in Part 1.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Histologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent and/or unresectable) with measurable disease per RECIST v1.1
At least 1 lesion accessible for biopsy
Eastern Cooperative Oncology Group Performance Status of 0 or 1
Exclusion Criteria:
Participants with CNS metastases as the only site of active disease (Participants with controlled brain metastases; however, will be allowed to enroll)
Participants with active, known or suspected autoimmune disease
Participants with conditions requiring systemic treatment with either corticosteroids (> 10mg prednisone equivalents) or other immunosuppressive medications within 14 days of study treatment administration
Participants with a known history of testing positive for Human Immunodeficiency Virus (HIV) or known Acquired Immunodeficiency Syndrome (AIDS)
Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study therapy
Other protocol defined inclusion/exclusion criteria could apply
Cai S, Wei X, Li Q, Jiang Z, Li L. Smart materials in pharmacological drug development: Neutrophils and its constituents for drug delivery and consequent antitumor effects. Mol Immunol. 2025 Jul;183:18-32. doi: 10.1016/j.molimm.2025.04.010. Epub 2025 May 2.
281 participants were randomized and 278 received treatment.
Part 1: 159 participants were directly treated and not blinded (open label).
Part 2: 122 participants were double-blinded and randomized. 122 participants were randomized in the pre-treatment phase while 119 received treatment. 3 participants were randomized but did not receive treatment.
Number of participants with any grade adverse events (AEs) leading to discontinuation of study treatment. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. Toxicities will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
This endpoint was prespecified in the protocol to include only participants in Part 1.
From first dose up to 100 days after last dose (up to 65 months)
Number of Participants Who Died - Part 1
The number of participants who died due to any cause are summarized. This endpoint was prespecified in the protocol to include only participants in Part 1.
From first dose up to 100 days after last dose (up to 65 months)
Most Frequently Reported Grade 3 and Grade 4 Laboratory Test Results - Part 1
Laboratory results were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Laboratory tests are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal.
This endpoint was prespecified in the protocol to include only participants in Part 1.
From first dose up to 30 days after last dose (up to 63 months)
Objective Response Rate (ORR) - Part 2
Objective Response Rate per blinded independent central review (BICR) is the percentage of participants who have a confirmed complete or partial best overall response (BOR) among participants who have measurable disease at baseline. Complete Response (CR) is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to =< 10 mm. Partial Response (PR) is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Baseline was defined as evaluations or events that occur before the date and time of the first dose of study treatment or evaluations on the same date and time of the first dose of study treatment were also considered as baseline evaluations. This endpoint was prespecified in the protocol to include only participants in Part 2.
From the date of the first dose to the date of first objectively documented progression per RECIST v1.1 or the date of subsequent therapy, whichever occurred first (up to approximately 22 months)
From the date of the first dose to the date of first objectively documented progression per RECIST v1.1 or the date of subsequent therapy, whichever occurred first (up to approximately 74 months)
Duration of Response (DOR) - Part 1
DOR for a participant with a best overall response (BOR) of CR or PR is defined as the date of first response up to the date of the first objectively documented tumor progression by the investigator per RECIST v1.1 or death, whichever occurs first. Analysis 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). The sum must also demonstrate an absolute increase of at least 5 mm.
This endpoint was prespecified in the protocol to include only participants in Part 1.
From the date of the first dose to the date of first objectively documented progression per RECIST v1.1 or the date of subsequent therapy, whichever occurred first (up to approximately 74 months)
Maximum Concentration (Cmax) - Part 1
Cmax is the maximum (or peak) serum concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administered and before the administration of a second dose.
1 cycle=28 days for all Arms/Groups except in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group (1 cycle=42 days)
Cycle 1 Day 1
AUC(0-T)-Area Under Curve From Time Zero up to Last Quantifiable Concentration - Part 1
AUC (0-T) represents the observed exposure to a drug (area under the concentration curve) from first exposure until the last quantifiable concentration. Only Part 1 pharmacokinetic evaluable participants were pre-specified to be evaluated in this endpoint.
1 cycle=28 days for all Arms/Groups except in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group (1 cycle=42 days)
0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on Cycle 1 Day 1
AUC(TAU)-Area Under Curve in 1 Dosing Interval - Part 1
Area under the concentration-time curve in 1 dosing interval. Only Part 1 pharmacokinetic evaluable participants were pre-specified to be evaluated in this endpoint.
1 cycle=28 days for all Arms/Groups except in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group (1 cycle=42 days)
Cycle 1 Day 1
Observed Serum Concentration at the End of a Dosing Interval (Ctau) - Part 1
BMS-986253 observed serum concentration at the end of a dosing interval (Ctau). Only Part 1 pharmacokinetic evaluable participants were pre-specified to be evaluated in this endpoint.
1 cycle=28 days for all Arms/Groups except Cycles 1 and 2 (1 cycle=42 days) in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group
Cycle 1 Day 1
Total Body Clearance (CLT) - Part 1
Clearance is the rate of elimination of BMS-986253 from the blood calculated as the rate of elimination divided by serum concentration. Only Part 1 pharmacokinetic evaluable participants were pre-specified to be evaluated in this endpoint.
1 cycle=28 days for all Arms/Groups except in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group (1 cycle=42 days)
Cycle 1 Day 1
Average Serum Concentration Over a Dosing Interval (Css-avg) - Part 1
BMS-986253 Average concentration over a dosing interval (\[AUC(TAU)/tau\] (Css-avg) at steady state. Only Part 1 pharmacokinetic evaluable participants were pre-specified to be evaluated in this endpoint.
1 cycle=28 days for all Arms/Groups except in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group (1 cycle=42 days)
Note: C2D1, C3D1, C4D1 were partial samplings only as pre-specified in the protocol and did not include a sampling for each arm.
Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1
AUC Accumulation Index (AI_AUC) - Part 1
AUC Accumulation Index is defined as the ratio of AUC(TAU) at steady state to AUC(TAU) after the first dose. Only Part 1 pharmacokinetic evaluable participants were pre-specified to be evaluated in this endpoint.
1 cycle=28 days for all Arms/Groups except in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group (1 cycle=42 days)
Note: C2D1, C3D1, C4D1 were partial samplings only as pre-specified in the protocol and did not include a sampling for each arm.
Cycle 2 Day 1, Cycle 3 Day 1, and Cycle 4 Day 1
Cmax Accumulation Index (AI_Cmax) - Part 1
BMS-986253 Cmax accumulation index (AI_Cmax). Ratio of an exposure measure at steady state to that after the first dose. Only Part 1 pharmacokinetic evaluable participants were pre-specified to be evaluated in this endpoint.
1 cycle=28 days for all Arms/Groups except in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group (1 cycle=42 days)
Note: C2D1, C3D1, C4D1 were partial samplings only as pre-specified in the protocol and did not include a sampling for each arm.
Cycle 2 Day 1, Cycle 3 Day 1, and Cycle 4 Day 1
Ctau Accumulation Index (AI_Ctau) - Part 1
Ctau is the observed serum concentration at the end of a dosing interval. Ctau accumulation index (AI_Ctau) is the ratio of an exposure measure at steady state to that after the first dose. Only Part 1 pharmacokinetic evaluable participants were pre-specified to be evaluated in this endpoint. Ctau was reported on non-compartmental analysis day, which is on Cycle 1 Day1, Cycle 2 Day 1, Cycle 3 Day 1, or Cycle 4 Day 1 based on data available.
1 cycle=28 days for all Arms/Groups except in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group (1 cycle=42 days)
Note: C2D1, C3D1, C4D1 were partial samplings only as pre-specified in the protocol and did not include a sampling for each arm.
Cycle 2 Day 1, Cycle 3 Day 1, and Cycle 4 Day 1
Effective Elimination (T-HALFeff) - Part 1
BMS-986253 effective elimination (T-HALFeff) that explains the degree of accumulation observed for a specific exposure measure. Only Part 1 pharmacokinetic evaluable participants were pre-specified to be evaluated in this endpoint.
1 cycle=28 days for all Arms/Groups except in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group (1 cycle=42 days)
Note: C2D1, C3D1, C4D1 were partial samplings only as pre-specified in the protocol and did not include a sampling for each arm.
Cycle 2 Day 1, Cycle 3 Day 1, and Cycle 4 Day 1
Time to Maximum Concentration (Tmax) - Part 1
Tmax is defined as the time it takes for a drug to reach the maximum concentration (Cmax) after administration of a drug.
1 cycle=28 days for all Arms/Groups except in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group (1 cycle=42 days)
Cycle 1 Day 1
Serum Trough Concentration (Ctrough) - Part 1
A serum trough concentration (Ctrough) is the concentration reached by a drug immediately before the next dose is administered. Serum trough concentrations (Ctrough) of BMS-986253 will be summarized with descriptive statistics by treatment and visit.
1 cycle=28 days for all Arms/Groups except in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group (1 cycle=42 days)
Note: The timepoints listed were partial samplings only as pre-specified in the protocol and did not include a sampling for each arm.
Number of Participants With Anti-Drug Antibodies (ADA) - Part 1
Blood samples were evaluated for development of Anti-Drug Antibody (ADA) by a validated electrochemiluminescent (ECL) immunoassay. Baseline is defined as first dose.
ADA-positive subject: A subject with at least one ADA positive-sample relative to baseline at any time after initiation of treatment.
Persistent Positive (PP): ADA-positive sample at 2 or more consecutive time points, where the first and last ADA-positive samples are at least 16 weeks apart
Not PP-Last Sample Positive: Not persistent positive with ADA-positive sample at the last sampling time point
Other Positive: Not persistent positive but some ADA-positive samples with the last sample being negative
Neutralizing Positive: At least one ADA-positive sample with neutralizing antibodies detected
ADA-negative subject: A subject with no ADA-positive sample after the initiation of treatment.
1 cycle=28 days for all Arms/Groups except in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group (1 cycle=42 days)
Change From Baseline in Interleukin 8 (IL-8)- Part 1
Change from baseline in IL-8 measured in pg/mL. Baseline is defined as first dose.
1 cycle=28 days for all Arms/Groups except in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group (1 cycle=42 days)
Note: Some timepoints were partial samplings only as pre-specified in the protocol and did not include a sampling for each arm.
C1D2, C1D8, C1D15, C1D22, C1D29, C1D36, C2D1, C2D2, C2D8, C2D15, C2D22, C2D29, C3D1, C3D2, C3D8, C4D1, C4D2, C4D8, C4D15, C4D22, C5D1, C7D1, C8D1, C9D1, C10D1, C11D1, C14D1, C16D1, C17D1, C20D1, C23D1, C26D1, at last dose, and 100 days post last dose
Progression Free Survival (PFS) - Part 2
Progression free survival (PFS) is defined for all randomized participants as the date from randomization to the date of the documentation of disease progression by BICR or death due to any cause, whichever is earlier.
Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.
This endpoint was prespecified in the protocol to include only participants in Part 2.
From the date of the first dose to the date of first objectively documented progression per RECIST v1.1 or the date of subsequent therapy, whichever occurred first (up to approximately 22 months)
Number of Participants Experiencing Adverse Events (AEs) - Part 2
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Adverse events are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal.
This endpoint was prespecified in the protocol to include only participants in Part 2.
From first dose up to 100 days after last dose (up to 25 months)
Number of Participants Experiencing Serious Adverse Events (SAEs) - Part 2
A serious adverse event is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event.
From first dose up to 100 days after last dose (up to 25 months)
Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation - Part 2
Number of participants with any grade adverse events (AEs) leading to discontinuation of study treatment. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. Toxicities will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
From first dose up to 100 days after last dose (up to 25 months)
Number of Participants Who Died - Part 2
The number of participants who died due to any cause are summarized.
From first dose up to 100 days after last dose (up to 25 months)
Most Frequently Reported Grade 3 and Grade 4 Laboratory Test Results - Part 2
Laboratory results were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Laboratory tests are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal.
This endpoint was prespecified in the protocol to include only participants in Part 2.
From first dose up to 30 days after last dose (up to 23 months)
Number of Participants Experiencing Adverse Events (AEs) - Part 1
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Adverse events are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal.
This endpoint was prespecified in the protocol to include only participants in Part 1.
All treated participants in Part 1
Posted
Count of Participants
Participants
From first dose up to 100 days after last dose (up to 65 months)
Number of Participants Experiencing Serious Adverse Events (SAEs) - Part 1
A serious adverse event is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event.
This endpoint was prespecified in the protocol to include only participants in Part 1.
All treated participants in Part 1
Posted
Count of Participants
Participants
From first dose up to 100 days after last dose (up to 65 months)
ID
Title
Description
OG000
Part 1: 600 Q4W
600 mg BMS-986253 Q4W + 480 mg nivolumab Q4W
OG001
Part 1: 1200 Q4W
1200 mg BMS-986253 Q4W + 480 mg nivolumab Q4W
OG002
Part 1: 2400 Q4W
2400 mg BMS-986253 Q4W + 480 mg nivolumab Q4W
OG003
Part 1: 1200 Q2W
1200 mg BMS-986253 Q2W + 480 mg nivolumab Q4W
Primary
Number of Participants Experiencing Dose Limiting Toxicities (DLTs) - Part 1
Dose-Limiting Toxicities (DLTs) are effects of a treatment that are serious enough to prevent an increase in dose of that treatment, as advised by the Dose Review Team. DLTs will be defined based on the incidence, intensity, and duration of AEs that are possibly related to study treatment. DLTs will include gastrointestinal, hepatic, hematologic, dermatologic, and other AEs.
This endpoint was prespecified in the protocol to include only participants in Part 1.
All treated participants in Part 1
Posted
Count of Participants
Participants
From first dose up to 100 days after last dose (up to 65 months)
ID
Title
Description
OG000
Part 1: 600 Q4W
600 mg BMS-986253 Q4W + 480 mg nivolumab Q4W
OG001
Part 1: 1200 Q4W
1200 mg BMS-986253 Q4W + 480 mg nivolumab Q4W
OG002
Part 1: 2400 Q4W
2400 mg BMS-986253 Q4W + 480 mg nivolumab Q4W
OG003
Part 1: 1200 Q2W
Primary
Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation - Part 1
Number of participants with any grade adverse events (AEs) leading to discontinuation of study treatment. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. Toxicities will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
This endpoint was prespecified in the protocol to include only participants in Part 1.
All treated participants in Part 1
Posted
Count of Participants
Participants
From first dose up to 100 days after last dose (up to 65 months)
ID
Title
Description
OG000
Part 1: 600 Q4W
600 mg BMS-986253 Q4W + 480 mg nivolumab Q4W
OG001
Part 1: 1200 Q4W
1200 mg BMS-986253 Q4W + 480 mg nivolumab Q4W
OG002
Part 1: 2400 Q4W
2400 mg BMS-986253 Q4W + 480 mg nivolumab Q4W
OG003
Primary
Number of Participants Who Died - Part 1
The number of participants who died due to any cause are summarized. This endpoint was prespecified in the protocol to include only participants in Part 1.
All treated participants in Part 1
Posted
Count of Participants
Participants
From first dose up to 100 days after last dose (up to 65 months)
ID
Title
Description
OG000
Part 1: 600 Q4W
600 mg BMS-986253 Q4W + 480 mg nivolumab Q4W
OG001
Part 1: 1200 Q4W
1200 mg BMS-986253 Q4W + 480 mg nivolumab Q4W
OG002
Part 1: 2400 Q4W
2400 mg BMS-986253 Q4W + 480 mg nivolumab Q4W
OG003
Part 1: 1200 Q2W
1200 mg BMS-986253 Q2W + 480 mg nivolumab Q4W
OG004
Part 1: 2400 Q2W
2400 mg BMS-986253 Q2W + 480 mg nivolumab Q4W
Primary
Most Frequently Reported Grade 3 and Grade 4 Laboratory Test Results - Part 1
Laboratory results were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Laboratory tests are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal.
This endpoint was prespecified in the protocol to include only participants in Part 1.
All treated participants in Part 1
Posted
Count of Participants
Participants
From first dose up to 30 days after last dose (up to 63 months)
ID
Title
Description
OG000
Part 1: 600 Q4W
600 mg BMS-986253 Q4W + 480 mg nivolumab Q4W
OG001
Part 1: 1200 Q4W
1200 mg BMS-986253 Q4W + 480 mg nivolumab Q4W
OG002
Part 1: 2400 Q4W
2400 mg BMS-986253 Q4W + 480 mg nivolumab Q4W
OG003
Part 1: 1200 Q2W
Secondary
Objective Response Rate (ORR) - Part 1
Objective Response Rate per investigator is the percentage of participants who have a confirmed complete or partial best overall response (BOR) among participants who have measurable disease at baseline. Complete Response (CR) is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to =< 10 mm. Partial Response (PR) is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Baseline was defined as evaluations or events that occur before the date and time of the first dose of study treatment or evaluations on the same date and time of the first dose of study treatment were also considered as baseline evaluations. This endpoint was prespecified in the protocol to include only participants in Part 1.
All treated participants in Part 1
Posted
Number
95% Confidence Interval
Percentage of Participants
From the date of the first dose to the date of first objectively documented progression per RECIST v1.1 or the date of subsequent therapy, whichever occurred first (up to approximately 74 months)
ID
Title
Description
OG000
Part 1: 600 Q4W
600 mg BMS-986253 Q4W + 480 mg nivolumab Q4W
OG001
Part 1: 1200 Q4W
1200 mg BMS-986253 Q4W + 480 mg nivolumab Q4W
Secondary
Duration of Response (DOR) - Part 1
DOR for a participant with a best overall response (BOR) of CR or PR is defined as the date of first response up to the date of the first objectively documented tumor progression by the investigator per RECIST v1.1 or death, whichever occurs first. Analysis 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). The sum must also demonstrate an absolute increase of at least 5 mm.
This endpoint was prespecified in the protocol to include only participants in Part 1.
All confirmed responders in Part 1
Posted
Median
Full Range
Months
From the date of the first dose to the date of first objectively documented progression per RECIST v1.1 or the date of subsequent therapy, whichever occurred first (up to approximately 74 months)
ID
Title
Description
OG000
Part 1: 600 Q4W
600 mg BMS-986253 Q4W + 480 mg nivolumab Q4W
OG001
Part 1: 1200 Q4W
1200 mg BMS-986253 Q4W + 480 mg nivolumab Q4W
Secondary
Maximum Concentration (Cmax) - Part 1
Cmax is the maximum (or peak) serum concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administered and before the administration of a second dose.
1 cycle=28 days for all Arms/Groups except in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group (1 cycle=42 days)
All treated participants in Part 1 who have evaluable concentration-time data.
Posted
Geometric Mean
Geometric Coefficient of Variation
ug/mL
Cycle 1 Day 1
ID
Title
Description
OG000
Part 1: 600 Q4W
600 mg BMS-986253 Q4W + 480 mg nivolumab Q4W
OG001
Part 1: 1200 Q4W
1200 mg BMS-986253 Q4W + 480 mg nivolumab Q4W
OG002
Part 1: 2400 Q4W
2400 mg BMS-986253 Q4W + 480 mg nivolumab Q4W
OG003
Part 1: 1200 Q2W
1200 mg BMS-986253 Q2W + 480 mg nivolumab Q4W
OG004
Secondary
AUC(0-T)-Area Under Curve From Time Zero up to Last Quantifiable Concentration - Part 1
AUC (0-T) represents the observed exposure to a drug (area under the concentration curve) from first exposure until the last quantifiable concentration. Only Part 1 pharmacokinetic evaluable participants were pre-specified to be evaluated in this endpoint.
1 cycle=28 days for all Arms/Groups except in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group (1 cycle=42 days)
All treated participants in Part 1 who have evaluable concentration-time data
Posted
Geometric Mean
Geometric Coefficient of Variation
h*ug/mL
0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on Cycle 1 Day 1
ID
Title
Description
OG000
Part 1: 600 Q4W
600 mg BMS-986253 Q4W + 480 mg nivolumab Q4W
OG001
Part 1: 1200 Q4W
1200 mg BMS-986253 Q4W + 480 mg nivolumab Q4W
OG002
Part 1: 2400 Q4W
2400 mg BMS-986253 Q4W + 480 mg nivolumab Q4W
OG003
Part 1: 1200 Q2W
1200 mg BMS-986253 Q2W + 480 mg nivolumab Q4W
Secondary
AUC(TAU)-Area Under Curve in 1 Dosing Interval - Part 1
Area under the concentration-time curve in 1 dosing interval. Only Part 1 pharmacokinetic evaluable participants were pre-specified to be evaluated in this endpoint.
1 cycle=28 days for all Arms/Groups except in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group (1 cycle=42 days)
All treated participants in Part 1 who have evaluable concentration-time data
Posted
Geometric Mean
Geometric Coefficient of Variation
h*ug/mL
Cycle 1 Day 1
ID
Title
Description
OG000
Part 1: 600 Q4W
600 mg BMS-986253 Q4W + 480 mg nivolumab Q4W
OG001
Part 1: 1200 Q4W
1200 mg BMS-986253 Q4W + 480 mg nivolumab Q4W
OG002
Part 1: 2400 Q4W
2400 mg BMS-986253 Q4W + 480 mg nivolumab Q4W
OG003
Part 1: 1200 Q2W
1200 mg BMS-986253 Q2W + 480 mg nivolumab Q4W
OG004
Secondary
Observed Serum Concentration at the End of a Dosing Interval (Ctau) - Part 1
BMS-986253 observed serum concentration at the end of a dosing interval (Ctau). Only Part 1 pharmacokinetic evaluable participants were pre-specified to be evaluated in this endpoint.
1 cycle=28 days for all Arms/Groups except Cycles 1 and 2 (1 cycle=42 days) in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group
All treated participants in Part 1 who have evaluable concentration-time data
Posted
Geometric Mean
Geometric Coefficient of Variation
ug/mL
Cycle 1 Day 1
ID
Title
Description
OG000
Part 1: 600 Q4W
600 mg BMS-986253 Q4W + 480 mg nivolumab Q4W
OG001
Part 1: 1200 Q4W
1200 mg BMS-986253 Q4W + 480 mg nivolumab Q4W
OG002
Part 1: 2400 Q4W
2400 mg BMS-986253 Q4W + 480 mg nivolumab Q4W
OG003
Part 1: 1200 Q2W
1200 mg BMS-986253 Q2W + 480 mg nivolumab Q4W
Secondary
Total Body Clearance (CLT) - Part 1
Clearance is the rate of elimination of BMS-986253 from the blood calculated as the rate of elimination divided by serum concentration. Only Part 1 pharmacokinetic evaluable participants were pre-specified to be evaluated in this endpoint.
1 cycle=28 days for all Arms/Groups except in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group (1 cycle=42 days)
All treated participants in Part 1 who have evaluable concentration-time data
Posted
Geometric Mean
Geometric Coefficient of Variation
mL/h
Cycle 1 Day 1
ID
Title
Description
OG000
Part 1: 600 Q4W
600 mg BMS-986253 Q4W + 480 mg nivolumab Q4W
OG001
Part 1: 1200 Q4W
1200 mg BMS-986253 Q4W + 480 mg nivolumab Q4W
OG002
Part 1: 2400 Q4W
2400 mg BMS-986253 Q4W + 480 mg nivolumab Q4W
OG003
Part 1: 1200 Q2W
1200 mg BMS-986253 Q2W + 480 mg nivolumab Q4W
Secondary
Average Serum Concentration Over a Dosing Interval (Css-avg) - Part 1
BMS-986253 Average concentration over a dosing interval (\[AUC(TAU)/tau\] (Css-avg) at steady state. Only Part 1 pharmacokinetic evaluable participants were pre-specified to be evaluated in this endpoint.
1 cycle=28 days for all Arms/Groups except in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group (1 cycle=42 days)
Note: C2D1, C3D1, C4D1 were partial samplings only as pre-specified in the protocol and did not include a sampling for each arm.
All treated participants in Part 1 who have evaluable concentration-time data
Posted
Geometric Mean
Geometric Coefficient of Variation
ug/mL
Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1
ID
Title
Description
OG000
Part 1: 600 Q4W
600 mg BMS-986253 Q4W + 480 mg nivolumab Q4W
OG001
Part 1: 1200 Q4W
1200 mg BMS-986253 Q4W + 480 mg nivolumab Q4W
OG002
Part 1: 2400 Q4W
2400 mg BMS-986253 Q4W + 480 mg nivolumab Q4W
OG003
Part 1: 1200 Q2W
Secondary
AUC Accumulation Index (AI_AUC) - Part 1
AUC Accumulation Index is defined as the ratio of AUC(TAU) at steady state to AUC(TAU) after the first dose. Only Part 1 pharmacokinetic evaluable participants were pre-specified to be evaluated in this endpoint.
1 cycle=28 days for all Arms/Groups except in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group (1 cycle=42 days)
Note: C2D1, C3D1, C4D1 were partial samplings only as pre-specified in the protocol and did not include a sampling for each arm.
All treated participants in Part 1 who have evaluable concentration-time data
Posted
Geometric Mean
Geometric Coefficient of Variation
Ratio
Cycle 2 Day 1, Cycle 3 Day 1, and Cycle 4 Day 1
ID
Title
Description
OG000
Part 1: 600 Q4W
600 mg BMS-986253 Q4W + 480 mg nivolumab Q4W
OG001
Part 1: 1200 Q4W
1200 mg BMS-986253 Q4W + 480 mg nivolumab Q4W
OG002
Part 1: 2400 Q4W
2400 mg BMS-986253 Q4W + 480 mg nivolumab Q4W
OG003
Part 1: 1200 Q2W
Secondary
Cmax Accumulation Index (AI_Cmax) - Part 1
BMS-986253 Cmax accumulation index (AI_Cmax). Ratio of an exposure measure at steady state to that after the first dose. Only Part 1 pharmacokinetic evaluable participants were pre-specified to be evaluated in this endpoint.
1 cycle=28 days for all Arms/Groups except in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group (1 cycle=42 days)
Note: C2D1, C3D1, C4D1 were partial samplings only as pre-specified in the protocol and did not include a sampling for each arm.
All treated participants in Part 1 who have evaluable concentration-time data
Posted
Geometric Mean
Geometric Coefficient of Variation
Ratio
Cycle 2 Day 1, Cycle 3 Day 1, and Cycle 4 Day 1
ID
Title
Description
OG000
Part 1: 600 Q4W
600 mg BMS-986253 Q4W + 480 mg nivolumab Q4W
OG001
Part 1: 1200 Q4W
1200 mg BMS-986253 Q4W + 480 mg nivolumab Q4W
OG002
Part 1: 2400 Q4W
2400 mg BMS-986253 Q4W + 480 mg nivolumab Q4W
OG003
Part 1: 1200 Q2W
Secondary
Ctau Accumulation Index (AI_Ctau) - Part 1
Ctau is the observed serum concentration at the end of a dosing interval. Ctau accumulation index (AI_Ctau) is the ratio of an exposure measure at steady state to that after the first dose. Only Part 1 pharmacokinetic evaluable participants were pre-specified to be evaluated in this endpoint. Ctau was reported on non-compartmental analysis day, which is on Cycle 1 Day1, Cycle 2 Day 1, Cycle 3 Day 1, or Cycle 4 Day 1 based on data available.
1 cycle=28 days for all Arms/Groups except in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group (1 cycle=42 days)
Note: C2D1, C3D1, C4D1 were partial samplings only as pre-specified in the protocol and did not include a sampling for each arm.
All treated participants in Part 1 who have evaluable concentration-time data
Posted
Geometric Mean
Geometric Coefficient of Variation
Ratio
Cycle 2 Day 1, Cycle 3 Day 1, and Cycle 4 Day 1
ID
Title
Description
OG000
Part 1: 600 Q4W
600 mg BMS-986253 Q4W + 480 mg nivolumab Q4W
OG001
Part 1: 1200 Q4W
1200 mg BMS-986253 Q4W + 480 mg nivolumab Q4W
OG002
Part 1: 2400 Q4W
2400 mg BMS-986253 Q4W + 480 mg nivolumab Q4W
Secondary
Effective Elimination (T-HALFeff) - Part 1
BMS-986253 effective elimination (T-HALFeff) that explains the degree of accumulation observed for a specific exposure measure. Only Part 1 pharmacokinetic evaluable participants were pre-specified to be evaluated in this endpoint.
1 cycle=28 days for all Arms/Groups except in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group (1 cycle=42 days)
Note: C2D1, C3D1, C4D1 were partial samplings only as pre-specified in the protocol and did not include a sampling for each arm.
All treated participants in Part 1 who have evaluable concentration-time data
Posted
Mean
Standard Deviation
Hours
Cycle 2 Day 1, Cycle 3 Day 1, and Cycle 4 Day 1
ID
Title
Description
OG000
Part 1: 600 Q4W
600 mg BMS-986253 Q4W + 480 mg nivolumab Q4W
OG001
Part 1: 1200 Q4W
1200 mg BMS-986253 Q4W + 480 mg nivolumab Q4W
OG002
Part 1: 2400 Q4W
2400 mg BMS-986253 Q4W + 480 mg nivolumab Q4W
OG003
Part 1: 1200 Q2W
Secondary
Time to Maximum Concentration (Tmax) - Part 1
Tmax is defined as the time it takes for a drug to reach the maximum concentration (Cmax) after administration of a drug.
1 cycle=28 days for all Arms/Groups except in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group (1 cycle=42 days)
All treated participants in Part 1 who have evaluable concentration-time data
Posted
Median
Full Range
Hours
Cycle 1 Day 1
ID
Title
Description
OG000
Part 1: 600 Q4W
600 mg BMS-986253 Q4W + 480 mg nivolumab Q4W
OG001
Part 1: 1200 Q4W
1200 mg BMS-986253 Q4W + 480 mg nivolumab Q4W
OG002
Part 1: 2400 Q4W
2400 mg BMS-986253 Q4W + 480 mg nivolumab Q4W
OG003
Part 1: 1200 Q2W
1200 mg BMS-986253 Q2W + 480 mg nivolumab Q4W
OG004
Part 1: 2400 Q2W
Secondary
Serum Trough Concentration (Ctrough) - Part 1
A serum trough concentration (Ctrough) is the concentration reached by a drug immediately before the next dose is administered. Serum trough concentrations (Ctrough) of BMS-986253 will be summarized with descriptive statistics by treatment and visit.
1 cycle=28 days for all Arms/Groups except in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group (1 cycle=42 days)
Note: The timepoints listed were partial samplings only as pre-specified in the protocol and did not include a sampling for each arm.
All treated participants in Part 1 who have evaluable concentration-time data
Number of Participants With Anti-Drug Antibodies (ADA) - Part 1
Blood samples were evaluated for development of Anti-Drug Antibody (ADA) by a validated electrochemiluminescent (ECL) immunoassay. Baseline is defined as first dose.
ADA-positive subject: A subject with at least one ADA positive-sample relative to baseline at any time after initiation of treatment.
Persistent Positive (PP): ADA-positive sample at 2 or more consecutive time points, where the first and last ADA-positive samples are at least 16 weeks apart
Not PP-Last Sample Positive: Not persistent positive with ADA-positive sample at the last sampling time point
Other Positive: Not persistent positive but some ADA-positive samples with the last sample being negative
Neutralizing Positive: At least one ADA-positive sample with neutralizing antibodies detected
ADA-negative subject: A subject with no ADA-positive sample after the initiation of treatment.
1 cycle=28 days for all Arms/Groups except in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group (1 cycle=42 days)
All treated participants in Part 1 with baseline and at least one post-baseline evaluable ADA assessment
Change From Baseline in Interleukin 8 (IL-8)- Part 1
Change from baseline in IL-8 measured in pg/mL. Baseline is defined as first dose.
1 cycle=28 days for all Arms/Groups except in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group (1 cycle=42 days)
Note: Some timepoints were partial samplings only as pre-specified in the protocol and did not include a sampling for each arm.
All treated participants in Part 1 with available biomarker data
Posted
Mean
Full Range
pg/mL
C1D2, C1D8, C1D15, C1D22, C1D29, C1D36, C2D1, C2D2, C2D8, C2D15, C2D22, C2D29, C3D1, C3D2, C3D8, C4D1, C4D2, C4D8, C4D15, C4D22, C5D1, C7D1, C8D1, C9D1, C10D1, C11D1, C14D1, C16D1, C17D1, C20D1, C23D1, C26D1, at last dose, and 100 days post last dose
ID
Title
Description
OG000
Part 1: 600 Q4W
600 mg BMS-986253 Q4W + 480 mg nivolumab Q4W
OG001
Part 1: 1200 Q4W
1200 mg BMS-986253 Q4W + 480 mg nivolumab Q4W
OG002
Part 1: 2400 Q4W
2400 mg BMS-986253 Q4W + 480 mg nivolumab Q4W
OG003
Part 1: 1200 Q2W
Primary
Objective Response Rate (ORR) - Part 2
Objective Response Rate per blinded independent central review (BICR) is the percentage of participants who have a confirmed complete or partial best overall response (BOR) among participants who have measurable disease at baseline. Complete Response (CR) is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to =< 10 mm. Partial Response (PR) is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Baseline was defined as evaluations or events that occur before the date and time of the first dose of study treatment or evaluations on the same date and time of the first dose of study treatment were also considered as baseline evaluations. This endpoint was prespecified in the protocol to include only participants in Part 2.
All randomized participants in Part 2
Posted
Number
95% Confidence Interval
Percentage of Participants
From the date of the first dose to the date of first objectively documented progression per RECIST v1.1 or the date of subsequent therapy, whichever occurred first (up to approximately 22 months)
Progression free survival (PFS) is defined for all randomized participants as the date from randomization to the date of the documentation of disease progression by BICR or death due to any cause, whichever is earlier.
Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.
This endpoint was prespecified in the protocol to include only participants in Part 2.
All randomized participants in Part 2
Posted
Median
95% Confidence Interval
Months
From the date of the first dose to the date of first objectively documented progression per RECIST v1.1 or the date of subsequent therapy, whichever occurred first (up to approximately 22 months)
Number of Participants Experiencing Adverse Events (AEs) - Part 2
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Adverse events are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal.
This endpoint was prespecified in the protocol to include only participants in Part 2.
All treated participants in Part 2
Posted
Count of Participants
Participants
From first dose up to 100 days after last dose (up to 25 months)
Number of Participants Experiencing Serious Adverse Events (SAEs) - Part 2
A serious adverse event is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event.
All treated participants in Part 2
Posted
Count of Participants
Participants
From first dose up to 100 days after last dose (up to 25 months)
Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation - Part 2
Number of participants with any grade adverse events (AEs) leading to discontinuation of study treatment. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. Toxicities will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
All treated participants in Part 2
Posted
Count of Participants
Participants
From first dose up to 100 days after last dose (up to 25 months)
Most Frequently Reported Grade 3 and Grade 4 Laboratory Test Results - Part 2
Laboratory results were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Laboratory tests are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal.
This endpoint was prespecified in the protocol to include only participants in Part 2.
All treated participants in Part 2
Posted
Count of Participants
Participants
From first dose up to 30 days after last dose (up to 23 months)
Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months).
Description
The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.0
Non-systematic Assessment
EG0005 affected16 at risk
EG0014 affected15 at risk
EG0028 affected18 at risk
EG003
Metastatic malignant melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Ataxia
Nervous system disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0021 affected18 at risk
EG003
Axonal neuropathy
Nervous system disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Carotid blowout syndrome
Nervous system disorders
MedDRA 27.0
Non-systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Cerebral haemorrhage
Nervous system disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0021 affected18 at risk
EG003
Diabetic coma
Nervous system disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Guillain-Barre syndrome
Nervous system disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Haemorrhage intracranial
Nervous system disorders
MedDRA 27.0
Non-systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Hemiparesis
Nervous system disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Hepatic encephalopathy
Nervous system disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Middle cerebral artery stroke
Nervous system disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Device occlusion
Product Issues
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0021 affected18 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Immune-mediated nephritis
Renal and urinary disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Tubulointerstitial nephritis
Renal and urinary disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Urinary tract obstruction
Renal and urinary disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected18 at risk
EG003
Vulvovaginal pain
Reproductive system and breast disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Bronchiectasis
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0021 affected18 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Non-systematic Assessment
EG0002 affected16 at risk
EG0011 affected15 at risk
EG0021 affected18 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0022 affected18 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0022 affected18 at risk
EG003
Organising pneumonia
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Pulmonary hypertension
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Respiratory distress
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Aortic aneurysm
Vascular disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0021 affected18 at risk
EG003
Aortic stenosis
Vascular disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Haematoma
Vascular disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Hypotension
Vascular disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0021 affected18 at risk
EG003
Superior vena cava syndrome
Vascular disorders
MedDRA 27.0
Non-systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 27.0
Non-systematic Assessment
EG0003 affected16 at risk
EG0012 affected15 at risk
EG0025 affected18 at risk
EG0032 affected12 at risk
EG00416 affected63 at risk
EG0057 affected20 at risk
EG0066 affected15 at risk
EG00721 affected62 at risk
EG00814 affected57 at risk
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0021 affected18 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Neutrophilia
Blood and lymphatic system disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Aortic valve incompetence
Cardiac disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected18 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0021 affected18 at risk
EG003
Bundle branch block bilateral
Cardiac disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0021 affected18 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected18 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0021 affected18 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0024 affected18 at risk
EG003
Deafness
Ear and labyrinth disorders
MedDRA 27.0
Non-systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Ear discomfort
Ear and labyrinth disorders
MedDRA 27.0
Non-systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Adrenal insufficiency
Endocrine disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected18 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0021 affected18 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 27.0
Non-systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0022 affected18 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Vision blurred
Eye disorders
MedDRA 27.0
Non-systematic Assessment
EG0002 affected16 at risk
EG0011 affected15 at risk
EG0021 affected18 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 27.0
Non-systematic Assessment
EG0001 affected16 at risk
EG0011 affected15 at risk
EG0020 affected18 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0012 affected15 at risk
EG0020 affected18 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 27.0
Non-systematic Assessment
EG0001 affected16 at risk
EG0011 affected15 at risk
EG0022 affected18 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 27.0
Non-systematic Assessment
EG0001 affected16 at risk
EG0011 affected15 at risk
EG0021 affected18 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0021 affected18 at risk
EG003
Anorectal discomfort
Gastrointestinal disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0021 affected18 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 27.0
Non-systematic Assessment
EG0003 affected16 at risk
EG0015 affected15 at risk
EG0024 affected18 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 27.0
Non-systematic Assessment
EG0001 affected16 at risk
EG0013 affected15 at risk
EG0022 affected18 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected18 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 27.0
Non-systematic Assessment
EG0001 affected16 at risk
EG0011 affected15 at risk
EG0021 affected18 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected18 at risk
EG003
Epigastric discomfort
Gastrointestinal disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Gastrointestinal fistula
Gastrointestinal disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0021 affected18 at risk
EG003
Gastrointestinal wall thickening
Gastrointestinal disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0021 affected18 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Haematemesis
Gastrointestinal disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0021 affected18 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Mucous stools
Gastrointestinal disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 27.0
Non-systematic Assessment
EG0003 affected16 at risk
EG0015 affected15 at risk
EG0024 affected18 at risk
EG003
Odynophagia
Gastrointestinal disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Oral dysaesthesia
Gastrointestinal disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0023 affected18 at risk
EG003
Tongue ulceration
Gastrointestinal disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 27.0
Non-systematic Assessment
EG0002 affected16 at risk
EG0014 affected15 at risk
EG0022 affected18 at risk
EG003
Asthenia
General disorders
MedDRA 27.0
Non-systematic Assessment
EG0002 affected16 at risk
EG0012 affected15 at risk
EG0020 affected18 at risk
EG003
Axillary pain
General disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected18 at risk
EG003
Chest discomfort
General disorders
MedDRA 27.0
Non-systematic Assessment
EG0001 affected16 at risk
EG0011 affected15 at risk
EG0020 affected18 at risk
EG003
Chest pain
General disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Chills
General disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected18 at risk
EG003
Face oedema
General disorders
MedDRA 27.0
Non-systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Fatigue
General disorders
MedDRA 27.0
Non-systematic Assessment
EG0006 affected16 at risk
EG0016 affected15 at risk
EG0026 affected18 at risk
EG003
General physical health deterioration
General disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Generalised oedema
General disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0021 affected18 at risk
EG003
Influenza like illness
General disorders
MedDRA 27.0
Non-systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Injection site extravasation
General disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0021 affected18 at risk
EG003
Localised oedema
General disorders
MedDRA 27.0
Non-systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Malaise
General disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0021 affected18 at risk
EG003
Medical device pain
General disorders
MedDRA 27.0
Non-systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0021 affected18 at risk
EG003
Oedema peripheral
General disorders
MedDRA 27.0
Non-systematic Assessment
EG0003 affected16 at risk
EG0010 affected15 at risk
EG0023 affected18 at risk
EG003
Pain
General disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0021 affected18 at risk
EG003
Peripheral swelling
General disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Pyrexia
General disorders
MedDRA 27.0
Non-systematic Assessment
EG0001 affected16 at risk
EG0012 affected15 at risk
EG0023 affected18 at risk
EG003
Hepatic failure
Hepatobiliary disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Hepatitis
Hepatobiliary disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0021 affected18 at risk
EG003
Immune-mediated hepatitis
Hepatobiliary disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Cytokine release syndrome
Immune system disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA 27.0
Non-systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
COVID-19
Infections and infestations
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Carbuncle
Infections and infestations
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0021 affected18 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Cystitis
Infections and infestations
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0021 affected18 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Herpes zoster reactivation
Infections and infestations
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Hordeolum
Infections and infestations
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Infection
Infections and infestations
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Influenza
Infections and infestations
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Kidney infection
Infections and infestations
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0021 affected18 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0023 affected18 at risk
EG003
Paronychia
Infections and infestations
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Peritonitis
Infections and infestations
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0022 affected18 at risk
EG003
Pneumonia pseudomonal
Infections and infestations
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0021 affected18 at risk
EG003
Postoperative wound infection
Infections and infestations
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected18 at risk
EG003
Rhinovirus infection
Infections and infestations
MedDRA 27.0
Non-systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Sialoadenitis
Infections and infestations
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Stoma site infection
Infections and infestations
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Tooth infection
Infections and infestations
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0021 affected18 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 27.0
Non-systematic Assessment
EG0004 affected16 at risk
EG0012 affected15 at risk
EG0021 affected18 at risk
EG003
Wound infection
Infections and infestations
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0021 affected18 at risk
EG003
Head injury
Injury, poisoning and procedural complications
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0021 affected18 at risk
EG003
Wound
Injury, poisoning and procedural complications
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Wound secretion
Injury, poisoning and procedural complications
MedDRA 27.0
Non-systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Wrist fracture
Injury, poisoning and procedural complications
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected18 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 27.0
Non-systematic Assessment
EG0001 affected16 at risk
EG0012 affected15 at risk
EG0021 affected18 at risk
EG003
Amylase increased
Investigations
MedDRA 27.0
Non-systematic Assessment
EG0001 affected16 at risk
EG0011 affected15 at risk
EG0022 affected18 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0023 affected18 at risk
EG003
Blood albumin decreased
Investigations
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0024 affected18 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0023 affected18 at risk
EG003
Blood folate decreased
Investigations
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Blood iron decreased
Investigations
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0021 affected18 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Blood magnesium decreased
Investigations
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected18 at risk
EG003
Blood pH decreased
Investigations
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Blood testosterone decreased
Investigations
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Blood urea increased
Investigations
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0021 affected18 at risk
EG003
Blood uric acid increased
Investigations
MedDRA 27.0
Non-systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0021 affected18 at risk
EG003
Lipase increased
Investigations
MedDRA 27.0
Non-systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0022 affected18 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0022 affected18 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Platelet count decreased
Investigations
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0021 affected18 at risk
EG003
Platelet count increased
Investigations
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Protein total decreased
Investigations
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Transaminases increased
Investigations
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Weight decreased
Investigations
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0013 affected15 at risk
EG0023 affected18 at risk
EG003
Weight increased
Investigations
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected18 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 27.0
Non-systematic Assessment
EG0005 affected16 at risk
EG0010 affected15 at risk
EG0024 affected18 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 27.0
Non-systematic Assessment
EG0001 affected16 at risk
EG0011 affected15 at risk
EG0023 affected18 at risk
EG003
Fluid retention
Metabolism and nutrition disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected18 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0021 affected18 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 27.0
Non-systematic Assessment
EG0001 affected16 at risk
EG0012 affected15 at risk
EG0020 affected18 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Hypervolaemia
Metabolism and nutrition disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0021 affected18 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0025 affected18 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 27.0
Non-systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0021 affected18 at risk
EG003
Hypochloraemia
Metabolism and nutrition disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0021 affected18 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0023 affected18 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0023 affected18 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 27.0
Non-systematic Assessment
EG0001 affected16 at risk
EG0012 affected15 at risk
EG0024 affected18 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0022 affected18 at risk
EG003
Hypovolaemia
Metabolism and nutrition disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected18 at risk
EG003
Iron deficiency
Metabolism and nutrition disorders
MedDRA 27.0
Non-systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Metabolic acidosis
Metabolism and nutrition disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected18 at risk
EG003
Vitamin D deficiency
Metabolism and nutrition disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected18 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Non-systematic Assessment
EG0001 affected16 at risk
EG0012 affected15 at risk
EG0022 affected18 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Non-systematic Assessment
EG0002 affected16 at risk
EG0014 affected15 at risk
EG0020 affected18 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected18 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected18 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected18 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Non-systematic Assessment
EG0001 affected16 at risk
EG0011 affected15 at risk
EG0020 affected18 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Non-systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0022 affected18 at risk
EG003
Myopathy
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0021 affected18 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0021 affected18 at risk
EG003
Tendon pain
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Torticollis
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.0
Non-systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Lipoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0021 affected18 at risk
EG003
Metastases to central nervous system
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Tumour associated fever
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected18 at risk
EG003
Amnesia
Nervous system disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Aphasia
Nervous system disorders
MedDRA 27.0
Non-systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Central nervous system lesion
Nervous system disorders
MedDRA 27.0
Non-systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 27.0
Non-systematic Assessment
EG0001 affected16 at risk
EG0011 affected15 at risk
EG0022 affected18 at risk
EG003
Dysarthria
Nervous system disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected18 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 27.0
Non-systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Headache
Nervous system disorders
MedDRA 27.0
Non-systematic Assessment
EG0001 affected16 at risk
EG0011 affected15 at risk
EG0023 affected18 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 27.0
Non-systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Hypokinesia
Nervous system disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Lethargy
Nervous system disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0021 affected18 at risk
EG003
Migraine
Nervous system disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 27.0
Non-systematic Assessment
EG0001 affected16 at risk
EG0011 affected15 at risk
EG0020 affected18 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 27.0
Non-systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected18 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Syncope
Nervous system disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected18 at risk
EG003
Tremor
Nervous system disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Agitation
Psychiatric disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 27.0
Non-systematic Assessment
EG0001 affected16 at risk
EG0011 affected15 at risk
EG0020 affected18 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Depression
Psychiatric disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0021 affected18 at risk
EG003
Dysphoria
Psychiatric disorders
MedDRA 27.0
Non-systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Hallucination
Psychiatric disorders
MedDRA 27.0
Non-systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0021 affected18 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 27.0
Non-systematic Assessment
EG0001 affected16 at risk
EG0012 affected15 at risk
EG0022 affected18 at risk
EG003
Personality change
Psychiatric disorders
MedDRA 27.0
Non-systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Poor quality sleep
Psychiatric disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected18 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0021 affected18 at risk
EG003
Cystitis haemorrhagic
Renal and urinary disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected18 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0021 affected18 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected18 at risk
EG003
Nocturia
Renal and urinary disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected18 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0024 affected18 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 27.0
Non-systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Urogenital haemorrhage
Renal and urinary disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected18 at risk
EG003
Scrotal oedema
Reproductive system and breast disorders
MedDRA 27.0
Non-systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Scrotal pain
Reproductive system and breast disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected18 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0021 affected18 at risk
EG003
Bronchiectasis
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0021 affected18 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0012 affected15 at risk
EG0022 affected18 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Non-systematic Assessment
EG0005 affected16 at risk
EG0015 affected15 at risk
EG0023 affected18 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0021 affected18 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Non-systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0021 affected18 at risk
EG003
Lung infiltration
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0021 affected18 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0022 affected18 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0022 affected18 at risk
EG003
Paranasal sinus discomfort
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Non-systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Non-systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Pleuritic pain
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected18 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Non-systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0023 affected18 at risk
EG003
Respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0021 affected18 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0021 affected18 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Rhonchi
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0021 affected18 at risk
EG003
Sinus pain
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Non-systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0021 affected18 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Decubitus ulcer
Skin and subcutaneous tissue disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0021 affected18 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0021 affected18 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0021 affected18 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected18 at risk
EG003
Nail bed bleeding
Skin and subcutaneous tissue disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0021 affected18 at risk
EG003
Nail disorder
Skin and subcutaneous tissue disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Nail ridging
Skin and subcutaneous tissue disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Panniculitis
Skin and subcutaneous tissue disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected18 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 27.0
Non-systematic Assessment
EG0001 affected16 at risk
EG0013 affected15 at risk
EG0021 affected18 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0012 affected15 at risk
EG0021 affected18 at risk
EG003
Skin hyperpigmentation
Skin and subcutaneous tissue disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected18 at risk
EG003
Skin hypopigmentation
Skin and subcutaneous tissue disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA 27.0
Non-systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Vitiligo
Skin and subcutaneous tissue disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Embolism
Vascular disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0021 affected18 at risk
EG003
Flushing
Vascular disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Haematoma
Vascular disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Hot flush
Vascular disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected15 at risk
EG0021 affected18 at risk
EG003
Hypertension
Vascular disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0012 affected15 at risk
EG0024 affected18 at risk
EG003
Hypotension
Vascular disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0021 affected18 at risk
EG003
Lymphoedema
Vascular disorders
MedDRA 27.0
Non-systematic Assessment
EG0000 affected16 at risk
EG0011 affected15 at risk
EG0020 affected18 at risk
EG003
Superior vena cava syndrome
Vascular disorders
MedDRA 27.0
Non-systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 at risk
EG003
Thrombosis
Vascular disorders
MedDRA 27.0
Non-systematic Assessment
EG0001 affected16 at risk
EG0010 affected15 at risk
EG0020 affected18 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