Phase 1/2 Study Exploring the Safety, Tolerability, and E... | NCT03126110 | Trialant
NCT03126110
Sponsor
Incyte Biosciences International SÃ rl
Status
Completed
Last Update Posted
Aug 14, 2025Actual
Enrollment
145Actual
Phase
Phase 1Phase 2
Conditions
Advanced Malignancies
Metastatic Cancer
Interventions
INCAGN01876
Nivolumab
Ipilimumab
Countries
United States
Australia
Belgium
Spain
Protocol Section
Identification Module
NCT ID
NCT03126110
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
INCAGN 1876-201
Secondary IDs
ID
Type
Description
Link
2016-004989-25
EudraCT Number
Brief Title
Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of INCAGN01876 Combined With Immune Therapies in Advanced or Metastatic Malignancies
Official Title
A Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of INCAGN01876 in Combination With Immune Therapies in Subjects With Advanced or Metastatic Malignancies
Acronym
Not provided
Organization
Incyte CorporationINDUSTRY
Status Module
Record Verification Date
Aug 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
Not provided
Start Date
Apr 25, 2017Actual
Primary Completion Date
Nov 9, 2021Actual
Completion Date
Nov 9, 2021Actual
First Submitted Date
Apr 19, 2017
First Submission Date that Met QC Criteria
Apr 21, 2017
First Posted Date
Apr 24, 2017Actual
Results Waived
Not provided
Results First Submitted Date
Nov 3, 2022
Results First Submitted that Met QC Criteria
Dec 6, 2022
Results First Posted Date
Dec 28, 2022Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Aug 12, 2025
Last Update Posted Date
Aug 14, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Incyte Biosciences International SÃ rlINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to determine the safety, tolerability, and efficacy of INCAGN01876 when given in combination with immune therapies in subjects with advanced or metastatic malignancies.
Detailed Description
Not provided
Conditions Module
Conditions
Advanced Malignancies
Metastatic Cancer
Keywords
cervical cancer
endometrial cancer
gastric cancer (stomach, esophageal, and gastroesophageal junction [GEJ])
hepatocellular carcinoma (HCC)
melanoma
Merkel cell carcinoma
mesothelioma
microsatellite instability-high (MSI-H) colorectal cancer (CRC)
non-small cell lung cancer (NSCLC)
ovarian cancer
squamous cell carcinoma of the head and neck (SCCHN)
Participants received INCAGN01876 1.0 milligrams per kilogram (mg/kg) administered intravenously (IV) every 2 weeks (Q2W) in combination with nivolumab 240 mg administered IV Q2W.
Participants received INCAGN01876 10.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
Drug: INCAGN01876
Drug: Nivolumab
Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, then nivolumab 240 mg Q2W
Experimental
Interventions
Name
Type
Description
Arm Group Labels
Other Names
INCAGN01876
Drug
In Phase 1 participants will receive INCAGN01876 administered intravenously (IV) at the protocol-defined dose according to cohort enrollment. In Phase 2, participants will be administered IV study drug at the recommended dose from Phase 1 ().
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Phase 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. Abnormal laboratory values or test results occurring after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study drug(s). A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study medication.
up to approximately 27.4 months
Phase 2: Objective Response Rate (ORR) Per RECIST v1.1
ORR was defined as the percentage of participants with a best overall response of confirmed complete response (CR) or partial response (PR), determined by investigator assessment of radiographic disease assessments per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1). CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.
up to approximately 44.7 months
Secondary Outcomes
Measure
Description
Time Frame
Phase 1: ORR Per RECIST v1.1
ORR was defined as the percentage of participants with a best overall response of unconfirmed CR or PR, determined by investigator assessment of radiographic disease assessments per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Locally advanced or metastatic disease; locally advanced disease must not be amenable to resection with curative intent.
Phase 1: Subjects with advanced or metastatic solid tumors.
Phase 1: Subjects who have disease progression after treatment with available therapies.
Phase 2: Subjects with advanced or metastatic cervical cancer, gastric cancer (including stomach, esophageal, and GEJ), SCCHN, PD-1 refractory SCCHN and PD-1/PD-L1 relapsed melanoma.
Presence of measurable disease based on RECIST v1.1.
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
Exclusion Criteria:
Laboratory and medical history parameters not within the Protocol-defined range
Prior treatment with any tumor necrosis factor super family agonist.
Receipt of anticancer medications or investigational drugs within protocol-defined intervals before the first administration of study drug.
Has not recovered to ≤ Grade 1 from toxic effects of prior therapy.
Active autoimmune disease.
Known active central nervous system metastases and/or carcinomatous meningitis.
Evidence of active, noninfectious pneumonitis or history of interstitial lung disease.
Evidence of hepatitis B virus or hepatitis C virus infection or risk of reactivation.
Known history of human immunodeficiency virus (HIV; HIV 1/2 antibodies).
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
John E. Janik, MD
Incyte Corporation
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
The Angeles Clinic and Research Institute
Los Angeles
California
90025
United States
University of Florida
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Participants were enrolled at 32 study centers in Australia, Belgium, Spain, and the United States.
Participants received INCAGN01876 1.0 milligrams per kilogram (mg/kg) administered intravenously (IV) every 2 weeks (Q2W) in combination with nivolumab 240 mg administered IV Q2W.
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by INCAGN01876 1.0 mg/kg Q2W in combination with nivolumab 240 mg administered IV Q2W starting at Cycle 3.
Drug: INCAGN01876
Drug: Nivolumab
Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, then nivolumab 240 mg Q2W
Experimental
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by INCAGN01876 1.0 mg/kg Q2W in combination with nivolumab 240 mg administered IV Q2W starting at Cycle 3.
Drug: INCAGN01876
Drug: Nivolumab
Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, then nivolumab 240 mg Q2W
Experimental
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by INCAGN01876 5.0 mg/kg Q2W in combination with nivolumab 240 mg administered IV Q2W starting at Cycle 3.
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
Drug: INCAGN01876
Drug: Ipilimumab
Phase 1 Group D: INCAGN01876 + Nivolumab + Ipilimumab
Experimental
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 3 mg/kg administered IV Q2W and ipilimumab 1 mg/kg administered IV Q6W.
Participants with programmed cell death protein/programmed cell death ligand 1 (PD-1/PD-L1) relapsed melanoma received INCAGN01876 300 mg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
Drug: INCAGN01876
Drug: Ipilimumab
Phase 2 Group F GC: INCAGN01876 300 mg + nivolumab 240 mg
Experimental
Participants with gastric cancer (GC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
Drug: INCAGN01876
Drug: Nivolumab
Phase 2 Group F SCCHN INCAGN01876 300 mg + nivolumab 240 mg
Experimental
Participants with squamous cell carcinoma of the head and neck (SCCHN) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
Drug: INCAGN01876
Drug: Nivolumab
Phase 2 Group F CC: INCAGN01876 300 mg + nivolumab 240 mg
Experimental
Participants with cervical cancer (CC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
Drug: INCAGN01876
Drug: Nivolumab
Phase 2 Group F PD-1/PD-L1: INCAGN01876 300 mg + nivolumab 240 mg
Experimental
Participants with PD-1/PD-L1 relapsed melanoma received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
Drug: INCAGN01876
Drug: Nivolumab
Phase 2 Group F Biopsy: INCAGN01876 300 mg + nivolumab 240 mg
Experimental
Participants with gastric cancer, squamous cell carcinoma of the head and neck, cervical cancer, or PD-1/PD-L1 relapsed melanoma who had tumor lesions that were amenable to percutaneous biopsy received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
ORR was defined as the percentage of participants with a best overall response of unconfirmed CR or PR, determined by investigator assessment of radiographic disease assessments per mRECIST v1.1. The response of target lesions was evaluated from the percentage change in the sum of the diameters of the viable portions (portions enhanced during the arterial phase). CR: Disappearance of any intratumoral arterial enhancement during in target lesions, disappearance of all non-target lesions, and no appearance of any new lesions. PR: ≥30% of the sum of the diameters of viable portions (enhancement on arterial phase) of target lesions taking as reference the Baseline sum, no new lesions, and no progression of non-target lesions.
up to approximately 44.7 months
Phase 2: ORR Per mRECIST v1.1
ORR was defined as the percentage of participants with a best overall response of confirmed CR or PR, determined by investigator assessment of radiographic disease assessments per mRECIST v1.1. The response of target lesions was evaluated from the percentage change in the sum of the diameters of the viable portions (portions enhanced during the arterial phase). CR: Disappearance of any intratumoral arterial enhancement during in target lesions, disappearance of all non-target lesions, and no appearance of any new lesions. PR: ≥30% of the sum of the diameters of viable portions (enhancement on arterial phase) of target lesions taking as reference the Baseline sum, no new lesions, and no progression of non-target lesions.
up to approximately 44.7 months
Phase 1: Duration of Response (DOR) Per RECIST v1.1
DOR was defined as the time from the first overall response contributing to an unconfirmed objective response (CR or PR) to the earlier of the participant's death from any cause or the first assessment of PD, determined by investigator assessment of radiographic disease assessment per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion.
up to approximately 44.7 months
Phase 2: DOR Per RECIST v1.1
DOR was defined as the time from the first overall response contributing to a confirmed objective response (CR or PR) to the earlier of the participant's death from any cause or the first assessment of PD, determined by investigator assessment of radiographic disease assessment per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion.
up to approximately 44.7 months
Phase 1: DOR Per mRECIST v1.1
DOR was defined as the time from the first unconfirmed overall response contributing to an unconfirmed objective response (CR or PR) to the earlier of the participant's death from any cause or the first confirmed assessment of PD, determined by investigator assessment of radiographic disease assessment per mRECIST v1.1. The response of target lesions was evaluated from the percentage change in the sum of the diameters of the viable portions (portions enhanced during the arterial phase). CR: Disappearance of any intratumoral arterial enhancement during in target lesions, disappearance of all non-target lesions, and no appearance of any new lesions. PR: ≥30% of the sum of the diameters of viable portions (enhancement on arterial phase) of target lesions taking as reference the Baseline sum, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion.
up to approximately 44.7 months
Phase 2: DOR Per mRECIST v1.1
DOR was defined as the time from the first overall response contributing to a confirmed objective response (CR or PR) to the earlier of the participant's death from any cause or the first assessment of PD, determined by investigator assessment of radiographic disease assessment per mRECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion.
up to approximately 44.7 months
Phase 1: Disease Control Rate (DCR) Per RECIST v1.1
DCR was defined as the percentage of participants with a best overall response of unconfirmed CR, unconfirmed PR, or stable disease (SD; ≥49 days), determined by investigator assessment of radiographic disease assessments per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD.
up to approximately 44.7 months
Phase 2: DCR Per RECIST v1.1
DCR was defined as the percentage of participants with a best overall response of confirmed CR, confirmed PR, or SD (≥49 days), determined by investigator assessment of radiographic disease assessments per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD.
up to approximately 44.7 months
Phase 1: DCR Per mRECIST v1.1
DCR was defined as the percentage of participants with a best overall response of unconfirmed CR, unconfirmed PR, or stable disease (SD; ≥49 days), determined by investigator assessment of radiographic disease assessments per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD.
up to approximately 44.7 months
Phase 2: DCR Per mRECIST v1.1
DCR was defined as the percentage of participants with a best overall response of confirmed CR, confirmed PR, or SD (≥49 days), determined by investigator assessment of radiographic disease assessments per mRECIST v1.1. The response of target lesions was evaluated from the percentage change in the sum of the diameters of the viable portions (portions enhanced during the arterial phase). CR: Disappearance of any intratumoral arterial enhancement during in target lesions, disappearance of all non-target lesions, and no appearance of any new lesions. PR: ≥30% of the sum of the diameters of viable portions (enhancement on arterial phase) of target lesions taking as reference the Baseline sum, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD.
up to approximately 44.7 months
Phase 1: Duration of Disease Control Per RECIST v1.1
Duration of disease control (CR, PR, and SD [≥49 days]) was measured from the start of treatment until PD or death from any cause, if occurring sooner than progression, determined by investigator assessment of radiographic disease per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD.
up to approximately 44.7 months
Phase 2: Duration of Disease Control Per RECIST v1.1
Duration of disease control (CR, PR, and SD [≥49 days]) was measured from the start of treatment until PD or death from any cause, if occurring sooner than progression, determined by investigator assessment of radiographic disease per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD.
up to approximately 44.7 months
Phase 1: Duration of Disease Control Per mRECIST v1.1
Duration of disease control (CR, PR, and SD [≥49 days]) was measured from the start of treatment until PD or death from any cause, if occurring sooner than progression, determined by investigator assessment of radiographic disease per RECIST v1.1. The response of target lesions was evaluated from the percentage change in the sum of the diameters of the viable portions (portions enhanced during the arterial phase). CR: Disappearance of any intratumoral arterial enhancement during in target lesions, disappearance of all non-target lesions, and no appearance of any new lesions. PR: ≥30% of the sum of the diameters of viable portions (enhancement on arterial phase) of target lesions taking as reference the Baseline sum, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD.
up to approximately 44.7 months
Phase 2: Duration of Disease Control Per mRECIST v1.1
Duration of disease control (CR, PR, and SD [≥49 days]) was measured from the start of treatment until PD or death from any cause, if occurring sooner than progression, determined by investigator assessment of radiographic disease per RECIST v1.1. The response of target lesions was evaluated from the percentage change in the sum of the diameters of the viable portions (portions enhanced during the arterial phase). CR: Disappearance of any intratumoral arterial enhancement during in target lesions, disappearance of all non-target lesions, and no appearance of any new lesions. PR: ≥30% of the sum of the diameters of viable portions (enhancement on arterial phase) of target lesions taking as reference the Baseline sum, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD. [](streamdown:incomplete-link)
up to approximately 44.7 months
Phase 1: Progression-free Survival (PFS) Per RECIST v1.1
According to RECIST 1.1, PFS was defined as the length of time between the Baseline visit (Day 1) and the earlier of death or the first assessment of PD, as determined by investigator assessment of objective radiographic disease assessments.
up to approximately 44.7 months
Phase 2: PFS Per RECIST v1.1
According to RECIST 1.1, PFS was defined as the length of time between the Baseline visit (Day 1) and the earlier of death or the first assessment of PD, as determined by investigator assessment of objective radiographic disease assessments.
up to approximately 44.7 months
Phase 1: PFS Per mRECIST v1.1
According to mRECIST 1.1, PFS was defined as the length of time between the Baseline visit (Day 1) and the earlier of the participant's death or the first confirmed assessment of PD, as determined by investigator assessment of objective radiographic disease assessments. The response of target lesions was evaluated from the percentage change in the sum of the diameters of the viable portions (portions enhanced during the arterial phase).
up to approximately 44.7 months
Phase 2: PFS Per mRECIST v1.1
According to mRECIST 1.1, PFS was defined as the length of time between the Baseline visit (Day 1) and the earlier of the participant's death or the first confirmed assessment of PD, as determined by investigator assessment of objective radiographic disease assessments. The response of target lesions was evaluated from the percentage change in the sum of the diameters of the viable portions (portions enhanced during the arterial phase).
up to approximately 44.7 months
Phase 1: Overall Survival
Overall survival was defined as the interval between the Baseline visit (Day 1) and the date of death due to any cause.
up to approximately 44.7 months
Phase 2: Overall Survival
Overall survival was defined as the interval between the Baseline visit (Day 1) and the date of death due to any cause.
up to approximately 44.7 months
Phase 2: : Number of Participants With Any TEAE
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. Abnormal laboratory values or test results occurring after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study drug(s). A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study medication.
up to approximately 27.4 months
Gainesville
Florida
32610
United States
Karmanos Cancer Institute
Detroit
Michigan
48201
United States
Washington University - Siteman Cancer Center
St Louis
Missouri
37201
United States
Hackensack University Medical Center
Hackensack
New Jersey
07601
United States
Memorial Sloan Kettering Cancer
New York
New York
10065
United States
The University of North Carolina at Chapel Hill
Chapel Hill
North Carolina
27599
United States
University of Oklahoma, Sarah Cannon Research Institute
Oklahoma City
Oklahoma
73104
United States
Providance Portland Medical Center
Portland
Oregon
97213
United States
Fox Chase Cancer Center
Philadelphia
Pennsylvania
19111
United States
University of Pittsburgh, UPMC Cancer Pavilion
Pittsburgh
Pennsylvania
15232
United States
Tennessee Oncology, Sarah Cannon Research Institute
Nashville
Tennessee
37201
United States
BUMC Mary Crowley Cancer Research Centers
Dallas
Texas
75230
United States
MD Anderson
Houston
Texas
77030
United States
Seattle Cancer Care Alliance
Seattle
Washington
98109
United States
Blacktown Cancer and Haematology Centre
Blacktown
New South Wales
2148
Australia
Scientia Clinical Research
Randwick
New South Wales
2148
Australia
Greenslopes Private Hospital
Brisbane
Queensland
4120
Australia
Austin Hospital
Heidelberg
Victoria
3084
Australia
Linear Clinical Research
Perth
Western Australia
6009
Australia
CHA Centre Hospitalier de l'Ardenne
Libramont
Chevigny
6800
Belgium
Saint Augustinus Hospital
Antwerp
2610
Belgium
Institut Jules Bordet
Brussels
1000
Belgium
CHU Brugmann
Brussels
1020
Belgium
Cliniques Universitaires Saint-Luc
Brussels
1200
Belgium
Mi Kryviy Rih Center of Dnipropetrovsk Regional Council
Charleroi
6000
Belgium
Ghent University Hospital
Ghent
37201
Belgium
AZ Groeninge
Kortrijk
8500
Belgium
Hospital Clinic I Provincial
Barcelona
08036
Spain
Hospital Clinico y Provincial de Barcelona
Barcelona
08036
Spain
Institut Catala D'Oncologia-Badalona
Barcelona
08916
Spain
Hospital Vall de Hebron
Barcelona
Spain
Hospital Reina Sophia
Córdoba
14004
Spain
University Hospital Ramon y Cajal
Madrid
28034
Spain
Hospital Universitario Doce de Octubre
Madrid
28041
Spain
Hospital HM Sanchinarro
Madrid
28050
Spain
Clinica Universidad De Navarra (CUN)
Pamplona
31008
Spain
Hospital Universitario Virgen Del Rocio
Seville
41015
Spain
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
Participants received INCAGN01876 10.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
FG004
Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
FG005
Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
FG006
Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
FG010
Phase 1 Group D: INCAGN01876 + Nivolumab + Ipilimumab
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 3 mg/kg administered IV Q2W and ipilimumab 1 mg/kg administered IV Q6W.
Participants with programmed cell death protein/programmed cell death ligand 1 (PD-1/PD-L1) relapsed melanoma (RM) received INCAGN01876 300 mg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
FG012
Phase 2 Group F GC: INCAGN01876 300 mg + Nivolumab 240 mg
Participants with gastric cancer (GC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
FG013
Phase 2 Group F SCCHN INCAGN01876 300 mg + Nivolumab 240 mg
Participants with squamous cell carcinoma of the head and neck (SCCHN) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
FG014
Phase 2 Group F CC: INCAGN01876 300 mg + Nivolumab 240 mg
Participants with cervical cancer (CC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
FG015
Phase 2 Group F PD-1/PD-L1 RM: INCAGN01876 300 mg + Nivolumab 240 mg
Participants with PD-1/PD-L1 relapsed melanoma received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
FG016
Phase 2 Group F Biopsy: INCAGN01876 300 mg + Nivolumab 240 mg
Participants with gastric cancer, squamous cell carcinoma of the head and neck, cervical cancer, or PD-1/PD-L1 relapsed melanoma who had tumor lesions that were amenable to percutaneous biopsy received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
FG0004 subjects
FG0014 subjects
FG0025 subjects
FG0034 subjects
FG0045 subjects
FG0054 subjects
FG0064 subjects
FG0074 subjects
FG0088 subjects
FG0093 subjects
FG0106 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
COMPLETED
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
NOT COMPLETED
FG0004 subjects
FG0013 subjects
FG0025 subjects
FG0034 subjects
FG0045 subjects
FG0054 subjects
FG0063 subjects
FG0074 subjects
FG0088 subjects
FG0093 subjects
FG0106 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
Type
Comment
Reasons
Death
FG0002 subjects
FG0012 subjects
FG0024 subjects
FG0033 subjects
FG0044 subjects
FG0054 subjects
FG0063 subjects
FG0074 subjects
FG0085 subjects
FG0092 subjects
FG0106 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
Lost to Follow-up
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Safety follow-up no longer necessary
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Survival follow-up no longer necessary
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Phase 2
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0118 subjects
FG01216 subjects
FG01346 subjects
FG01418 subjects
FG0154 subjects
FG0162 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Study terminated by the sponsor
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
The full analysis set (FAS) included all participants enrolled in the study who received at least 1 dose of study drug.
Participants received INCAGN01876 1.0 milligrams per kilogram (mg/kg) administered intravenously (IV) every 2 weeks (Q2W) in combination with nivolumab 240 mg administered IV Q2W.
Participants received INCAGN01876 10.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
BG004
Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
BG005
Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
BG006
Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
BG010
Phase 1 Group D: INCAGN01876 + Nivolumab + Ipilimumab
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 3 mg/kg administered IV Q2W and ipilimumab 1 mg/kg administered IV Q6W.
Participants with programmed cell death protein/programmed cell death ligand 1 (PD-1/PD-L1) relapsed melanoma (RM) received INCAGN01876 300 mg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
BG012
Phase 2 Group F GC: INCAGN01876 300 mg + Nivolumab 240 mg
Participants with gastric cancer (GC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
BG013
Phase 2 Group F SCCHN INCAGN01876 300 mg + Nivolumab 240 mg
Participants with squamous cell carcinoma of the head and neck (SCCHN) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
BG014
Phase 2 Group F CC: INCAGN01876 300 mg + Nivolumab 240 mg
Participants with cervical cancer (CC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
BG015
Phase 2 Group F PD-1/PD-L1 RM: INCAGN01876 300 mg + Nivolumab 240 mg
Participants with PD-1/PD-L1 relapsed melanoma received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
BG016
Phase 2 Group F Biopsy: INCAGN01876 300 mg + Nivolumab 240 mg
Participants with gastric cancer, squamous cell carcinoma of the head and neck, cervical cancer, or PD-1/PD-L1 relapsed melanoma who had tumor lesions that were amenable to percutaneous biopsy received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
BG017
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0004
BG0014
BG0025
BG0034
BG0045
BG0054
BG0064
BG0074
BG0088
BG0093
BG0106
BG0118
BG01216
BG01346
BG01418
BG0154
BG0162
BG017145
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00051.3± 7.37
BG00159.8± 14.03
BG00248.0± 18.23
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0002
BG0012
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0001
BG0011
BG002
Race/Ethnicity, Customized
Ethnicity
Number
Participants
Title
Denominators
Categories
White/Caucasian
Title
Measurements
BG0002
BG0013
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Phase 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. Abnormal laboratory values or test results occurring after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study drug(s). A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study medication.
Phase 1 Full Analysis Set (FAS): all participants enrolled in Phase 1 of the study who received at least 1 dose of INCAGN01876, nivolumab, or ipilimumab
Participants received INCAGN01876 10.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
OG004
Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
OG005
Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
OG006
Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 3 mg/kg administered IV Q2W and ipilimumab 1 mg/kg administered IV Q6W.
Units
Counts
Participants
OG0004
OG0014
OG0025
OG003
Title
Denominators
Categories
Title
Measurements
OG0004
OG0014
OG0025
OG003
Primary
Phase 2: Objective Response Rate (ORR) Per RECIST v1.1
ORR was defined as the percentage of participants with a best overall response of confirmed complete response (CR) or partial response (PR), determined by investigator assessment of radiographic disease assessments per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1). CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.
Phase 2 Response Evaluable Population: all participants enrolled in Phase 2 who received at least 1 dose of INCAGN01876, nivolumab, or ipilimumab; completed a Baseline scan; and met at least 1 of the following criteria: (a) ≥1 post-Baseline scan (b) the participant has been in the study for a minimum of 64 days of follow-up; or (c) the participant had discontinued from treatment
Participants with programmed cell death protein/programmed cell death ligand 1 (PD-1/PD-L1) relapsed melanoma (RM) received INCAGN01876 300 mg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
OG001
Phase 2 Group F GC: INCAGN01876 300 mg + Nivolumab 240 mg
Secondary
Phase 1: ORR Per RECIST v1.1
ORR was defined as the percentage of participants with a best overall response of unconfirmed CR or PR, determined by investigator assessment of radiographic disease assessments per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.
Phase 1 Response Evaluable Population: all participants enrolled in Phase 1 who received at least 1 dose of INCAGN01876, nivolumab, or ipilimumab; completed a Baseline scan; and met at least 1 of the following criteria: (a) ≥1 post-Baseline scan (b) the participant has been in the study for a minimum of 64 days of follow-up; or (c) the participant had discontinued from treatment
Participants received INCAGN01876 1.0 milligrams per kilogram (mg/kg) administered intravenously (IV) every 2 weeks (Q2W) in combination with nivolumab 240 mg administered IV Q2W.INCAGN01876 combined with nivolumab.
ORR was defined as the percentage of participants with a best overall response of unconfirmed CR or PR, determined by investigator assessment of radiographic disease assessments per mRECIST v1.1. The response of target lesions was evaluated from the percentage change in the sum of the diameters of the viable portions (portions enhanced during the arterial phase). CR: Disappearance of any intratumoral arterial enhancement during in target lesions, disappearance of all non-target lesions, and no appearance of any new lesions. PR: ≥30% of the sum of the diameters of viable portions (enhancement on arterial phase) of target lesions taking as reference the Baseline sum, no new lesions, and no progression of non-target lesions.
Participants received INCAGN01876 1.0 milligrams per kilogram (mg/kg) administered intravenously (IV) every 2 weeks (Q2W) in combination with nivolumab 240 mg administered IV Q2W.INCAGN01876 combined with nivolumab.
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
Secondary
Phase 2: ORR Per mRECIST v1.1
ORR was defined as the percentage of participants with a best overall response of confirmed CR or PR, determined by investigator assessment of radiographic disease assessments per mRECIST v1.1. The response of target lesions was evaluated from the percentage change in the sum of the diameters of the viable portions (portions enhanced during the arterial phase). CR: Disappearance of any intratumoral arterial enhancement during in target lesions, disappearance of all non-target lesions, and no appearance of any new lesions. PR: ≥30% of the sum of the diameters of viable portions (enhancement on arterial phase) of target lesions taking as reference the Baseline sum, no new lesions, and no progression of non-target lesions.
Participants with programmed cell death protein/programmed cell death ligand 1 (PD-1/PD-L1) relapsed melanoma (RM) received INCAGN01876 300 mg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
OG001
Phase 2 Group F GC: INCAGN01876 300 mg + Nivolumab 240 mg
Participants with gastric cancer (GC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
Secondary
Phase 1: Duration of Response (DOR) Per RECIST v1.1
DOR was defined as the time from the first overall response contributing to an unconfirmed objective response (CR or PR) to the earlier of the participant's death from any cause or the first assessment of PD, determined by investigator assessment of radiographic disease assessment per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion.
Phase 1 Response Evaluable Population. Only those participants with a response of CR or PR were analyzed. The confidence interval for median survival time was calculated using the method of Brookmeyer and Crowley.
Participants received INCAGN01876 1.0 milligrams per kilogram (mg/kg) administered intravenously (IV) every 2 weeks (Q2W) in combination with nivolumab 240 mg administered IV Q2W.INCAGN01876 combined with nivolumab.
DOR was defined as the time from the first overall response contributing to a confirmed objective response (CR or PR) to the earlier of the participant's death from any cause or the first assessment of PD, determined by investigator assessment of radiographic disease assessment per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion.
Phase 2 Response Evaluable Population. Only those participants with a response of CR or PR were analyzed. The confidence interval for median survival time was calculated using the method of Brookmeyer and Crowley.
Participants with programmed cell death protein/programmed cell death ligand 1 (PD-1/PD-L1) relapsed melanoma (RM) received INCAGN01876 300 mg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
OG001
Phase 2 Group F GC: INCAGN01876 300 mg + Nivolumab 240 mg
Secondary
Phase 1: DOR Per mRECIST v1.1
DOR was defined as the time from the first unconfirmed overall response contributing to an unconfirmed objective response (CR or PR) to the earlier of the participant's death from any cause or the first confirmed assessment of PD, determined by investigator assessment of radiographic disease assessment per mRECIST v1.1. The response of target lesions was evaluated from the percentage change in the sum of the diameters of the viable portions (portions enhanced during the arterial phase). CR: Disappearance of any intratumoral arterial enhancement during in target lesions, disappearance of all non-target lesions, and no appearance of any new lesions. PR: ≥30% of the sum of the diameters of viable portions (enhancement on arterial phase) of target lesions taking as reference the Baseline sum, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion.
Phase 1 Response Evaluable Population. Only those participants with a response of CR or PR were analyzed. The confidence interval for median survival time was calculated using the method of Brookmeyer and Crowley.
DOR was defined as the time from the first overall response contributing to a confirmed objective response (CR or PR) to the earlier of the participant's death from any cause or the first assessment of PD, determined by investigator assessment of radiographic disease assessment per mRECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion.
Phase 2 Response Evaluable Population. Only those participants with a response of CR or PR were analyzed. The confidence interval for median survival time was calculated using the method of Brookmeyer and Crowley.
Participants with programmed cell death protein/programmed cell death ligand 1 (PD-1/PD-L1) relapsed melanoma (RM) received INCAGN01876 300 mg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
OG001
Phase 2 Group F GC: INCAGN01876 300 mg + Nivolumab 240 mg
Secondary
Phase 1: Disease Control Rate (DCR) Per RECIST v1.1
DCR was defined as the percentage of participants with a best overall response of unconfirmed CR, unconfirmed PR, or stable disease (SD; ≥49 days), determined by investigator assessment of radiographic disease assessments per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD.
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
Secondary
Phase 2: DCR Per RECIST v1.1
DCR was defined as the percentage of participants with a best overall response of confirmed CR, confirmed PR, or SD (≥49 days), determined by investigator assessment of radiographic disease assessments per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD.
Participants with programmed cell death protein/programmed cell death ligand 1 (PD-1/PD-L1) relapsed melanoma (RM) received INCAGN01876 300 mg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
OG001
Phase 2 Group F GC: INCAGN01876 300 mg + Nivolumab 240 mg
Participants with gastric cancer (GC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
Secondary
Phase 1: DCR Per mRECIST v1.1
DCR was defined as the percentage of participants with a best overall response of unconfirmed CR, unconfirmed PR, or stable disease (SD; ≥49 days), determined by investigator assessment of radiographic disease assessments per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD.
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
OG002
Secondary
Phase 2: DCR Per mRECIST v1.1
DCR was defined as the percentage of participants with a best overall response of confirmed CR, confirmed PR, or SD (≥49 days), determined by investigator assessment of radiographic disease assessments per mRECIST v1.1. The response of target lesions was evaluated from the percentage change in the sum of the diameters of the viable portions (portions enhanced during the arterial phase). CR: Disappearance of any intratumoral arterial enhancement during in target lesions, disappearance of all non-target lesions, and no appearance of any new lesions. PR: ≥30% of the sum of the diameters of viable portions (enhancement on arterial phase) of target lesions taking as reference the Baseline sum, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD.
Participants with programmed cell death protein/programmed cell death ligand 1 (PD-1/PD-L1) relapsed melanoma (RM) received INCAGN01876 300 mg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
OG001
Phase 2 Group F GC: INCAGN01876 300 mg + Nivolumab 240 mg
Participants with gastric cancer (GC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
Secondary
Phase 1: Duration of Disease Control Per RECIST v1.1
Duration of disease control (CR, PR, and SD [≥49 days]) was measured from the start of treatment until PD or death from any cause, if occurring sooner than progression, determined by investigator assessment of radiographic disease per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD.
Phase 1 Response Evaluable Population. The confidence intervals was calculated based on the exact method for binomial distributions. Only those participants with a response of SD, CR, or PR were analyzed.
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
Secondary
Phase 2: Duration of Disease Control Per RECIST v1.1
Duration of disease control (CR, PR, and SD [≥49 days]) was measured from the start of treatment until PD or death from any cause, if occurring sooner than progression, determined by investigator assessment of radiographic disease per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD.
Phase 2 Response Evaluable Population. The confidence intervals was calculated based on the exact method for binomial distributions. Only those participants with a response of SD, CR, or PR were analyzed.
Participants with programmed cell death protein/programmed cell death ligand 1 (PD-1/PD-L1) relapsed melanoma (RM) received INCAGN01876 300 mg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
OG001
Phase 2 Group F GC: INCAGN01876 300 mg + Nivolumab 240 mg
Secondary
Phase 1: Duration of Disease Control Per mRECIST v1.1
Duration of disease control (CR, PR, and SD [≥49 days]) was measured from the start of treatment until PD or death from any cause, if occurring sooner than progression, determined by investigator assessment of radiographic disease per RECIST v1.1. The response of target lesions was evaluated from the percentage change in the sum of the diameters of the viable portions (portions enhanced during the arterial phase). CR: Disappearance of any intratumoral arterial enhancement during in target lesions, disappearance of all non-target lesions, and no appearance of any new lesions. PR: ≥30% of the sum of the diameters of viable portions (enhancement on arterial phase) of target lesions taking as reference the Baseline sum, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD.
Phase 1 Response Evaluable Population. The confidence intervals was calculated based on the exact method for binomial distributions. Only those participants with a response of SD, CR, or PR were analyzed.
Phase 2: Duration of Disease Control Per mRECIST v1.1
Duration of disease control (CR, PR, and SD [≥49 days]) was measured from the start of treatment until PD or death from any cause, if occurring sooner than progression, determined by investigator assessment of radiographic disease per RECIST v1.1. The response of target lesions was evaluated from the percentage change in the sum of the diameters of the viable portions (portions enhanced during the arterial phase). CR: Disappearance of any intratumoral arterial enhancement during in target lesions, disappearance of all non-target lesions, and no appearance of any new lesions. PR: ≥30% of the sum of the diameters of viable portions (enhancement on arterial phase) of target lesions taking as reference the Baseline sum, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD. [](streamdown:incomplete-link)
Phase 2 Response Evaluable Population. The confidence intervals was calculated based on the exact method for binomial distributions. Only those participants with a response of SD, CR, or PR were analyzed.
Participants with programmed cell death protein/programmed cell death ligand 1 (PD-1/PD-L1) relapsed melanoma (RM) received INCAGN01876 300 mg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
OG001
Secondary
Phase 1: Progression-free Survival (PFS) Per RECIST v1.1
According to RECIST 1.1, PFS was defined as the length of time between the Baseline visit (Day 1) and the earlier of death or the first assessment of PD, as determined by investigator assessment of objective radiographic disease assessments.
Phase 1 FAS. Median survival time was estimated using the Kaplan-Meier method. The confidence interval for median survival time was calculated using the method of Brookmeyer and Crowley.
Participants received INCAGN01876 1.0 milligrams per kilogram (mg/kg) administered intravenously (IV) every 2 weeks (Q2W) in combination with nivolumab 240 mg administered IV Q2W.INCAGN01876 combined with nivolumab.
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
Secondary
Phase 2: PFS Per RECIST v1.1
According to RECIST 1.1, PFS was defined as the length of time between the Baseline visit (Day 1) and the earlier of death or the first assessment of PD, as determined by investigator assessment of objective radiographic disease assessments.
Phase 2 FAS. Median survival time was estimated using the Kaplan-Meier method. The confidence interval for median survival time was calculated using the method of Brookmeyer and Crowley.
Participants with programmed cell death protein/programmed cell death ligand 1 (PD-1/PD-L1) relapsed melanoma (RM) received INCAGN01876 300 mg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
OG001
Phase 2 Group F GC: INCAGN01876 300 mg + Nivolumab 240 mg
Participants with gastric cancer (GC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
OG002
Phase 2 Group F SCCHN INCAGN01876 300 mg + Nivolumab 240 mg
Participants with squamous cell carcinoma of the head and neck (SCCHN) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
Secondary
Phase 1: PFS Per mRECIST v1.1
According to mRECIST 1.1, PFS was defined as the length of time between the Baseline visit (Day 1) and the earlier of the participant's death or the first confirmed assessment of PD, as determined by investigator assessment of objective radiographic disease assessments. The response of target lesions was evaluated from the percentage change in the sum of the diameters of the viable portions (portions enhanced during the arterial phase).
Phase 1 FAS. Median survival time was estimated using the Kaplan-Meier method. The confidence interval for median survival time was calculated using the method of Brookmeyer and Crowley.
Participants received INCAGN01876 1.0 milligrams per kilogram (mg/kg) administered intravenously (IV) every 2 weeks (Q2W) in combination with nivolumab 240 mg administered IV Q2W.INCAGN01876 combined with nivolumab.
According to mRECIST 1.1, PFS was defined as the length of time between the Baseline visit (Day 1) and the earlier of the participant's death or the first confirmed assessment of PD, as determined by investigator assessment of objective radiographic disease assessments. The response of target lesions was evaluated from the percentage change in the sum of the diameters of the viable portions (portions enhanced during the arterial phase).
Phase 2 FAS. Median survival time was estimated using the Kaplan-Meier method. The confidence interval for median survival time was calculated using the method of Brookmeyer and Crowley.
Participants with programmed cell death protein/programmed cell death ligand 1 (PD-1/PD-L1) relapsed melanoma (RM) received INCAGN01876 300 mg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
OG001
Phase 2 Group F GC: INCAGN01876 300 mg + Nivolumab 240 mg
Participants with gastric cancer (GC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
OG002
Phase 2 Group F SCCHN INCAGN01876 300 mg + Nivolumab 240 mg
Secondary
Phase 1: Overall Survival
Overall survival was defined as the interval between the Baseline visit (Day 1) and the date of death due to any cause.
Phase 1 FAS. Median survival time was estimated using the Kaplan-Meier method. The confidence interval for median survival time was calculated using the method of Brookmeyer and Crowley.
Participants received INCAGN01876 1.0 milligrams per kilogram (mg/kg) administered intravenously (IV) every 2 weeks (Q2W) in combination with nivolumab 240 mg administered IV Q2W.INCAGN01876 combined with nivolumab.
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
Secondary
Phase 2: Overall Survival
Overall survival was defined as the interval between the Baseline visit (Day 1) and the date of death due to any cause.
Phase 2 FAS. Median survival time was estimated using the Kaplan-Meier method. The confidence interval for median survival time was calculated using the method of Brookmeyer and Crowley.
Participants with programmed cell death protein/programmed cell death ligand 1 (PD-1/PD-L1) relapsed melanoma (RM) received INCAGN01876 300 mg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
OG001
Phase 2 Group F GC: INCAGN01876 300 mg + Nivolumab 240 mg
Participants with gastric cancer (GC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
OG002
Phase 2 Group F SCCHN INCAGN01876 300 mg + Nivolumab 240 mg
Participants with squamous cell carcinoma of the head and neck (SCCHN) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
Secondary
Phase 2: : Number of Participants With Any TEAE
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. Abnormal laboratory values or test results occurring after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study drug(s). A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study medication.
Participants with programmed cell death protein/programmed cell death ligand 1 (PD-1/PD-L1) relapsed melanoma (RM) received INCAGN01876 300 mg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
OG001
Phase 2 Group F GC: INCAGN01876 300 mg + Nivolumab 240 mg
Participants with gastric cancer (GC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
OG002
Time Frame
up to approximately 27.4 months
Description
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
Participants received INCAGN01876 1.0 milligrams per kilogram (mg/kg) administered intravenously (IV) every 2 weeks (Q2W) in combination with nivolumab 240 mg administered IV Q2W.
Participants received INCAGN01876 10.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
3
4
2
4
3
4
EG004
Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
4
5
2
5
5
5
EG005
Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
4
4
1
4
4
4
EG006
Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
2
3
1
3
3
3
EG010
Phase 1 Group D: INCAGN01876 + Nivolumab + Ipilimumab
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 3 mg/kg administered IV Q2W and ipilimumab 1 mg/kg administered IV Q6W.
Participants with programmed cell death protein/programmed cell death ligand 1 (PD-1/PD-L1) relapsed melanoma (RM) received INCAGN01876 300 mg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
6
8
3
8
8
8
EG012
Phase 2 Group F GC: INCAGN01876 300 mg + Nivolumab 240 mg
Participants with gastric cancer (GC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
12
16
11
16
15
16
EG013
Phase 2 Group F SCCHN INCAGN01876 300 mg + Nivolumab 240 mg
Participants with squamous cell carcinoma of the head and neck (SCCHN) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
25
46
19
46
43
46
EG014
Phase 2 Group F CC: INCAGN01876 300 mg + Nivolumab 240 mg
Participants with cervical cancer (CC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
11
18
10
18
18
18
EG015
Phase 2 Group F PD-1/PD-L1 RM: INCAGN01876 300 mg + Nivolumab 240 mg
Participants with PD-1/PD-L1 relapsed melanoma received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
3
4
2
4
4
4
EG016
Phase 2 Group F Biopsy: INCAGN01876 300 mg + Nivolumab 240 mg
Participants with gastric cancer, squamous cell carcinoma of the head and neck, cervical cancer, or PD-1/PD-L1 relapsed melanoma who had tumor lesions that were amenable to percutaneous biopsy received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
2
2
1
2
2
2
EG017
Total
Total
98
145
68
145
139
145
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal pain
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0002 events1 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected8 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected8 at risk
EG0122 events2 affected16 at risk
EG0130 events0 affected46 at risk
EG0141 events1 affected18 at risk
EG0150 events0 affected4 at risk
EG0160 events0 affected2 at risk
EG0175 events4 affected145 at risk
Abdominal pain upper
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Atrioventricular block
Cardiac disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Breast cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Bronchial obstruction
Respiratory, thoracic and mediastinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Cerebral artery embolism
Nervous system disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Cerebral ischaemia
Nervous system disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Chest pain
General disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Death
General disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Device occlusion
Product Issues
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Diabetic ketoacidosis
Metabolism and nutrition disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected5 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Encephalopathy
Nervous system disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Endocarditis staphylococcal
Infections and infestations
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Escherichia urinary tract infection
Infections and infestations
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Facial pain
General disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Failure to thrive
Metabolism and nutrition disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
General physical health deterioration
General disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Headache
Nervous system disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0022 events1 affected5 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected5 at risk
EG003
Hypotension
Vascular disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Large intestine perforation
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Myocarditis
Cardiac disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Myoclonus
Nervous system disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Myopathy
Musculoskeletal and connective tissue disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Obstructive airways disorder
Respiratory, thoracic and mediastinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Oesophageal obstruction
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Performance status decreased
General disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Peripheral motor neuropathy
Nervous system disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Peripheral swelling
General disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Pneumonia klebsiella
Infections and infestations
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0022 events2 affected5 at risk
EG003
Post procedural haemorrhage
Injury, poisoning and procedural complications
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Pseudomonal bacteraemia
Infections and infestations
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Pulmonary artery aneurysm
Respiratory, thoracic and mediastinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Pyelonephritis acute
Infections and infestations
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Pyrexia
General disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Sepsis
Infections and infestations
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Spinal cord compression
Nervous system disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Spinal fracture
Injury, poisoning and procedural complications
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Syncope
Nervous system disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Toxicity to various agents
Injury, poisoning and procedural complications
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Tumour haemorrhage
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Urinary tract disorder
Renal and urinary disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Urosepsis
Infections and infestations
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Wound complication
Injury, poisoning and procedural complications
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Wound infection
Infections and infestations
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal discomfort
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected4 at risk
EG0081 events1 affected8 at risk
EG0090 events0 affected3 at risk
EG0101 events1 affected6 at risk
EG0110 events0 affected8 at risk
EG0120 events0 affected16 at risk
EG0130 events0 affected46 at risk
EG0140 events0 affected18 at risk
EG0150 events0 affected4 at risk
EG0160 events0 affected2 at risk
EG0172 events2 affected145 at risk
Abdominal distension
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected4 at risk
EG0012 events2 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 24
Systematic Assessment
EG0002 events1 affected4 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Allodynia
Nervous system disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Amylase increased
Investigations
MedDRA 24
Systematic Assessment
EG0003 events1 affected4 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 24
Systematic Assessment
EG0002 events1 affected4 at risk
EG0011 events1 affected4 at risk
EG0021 events1 affected5 at risk
EG003
Anorectal discomfort
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected4 at risk
EG0022 events2 affected5 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 24
Systematic Assessment
EG0001 events1 affected4 at risk
EG0012 events2 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Asthenia
General disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Atelectasis
Respiratory, thoracic and mediastinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Balance disorder
Nervous system disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Bladder irritation
Renal and urinary disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Blood cholesterol increased
Investigations
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Breast hyperplasia
Reproductive system and breast disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Breast pain
Reproductive system and breast disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
C-reactive protein increased
Investigations
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Cataract
Eye disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Catheter site pain
General disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Cestode infection
Infections and infestations
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Chest discomfort
General disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Chest pain
General disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Chills
General disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Chromaturia
Renal and urinary disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Chronic kidney disease
Renal and urinary disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Clostridium test positive
Investigations
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Conjunctival haemorrhage
Eye disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Corneal abrasion
Injury, poisoning and procedural complications
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected4 at risk
EG0012 events2 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected5 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Depression
Psychiatric disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Diaphragmatic hernia
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected5 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Dizziness postural
Nervous system disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Duodenal ulcer
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected5 at risk
EG003
Dyschezia
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected5 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Ear infection
Infections and infestations
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Embolism
Vascular disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Encephalopathy
Nervous system disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Eructation
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Eye pruritus
Eye disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 24
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Fatigue
General disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected4 at risk
EG0022 events2 affected5 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0002 events1 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Flushing
Vascular disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected5 at risk
EG003
Folate deficiency
Metabolism and nutrition disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Folliculitis
Infections and infestations
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Fungal infection
Infections and infestations
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Fungal skin infection
Infections and infestations
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected5 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Headache
Nervous system disorders
MedDRA 24
Systematic Assessment
EG0002 events2 affected4 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected5 at risk
EG003
Heart rate increased
Investigations
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Helminthic infection
Infections and infestations
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Hepatic enzyme increased
Investigations
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Hordeolum
Infections and infestations
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Hot flush
Vascular disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected5 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0022 events2 affected5 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Hypernatraemia
Metabolism and nutrition disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected5 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Hypertension
Vascular disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected5 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected5 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected5 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected5 at risk
EG003
Hypotension
Vascular disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Inadequate analgesia
General disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Incontinence
Renal and urinary disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Increased tendency to bruise
Blood and lymphatic system disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Infected cyst
Infections and infestations
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Influenza
Infections and infestations
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Influenza like illness
General disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Ingrowing nail
Skin and subcutaneous tissue disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Intermenstrual bleeding
Reproductive system and breast disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Iridocyclitis
Eye disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Iron deficiency
Metabolism and nutrition disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Lethargy
Nervous system disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Lipase increased
Investigations
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected5 at risk
EG003
Lymph node pain
Blood and lymphatic system disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Malaise
General disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Malnutrition
Metabolism and nutrition disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Medical device site pain
General disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Menopausal symptoms
Reproductive system and breast disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Mucosal infection
Infections and infestations
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Muscle disorder
Musculoskeletal and connective tissue disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0022 events2 affected5 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0013 events1 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected5 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Oedema
General disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Oedema peripheral
General disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Oesophageal candidiasis
Infections and infestations
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Oesophageal stenosis
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Omphalitis
Infections and infestations
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Pain
General disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Pelvic discomfort
Reproductive system and breast disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Penile infection
Infections and infestations
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Penile pain
Reproductive system and breast disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Peripheral coldness
Vascular disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected5 at risk
EG003
Peripheral motor neuropathy
Nervous system disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Peripheral swelling
General disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Platelet count decreased
Investigations
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Pneumococcal sepsis
Infections and infestations
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Polydipsia
Metabolism and nutrition disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Proctalgia
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Protein total decreased
Investigations
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0012 events1 affected4 at risk
EG0022 events2 affected5 at risk
EG003
Pruritus genital
Reproductive system and breast disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Pyelonephritis acute
Infections and infestations
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Pyrexia
General disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected5 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected5 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Rash pustular
Infections and infestations
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Renal impairment
Renal and urinary disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Respiratory disorder
Respiratory, thoracic and mediastinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Retinal tear
Eye disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Sciatica
Nervous system disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Scrotal infection
Infections and infestations
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Seroma
Injury, poisoning and procedural complications
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Skin infection
Infections and infestations
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected5 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Syncope
Nervous system disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Synovial rupture
Injury, poisoning and procedural complications
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Tendon pain
Musculoskeletal and connective tissue disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Tension headache
Nervous system disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Tremor
Nervous system disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Troponin I increased
Investigations
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Ureteric obstruction
Renal and urinary disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected5 at risk
EG003
Urinary tract obstruction
Renal and urinary disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Urosepsis
Infections and infestations
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Varices oesophageal
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Vision blurred
Eye disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Vitamin B12 deficiency
Metabolism and nutrition disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Vitamin D deficiency
Metabolism and nutrition disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Vulvovaginal dryness
Reproductive system and breast disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Vulvovaginal mycotic infection
Infections and infestations
MedDRA 24
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 at risk
EG003
Weight decreased
Investigations
MedDRA 24
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected5 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
Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.
Female Urogenital Diseases and Pregnancy Complications
D000091642
Urogenital Diseases
D000091662
Genital Diseases
D005770
Gastrointestinal Neoplasms
D004067
Digestive System Neoplasms
D004066
Digestive System Diseases
D005767
Gastrointestinal Diseases
D013272
Stomach Diseases
D000230
Adenocarcinoma
D002277
Carcinoma
D009375
Neoplasms, Glandular and Epithelial
D009370
Neoplasms by Histologic Type
D008113
Liver Neoplasms
D008107
Liver Diseases
D018358
Neuroendocrine Tumors
D017599
Neuroectodermal Tumors
D009373
Neoplasms, Germ Cell and Embryonal
D009380
Neoplasms, Nerve Tissue
D018326
Nevi and Melanomas
D012878
Skin Neoplasms
D012871
Skin Diseases
D017437
Skin and Connective Tissue Diseases
D027601
Polyomavirus Infections
D004266
DNA Virus Infections
D014777
Virus Diseases
D007239
Infections
D014412
Tumor Virus Infections
D018278
Carcinoma, Neuroendocrine
D000236
Adenoma
D018301
Neoplasms, Mesothelial
D007414
Intestinal Neoplasms
D003108
Colonic Diseases
D007410
Intestinal Diseases
D012002
Rectal Diseases
D002283
Carcinoma, Bronchogenic
D001984
Bronchial Neoplasms
D008175
Lung Neoplasms
D012142
Respiratory Tract Neoplasms
D013899
Thoracic Neoplasms
D008171
Lung Diseases
D012140
Respiratory Tract Diseases
D004701
Endocrine Gland Neoplasms
D010049
Ovarian Diseases
D000291
Adnexal Diseases
D004700
Endocrine System Diseases
D006058
Gonadal Disorders
D002294
Carcinoma, Squamous Cell
D006258
Head and Neck Neoplasms
D007680
Kidney Neoplasms
D014571
Urologic Neoplasms
D007674
Kidney Diseases
D014570
Urologic Diseases
D052801
Male Urogenital Diseases
D001943
Breast Neoplasms
D001941
Breast Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D000077594
Nivolumab
D000074324
Ipilimumab
Ancestor Terms
ID
Term
D061067
Antibodies, Monoclonal, Humanized
D000911
Antibodies, Monoclonal
D000906
Antibodies
D007136
Immunoglobulins
D007162
Immunoproteins
D001798
Blood Proteins
D011506
Proteins
D000602
Amino Acids, Peptides, and Proteins
D012712
Serum Globulins
D005916
Globulins
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
1 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0082 subjects
FG0091 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG01312 subjects
FG0142 subjects
FG0150 subjects
FG0160 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0118 subjects
FG01216 subjects
FG01334 subjects
FG01416 subjects
FG0154 subjects
FG0162 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0134 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0111 subjects
FG0123 subjects
FG0133 subjects
FG0142 subjects
FG0151 subjects
FG0160 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0111 subjects
FG0121 subjects
FG0131 subjects
FG0142 subjects
FG0150 subjects
FG0160 subjects
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0116 subjects
FG01212 subjects
FG01325 subjects
FG01411 subjects
FG0153 subjects
FG0162 subjects
Progressive Disease
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0131 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
Started new treatment
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0141 subjects
FG0150 subjects
FG0160 subjects
62.3
± 7.04
BG00460.8± 12.40
BG00562.5± 16.36
BG00663.0± 9.90
BG00761.5± 11.73
BG00861.8± 7.70
BG00967.7± 4.16
BG01058.5± 11.24
BG01169.1± 9.46
BG01259.1± 10.48
BG01360.5± 9.46
BG01448.6± 9.43
BG01554.3± 9.29
BG01642.0± 16.97
BG01758.56± 11.38
5
BG0033
BG0043
BG0053
BG0063
BG0073
BG0085
BG0091
BG0102
BG0113
BG0125
BG0138
BG01418
BG0151
BG0161
BG01768
Male
BG0002
BG0012
BG0020
BG0031
BG0042
BG0051
BG0061
BG0071
BG0083
BG0092
BG0104
BG0115
BG01211
BG01338
BG0140
BG0153
BG0161
BG01777
1
BG0030
BG0041
BG0050
BG0060
BG0070
BG0081
BG0090
BG0100
BG0110
BG0121
BG0131
BG0141
BG0150
BG0160
BG0178
Not Hispanic or Latino
BG0003
BG0013
BG0024
BG0034
BG0044
BG0054
BG0064
BG0074
BG0087
BG0093
BG0106
BG0118
BG01214
BG01343
BG01417
BG0154
BG0162
BG017134
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0121
BG0132
BG0140
BG0150
BG0160
BG0173
4
BG0033
BG0042
BG0053
BG0064
BG0073
BG0086
BG0093
BG0106
BG0118
BG01214
BG01345
BG01416
BG0154
BG0162
BG017128
Black or African American
Title
Measurements
BG0001
BG0010
BG0021
BG0031
BG0040
BG0051
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0121
BG0131
BG0141
BG0150
BG0160
BG0177
Asian
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0042
BG0050
BG0060
BG0071
BG0081
BG0090
BG0100
BG0110
BG0120
BG0130
BG0141
BG0150
BG0160
BG0175
American Indian or Alaska Native
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
BG0160
BG0170
Native Hawaiin or Other Pacific Islander
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
BG0160
BG0170
Other: Captured as "Other"
Title
Measurements
BG0001
BG0011
BG0020
BG0030
BG0041
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
BG0160
BG0173
Other: Zimbabwean
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0121
BG0130
BG0140
BG0150
BG0160
BG0171
Other: Mexican
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0081
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
BG0160
BG0171
4
OG0045
OG0054
OG0064
OG0074
OG0088
OG0093
OG0106
4
OG0045
OG0054
OG0064
OG0074
OG0087
OG0093
OG0106
Participants with gastric cancer (GC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
OG002
Phase 2 Group F SCCHN INCAGN01876 300 mg + Nivolumab 240 mg
Participants with squamous cell carcinoma of the head and neck (SCCHN) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
OG003
Phase 2 Group F CC: INCAGN01876 300 mg + Nivolumab 240 mg
Participants with cervical cancer (CC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
OG004
Phase 2 Group F PD-1/PD-L1 RM: INCAGN01876 300 mg + Nivolumab 240 mg
Participants with PD-1/PD-L1 relapsed melanoma received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
OG005
Phase 2 Group F Biopsy: INCAGN01876 300 mg + Nivolumab 240 mg
Participants with gastric cancer, squamous cell carcinoma of the head and neck, cervical cancer, or PD-1/PD-L1 relapsed melanoma who had tumor lesions that were amenable to percutaneous biopsy received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
Units
Counts
Participants
OG0008
OG00116
OG00246
OG00318
OG0044
OG0052
Title
Denominators
Categories
Title
Measurements
OG0000.0
OG0010.0
OG00223.9
OG00316.7
OG0040.0
OG0050.0
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
Participants received INCAGN01876 10.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
OG004
Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
OG005
Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
OG006
Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
OG010
Phase 1 Group D: INCAGN01876 + Nivolumab + Ipilimumab
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 3 mg/kg administered IV Q2W and ipilimumab 1 mg/kg administered IV Q6W.
Participants received INCAGN01876 10.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
OG004
Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
OG005
Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
OG006
Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
OG010
Phase 1 Group D: INCAGN01876 + Nivolumab + Ipilimumab
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 3 mg/kg administered IV Q2W and ipilimumab 1 mg/kg administered IV Q6W.
Units
Counts
Participants
OG0004
OG0014
OG0025
OG0034
OG0045
OG0054
OG0064
OG0074
OG0088
OG0093
OG0106
Title
Denominators
Categories
Title
Measurements
OG00025.0
OG0010.0
OG00220.0
OG0030.0
OG0040.0
OG0050.0
OG00625.0
OG00725.0
OG00812.5
OG0090.0
OG0100.0
OG002
Phase 2 Group F SCCHN INCAGN01876 300 mg + Nivolumab 240 mg
Participants with squamous cell carcinoma of the head and neck (SCCHN) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
OG003
Phase 2 Group F CC: INCAGN01876 300 mg + Nivolumab 240 mg
Participants with cervical cancer (CC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
OG004
Phase 2 Group F PD-1/PD-L1 RM: INCAGN01876 300 mg + Nivolumab 240 mg
Participants with PD-1/PD-L1 relapsed melanoma received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
OG005
Phase 2 Group F Biopsy: INCAGN01876 300 mg + Nivolumab 240 mg
Participants with gastric cancer, squamous cell carcinoma of the head and neck, cervical cancer, or PD-1/PD-L1 relapsed melanoma who had tumor lesions that were amenable to percutaneous biopsy received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
Units
Counts
Participants
OG0008
OG00116
OG00246
OG00318
OG0044
OG0052
Title
Denominators
Categories
Title
Measurements
OG0000.0
OG0010.0
OG00226.1
OG00316.7
OG0040.0
OG0050.0
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
Participants received INCAGN01876 10.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
OG004
Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
OG005
Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
OG006
Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
OG010
Phase 1 Group D: INCAGN01876 + Nivolumab + Ipilimumab
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 3 mg/kg administered IV Q2W and ipilimumab 1 mg/kg administered IV Q6W.
Units
Counts
Participants
OG0001
OG0010
OG0021
OG0030
OG0040
OG0050
OG0061
OG0071
OG0081
OG0090
OG0100
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)The median and the upper and lower limits of the confidence interval were not estimable because too few participants had disease progression or died.
OG002573.0(NA to NA)The upper and lower limits of the confidence interval were not estimable because too few participants had disease progression or died.
OG006876.0(NA to NA)The upper and lower limits of the confidence interval were not estimable because too few participants had disease progression or died.
OG007NA(NA to NA)The median and the upper and lower limits of the confidence interval were not estimable because too few participants had disease progression or died.
OG008281.0(NA to NA)The upper and lower limits of the confidence interval were not estimable because too few participants had disease progression or died.
Participants with gastric cancer (GC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
OG002
Phase 2 Group F SCCHN INCAGN01876 300 mg + Nivolumab 240 mg
Participants with squamous cell carcinoma of the head and neck (SCCHN) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
OG003
Phase 2 Group F CC: INCAGN01876 300 mg + Nivolumab 240 mg
Participants with cervical cancer (CC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
OG004
Phase 2 Group F PD-1/PD-L1 RM: INCAGN01876 300 mg + Nivolumab 240 mg
Participants with PD-1/PD-L1 relapsed melanoma received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
Participants with gastric cancer, squamous cell carcinoma of the head and neck, cervical cancer, or PD-1/PD-L1 relapsed melanoma who had tumor lesions that were amenable to percutaneous biopsy received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
Units
Counts
Participants
OG0000
OG0010
OG00211
OG0033
OG0040
OG0050
Title
Denominators
Categories
Title
Measurements
OG002NA(118.0 to NA)The median and the upper limit of the confidence interval were not estimable because too few participants had disease progression or died.
OG003120.0(113.0 to NA)The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
Participants received INCAGN01876 10.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
OG004
Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
OG005
Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
OG006
Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 3 mg/kg administered IV Q2W and ipilimumab 1 mg/kg administered IV Q6W.
Units
Counts
Participants
OG0001
OG0010
OG0021
OG0030
OG0040
OG0050
OG0061
OG0071
OG0081
OG0090
OG0100
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)The median and the upper and lower limits of the confidence interval were not estimable because too few participants had disease progression or died.
OG002NA(NA to NA)The median and the upper and lower limits of the confidence interval were not estimable because too few participants had disease progression or died.
OG006876.0(NA to NA)The upper and lower limits of the confidence interval were not estimable because too few participants had disease progression or died.
OG007NA(NA to NA)The median and the upper and lower limits of the confidence interval were not estimable because too few participants had disease progression or died.
OG008NA(NA to NA)The median and the upper and lower limits of the confidence interval were not estimable because too few participants had disease progression or died.
Participants with gastric cancer (GC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
OG002
Phase 2 Group F SCCHN INCAGN01876 300 mg + Nivolumab 240 mg
Participants with squamous cell carcinoma of the head and neck (SCCHN) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
OG003
Phase 2 Group F CC: INCAGN01876 300 mg + Nivolumab 240 mg
Participants with cervical cancer (CC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
OG004
Phase 2 Group F PD-1/PD-L1 RM: INCAGN01876 300 mg + Nivolumab 240 mg
Participants with PD-1/PD-L1 relapsed melanoma received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
Participants with gastric cancer, squamous cell carcinoma of the head and neck, cervical cancer, or PD-1/PD-L1 relapsed melanoma who had tumor lesions that were amenable to percutaneous biopsy received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
Units
Counts
Participants
OG0000
OG0010
OG00212
OG0033
OG0040
OG0050
Title
Denominators
Categories
Title
Measurements
OG002NA(NA to NA)The median and the upper and lower limits of the confidence interval were not estimable because too few participants had disease progression or died.
OG003NA(113.0 to NA)The median and the upper limit of the confidence interval were not estimable because too few participants had disease progression or died.
Participants received INCAGN01876 10.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
OG004
Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
OG005
Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
OG006
Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 3 mg/kg administered IV Q2W and ipilimumab 1 mg/kg administered IV Q6W.
Units
Counts
Participants
OG0004
OG0014
OG0025
OG0034
OG0045
OG0054
OG0064
OG0074
OG0088
OG0093
OG0106
Title
Denominators
Categories
Title
Measurements
OG00025.0
OG00150.0
OG00220.0
OG00350.0
OG0040.0
OG00525.0
OG00650.0
OG00725.0
OG00850.0
OG0090.0
OG0100.0
OG002
Phase 2 Group F SCCHN INCAGN01876 300 mg + Nivolumab 240 mg
Participants with squamous cell carcinoma of the head and neck (SCCHN) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
OG003
Phase 2 Group F CC: INCAGN01876 300 mg + Nivolumab 240 mg
Participants with cervical cancer (CC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
OG004
Phase 2 Group F PD-1/PD-L1 RM: INCAGN01876 300 mg + Nivolumab 240 mg
Participants with PD-1/PD-L1 relapsed melanoma received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
Participants with gastric cancer, squamous cell carcinoma of the head and neck, cervical cancer, or PD-1/PD-L1 relapsed melanoma who had tumor lesions that were amenable to percutaneous biopsy received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
Participants received INCAGN01876 10.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
OG004
Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
OG005
Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
OG006
Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 3 mg/kg administered IV Q2W and ipilimumab 1 mg/kg administered IV Q6W.
Units
Counts
Participants
OG0004
OG0014
OG0025
OG0034
OG0045
OG0054
OG0064
OG0074
OG0088
OG0093
OG0106
Title
Denominators
Categories
Title
Measurements
OG00025.0
OG00150.0
OG00220.0
OG00350.0
OG0040.0
OG00525.0
OG00650.0
OG00725.0
OG00850.0
OG0090.0
OG0100.0
OG002
Phase 2 Group F SCCHN INCAGN01876 300 mg + Nivolumab 240 mg
Participants with squamous cell carcinoma of the head and neck (SCCHN) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
OG003
Phase 2 Group F CC: INCAGN01876 300 mg + Nivolumab 240 mg
Participants with cervical cancer (CC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
OG004
Phase 2 Group F PD-1/PD-L1 RM: INCAGN01876 300 mg + Nivolumab 240 mg
Participants with PD-1/PD-L1 relapsed melanoma received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
Participants with gastric cancer, squamous cell carcinoma of the head and neck, cervical cancer, or PD-1/PD-L1 relapsed melanoma who had tumor lesions that were amenable to percutaneous biopsy received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
Participants received INCAGN01876 10.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
OG004
Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
OG005
Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
OG006
Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 3 mg/kg administered IV Q2W and ipilimumab 1 mg/kg administered IV Q6W.
Units
Counts
Participants
OG0001
OG0012
OG0021
OG0032
OG0040
OG0051
OG0062
OG0071
OG0084
OG0090
OG0100
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)The median and the upper and lower limits of the confidence interval were not estimable because too few participants had disease progression or died.
OG001NA(89.0 to NA)The median and the upper limit of the confidence interval were not estimable because too few participants had disease progression or died.
OG002624.0(NA to NA)The median was not estimable because too few participants had disease progression or died.
OG00376.0(NA to NA)The upper and lower limits of the confidence interval were not estimable because too few participants had disease progression or died.
OG005167.0(NA to NA)The upper and lower limits of the confidence interval were not estimable because too few participants had disease progression or died.
OG006668.5(125.0 to NA)The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
OG007NA(NA to NA)The median and the upper and lower limits of the confidence interval were not estimable because too few participants had disease progression or died.
OG008250.5(110.0 to NA)The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
Participants with gastric cancer (GC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
OG002
Phase 2 Group F SCCHN INCAGN01876 300 mg + Nivolumab 240 mg
Participants with squamous cell carcinoma of the head and neck (SCCHN) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
OG003
Phase 2 Group F CC: INCAGN01876 300 mg + Nivolumab 240 mg
Participants with cervical cancer (CC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
OG004
Phase 2 Group F PD-1/PD-L1 RM: INCAGN01876 300 mg + Nivolumab 240 mg
Participants with PD-1/PD-L1 relapsed melanoma received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
Participants with gastric cancer, squamous cell carcinoma of the head and neck, cervical cancer, or PD-1/PD-L1 relapsed melanoma who had tumor lesions that were amenable to percutaneous biopsy received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
Units
Counts
Participants
OG0003
OG0019
OG00225
OG00310
OG0042
OG0051
Title
Denominators
Categories
Title
Measurements
OG000218.0(106.0 to NA)The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
OG001109.0(63.0 to NA)The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
OG002253.0(156.0 to NA)The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
OG003168.0(71.0 to NA)The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
OG004206.5(118.0 to NA)The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
OG005109.0(NA to NA)The upper and lower limits of the confidence interval were not estimable because too few participants had disease progression or died.
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
Participants received INCAGN01876 10.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
OG004
Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
OG005
Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
OG006
Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 3 mg/kg administered IV Q2W and ipilimumab 1 mg/kg administered IV Q6W.
Units
Counts
Participants
OG0001
OG0012
OG0021
OG0032
OG0040
OG0051
OG0062
OG0071
OG0084
OG0090
OG0100
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)The median and the upper and lower limits of the confidence interval were not estimable because too few participants had disease progression or died.
OG001NA(NA to NA)The median and the upper and lower limits of the confidence interval were not estimable because too few participants had disease progression or died.
OG002NA(NA to NA)The median and the upper and lower limits of the confidence interval were not estimable because too few participants had disease progression or died.
OG00376.0(NA to NA)The upper and lower limits of the confidence interval were not estimable because too few participants had disease progression or died.
OG005NA(NA to NA)The median and the upper and lower limits of the confidence interval were not estimable because too few participants had disease progression or died.
OG006668.5(125.0 to NA)The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
OG007NA(NA to NA)The median and the upper and lower limits of the confidence interval were not estimable because too few participants had disease progression or died.
OG008NA(134.0 to NA)The median and the upper limit of the confidence interval were not estimable because too few participants had disease progression or died.
Phase 2 Group F GC: INCAGN01876 300 mg + Nivolumab 240 mg
Participants with gastric cancer (GC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
OG002
Phase 2 Group F SCCHN INCAGN01876 300 mg + Nivolumab 240 mg
Participants with squamous cell carcinoma of the head and neck (SCCHN) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
OG003
Phase 2 Group F CC: INCAGN01876 300 mg + Nivolumab 240 mg
Participants with cervical cancer (CC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
OG004
Phase 2 Group F PD-1/PD-L1 RM: INCAGN01876 300 mg + Nivolumab 240 mg
Participants with PD-1/PD-L1 relapsed melanoma received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
Participants with gastric cancer, squamous cell carcinoma of the head and neck, cervical cancer, or PD-1/PD-L1 relapsed melanoma who had tumor lesions that were amenable to percutaneous biopsy received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
Units
Counts
Participants
OG0003
OG0019
OG00226
OG00310
OG0042
OG0051
Title
Denominators
Categories
Title
Measurements
OG000218.0(133.0 to NA)The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
OG001168.0(63.0 to NA)The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
OG002NA(202.0 to NA)The median and the upper limit of the confidence interval were not estimable because too few participants had disease progression or died.
OG003NA(137.0 to NA)The median and the upper limit of the confidence interval were not estimable because too few participants had disease progression or died.
OG004NA(118.0 to NA)The median and the upper limit of the confidence interval were not estimable because too few participants had disease progression or died.
OG005NA(NA to NA)The median and the upper and lower limits of the confidence interval were not estimable because too few participants had disease progression or died.
Participants received INCAGN01876 10.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
OG004
Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
OG005
Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
OG006
Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
OG010
Phase 1 Group D: INCAGN01876 + Nivolumab + Ipilimumab
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 3 mg/kg administered IV Q2W and ipilimumab 1 mg/kg administered IV Q6W.
Units
Counts
Participants
OG0004
OG0014
OG0025
OG0034
OG0045
OG0054
OG0064
OG0074
OG0088
OG0093
OG0106
Title
Denominators
Categories
Title
Measurements
OG00052.5(48.0 to NA)The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
OG00172.0(53.0 to NA)The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
OG00253.0(9.0 to NA)The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
OG00364.0(48.0 to NA)The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
OG00447.5(29.0 to NA)The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
OG00560.0(50.0 to NA)The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
OG00688.5(44.0 to NA)The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
OG00741.0(15.0 to NA)The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
OG008110.0(53.0 to 276.0)
OG00956.0(53.0 to NA)The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
OG01054.5(21.0 to NA)The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
OG003
Phase 2 Group F CC: INCAGN01876 300 mg + Nivolumab 240 mg
Participants with cervical cancer (CC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
OG004
Phase 2 Group F PD-1/PD-L1 RM: INCAGN01876 300 mg + Nivolumab 240 mg
Participants with PD-1/PD-L1 relapsed melanoma received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
OG005
Phase 2 Group F Biopsy: INCAGN01876 300 mg + Nivolumab 240 mg
Participants with gastric cancer, squamous cell carcinoma of the head and neck, cervical cancer, or PD-1/PD-L1 relapsed melanoma who had tumor lesions that were amenable to percutaneous biopsy received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
Units
Counts
Participants
OG0008
OG00116
OG00246
OG00318
OG0044
OG0052
Title
Denominators
Categories
Title
Measurements
OG00057.0(20.0 to 218.0)
OG00175.0(45.0 to 120.0)
OG002115.0(59.0 to 174.0)
OG003102.0(51.0 to 225.0)
OG00487.0(52.0 to NA)The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
OG00564.5(20.0 to NA)The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
Participants received INCAGN01876 10.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
OG004
Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
OG005
Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
OG006
Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
OG010
Phase 1 Group D: INCAGN01876 + Nivolumab + Ipilimumab
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 3 mg/kg administered IV Q2W and ipilimumab 1 mg/kg administered IV Q6W.
Units
Counts
Participants
OG0004
OG0014
OG0025
OG0034
OG0045
OG0054
OG0064
OG0074
OG0088
OG0093
OG0106
Title
Denominators
Categories
Title
Measurements
OG00066.0(48.0 to NA)The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
OG001NA(55.0 to NA)The median and the upper limit of the confidence interval were not estimable because too few participants had disease progression or died.
OG002116.0(64.0 to NA)The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
OG00388.0(76.0 to NA)The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
OG00457.0(29.0 to NA)The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
OG005NA(100.0 to NA)The median and the upper limit of the confidence interval were not estimable because too few participants had disease progression or died.
OG00698.0(52.0 to NA)The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
OG007NA(97.0 to NA)The median and the upper limit of the confidence interval were not estimable because too few participants had disease progression or died.
OG008134.0(53.0 to NA)The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
OG009128.0(56.0 to NA)The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
OG010NA(46.0 to NA)The median and the upper limit of the confidence interval were not estimable because too few participants had disease progression or died.
Participants with squamous cell carcinoma of the head and neck (SCCHN) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
OG003
Phase 2 Group F CC: INCAGN01876 300 mg + Nivolumab 240 mg
Participants with cervical cancer (CC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
OG004
Phase 2 Group F PD-1/PD-L1 RM: INCAGN01876 300 mg + Nivolumab 240 mg
Participants with PD-1/PD-L1 relapsed melanoma received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
OG005
Phase 2 Group F Biopsy: INCAGN01876 300 mg + Nivolumab 240 mg
Participants with gastric cancer, squamous cell carcinoma of the head and neck, cervical cancer, or PD-1/PD-L1 relapsed melanoma who had tumor lesions that were amenable to percutaneous biopsy received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
Units
Counts
Participants
OG0008
OG00116
OG00246
OG00318
OG0044
OG0052
Title
Denominators
Categories
Title
Measurements
OG00085.0(20.0 to 218.0)
OG001105.0(63.0 to NA)The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
OG002235.0(129.0 to NA)The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
OG003168.0(51.0 to NA)The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
OG004118.0(52.0 to NA)The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
OG005NA(20.0 to NA)The median and the upper limit of the confidence interval were not estimable because too few participants had disease progression or died.
Participants received INCAGN01876 10.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
OG004
Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
OG005
Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
OG006
Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
OG010
Phase 1 Group D: INCAGN01876 + Nivolumab + Ipilimumab
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 3 mg/kg administered IV Q2W and ipilimumab 1 mg/kg administered IV Q6W.
Units
Counts
Participants
OG0004
OG0014
OG0025
OG0034
OG0045
OG0054
OG0064
OG0074
OG0088
OG0093
OG0106
Title
Denominators
Categories
Title
Measurements
OG000NA(76.0 to NA)The median and the upper limit of the confidence interval were not estimable because too few participants had disease progression or died.
OG001NA(55.0 to NA)The median and the upper limit of the confidence interval were not estimable because too few participants had disease progression or died.
OG002253.0(77.0 to NA)The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
OG003100.0(76.0 to NA)The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
OG004289.5(170.0 to NA)The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
OG005266.5(100.0 to NA)The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
OG006588.0(424.0 to NA)The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
OG007200.0(97.0 to NA)The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
OG008425.0(110.0 to NA)The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
OG009627.0(128.0 to NA)The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
OG010229.5(46.0 to NA)The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
OG003
Phase 2 Group F CC: INCAGN01876 300 mg + Nivolumab 240 mg
Participants with cervical cancer (CC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
OG004
Phase 2 Group F PD-1/PD-L1 RM: INCAGN01876 300 mg + Nivolumab 240 mg
Participants with PD-1/PD-L1 relapsed melanoma received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
OG005
Phase 2 Group F Biopsy: INCAGN01876 300 mg + Nivolumab 240 mg
Participants with gastric cancer, squamous cell carcinoma of the head and neck, cervical cancer, or PD-1/PD-L1 relapsed melanoma who had tumor lesions that were amenable to percutaneous biopsy received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
Units
Counts
Participants
OG0008
OG00116
OG00246
OG00318
OG0044
OG0052
Title
Denominators
Categories
Title
Measurements
OG000290.5(20.0 to NA)The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
OG001179.0(75.0 to 404.0)
OG002491.0(344.0 to NA)The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
OG003492.0(92.0 to 733.0)
OG004485.0(52.0 to NA)The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
OG005264.0(20.0 to NA)The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
Phase 2 Group F SCCHN INCAGN01876 300 mg + Nivolumab 240 mg
Participants with squamous cell carcinoma of the head and neck (SCCHN) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
OG003
Phase 2 Group F CC: INCAGN01876 300 mg + Nivolumab 240 mg
Participants with cervical cancer (CC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
OG004
Phase 2 Group F PD-1/PD-L1 RM: INCAGN01876 300 mg + Nivolumab 240 mg
Participants with PD-1/PD-L1 relapsed melanoma received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
OG005
Phase 2 Group F Biopsy: INCAGN01876 300 mg + Nivolumab 240 mg
Participants with gastric cancer, squamous cell carcinoma of the head and neck, cervical cancer, or PD-1/PD-L1 relapsed melanoma who had tumor lesions that were amenable to percutaneous biopsy received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.