A Study of Subcutaneous Nivolumab Monotherapy With or Wit... | NCT03656718 | Trialant
NCT03656718
Sponsor
Bristol-Myers Squibb
Status
Completed
Last Update Posted
Nov 12, 2025Actual
Enrollment
139Actual
Phase
Phase 1Phase 2
Conditions
Neoplasms by Site
Interventions
nivolumab
rHuPH20
nivolumab
Countries
United States
Argentina
Brazil
Chile
France
Italy
Mexico
Netherlands
New Zealand
Poland
Spain
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT03656718
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CA209-8KX
Secondary IDs
ID
Type
Description
Link
2018-001585-42
EudraCT Number
Brief Title
A Study of Subcutaneous Nivolumab Monotherapy With or Without Recombinant Human Hyaluronidase PH20 (rHuPH20)
Official Title
Phase I/II Pharmacokinetic Multi-Tumor Study of Subcutaneous Formulation of Nivolumab Monotherapy
Acronym
Not provided
Organization
Bristol-Myers SquibbINDUSTRY
Status Module
Record Verification Date
Oct 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Oct 29, 2018Actual
Primary Completion Date
Sep 7, 2022Actual
Completion Date
Sep 12, 2024Actual
First Submitted Date
Aug 28, 2018
First Submission Date that Met QC Criteria
Aug 31, 2018
First Posted Date
Sep 4, 2018Actual
Results Waived
Not provided
Results First Submitted Date
Jan 6, 2025
Results First Submitted that Met QC Criteria
Jan 29, 2025
Results First Posted Date
Feb 20, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Mar 15, 2023
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Feb 20, 2025Actual
Last Update Submitted Date
Oct 28, 2025
Last Update Posted Date
Nov 12, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Bristol-Myers SquibbINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to investigate the effects of nivolumab when given under the skin with or without rHuPH20.
This study will include participants with 1 of the following advanced or metastatic tumors approved for treatment with nivolumab monotherapy:
non-small cell lung cancer (NSCLC)
renal cell carcinoma (RCC)
unresectable or metastatic melanoma
hepatocellular carcinoma (HCC)
microsatellite instability-high or mismatch repair deficient colorectal cancer (MSI-H/dMMR CRC)
in Part B, other solid tumors may be considered at the discretion of the Clinical Trial Physician
In addition to the above tumors, Part E will also include participants with metastatic urothelial carcinoma (mUC).
Detailed Description
Not provided
Conditions Module
Conditions
Neoplasms by Site
Keywords
Subcutaneous
Nivolumab
rHuPH20
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
139Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part A, Group 1: nivolumab (dose 1) + rHuPH20
Experimental
Biological: nivolumab
Drug: rHuPH20
Part B, Group 3: nivolumab (dose 2) + rHuPH20
Experimental
Biological: nivolumab
Drug: rHuPH20
Part B, Group 2: nivolumab (dose 1)
Experimental
Biological: nivolumab
Part B, Group 4: nivolumab (dose 2)
Experimental
Biological: nivolumab
Part C: nivolumab (dose 3) + rHuPH20
Experimental
Biological: nivolumab
Drug: rHuPH20
Part D, Group 5: nivolumab (dose 3) + rHuPH20
Experimental
Biological: nivolumab
Drug: rHuPH20
Part E, Group 6: nivolumab (dose 4) coformulated with rHuPH20
Experimental
Interventions
Name
Type
Description
Arm Group Labels
Other Names
nivolumab
Biological
(Subcutaneous) Specified dose on specified days
Part A, Group 1: nivolumab (dose 1) + rHuPH20
Part B, Group 2: nivolumab (dose 1)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Maximum Observed Serum Nivolumab Concentration (Cmax) - Parts A, B, D, and E
Cmax is the maximum observed serum nivolumab concentration. Collected for Arm A, B, and D on Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 4, Cycle 1 Day 8, Cycle 1 Day 15, and Cycle 1 Day 21. Collected for Arm E on Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 4, Cycle 1 Day 8, Cycle 1 Day 15.
From first dose until approximately 21 days post first dose.
Time Taken to Reach Cmax (Tmax) - Parts A, B, D, and E
Tmax is the time taken to reach the maximum observed serum nivolumab concentration (Cmax). Collected for Arm A, B, and D on Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 4, Cycle 1 Day 8, Cycle 1 Day 15, and Cycle 1 Day 21. Collected for Arm E on Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 4, Cycle 1 Day 8, Cycle 1 Day 15.
From first dose until approximately 21 days post first dose.
Area Under the Time-Serum Nivolumab Concentration Curve (AUC (TAU)) - Parts A, B, D, and E
AUC (TAU) is the area measured under the concentration-time curve taken over the dosing interval. Collected for Arm A, B, and D on Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 4, Cycle 1 Day 8, Cycle 1 Day 15, and Cycle 1 Day 21. Collected for Arm E on Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 4, Cycle 1 Day 8, Cycle 1 Day 15.
From first dose until approximately 21 days post first dose.
Observed Serum Nivolumab Concentration at the End of Dosing (Ctau) - Parts A, B, D, and E
Ctau is the observed serum nivolumab concentration at the end of the dosing interval. Collected for Arma A, B, and D.
At the end of dosing interval of Cycle 1 - first dose (Day 21 for Parts A, B and D; Day 15 for Part E)
Lowest Observed Serum Nivolumab Concentration (Ctrough) During Part C - Part A and B Crossover Participants to Part C
Secondary Outcomes
Measure
Description
Time Frame
Number of Participants Experiencing Adverse Events (AEs)
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Histologic or cytologic confirmation of advanced (metastatic and/or unresectable) solid tumors of one of the following tumor types:
Metastatic squamous or non-squamous NSCLC
RCC, advanced or metastatic
Melanoma
HCC
CRC, metastatic (MSI-H or dMMR)
In Part B, other solid tumor types may be considered at the discretion of the Medical Monitor
In Part E, Metastatic urothelial carcinoma
Measurable disease as per RECIST version 1.1 criteria
ECOG performance status of 0 or 1
Exclusion Criteria:
Active brain metastases or leptomeningeal metastases
Ocular melanoma
Active, known, or suspected autoimmune disease
Other protocol defined inclusion/exclusion criteria apply
Lonardi S, Lugowska I, O'Donnell A, Jackson C, Latten-Jansen LM, North R, Bahleda R, Garrido M, Santoro A, Chacon MR, Li L, Joseph D, Vezina HE, Aras U, Bennett B, Perumal D, Gurm B, Ng WT, Harvey RD, Trigo J, Calvo A. Pharmacokinetics and safety of subcutaneous nivolumab: results from the phase I/II CheckMate 8KX study. J Immunother Cancer. 2025 Oct 5;13(10):e011918. doi: 10.1136/jitc-2025-011918.
28 participants from Part A and Part B crossed over after completing treatment in their originally assigned Arms to form Part C.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part A - Group 1: Nivolumab + rHuPH20 SC 720mg
Single dose of nivolumab (BMS-986298) 720 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
Periods
Title
Milestones
Reasons Not Completed
Pre-Treatment Period
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot_SAP
Yes
Yes
No
Study Protocol and Statistical Analysis Plan
Sep 8, 2021
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Biological: nivolumab
Drug: rHuPH20
Part B, Group 3: nivolumab (dose 2) + rHuPH20
Part B, Group 4: nivolumab (dose 2)
Part C: nivolumab (dose 3) + rHuPH20
Part D, Group 5: nivolumab (dose 3) + rHuPH20
Part E, Group 6: nivolumab (dose 4) coformulated with rHuPH20
Opdivo
BMS-986298
rHuPH20
Drug
Specified dose on specified days Permeation enhancer
Part A, Group 1: nivolumab (dose 1) + rHuPH20
Part B, Group 3: nivolumab (dose 2) + rHuPH20
Part C: nivolumab (dose 3) + rHuPH20
Part D, Group 5: nivolumab (dose 3) + rHuPH20
Part E, Group 6: nivolumab (dose 4) coformulated with rHuPH20
ENHANZEâ„¢ DP
nivolumab
Biological
(IV) Specified Dose on Specified Days
Part A, Group 1: nivolumab (dose 1) + rHuPH20
Part B, Group 2: nivolumab (dose 1)
Part B, Group 3: nivolumab (dose 2) + rHuPH20
Part B, Group 4: nivolumab (dose 2)
BMS-936558
Ctrough assessed during Part C. Ctrough is the lowest observed serum nivolumab concentration.
On Day 1 of Cycles 2, 3, 5, 9, 13, and 19 of Part C (Day 1 of Part C: up to 14 months from Baseline; each cycle was 28 days)
From first dose until 100 days post last dose (up to approximately 70 months).
Number of Participants Experiencing Treatment Related Adverse Events (TRAEs)
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. TRAEs are AEs where a reasonable causal relationship exists between study treatment administration and the AE.
From first dose until 100 days post last dose (up to approximately 70 months).
Number of Participants Experiencing Serious Adverse Events (SAEs)
A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose: (a) results in death, (b) is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), and/ or (c) requires inpatient hospitalization or causes prolongation of existing hospitalization.
From first dose until 100 days post last dose (up to approximately 70 months).
Number of Participants Experiencing Treatment Related Serious Adverse Events (TRSAEs)
A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose: (a) results in death, (b) is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), and/ or (c) requires inpatient hospitalization or causes prolongation of existing hospitalization. TRSAEs are SAEs where a reasonable causal relationship exists between study treatment administration and the SAE.
From first dose until 100 days post last dose (up to approximately 70 months).
Number of Participants Experiencing Treatment Related Adverse Events (TRAEs) Leading to Discontinuation
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. TRAEs are AEs where a reasonable causal relationship exists between study treatment administration and the AE.
From first dose until 100 days post last dose (up to approximately 70 months).
Number of Participants Who Died
Number of participants who died due to any cause.
From randomization until data cutoff (up to approximately 70 months).
Number of Participants With Select Laboratory Changes From Baseline
Laboratory parameters including hematology, chemistry, liver function, and renal function summarized using worst grade NCI CTCAE v.5 criteria. Baseline refers to evaluations with a date on or prior to the day of first dose of study treatment.
From first dose until 30 days post last dose (up to approximately 67 months and 20 days).
Number of Participants Experiencing Any Select Adverse Events Within the Hypersensitivity/Infusion Reaction Category and Broad Standardized MedDRA Query (SMQ) of Anaphylactic Reaction Occurring Within 2 Days of Study Drug Administration
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.
From first dose until 2 days post last dose (up to approximately 66 months and 22 days).
Number of Participants With Anti-Nivolumab Antibodies (ADAs) and Neutralizing Antibodies
Anti-drug antibody (ADA) Positive: A participant with at least one ADA-positive sample relative to baseline (ADA negative at baseline or ADA titer to be at least 4-fold or greater (>=) than baseline positive titer) at any time after initiation of treatment; Neutralizing Positive: At least one ADA-positive sample with neutralizing antibodies detected post-baseline.
Baseline ADA Positive: A participant with a baseline ADA-positive sample. Baseline refers to evaluations with a date on or prior to the day of first dose of study treatment.
At baseline and up to 100 days post last dose (up to approximately 70 months).
Single dose of nivolumab (BMS-986298) 720 mg administered subcutaneously (SC) without recombinant human hyaluronidase (rHuPH20) by syringe pump. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
FG002
Part B - Group 3: Nivolumab + rHuPH20 SC 960mg
Single dose of nivolumab (BMS-986298) 960 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
FG003
Part B - Group 4: Nivolumab SC 960mg
Single dose of nivolumab (BMS-986298) 960 mg administered subcutaneously (SC) without recombinant human hyaluronidase (rHuPH20) by syringe pump. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
FG004
Part C - Nivolumab SC + rHuPH20 1200 mg Q4W
Some participants in Part A and Part B crossed over to Part C, four weeks after their last nivolumab IV dose to receive nivolumab (BMS-986298) 1200 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe every 4 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
FG005
Part D: Nivolumab SC + rHuPH20 SC 1200mg Q4W
Nivolumab (BMS-986298) 1200 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe every 4 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
FG006
Part E: Nivolumab SC Co-Formulated With rHuPH20 600mg Q2W
Nivolumab (BMS-986298) 600 mg coformulated with recombinant human hyaluronidase (rHuPH20) administered subcutaneously (SC) manually by syringe every 2 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
FG00022 subjects
FG00118 subjects
FG00210 subjects
FG00317 subjects
FG0040 subjects
FG00536 subjects
FG00636 subjects
COMPLETED
FG00022 subjects
FG00118 subjects
FG00210 subjects
FG00317 subjects
FG0040 subjects
FG00536 subjects
FG00636 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Treatment Period Parts A, B, D, and E
Type
Comment
Milestone Data
STARTED
FG00022 subjects
FG00118 subjects
FG00210 subjects
FG00317 subjects
FG0040 subjects
FG00536 subjects
FG00636 subjects
COMPLETED
FG00010 subjects
FG0016 subjects
FG0025 subjects
FG0039 subjects
FG004
NOT COMPLETED
FG00012 subjects
FG00112 subjects
FG0025 subjects
FG0038 subjects
FG004
Type
Comment
Reasons
Disease progression
FG0008 subjects
FG00111 subjects
FG0024 subjects
FG003
Treatment Period Part C
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG00428 subjects9 Participants crossed over from Part A - Group 1, 6 participants crossed over from Part B -Group 2, 5 participants crossed over from Part B -Group 3, 8 participants crossed over from Part B -Group 4.
FG0050 subjects
FG0060 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
Disease progression
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Participants in Part C are presented under their original treatment assignment.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part A - Group 1: Nivolumab + rHuPH20 SC 720mg
Single dose of nivolumab (BMS-986298) 720 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
BG001
Part B - Group 2: Nivolumab SC 720mg
Single dose of nivolumab (BMS-986298) 720 mg administered subcutaneously (SC) without recombinant human hyaluronidase (rHuPH20) by syringe pump. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
BG002
Part B - Group 3: Nivolumab + rHuPH20 SC 960mg
Single dose of nivolumab (BMS-986298) 960 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
BG003
Part B - Group 4: Nivolumab SC 960mg
Single dose of nivolumab (BMS-986298) 960 mg administered subcutaneously (SC) without recombinant human hyaluronidase (rHuPH20) by syringe pump. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
BG004
Part D: Nivolumab SC + rHuPH20 SC 1200mg Q4W
Nivolumab (BMS-986298) 1200 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe every 4 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
BG005
Part E: Nivolumab SC Co-Formulated With rHuPH20 600mg Q2W
Nivolumab (BMS-986298) 600 mg coformulated with recombinant human hyaluronidase (rHuPH20) administered subcutaneously (SC) manually by syringe every 2 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00022
BG00118
BG00210
BG00317
BG00436
BG00536
BG006139
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00012
BG0015
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0001
BG0010
BG002
Race/Ethnicity, Customized
Race
Number
Participants
Title
Denominators
Categories
White
Title
Measurements
BG00018
BG00118
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
Maximum Observed Serum Nivolumab Concentration (Cmax) - Parts A, B, D, and E
Cmax is the maximum observed serum nivolumab concentration. Collected for Arm A, B, and D on Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 4, Cycle 1 Day 8, Cycle 1 Day 15, and Cycle 1 Day 21. Collected for Arm E on Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 4, Cycle 1 Day 8, Cycle 1 Day 15.
All treated participants with available Cycle 1 PK results in Parts A, B, D, and E. Pre-specified for data to be reported for Parts A, B, D, and E only.
Posted
Geometric Mean
Geometric Coefficient of Variation
ug/mL
From first dose until approximately 21 days post first dose.
ID
Title
Description
OG000
Part A - Group 1: Nivolumab + rHuPH20 SC 720mg
Single dose of nivolumab (BMS-986298) 720 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
OG001
Part B - Group 2: Nivolumab SC 720mg
Single dose of nivolumab (BMS-986298) 720 mg administered subcutaneously (SC) without recombinant human hyaluronidase (rHuPH20) by syringe pump. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
OG002
Part B - Group 3: Nivolumab + rHuPH20 SC 960mg
Single dose of nivolumab (BMS-986298) 960 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
OG003
Part B - Group 4: Nivolumab SC 960mg
Single dose of nivolumab (BMS-986298) 960 mg administered subcutaneously (SC) without recombinant human hyaluronidase (rHuPH20) by syringe pump. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
OG004
Part D: Nivolumab SC + rHuPH20 SC 1200mg Q4W
Nivolumab (BMS-986298) 1200 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe every 4 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
OG005
Part E: Nivolumab SC Co-Formulated With rHuPH20 600mg Q2W
Nivolumab (BMS-986298) 600 mg coformulated with recombinant human hyaluronidase (rHuPH20) administered subcutaneously (SC) manually by syringe every 2 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
Units
Counts
Participants
OG00022
OG00118
OG00210
OG003
Title
Denominators
Categories
Title
Measurements
OG00054.8± 51.0
OG00156.6± 34.0
OG00281.4± 41.0
OG003
Primary
Time Taken to Reach Cmax (Tmax) - Parts A, B, D, and E
Tmax is the time taken to reach the maximum observed serum nivolumab concentration (Cmax). Collected for Arm A, B, and D on Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 4, Cycle 1 Day 8, Cycle 1 Day 15, and Cycle 1 Day 21. Collected for Arm E on Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 4, Cycle 1 Day 8, Cycle 1 Day 15.
All treated participants with available cycle 1 PK results in Parts A, B, D, and E. Pre-specified for data to be reported for Parts A, B, D, and E only.
Posted
Median
Full Range
hours
From first dose until approximately 21 days post first dose.
ID
Title
Description
OG000
Part A - Group 1: Nivolumab + rHuPH20 SC 720mg
Single dose of nivolumab (BMS-986298) 720 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
OG001
Part B - Group 2: Nivolumab SC 720mg
Primary
Area Under the Time-Serum Nivolumab Concentration Curve (AUC (TAU)) - Parts A, B, D, and E
AUC (TAU) is the area measured under the concentration-time curve taken over the dosing interval. Collected for Arm A, B, and D on Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 4, Cycle 1 Day 8, Cycle 1 Day 15, and Cycle 1 Day 21. Collected for Arm E on Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 4, Cycle 1 Day 8, Cycle 1 Day 15.
All treated participants with available cycle 1 PK results in Parts A, B, D, and E. Pre-specified for data to be reported for Parts A, B, D, and E only.
Posted
Geometric Mean
Geometric Coefficient of Variation
h*ug/mL
From first dose until approximately 21 days post first dose.
ID
Title
Description
OG000
Part A - Group 1: Nivolumab + rHuPH20 SC 720mg
Single dose of nivolumab (BMS-986298) 720 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
OG001
Part B - Group 2: Nivolumab SC 720mg
Primary
Observed Serum Nivolumab Concentration at the End of Dosing (Ctau) - Parts A, B, D, and E
Ctau is the observed serum nivolumab concentration at the end of the dosing interval. Collected for Arma A, B, and D.
All treated participants with available cycle 1 PK results in Parts A, B, D, and E. Pre-specified for data to be collected only in Parts A, B, D, and E.
Posted
Geometric Mean
Geometric Coefficient of Variation
ug/mL
At the end of dosing interval of Cycle 1 - first dose (Day 21 for Parts A, B and D; Day 15 for Part E)
ID
Title
Description
OG000
Part A - Group 1: Nivolumab + rHuPH20 SC 720mg
Single dose of nivolumab (BMS-986298) 720 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
OG001
Part B - Group 2: Nivolumab SC 720mg
Single dose of nivolumab (BMS-986298) 720 mg administered subcutaneously (SC) without recombinant human hyaluronidase (rHuPH20) by syringe pump. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
Primary
Lowest Observed Serum Nivolumab Concentration (Ctrough) During Part C - Part A and B Crossover Participants to Part C
Ctrough assessed during Part C. Ctrough is the lowest observed serum nivolumab concentration.
All participants in Part C (who crossed over from Part A or B) with available PK results for each visit. Pre-specified for data to be reported for Part C crossover participants only. Participants are presented under their original treatment assignment.
Posted
Geometric Mean
Geometric Coefficient of Variation
ug/mL
On Day 1 of Cycles 2, 3, 5, 9, 13, and 19 of Part C (Day 1 of Part C: up to 14 months from Baseline; each cycle was 28 days)
ID
Title
Description
OG000
Part A - Group 1: Nivolumab + rHuPH20 SC 720mg
Single dose of nivolumab (BMS-986298) 720 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
OG001
Part B - Group 2: Nivolumab SC 720mg
Secondary
Number of Participants Experiencing Adverse Events (AEs)
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.
All treated participants who received nivolumab subcutaneously (SC) and/or nivolumab intravenously (IV).
Posted
Count of Participants
Participants
From first dose until 100 days post last dose (up to approximately 70 months).
ID
Title
Description
OG000
Part A - Group 1: Nivolumab + rHuPH20 SC 720mg
Single dose of nivolumab (BMS-986298) 720 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
OG001
Secondary
Number of Participants Experiencing Treatment Related Adverse Events (TRAEs)
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. TRAEs are AEs where a reasonable causal relationship exists between study treatment administration and the AE.
All treated participants who received nivolumab subcutaneously (SC) and/or nivolumab intravenously (IV).
Posted
Count of Participants
Participants
From first dose until 100 days post last dose (up to approximately 70 months).
ID
Title
Description
OG000
Part A - Group 1: Nivolumab + rHuPH20 SC 720mg
Single dose of nivolumab (BMS-986298) 720 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
Secondary
Number of Participants Experiencing Serious Adverse Events (SAEs)
A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose: (a) results in death, (b) is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), and/ or (c) requires inpatient hospitalization or causes prolongation of existing hospitalization.
All treated participants who received nivolumab subcutaneously (SC) and/or nivolumab intravenously (IV).
Posted
Count of Participants
Participants
From first dose until 100 days post last dose (up to approximately 70 months).
ID
Title
Description
OG000
Part A - Group 1: Nivolumab + rHuPH20 SC 720mg
Single dose of nivolumab (BMS-986298) 720 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
OG001
Part B - Group 2: Nivolumab SC 720mg
Secondary
Number of Participants Experiencing Treatment Related Serious Adverse Events (TRSAEs)
A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose: (a) results in death, (b) is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), and/ or (c) requires inpatient hospitalization or causes prolongation of existing hospitalization. TRSAEs are SAEs where a reasonable causal relationship exists between study treatment administration and the SAE.
All treated participants who received nivolumab subcutaneously (SC) and/or nivolumab intravenously (IV).
Posted
Count of Participants
Participants
From first dose until 100 days post last dose (up to approximately 70 months).
ID
Title
Description
OG000
Part A - Group 1: Nivolumab + rHuPH20 SC 720mg
Single dose of nivolumab (BMS-986298) 720 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
Secondary
Number of Participants Experiencing Treatment Related Adverse Events (TRAEs) Leading to Discontinuation
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. TRAEs are AEs where a reasonable causal relationship exists between study treatment administration and the AE.
All treated participants who received nivolumab subcutaneously (SC) and/or nivolumab intravenously (IV).
Posted
Count of Participants
Participants
From first dose until 100 days post last dose (up to approximately 70 months).
ID
Title
Description
OG000
Part A - Group 1: Nivolumab + rHuPH20 SC 720mg
Single dose of nivolumab (BMS-986298) 720 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
Secondary
Number of Participants Who Died
Number of participants who died due to any cause.
All treated participants.
Posted
Count of Participants
Participants
From randomization until data cutoff (up to approximately 70 months).
ID
Title
Description
OG000
Part A - Group 1: Nivolumab + rHuPH20 SC 720mg
Single dose of nivolumab (BMS-986298) 720 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
OG001
Part B - Group 2: Nivolumab SC 720mg
Single dose of nivolumab (BMS-986298) 720 mg administered subcutaneously (SC) without recombinant human hyaluronidase (rHuPH20) by syringe pump. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
Secondary
Number of Participants With Select Laboratory Changes From Baseline
Laboratory parameters including hematology, chemistry, liver function, and renal function summarized using worst grade NCI CTCAE v.5 criteria. Baseline refers to evaluations with a date on or prior to the day of first dose of study treatment.
All treated participants with baseline and at least one on treatment laboratory measurement.
Posted
Count of Participants
Participants
From first dose until 30 days post last dose (up to approximately 67 months and 20 days).
ID
Title
Description
OG000
Part A - Group 1: Nivolumab + rHuPH20 SC 720mg
Single dose of nivolumab (BMS-986298) 720 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
OG001
Part B - Group 2: Nivolumab SC 720mg
Single dose of nivolumab (BMS-986298) 720 mg administered subcutaneously (SC) without recombinant human hyaluronidase (rHuPH20) by syringe pump. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
Secondary
Number of Participants Experiencing Any Select Adverse Events Within the Hypersensitivity/Infusion Reaction Category and Broad Standardized MedDRA Query (SMQ) of Anaphylactic Reaction Occurring Within 2 Days of Study Drug Administration
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.
All treated participants who received nivolumab subcutaneously (SC) and/or nivolumab intravenously (IV).
Posted
Count of Participants
Participants
From first dose until 2 days post last dose (up to approximately 66 months and 22 days).
ID
Title
Description
OG000
Part A - Group 1: Nivolumab + rHuPH20 SC 720mg
Single dose of nivolumab (BMS-986298) 720 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
Secondary
Number of Participants With Anti-Nivolumab Antibodies (ADAs) and Neutralizing Antibodies
Anti-drug antibody (ADA) Positive: A participant with at least one ADA-positive sample relative to baseline (ADA negative at baseline or ADA titer to be at least 4-fold or greater (>=) than baseline positive titer) at any time after initiation of treatment; Neutralizing Positive: At least one ADA-positive sample with neutralizing antibodies detected post-baseline.
Baseline ADA Positive: A participant with a baseline ADA-positive sample. Baseline refers to evaluations with a date on or prior to the day of first dose of study treatment.
Immunogenicity Evaluable Participants: All treated participants in Parts A-E who have a baseline and at least 1 post-baseline immunogenicity assessment.
Posted
Count of Participants
Participants
At baseline and up to 100 days post last dose (up to approximately 70 months).
ID
Title
Description
OG000
Part A - Group 1: Nivolumab + rHuPH20 SC 720mg
Single dose of nivolumab (BMS-986298) 720 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
Time Frame
All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months).
Description
All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Part A - Group 1: Nivolumab + rHuPH20 SC 720mg
Single dose of nivolumab (BMS-986298) 720 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
18
22
12
22
22
22
EG001
PART A - GRP 1 CROSSOVER to PART C
Some participants in Part A crossed over to Part C, four weeks after their last nivolumab IV dose to receive nivolumab (BMS-986298) 1200 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe every 4 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occured first.
6
9
4
9
9
9
EG002
Part B - Group 2: Nivolumab SC 720mg
Single dose of nivolumab (BMS-986298) 720 mg administered subcutaneously (SC) without recombinant human hyaluronidase (rHuPH20) by syringe pump. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
14
18
10
18
18
18
EG003
PART B - GRP 2 CROSSOVER to PART C
Some participants in Part B - Group 2 crossed over to Part C, four weeks after their last nivolumab IV dose to receive nivolumab (BMS-986298) 1200 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe every 4 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occured first.
2
6
1
6
6
6
EG004
Part B - Group 3: Nivolumab + rHuPH20 SC 960mg
Single dose of nivolumab (BMS-986298) 960 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
8
10
4
10
10
10
EG005
PART B - GRP 3 CROSSOVER to PART C
Some participants in Part B - Group 3 crossed over to Part C, four weeks after their last nivolumab IV dose to receive nivolumab (BMS-986298) 1200 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe every 4 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occured first.
4
5
2
5
5
5
EG006
Part B - Group 4: Nivolumab SC 960mg
Single dose of nivolumab (BMS-986298) 960 mg administered subcutaneously (SC) without recombinant human hyaluronidase (rHuPH20) by syringe pump. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
14
17
11
17
17
17
EG007
PART B - GRP 4 CROSSOVER to PART C
Some participants in Part B - Group 4 crossed over to Part C, four weeks after their last nivolumab IV dose to receive nivolumab (BMS-986298) 1200 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe every 4 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occured first.
5
8
4
8
8
8
EG008
Part D: Nivolumab SC + rHuPH20 SC 1200mg Q4W
Nivolumab (BMS-986298) 1200 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe every 4 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
25
36
19
36
34
36
EG009
Part E: Nivolumab SC Co-Formulated With rHuPH20 600mg Q2W
Nivolumab (BMS-986298) 600 mg coformulated with recombinant human hyaluronidase (rHuPH20) administered subcutaneously (SC) manually by syringe every 2 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
30
36
25
36
35
36
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0021 affected18 at risk
EG0030 affected6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0090 affected36 at risk
Acute myocardial infarction
Cardiac disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Atrial flutter
Cardiac disorders
27.0
Systematic Assessment
EG0001 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Atrial thrombosis
Cardiac disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Coronary artery disease
Cardiac disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Myocardial infarction
Cardiac disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Myocarditis
Cardiac disorders
27.0
Systematic Assessment
EG0001 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Abdominal pain
Gastrointestinal disorders
27.0
Systematic Assessment
EG0001 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Ascites
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
27.0
Systematic Assessment
EG0001 affected22 at risk
EG0011 affected9 at risk
EG0020 affected18 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
27.0
Systematic Assessment
EG0001 affected22 at risk
EG0010 affected9 at risk
EG0021 affected18 at risk
EG003
Intestinal perforation
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Pancreatitis
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Subileus
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Vomiting
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Death
General disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0021 affected18 at risk
EG003
Fatigue
General disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
General physical health deterioration
General disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Pain
General disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Pyrexia
General disorders
27.0
Systematic Assessment
EG0001 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Cholangitis
Hepatobiliary disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0022 affected18 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0021 affected18 at risk
EG003
Hepatic failure
Hepatobiliary disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Hepatitis
Hepatobiliary disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Contrast media allergy
Immune system disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
COVID-19
Infections and infestations
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
COVID-19 pneumonia
Infections and infestations
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Empyema
Infections and infestations
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0021 affected18 at risk
EG003
Escherichia infection
Infections and infestations
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Infective exacerbation of chronic obstructive airways disease
Infections and infestations
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Lung abscess
Infections and infestations
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Pneumonia
Infections and infestations
27.0
Systematic Assessment
EG0001 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Pseudomonal sepsis
Infections and infestations
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Sepsis
Infections and infestations
27.0
Systematic Assessment
EG0001 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Urinary tract infection
Infections and infestations
27.0
Systematic Assessment
EG0001 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Cervical vertebral fracture
Injury, poisoning and procedural complications
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
27.0
Systematic Assessment
EG0001 affected22 at risk
EG0011 affected9 at risk
EG0020 affected18 at risk
EG003
Alanine aminotransferase increased
Investigations
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Aspartate aminotransferase increased
Investigations
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Blood bilirubin increased
Investigations
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Lipase increased
Investigations
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0001 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0001 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Pathological fracture
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0021 affected18 at risk
EG003
Infected metastasis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.0
Systematic Assessment
EG0001 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.0
Systematic Assessment
EG0005 affected22 at risk
EG0011 affected9 at risk
EG0025 affected18 at risk
EG003
Metastases to central nervous system
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Metastases to meninges
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0021 affected18 at risk
EG003
Tumour associated fever
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Tumour fistulisation
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Tumour obstruction
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Brain stem haemorrhage
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Cerebellar haemorrhage
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Epilepsy
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Hypoaesthesia
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Ischaemic cerebral infarction
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Neuralgia
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Paraesthesia
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Spinal cord compression
Nervous system disorders
27.0
Systematic Assessment
EG0001 affected22 at risk
EG0011 affected9 at risk
EG0020 affected18 at risk
EG003
Device dislocation
Product Issues
27.0
Systematic Assessment
EG0001 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Confusional state
Psychiatric disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Acute kidney injury
Renal and urinary disorders
27.0
Systematic Assessment
EG0001 affected22 at risk
EG0011 affected9 at risk
EG0020 affected18 at risk
EG003
Tubulointerstitial nephritis
Renal and urinary disorders
27.0
Systematic Assessment
EG0001 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0021 affected18 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0001 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0001 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0001 affected22 at risk
EG0010 affected9 at risk
EG0021 affected18 at risk
EG003
Pleuritic pain
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0001 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Pulmonary fibrosis
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Pemphigoid
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Hypotension
Vascular disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
27.0
Systematic Assessment
EG0005 affected22 at risk
EG0011 affected9 at risk
EG0026 affected18 at risk
EG0031 affected6 at risk
EG0043 affected10 at risk
EG0052 affected5 at risk
EG0062 affected17 at risk
EG0071 affected8 at risk
EG0083 affected36 at risk
EG0097 affected36 at risk
Lymphopenia
Blood and lymphatic system disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0021 affected18 at risk
EG003
Atrial fibrillation
Cardiac disorders
27.0
Systematic Assessment
EG0001 affected22 at risk
EG0010 affected9 at risk
EG0021 affected18 at risk
EG003
Palpitations
Cardiac disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0021 affected18 at risk
EG003
Tachycardia
Cardiac disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Ear discomfort
Ear and labyrinth disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0021 affected18 at risk
EG003
Adrenal insufficiency
Endocrine disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Hyperthyroidism
Endocrine disorders
27.0
Systematic Assessment
EG0003 affected22 at risk
EG0012 affected9 at risk
EG0020 affected18 at risk
EG003
Hypothyroidism
Endocrine disorders
27.0
Systematic Assessment
EG0002 affected22 at risk
EG0012 affected9 at risk
EG0022 affected18 at risk
EG003
Eye pruritus
Eye disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Lacrimation increased
Eye disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Abdominal pain
Gastrointestinal disorders
27.0
Systematic Assessment
EG0003 affected22 at risk
EG0011 affected9 at risk
EG0022 affected18 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
27.0
Systematic Assessment
EG0003 affected22 at risk
EG0011 affected9 at risk
EG0021 affected18 at risk
EG003
Autoimmune colitis
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0021 affected18 at risk
EG003
Chronic gastritis
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0021 affected18 at risk
EG003
Constipation
Gastrointestinal disorders
27.0
Systematic Assessment
EG0002 affected22 at risk
EG0012 affected9 at risk
EG0023 affected18 at risk
EG003
Diarrhoea
Gastrointestinal disorders
27.0
Systematic Assessment
EG0005 affected22 at risk
EG0012 affected9 at risk
EG0024 affected18 at risk
EG003
Dry mouth
Gastrointestinal disorders
27.0
Systematic Assessment
EG0001 affected22 at risk
EG0011 affected9 at risk
EG0023 affected18 at risk
EG003
Dyspepsia
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0021 affected18 at risk
EG003
Nausea
Gastrointestinal disorders
27.0
Systematic Assessment
EG0005 affected22 at risk
EG0011 affected9 at risk
EG0023 affected18 at risk
EG003
Oesophagitis
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Stomatitis
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Subileus
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Vomiting
Gastrointestinal disorders
27.0
Systematic Assessment
EG0004 affected22 at risk
EG0011 affected9 at risk
EG0022 affected18 at risk
EG003
Asthenia
General disorders
27.0
Systematic Assessment
EG0005 affected22 at risk
EG0012 affected9 at risk
EG0027 affected18 at risk
EG003
Chest pain
General disorders
27.0
Systematic Assessment
EG0001 affected22 at risk
EG0010 affected9 at risk
EG0021 affected18 at risk
EG003
Chills
General disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0021 affected18 at risk
EG003
Facial pain
General disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Fatigue
General disorders
27.0
Systematic Assessment
EG0005 affected22 at risk
EG0013 affected9 at risk
EG0023 affected18 at risk
EG003
Influenza like illness
General disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Injection site erythema
General disorders
27.0
Systematic Assessment
EG0004 affected22 at risk
EG0012 affected9 at risk
EG0021 affected18 at risk
EG003
Injection site pain
General disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Injection site pruritus
General disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0021 affected18 at risk
EG003
Injection site reaction
General disorders
27.0
Systematic Assessment
EG0001 affected22 at risk
EG0011 affected9 at risk
EG0020 affected18 at risk
EG003
Injection site swelling
General disorders
27.0
Systematic Assessment
EG0003 affected22 at risk
EG0011 affected9 at risk
EG0020 affected18 at risk
EG003
Mucosal inflammation
General disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0021 affected18 at risk
EG003
Nodule
General disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Non-cardiac chest pain
General disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Oedema peripheral
General disorders
27.0
Systematic Assessment
EG0007 affected22 at risk
EG0013 affected9 at risk
EG0022 affected18 at risk
EG003
Pain
General disorders
27.0
Systematic Assessment
EG0001 affected22 at risk
EG0011 affected9 at risk
EG0020 affected18 at risk
EG003
Pyrexia
General disorders
27.0
Systematic Assessment
EG0005 affected22 at risk
EG0012 affected9 at risk
EG0026 affected18 at risk
EG003
Secretion discharge
General disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Cholangitis
Hepatobiliary disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Cholestasis
Hepatobiliary disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0022 affected18 at risk
EG003
Hepatic cytolysis
Hepatobiliary disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
27.0
Systematic Assessment
EG0001 affected22 at risk
EG0010 affected9 at risk
EG0021 affected18 at risk
EG003
Hypertransaminasaemia
Hepatobiliary disorders
27.0
Systematic Assessment
EG0001 affected22 at risk
EG0010 affected9 at risk
EG0021 affected18 at risk
EG003
Hypersensitivity
Immune system disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0021 affected18 at risk
EG003
Bronchitis
Infections and infestations
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
COVID-19
Infections and infestations
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Candida infection
Infections and infestations
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Cellulitis
Infections and infestations
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Ear infection
Infections and infestations
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0021 affected18 at risk
EG003
Gastroenteritis
Infections and infestations
27.0
Systematic Assessment
EG0001 affected22 at risk
EG0011 affected9 at risk
EG0020 affected18 at risk
EG003
Herpes zoster
Infections and infestations
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Hordeolum
Infections and infestations
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Lower respiratory tract infection
Infections and infestations
27.0
Systematic Assessment
EG0002 affected22 at risk
EG0012 affected9 at risk
EG0020 affected18 at risk
EG003
Nasopharyngitis
Infections and infestations
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Norovirus infection
Infections and infestations
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Oral candidiasis
Infections and infestations
27.0
Systematic Assessment
EG0001 affected22 at risk
EG0010 affected9 at risk
EG0021 affected18 at risk
EG003
Pilonidal disease
Infections and infestations
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Pneumonia
Infections and infestations
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Rash pustular
Infections and infestations
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0021 affected18 at risk
EG003
Rhinitis
Infections and infestations
27.0
Systematic Assessment
EG0002 affected22 at risk
EG0012 affected9 at risk
EG0020 affected18 at risk
EG003
Skin infection
Infections and infestations
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0021 affected18 at risk
EG003
Upper respiratory tract infection
Infections and infestations
27.0
Systematic Assessment
EG0001 affected22 at risk
EG0011 affected9 at risk
EG0021 affected18 at risk
EG003
Urinary tract infection
Infections and infestations
27.0
Systematic Assessment
EG0002 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Vulvovaginal candidiasis
Infections and infestations
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Immunisation reaction
Injury, poisoning and procedural complications
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Injection related reaction
Injury, poisoning and procedural complications
27.0
Systematic Assessment
EG0001 affected22 at risk
EG0010 affected9 at risk
EG0021 affected18 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
27.0
Systematic Assessment
EG0001 affected22 at risk
EG0011 affected9 at risk
EG0020 affected18 at risk
EG003
Wrist fracture
Injury, poisoning and procedural complications
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Alanine aminotransferase increased
Investigations
27.0
Systematic Assessment
EG0001 affected22 at risk
EG0011 affected9 at risk
EG0021 affected18 at risk
EG003
Amylase increased
Investigations
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Aspartate aminotransferase increased
Investigations
27.0
Systematic Assessment
EG0001 affected22 at risk
EG0011 affected9 at risk
EG0022 affected18 at risk
EG003
Blood albumin decreased
Investigations
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0021 affected18 at risk
EG003
Blood alkaline phosphatase increased
Investigations
27.0
Systematic Assessment
EG0001 affected22 at risk
EG0010 affected9 at risk
EG0024 affected18 at risk
EG003
Blood bilirubin increased
Investigations
27.0
Systematic Assessment
EG0001 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Blood creatine phosphokinase increased
Investigations
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0021 affected18 at risk
EG003
Blood creatinine increased
Investigations
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
27.0
Systematic Assessment
EG0001 affected22 at risk
EG0010 affected9 at risk
EG0022 affected18 at risk
EG003
Hepatic enzyme increased
Investigations
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Lipase increased
Investigations
27.0
Systematic Assessment
EG0001 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Protein total decreased
Investigations
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0021 affected18 at risk
EG003
Weight decreased
Investigations
27.0
Systematic Assessment
EG0003 affected22 at risk
EG0010 affected9 at risk
EG0021 affected18 at risk
EG003
Weight increased
Investigations
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0021 affected18 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0001 affected22 at risk
EG0010 affected9 at risk
EG0022 affected18 at risk
EG003
Hyperamylasaemia
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0001 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0001 affected22 at risk
EG0010 affected9 at risk
EG0021 affected18 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0001 affected22 at risk
EG0011 affected9 at risk
EG0020 affected18 at risk
EG003
Hyperlipasaemia
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0001 affected22 at risk
EG0010 affected9 at risk
EG0021 affected18 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0021 affected18 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0021 affected18 at risk
EG003
Underweight
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0021 affected18 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0007 affected22 at risk
EG0014 affected9 at risk
EG0022 affected18 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0002 affected22 at risk
EG0012 affected9 at risk
EG0020 affected18 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0004 affected22 at risk
EG0011 affected9 at risk
EG0020 affected18 at risk
EG003
Gouty arthritis
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Ligament pain
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0001 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0001 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0001 affected22 at risk
EG0011 affected9 at risk
EG0020 affected18 at risk
EG003
Musculoskeletal discomfort
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0001 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0002 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0001 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Rib deformity
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Spinal pain
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0021 affected18 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.0
Systematic Assessment
EG0001 affected22 at risk
EG0011 affected9 at risk
EG0020 affected18 at risk
EG003
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.0
Systematic Assessment
EG0001 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0021 affected18 at risk
EG003
Dizziness
Nervous system disorders
27.0
Systematic Assessment
EG0002 affected22 at risk
EG0012 affected9 at risk
EG0020 affected18 at risk
EG003
Dizziness postural
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Dysgeusia
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Headache
Nervous system disorders
27.0
Systematic Assessment
EG0003 affected22 at risk
EG0012 affected9 at risk
EG0020 affected18 at risk
EG003
Monoparesis
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Neuralgia
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Neuropathy peripheral
Nervous system disorders
27.0
Systematic Assessment
EG0002 affected22 at risk
EG0012 affected9 at risk
EG0020 affected18 at risk
EG003
Paraesthesia
Nervous system disorders
27.0
Systematic Assessment
EG0001 affected22 at risk
EG0011 affected9 at risk
EG0020 affected18 at risk
EG003
Agitation
Psychiatric disorders
27.0
Systematic Assessment
EG0001 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Anxiety
Psychiatric disorders
27.0
Systematic Assessment
EG0001 affected22 at risk
EG0010 affected9 at risk
EG0021 affected18 at risk
EG003
Depressed mood
Psychiatric disorders
27.0
Systematic Assessment
EG0001 affected22 at risk
EG0011 affected9 at risk
EG0020 affected18 at risk
EG003
Insomnia
Psychiatric disorders
27.0
Systematic Assessment
EG0002 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Haematuria
Renal and urinary disorders
27.0
Systematic Assessment
EG0002 affected22 at risk
EG0011 affected9 at risk
EG0020 affected18 at risk
EG003
Micturition urgency
Renal and urinary disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Urinary incontinence
Renal and urinary disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Urinary retention
Renal and urinary disorders
27.0
Systematic Assessment
EG0002 affected22 at risk
EG0011 affected9 at risk
EG0020 affected18 at risk
EG003
Vulvovaginal pruritus
Reproductive system and breast disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Asthma late onset
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Bronchial obstruction
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0021 affected18 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0003 affected22 at risk
EG0012 affected9 at risk
EG0021 affected18 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0021 affected18 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0003 affected22 at risk
EG0010 affected9 at risk
EG0022 affected18 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0021 affected18 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0021 affected18 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0021 affected18 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0021 affected18 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0001 affected22 at risk
EG0011 affected9 at risk
EG0020 affected18 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0021 affected18 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0021 affected18 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Throat irritation
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0021 affected18 at risk
EG003
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0021 affected18 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0001 affected22 at risk
EG0011 affected9 at risk
EG0020 affected18 at risk
EG003
Lividity
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Nail dystrophy
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0021 affected18 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0003 affected22 at risk
EG0012 affected9 at risk
EG0022 affected18 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0001 affected22 at risk
EG0010 affected9 at risk
EG0022 affected18 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0003 affected22 at risk
EG0012 affected9 at risk
EG0020 affected18 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0001 affected22 at risk
EG0011 affected9 at risk
EG0020 affected18 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0021 affected18 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0020 affected18 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected9 at risk
EG0021 affected18 at risk
EG003
Hypertension
Vascular disorders
27.0
Systematic Assessment
EG0001 affected22 at risk
EG0011 affected9 at risk
EG0021 affected18 at risk
EG003
Granulomatous lymphadenitis
Blood and lymphatic system disorders
27.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Lymph node pain
Blood and lymphatic system disorders
27.0
Systematic Assessment
EG0001 affected22 at risk
EG0011 affected9 at risk
EG0020 affected18 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
27.0
Systematic Assessment
EG0001 affected22 at risk
EG0011 affected9 at risk
EG0020 affected18 at risk
EG003
Cardiac failure chronic
Cardiac disorders
27.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Diplopia
Eye disorders
27.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Dry eye
Eye disorders
27.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Periorbital swelling
Eye disorders
27.0
Systematic Assessment
EG0001 affected22 at risk
EG0011 affected9 at risk
EG0020 affected18 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
27.0
Systematic Assessment
EG0001 affected22 at risk
EG0011 affected9 at risk
EG0020 affected18 at risk
EG003
Gastritis
Gastrointestinal disorders
27.0
Systematic Assessment
EG0001 affected22 at risk
EG0011 affected9 at risk
EG0020 affected18 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
27.0
Systematic Assessment
EG0001 affected22 at risk
EG0011 affected9 at risk
EG0020 affected18 at risk
EG003
Gait disturbance
General disorders
27.0
Systematic Assessment
EG0001 affected22 at risk
EG0011 affected9 at risk
EG0020 affected18 at risk
EG003
Injection site irritation
General disorders
27.0
Systematic Assessment
EG0001 affected22 at risk
EG0011 affected9 at risk
EG0020 affected18 at risk
EG003
Diverticulitis
Infections and infestations
27.0
Systematic Assessment
EG0001 affected22 at risk
EG0011 affected9 at risk
EG0020 affected18 at risk
EG003
Folliculitis
Infections and infestations
27.0
Systematic Assessment
EG0001 affected22 at risk
EG0011 affected9 at risk
EG0020 affected18 at risk
EG003
Influenza
Infections and infestations
27.0
Systematic Assessment
EG0001 affected22 at risk
EG0011 affected9 at risk
EG0020 affected18 at risk
EG003
Tooth abscess
Infections and infestations
27.0
Systematic Assessment
EG0001 affected22 at risk
EG0011 affected9 at risk
EG0020 affected18 at risk
EG003
Pelvic fracture
Injury, poisoning and procedural complications
27.0
Systematic Assessment
EG0001 affected22 at risk
EG0011 affected9 at risk
EG0020 affected18 at risk
EG003
Blood folate decreased
Investigations
27.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Thyroxine free increased
Investigations
27.0
Systematic Assessment
EG0001 affected22 at risk
EG0011 affected9 at risk
EG0020 affected18 at risk
EG003
Fluid retention
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0001 affected22 at risk
EG0011 affected9 at risk
EG0020 affected18 at risk
EG003
Gout
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0001 affected22 at risk
EG0011 affected9 at risk
EG0020 affected18 at risk
EG003
Vitamin B12 deficiency
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0001 affected22 at risk
EG0011 affected9 at risk
EG0020 affected18 at risk
EG003
Coccydynia
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Hypercreatinaemia
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Osteopenia
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Psoriatic arthropathy
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Burning sensation
Nervous system disorders
27.0
Systematic Assessment
EG0001 affected22 at risk
EG0011 affected9 at risk
EG0020 affected18 at risk
EG003
Hyperaesthesia
Nervous system disorders
27.0
Systematic Assessment
EG0001 affected22 at risk
EG0011 affected9 at risk
EG0020 affected18 at risk
EG003
Hypoaesthesia
Nervous system disorders
27.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Motor dysfunction
Nervous system disorders
27.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Sciatica
Nervous system disorders
27.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Tremor
Nervous system disorders
27.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Device dislocation
Product Issues
27.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Confusional state
Psychiatric disorders
27.0
Systematic Assessment
EG0001 affected22 at risk
EG0011 affected9 at risk
EG0020 affected18 at risk
EG003
Delirium
Psychiatric disorders
27.0
Systematic Assessment
EG0001 affected22 at risk
EG0011 affected9 at risk
EG0020 affected18 at risk
EG003
Depression
Psychiatric disorders
27.0
Systematic Assessment
EG0001 affected22 at risk
EG0011 affected9 at risk
EG0020 affected18 at risk
EG003
Sleep disorder
Psychiatric disorders
27.0
Systematic Assessment
EG0001 affected22 at risk
EG0011 affected9 at risk
EG0020 affected18 at risk
EG003
Dysuria
Renal and urinary disorders
27.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
27.0
Systematic Assessment
EG0001 affected22 at risk
EG0011 affected9 at risk
EG0020 affected18 at risk
EG003
Bronchospasm
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Decubitus ulcer
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Skin disorder
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0001 affected22 at risk
EG0011 affected9 at risk
EG0020 affected18 at risk
EG003
Skin mass
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Haemorrhage
Vascular disorders
27.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Hypotension
Vascular disorders
27.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Vena cava thrombosis
Vascular disorders
27.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected9 at risk
EG0020 affected12 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Participant requested to discontinue study treatment
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0062 subjects
Other reasons
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0063 subjects
12 subjects
FG0050 subjects
FG0060 subjects
16 subjects
FG0050 subjects
FG0060 subjects
0 subjects
FG00412 subjects
FG0050 subjects
FG0060 subjects
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
Participant requested to discontinue study treatment
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
Other reasons
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
Maximum clinical benefit
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
0
BG0040
BG0050
BG0060
Between 18 and 65 years
BG0006
BG00112
BG0025
BG0036
BG00414
BG00519
BG00662
>=65 years
BG00016
BG0016
BG0025
BG00311
BG00422
BG00517
BG00677
6
BG0035
BG00410
BG0059
BG00647
Male
BG00010
BG00113
BG0024
BG00312
BG00426
BG00527
BG00692
0
BG0030
BG0044
BG0051
BG0066
Not Hispanic or Latino
BG0004
BG0015
BG0022
BG0037
BG00416
BG00522
BG00656
Unknown or Not Reported
BG00017
BG00113
BG0028
BG00310
BG00416
BG00513
BG00677
8
BG00317
BG00431
BG00534
BG006126
Black or African American
Title
Measurements
BG0002
BG0010
BG0020
BG0030
BG0041
BG0050
BG0063
Other
Title
Measurements
BG0002
BG0010
BG0022
BG0030
BG0043
BG0051
BG0068
Not Reported
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
Asian
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0041
BG0051
BG0062
17
OG00434
OG00536
63.9
± 30.0
OG004106.0± 46.0
OG00557.8± 31.0
Single dose of nivolumab (BMS-986298) 720 mg administered subcutaneously (SC) without recombinant human hyaluronidase (rHuPH20) by syringe pump. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
OG002
Part B - Group 3: Nivolumab + rHuPH20 SC 960mg
Single dose of nivolumab (BMS-986298) 960 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
OG003
Part B - Group 4: Nivolumab SC 960mg
Single dose of nivolumab (BMS-986298) 960 mg administered subcutaneously (SC) without recombinant human hyaluronidase (rHuPH20) by syringe pump. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
OG004
Part D: Nivolumab SC + rHuPH20 SC 1200mg Q4W
Nivolumab (BMS-986298) 1200 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe every 4 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
OG005
Part E: Nivolumab SC Co-Formulated With rHuPH20 600mg Q2W
Nivolumab (BMS-986298) 600 mg coformulated with recombinant human hyaluronidase (rHuPH20) administered subcutaneously (SC) manually by syringe every 2 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
Units
Counts
Participants
OG00022
OG00118
OG00210
OG00317
OG00434
OG00536
Title
Denominators
Categories
Title
Measurements
OG000167(47.0 to 357.0)
OG001167(50.1 to 339.0)
OG002141(47.2 to 333.0)
OG003168(139.0 to 355.0)
OG004130(44.5 to 317.0)
OG005130(45.2 to 337.0)
Single dose of nivolumab (BMS-986298) 720 mg administered subcutaneously (SC) without recombinant human hyaluronidase (rHuPH20) by syringe pump. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
OG002
Part B - Group 3: Nivolumab + rHuPH20 SC 960mg
Single dose of nivolumab (BMS-986298) 960 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
OG003
Part B - Group 4: Nivolumab SC 960mg
Single dose of nivolumab (BMS-986298) 960 mg administered subcutaneously (SC) without recombinant human hyaluronidase (rHuPH20) by syringe pump. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
OG004
Part D: Nivolumab SC + rHuPH20 SC 1200mg Q4W
Nivolumab (BMS-986298) 1200 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe every 4 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
OG005
Part E: Nivolumab SC Co-Formulated With rHuPH20 600mg Q2W
Nivolumab (BMS-986298) 600 mg coformulated with recombinant human hyaluronidase (rHuPH20) administered subcutaneously (SC) manually by syringe every 2 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
Units
Counts
Participants
OG00020
OG00116
OG00210
OG00313
OG00433
OG00535
Title
Denominators
Categories
Title
Measurements
OG00024908± 53
OG00127909± 36
OG00240264± 45
OG00332702± 31
OG00453561± 40
OG00515857± 30
OG002
Part B - Group 3: Nivolumab + rHuPH20 SC 960mg
Single dose of nivolumab (BMS-986298) 960 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
OG003
Part B - Group 4: Nivolumab SC 960mg
Single dose of nivolumab (BMS-986298) 960 mg administered subcutaneously (SC) without recombinant human hyaluronidase (rHuPH20) by syringe pump. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
OG004
Part D: Nivolumab SC + rHuPH20 SC 1200mg Q4W
Nivolumab (BMS-986298) 1200 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe every 4 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
OG005
Part E: Nivolumab SC Co-Formulated With rHuPH20 600mg Q2W
Nivolumab (BMS-986298) 600 mg coformulated with recombinant human hyaluronidase (rHuPH20) administered subcutaneously (SC) manually by syringe every 2 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
Units
Counts
Participants
OG00020
OG00116
OG00210
OG00313
OG00433
OG00535
Title
Denominators
Categories
Title
Measurements
OG00022.2± 86
OG00126.9± 65
OG00239.2± 67
OG00334.8± 41
OG00454.4± 49
OG00543.6± 36
Single dose of nivolumab (BMS-986298) 720 mg administered subcutaneously (SC) without recombinant human hyaluronidase (rHuPH20) by syringe pump. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
OG002
Part B - Group 3: Nivolumab + rHuPH20 SC 960mg
Single dose of nivolumab (BMS-986298) 960 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
OG003
Part B - Group 4: Nivolumab SC 960mg
Single dose of nivolumab (BMS-986298) 960 mg administered subcutaneously (SC) without recombinant human hyaluronidase (rHuPH20) by syringe pump. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
Units
Counts
Participants
OG0007
OG0016
OG0022
OG0038
Title
Denominators
Categories
Cycle 2 Day 1
ParticipantsOG0007
ParticipantsOG0016
ParticipantsOG0022
ParticipantsOG0038
Title
Measurements
OG000115± 58
OG001106± 42
OG002124± 38
OG003
Cycle 3 Day 1
ParticipantsOG0007
ParticipantsOG0015
ParticipantsOG0022
ParticipantsOG0033
Cycle 5 Day 1
ParticipantsOG0006
ParticipantsOG0014
ParticipantsOG0022
ParticipantsOG0032
Cycle 9 Day 1
ParticipantsOG0006
ParticipantsOG0012
ParticipantsOG0021
ParticipantsOG0032
Cycle 13 Day 1
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG0021
ParticipantsOG0032
Cycle 19 Day 1
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0031
Part B - Group 2: Nivolumab SC 720mg
Single dose of nivolumab (BMS-986298) 720 mg administered subcutaneously (SC) without recombinant human hyaluronidase (rHuPH20) by syringe pump. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
OG002
Part B - Group 3: Nivolumab + rHuPH20 SC 960mg
Single dose of nivolumab (BMS-986298) 960 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
OG003
Part B - Group 4: Nivolumab SC 960mg
Single dose of nivolumab (BMS-986298) 960 mg administered subcutaneously (SC) without recombinant human hyaluronidase (rHuPH20) by syringe pump. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
OG004
Part C - Nivolumab + rHuPH20 SC 1200mg Q4W (Crossover Participants From Parts A and B)
Participants in Part A and Part B crossed over from nivolumab (BMS-936558) IV dosing (four [4] weeks after last IV dose) to nivolumab (BMS-986298) 1200 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe every 4 weeks. Treatment continued until until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occured first.
OG005
Part D: Nivolumab SC + rHuPH20 SC 1200mg Q4W
Nivolumab (BMS-986298) 1200 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe every 4 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
OG006
Part E: Nivolumab SC Co-Formulated With rHuPH20 600mg Q2W
Nivolumab (BMS-986298) 600 mg coformulated with recombinant human hyaluronidase (rHuPH20) administered subcutaneously (SC) manually by syringe every 2 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
Units
Counts
Participants
OG00022
OG00118
OG00210
OG00317
OG00428
OG00536
OG00636
Title
Denominators
Categories
Title
Measurements
OG00022
OG00118
OG00210
OG00317
OG00427
OG00536
OG00636
OG001
Part B - Group 2: Nivolumab SC 720mg
Single dose of nivolumab (BMS-986298) 720 mg administered subcutaneously (SC) without recombinant human hyaluronidase (rHuPH20) by syringe pump. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
OG002
Part B - Group 3: Nivolumab + rHuPH20 SC 960mg
Single dose of nivolumab (BMS-986298) 960 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
OG003
Part B - Group 4: Nivolumab SC 960mg
Single dose of nivolumab (BMS-986298) 960 mg administered subcutaneously (SC) without recombinant human hyaluronidase (rHuPH20) by syringe pump. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
OG004
Part C - Nivolumab + rHuPH20 SC 1200mg Q4W (Crossover Participants From Parts A and B)
Participants in Part A and Part B crossed over from nivolumab (BMS-936558) IV dosing (four [4] weeks after last IV dose) to nivolumab (BMS-986298) 1200 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe every 4 weeks. Treatment continued until until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occured first.
OG005
Part D: Nivolumab SC + rHuPH20 SC 1200mg Q4W
Nivolumab (BMS-986298) 1200 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe every 4 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
OG006
Part E: Nivolumab SC Co-Formulated With rHuPH20 600mg Q2W
Nivolumab (BMS-986298) 600 mg coformulated with recombinant human hyaluronidase (rHuPH20) administered subcutaneously (SC) manually by syringe every 2 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
Units
Counts
Participants
OG00022
OG00118
OG00210
OG00317
OG00428
OG00536
OG00636
Title
Denominators
Categories
Title
Measurements
OG00014
OG00110
OG0028
OG00311
OG00416
OG00527
OG00628
Single dose of nivolumab (BMS-986298) 720 mg administered subcutaneously (SC) without recombinant human hyaluronidase (rHuPH20) by syringe pump. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
OG002
Part B - Group 3: Nivolumab + rHuPH20 SC 960mg
Single dose of nivolumab (BMS-986298) 960 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
OG003
Part B - Group 4: Nivolumab SC 960mg
Single dose of nivolumab (BMS-986298) 960 mg administered subcutaneously (SC) without recombinant human hyaluronidase (rHuPH20) by syringe pump. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
OG004
Part C - Nivolumab + rHuPH20 SC 1200mg Q4W (Crossover Participants From Parts A and B)
Participants in Part A and Part B crossed over from nivolumab (BMS-936558) IV dosing (four [4] weeks after last IV dose) to nivolumab (BMS-986298) 1200 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe every 4 weeks. Treatment continued until until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occured first.
OG005
Part D: Nivolumab SC + rHuPH20 SC 1200mg Q4W
Nivolumab (BMS-986298) 1200 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe every 4 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
OG006
Part E: Nivolumab SC Co-Formulated With rHuPH20 600mg Q2W
Nivolumab (BMS-986298) 600 mg coformulated with recombinant human hyaluronidase (rHuPH20) administered subcutaneously (SC) manually by syringe every 2 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
Units
Counts
Participants
OG00022
OG00118
OG00210
OG00317
OG00428
OG00536
OG00636
Title
Denominators
Categories
Title
Measurements
OG00012
OG00110
OG0024
OG00311
OG00411
OG00519
OG00625
OG001
Part B - Group 2: Nivolumab SC 720mg
Single dose of nivolumab (BMS-986298) 720 mg administered subcutaneously (SC) without recombinant human hyaluronidase (rHuPH20) by syringe pump. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
OG002
Part B - Group 3: Nivolumab + rHuPH20 SC 960mg
Single dose of nivolumab (BMS-986298) 960 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
OG003
Part B - Group 4: Nivolumab SC 960mg
Single dose of nivolumab (BMS-986298) 960 mg administered subcutaneously (SC) without recombinant human hyaluronidase (rHuPH20) by syringe pump. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
OG004
Part C - Nivolumab + rHuPH20 SC 1200mg Q4W (Crossover Participants From Parts A and B)
Participants in Part A and Part B crossed over from nivolumab (BMS-936558) IV dosing (four [4] weeks after last IV dose) to nivolumab (BMS-986298) 1200 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe every 4 weeks. Treatment continued until until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occured first.
OG005
Part D: Nivolumab SC + rHuPH20 SC 1200mg Q4W
Nivolumab (BMS-986298) 1200 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe every 4 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
OG006
Part E: Nivolumab SC Co-Formulated With rHuPH20 600mg Q2W
Nivolumab (BMS-986298) 600 mg coformulated with recombinant human hyaluronidase (rHuPH20) administered subcutaneously (SC) manually by syringe every 2 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
Units
Counts
Participants
OG00022
OG00118
OG00210
OG00317
OG00428
OG00536
OG00636
Title
Denominators
Categories
Title
Measurements
OG0001
OG0011
OG0020
OG0032
OG0040
OG0053
OG0061
OG001
Part B - Group 2: Nivolumab SC 720mg
Single dose of nivolumab (BMS-986298) 720 mg administered subcutaneously (SC) without recombinant human hyaluronidase (rHuPH20) by syringe pump. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
OG002
Part B - Group 3: Nivolumab + rHuPH20 SC 960mg
Single dose of nivolumab (BMS-986298) 960 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
OG003
Part B - Group 4: Nivolumab SC 960mg
Single dose of nivolumab (BMS-986298) 960 mg administered subcutaneously (SC) without recombinant human hyaluronidase (rHuPH20) by syringe pump. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
OG004
Part C - Nivolumab + rHuPH20 SC 1200mg Q4W (Crossover Participants From Parts A and B)
Participants in Part A and Part B crossed over from nivolumab (BMS-936558) IV dosing (four [4] weeks after last IV dose) to nivolumab (BMS-986298) 1200 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe every 4 weeks. Treatment continued until until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occured first.
OG005
Part D: Nivolumab SC + rHuPH20 SC 1200mg Q4W
Nivolumab (BMS-986298) 1200 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe every 4 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
OG006
Part E: Nivolumab SC Co-Formulated With rHuPH20 600mg Q2W
Nivolumab (BMS-986298) 600 mg coformulated with recombinant human hyaluronidase (rHuPH20) administered subcutaneously (SC) manually by syringe every 2 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
Units
Counts
Participants
OG00022
OG00118
OG00210
OG00317
OG00428
OG00536
OG00636
Title
Denominators
Categories
Title
Measurements
OG0002
OG0011
OG0021
OG0032
OG0040
OG0054
OG0062
OG002
Part B - Group 3: Nivolumab + rHuPH20 SC 960mg
Single dose of nivolumab (BMS-986298) 960 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
OG003
Part B - Group 4: Nivolumab SC 960mg
Single dose of nivolumab (BMS-986298) 960 mg administered subcutaneously (SC) without recombinant human hyaluronidase (rHuPH20) by syringe pump. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
OG004
Part C - Nivolumab + rHuPH20 SC 1200mg Q4W (Crossover Participants From Parts A and B)
Participants in Part A and Part B crossed over from nivolumab (BMS-936558) IV dosing (four [4] weeks after last IV dose) to nivolumab (BMS-986298) 1200 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe every 4 weeks. Treatment continued until until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occured first.
OG005
Part D: Nivolumab SC + rHuPH20 SC 1200mg Q4W
Nivolumab (BMS-986298) 1200 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe every 4 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
OG006
Part E: Nivolumab SC Co-Formulated With rHuPH20 600mg Q2W
Nivolumab (BMS-986298) 600 mg coformulated with recombinant human hyaluronidase (rHuPH20) administered subcutaneously (SC) manually by syringe every 2 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
Units
Counts
Participants
OG00022
OG00118
OG00210
OG00317
OG00428
OG00536
OG00636
Title
Denominators
Categories
Title
Measurements
OG00018
OG00114
OG0028
OG00314
OG00417
OG00525
OG00630
OG002
Part B - Group 3: Nivolumab + rHuPH20 SC 960mg
Single dose of nivolumab (BMS-986298) 960 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
OG003
Part B - Group 4: Nivolumab SC 960mg
Single dose of nivolumab (BMS-986298) 960 mg administered subcutaneously (SC) without recombinant human hyaluronidase (rHuPH20) by syringe pump. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
OG004
Part C - Nivolumab + rHuPH20 SC 1200mg Q4W (Crossover Participants From Parts A and B)
Participants in Part A and Part B crossed over from nivolumab (BMS-936558) IV dosing (four [4] weeks after last IV dose) to nivolumab (BMS-986298) 1200 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe every 4 weeks. Treatment continued until until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occured first.
OG005
Part D: Nivolumab SC + rHuPH20 SC 1200mg Q4W
Nivolumab (BMS-986298) 1200 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe every 4 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
OG006
Part E: Nivolumab SC Co-Formulated With rHuPH20 600mg Q2W
Nivolumab (BMS-986298) 600 mg coformulated with recombinant human hyaluronidase (rHuPH20) administered subcutaneously (SC) manually by syringe every 2 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
Units
Counts
Participants
OG00021
OG00116
OG00210
OG00316
OG00428
OG00536
OG00636
Title
Denominators
Categories
HEMOGLOBIN (g/L)
ParticipantsOG00021
ParticipantsOG00116
ParticipantsOG00210
ParticipantsOG00316
ParticipantsOG00428
ParticipantsOG00536
ParticipantsOG00636
Title
Measurements
OG00013
OG0017
OG0023
OG003
PLATELET COUNT (10^9/L)
ParticipantsOG00021
ParticipantsOG00116
ParticipantsOG00210
ParticipantsOG00316
LEUKOCYTES, LOCAL LAB (10^9/L)
ParticipantsOG00021
ParticipantsOG00116
ParticipantsOG00210
ParticipantsOG00316
ABSOLUTE NEUTROPHIL COUNT DRV. (10^9/L)
ParticipantsOG00021
ParticipantsOG00116
ParticipantsOG00210
ParticipantsOG00316
LYMPHOCYTES (ABSOLUTE) (10^9/L)
ParticipantsOG0000
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0034
LYMPHOCYTES (ABSOLUTE), LOCAL LAB (10^9/L)
ParticipantsOG00021
ParticipantsOG00113
ParticipantsOG00210
ParticipantsOG00311
CREATININE, LOCAL LAB (umol/L)
ParticipantsOG00021
ParticipantsOG00116
ParticipantsOG00210
ParticipantsOG00316
ALKALINE PHOSPHATASE (ALP) LOCAL LAB (U/L)
ParticipantsOG00020
ParticipantsOG00116
ParticipantsOG00210
ParticipantsOG00316
ALANINE AMINOTRANSFERASE (ALT), LOCAL LAB (U/L)
ParticipantsOG00021
ParticipantsOG00116
ParticipantsOG00210
ParticipantsOG003
ASPARTATE AMINOTRANSFERASE (AST), LOCAL LAB (U/L)
ParticipantsOG00021
ParticipantsOG00116
ParticipantsOG00210
ParticipantsOG003
BILIRUBIN, TOTAL, LOCAL LAB (umol/L)
ParticipantsOG00021
ParticipantsOG00116
ParticipantsOG00210
ParticipantsOG00316
HYPERCALCEMIA (mmol/L)
ParticipantsOG00020
ParticipantsOG00116
ParticipantsOG00210
ParticipantsOG00315
HYPERKALEMIA (mmol/L)
ParticipantsOG00021
ParticipantsOG00116
ParticipantsOG00210
ParticipantsOG00315
HYPERMAGNESEMIA (mmol/L)
ParticipantsOG00020
ParticipantsOG00116
ParticipantsOG00210
ParticipantsOG00315
HYPERNATREMIA (mmol/L)
ParticipantsOG00021
ParticipantsOG00116
ParticipantsOG00210
ParticipantsOG00315
HYPOCALCEMIA (mmol/L)
ParticipantsOG00020
ParticipantsOG00116
ParticipantsOG00210
ParticipantsOG00315
HYPOKALEMIA (mmol/L)
ParticipantsOG00021
ParticipantsOG00116
ParticipantsOG00210
ParticipantsOG00315
HYPOMAGNESEMIA (mmol/L)
ParticipantsOG00020
ParticipantsOG00116
ParticipantsOG00210
ParticipantsOG00315
HYPONATREMIA (mmol/L)
ParticipantsOG00021
ParticipantsOG00116
ParticipantsOG00210
ParticipantsOG00315
HYPOGLYCEMIA (mmol/L)
ParticipantsOG00020
ParticipantsOG00116
ParticipantsOG00210
ParticipantsOG00316
ALBUMIN, LOCAL LAB (g/L)
ParticipantsOG00020
ParticipantsOG00116
ParticipantsOG00210
ParticipantsOG00316
ACTIVATED PARTIAL THROMBOPLASTIN TIME (sec)
ParticipantsOG0003
ParticipantsOG0018
ParticipantsOG0020
ParticipantsOG0038
FIBRINOGEN (g/L)
ParticipantsOG0002
ParticipantsOG0019
ParticipantsOG0020
ParticipantsOG0038
OG001
Part B - Group 2: Nivolumab SC 720mg
Single dose of nivolumab (BMS-986298) 720 mg administered subcutaneously (SC) without recombinant human hyaluronidase (rHuPH20) by syringe pump. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
OG002
Part B - Group 3: Nivolumab + rHuPH20 SC 960mg
Single dose of nivolumab (BMS-986298) 960 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
OG003
Part B - Group 4: Nivolumab SC 960mg
Single dose of nivolumab (BMS-986298) 960 mg administered subcutaneously (SC) without recombinant human hyaluronidase (rHuPH20) by syringe pump. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
OG004
Part C - Nivolumab + rHuPH20 SC 1200mg Q4W (Crossover Participants From Parts A and B)
Participants in Part A and Part B crossed over from nivolumab (BMS-936558) IV dosing (four [4] weeks after last IV dose) to nivolumab (BMS-986298) 1200 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe every 4 weeks. Treatment continued until until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occured first.
OG005
Part D: Nivolumab SC + rHuPH20 SC 1200mg Q4W
Nivolumab (BMS-986298) 1200 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe every 4 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
OG006
Part E: Nivolumab SC Co-Formulated With rHuPH20 600mg Q2W
Nivolumab (BMS-986298) 600 mg coformulated with recombinant human hyaluronidase (rHuPH20) administered subcutaneously (SC) manually by syringe every 2 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
Single dose of nivolumab (BMS-986298) 720 mg administered subcutaneously (SC) without recombinant human hyaluronidase (rHuPH20) by syringe pump. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
OG002
Part B - Group 3: Nivolumab + rHuPH20 SC 960mg
Single dose of nivolumab (BMS-986298) 960 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
OG003
Part B - Group 4: Nivolumab SC 960mg
Single dose of nivolumab (BMS-986298) 960 mg administered subcutaneously (SC) without recombinant human hyaluronidase (rHuPH20) by syringe pump. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
OG004
Part C - Nivolumab + rHuPH20 SC 1200mg Q4W (Crossover Participants From Parts A and B)
Participants in Part A and Part B crossed over from nivolumab (BMS-936558) IV dosing (four [4] weeks after last IV dose) to nivolumab (BMS-986298) 1200 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe every 4 weeks. Treatment continued until until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occured first.
OG005
Part D: Nivolumab SC + rHuPH20 SC 1200mg Q4W
Nivolumab (BMS-986298) 1200 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe every 4 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
OG006
Part E: Nivolumab SC Co-Formulated With rHuPH20 600mg Q2W
Nivolumab (BMS-986298) 600 mg coformulated with recombinant human hyaluronidase (rHuPH20) administered subcutaneously (SC) manually by syringe every 2 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
Units
Counts
Participants
OG00021
OG00118
OG00210
OG00317
OG00428
OG00536
OG00635
Title
Denominators
Categories
ANTI-DRUG ANTIBODY (ADA) POSITIVE
Title
Measurements
OG0007
OG0015
OG0023
OG0030
OG0047
OG0055
OG00610
NEUTRALIZING POSITIVE
Title
Measurements
OG0000
OG0010
OG0020
OG003
BASELINE ANTI-DRUG ANTIBODY (ADA) POSITIVE
Title
Measurements
OG0002
OG0010
OG0022
OG003
0 affected
6 at risk
EG0041 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0092 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0081 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0091 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0091 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0081 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0091 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0091 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0081 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0061 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0061 affected17 at risk
EG0071 affected8 at risk
EG0080 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0041 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0081 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0091 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0092 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0091 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0061 affected17 at risk
EG0070 affected8 at risk
EG0081 affected36 at risk
EG0091 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0091 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0092 affected36 at risk
1 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0061 affected17 at risk
EG0071 affected8 at risk
EG0080 affected36 at risk
EG0090 affected36 at risk
1 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0081 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
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6 at risk
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EG0050 affected5 at risk
EG0061 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0090 affected36 at risk
1 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0061 affected17 at risk
EG0070 affected8 at risk
EG0082 affected36 at risk
EG0092 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0061 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0083 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0081 affected36 at risk
EG0092 affected36 at risk
1 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0081 affected36 at risk
EG0091 affected36 at risk
0 affected
6 at risk
EG0041 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0083 affected36 at risk
EG0093 affected36 at risk
0 affected
6 at risk
EG0041 affected10 at risk
EG0051 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0041 affected10 at risk
EG0050 affected5 at risk
EG0061 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0092 affected36 at risk
1 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0061 affected17 at risk
EG0070 affected8 at risk
EG0081 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0041 affected10 at risk
EG0051 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0091 affected36 at risk
1 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0081 affected36 at risk
EG0091 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0090 affected36 at risk
2 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0065 affected17 at risk
EG0072 affected8 at risk
EG0085 affected36 at risk
EG00910 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0041 affected10 at risk
EG0051 affected5 at risk
EG0063 affected17 at risk
EG0073 affected8 at risk
EG0085 affected36 at risk
EG0095 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0061 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0061 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0041 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0093 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0061 affected17 at risk
EG0070 affected8 at risk
EG0081 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0041 affected10 at risk
EG0051 affected5 at risk
EG0062 affected17 at risk
EG0071 affected8 at risk
EG0081 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0082 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0061 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0092 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0063 affected17 at risk
EG0072 affected8 at risk
EG0081 affected36 at risk
EG0092 affected36 at risk
0 affected
6 at risk
EG0041 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0091 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0061 affected17 at risk
EG0071 affected8 at risk
EG0082 affected36 at risk
EG0091 affected36 at risk
0 affected
6 at risk
EG0041 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0061 affected17 at risk
EG0071 affected8 at risk
EG0080 affected36 at risk
EG0090 affected36 at risk
1 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0041 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0091 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0081 affected36 at risk
EG0092 affected36 at risk
1 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0082 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0041 affected10 at risk
EG0051 affected5 at risk
EG0062 affected17 at risk
EG0071 affected8 at risk
EG0082 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0041 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0041 affected10 at risk
EG0051 affected5 at risk
EG0061 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0091 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0064 affected17 at risk
EG0072 affected8 at risk
EG0082 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0061 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0091 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0061 affected17 at risk
EG0070 affected8 at risk
EG0082 affected36 at risk
EG0091 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0061 affected17 at risk
EG0071 affected8 at risk
EG0080 affected36 at risk
EG0091 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0061 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0091 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0092 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0081 affected36 at risk
EG0091 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0081 affected36 at risk
EG0091 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0061 affected17 at risk
EG0071 affected8 at risk
EG0080 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0061 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0041 affected10 at risk
EG0051 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0041 affected10 at risk
EG0051 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0041 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0061 affected17 at risk
EG0071 affected8 at risk
EG0081 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0064 affected17 at risk
EG0073 affected8 at risk
EG0083 affected36 at risk
EG0094 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0091 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0064 affected17 at risk
EG0072 affected8 at risk
EG0081 affected36 at risk
EG0091 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0090 affected36 at risk
1 affected
6 at risk
EG0041 affected10 at risk
EG0051 affected5 at risk
EG0061 affected17 at risk
EG0070 affected8 at risk
EG0083 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0061 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0090 affected36 at risk
1 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0081 affected36 at risk
EG0091 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0062 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0081 affected36 at risk
EG0091 affected36 at risk
1 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0061 affected17 at risk
EG0071 affected8 at risk
EG0081 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0082 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0092 affected36 at risk
1 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0061 affected17 at risk
EG0071 affected8 at risk
EG0080 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0041 affected10 at risk
EG0051 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0081 affected36 at risk
EG0092 affected36 at risk
1 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0061 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0091 affected36 at risk
0 affected
6 at risk
EG0041 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0081 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0041 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0061 affected17 at risk
EG0071 affected8 at risk
EG0080 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0041 affected10 at risk
EG0051 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0091 affected36 at risk
1 affected
6 at risk
EG0041 affected10 at risk
EG0050 affected5 at risk
EG0061 affected17 at risk
EG0071 affected8 at risk
EG0088 affected36 at risk
EG0099 affected36 at risk
1 affected
6 at risk
EG0041 affected10 at risk
EG0050 affected5 at risk
EG0062 affected17 at risk
EG0072 affected8 at risk
EG0084 affected36 at risk
EG0094 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0082 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0041 affected10 at risk
EG0051 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0091 affected36 at risk
1 affected
6 at risk
EG0041 affected10 at risk
EG0051 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0081 affected36 at risk
EG0092 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0092 affected36 at risk
1 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0090 affected36 at risk
1 affected
6 at risk
EG0041 affected10 at risk
EG0050 affected5 at risk
EG0061 affected17 at risk
EG0071 affected8 at risk
EG0081 affected36 at risk
EG0091 affected36 at risk
0 affected
6 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0060 affected9 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0060 affected9 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0060 affected9 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0060 affected9 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0060 affected9 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0060 affected9 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0091 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0081 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0060 affected9 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0060 affected9 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0060 affected9 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0060 affected9 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0060 affected9 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0091 affected36 at risk
0 affected
6 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0060 affected9 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0060 affected9 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0060 affected9 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0060 affected9 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0091 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0081 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0091 affected36 at risk
0 affected
6 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0060 affected9 at risk
EG0070 affected8 at risk
EG0081 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0060 affected9 at risk
EG0070 affected8 at risk
EG0081 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0060 affected9 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0060 affected9 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0091 affected36 at risk
0 affected
6 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0060 affected9 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0091 affected36 at risk
0 affected
6 at risk
EG0040 affected10 at risk
EG0050 affected5 at risk
EG0060 affected17 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0060 affected9 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0060 affected9 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0060 affected9 at risk
EG0070 affected8 at risk
EG0080 affected36 at risk
EG0090 affected36 at risk
0 affected
6 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0060 affected9 at risk
EG0070 affected8 at risk
EG0081 affected36 at risk
EG0090 affected36 at risk
85.7
± 48
Title
Measurements
OG000119± 51
OG001118± 34
OG002149± 42
OG003104± 44
Title
Measurements
OG000149± 55
OG001144± 66
OG002192± 16
OG003171± 8
Title
Measurements
OG000170± 55
OG001138± 81
OG002228± NAInsufficient number of participants to calculate Geometric Coefficient of Variation.
OG003208± 38
Title
Measurements
OG000183± 34
OG001113± 48
OG002246± NAInsufficient number of participants to calculate Geometric Coefficient of Variation.
OG003217± 16
Title
Measurements
OG00174.7± NAInsufficient number of participants to calculate Geometric Coefficient of Variation.
OG003212± NAInsufficient number of participants to calculate Geometric Coefficient of Variation.